October 2013 by McMahon Group

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AnesthesiologyNews.com • O c t o b e r 2 0 1 3 • Volume 39 Number 10

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Fluid Protocol Promises New ERAS In Surgery San Diego—Programs that promote enhanced recovery after surgery are beneficial for both patients and institutions, according to a recent study that supports the use of the increasingly common treatment plans. Popularized in Europe, so-called ERAS programs are becoming more widespread in the United States, although the data for their overall efficacy here are still lacking. The latest study should help. North Carolina researchers found that surgical patients undergoing see ERAS page 36

ASA Blasts Proposed Change To VA Nursing Guidelines

he American Society of Anesthesiologists is calling “ill-conceived” a draft document from the Veterans Health Administration that, it claims, would require nurse anesthetists to practice without physician supervision and in the process jeopardize patient safety. The ASA says the new rules abandon “team-based anesthesia care” led by physicians and undermine the quality of care in VA hospitals in the service of further expanding the scope of practice of advanced practice nurses (APRNs) and other so-called physician extenders. But see VA change page 26

Doctor Onboard

lexander Popov, MD, has the heaviest clinic on the planet. Dr. Popov is chief medical officer on the Oasis of the Seas, a Royal Caribbean liner that, at about 225,000 tons, is the largest cruise ship on the ocean— roughly 4.5 times heftier than the Titanic. Dr. Popov, v an anesthesiologist, along with two other physicians and five nurses, is responsible for the medical care of the 6,300 guests and 2,200 crewmembers on board every time the Oasis of the Seas leaves port.

Dr. Popov was trained in Bulgaria andd worked in South Africa. While there, he read an adveertisement in a Souuth African journall for ships’ doc-tors and appliedd. a special Requirements for interest in ortho-the position included cluded pedics and regional anesthesia— three years of experience in inter- he was hired. He also speaks four nal medicine and/or training in languages fluently—Russian, Bulcritical care. Because Dr. Popov garian, German and English— had surgical training, a fellowship helpful on a cruise ship with many in pulmonology and board quali- international travelers. fications in anesthesiology—with see sea page 16

COMMENTARY

NPO: Never Prudently Ordered (or Nonliterate Palaveric Officialese).

TECHNOLOGY

Reclaiming PGY-1 ‘Lost Year’.

CLINICAL ANESTHESIOLOGY

Rethinking anesthesia care for ankle surgery.

CME: PREANESTHETIC ASSESSMENT

Lesson 306: Management of the Patient At Risk for an Operating Room Fire: Part 1

24 Perioperative Patient Monitoring: Utilizing BIS In Total Intravenous Anesthesia Procedures (Part 3 of a 3-Part Series)

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Make An Educated Decision Information You Need To Be Informed and Stay Competitive Anesthesia Business Consultants (ABC) believes the more you know, the better the decisions you can make. ABC places the highest value on continuing education. As the health care world continues to evolve, offering new technological advances and business models, along with changing laws and regulations, it’s imperative to keep informed. We provide our clients and associates regular updates on what is happening in the world of anesthesiology through our weekly eAlerts. These Alerts highlight the very latest in developments, changing requirements and opportunities and are a complimentary service. If you are interested in receiving these Alerts just send your name, e-mail address, the name of your practice or company, city and state to info@anesthesiallc.com. ABC is also pleased to offer the Communiqué, our quarterly newsletter, to interested individuals. It is available electronically as well as in print. The Communiqué features articles written by industry leaders focusing on the latest hot topics in group management, compliance and future business models for anesthesiologists, nurse anesthetists, pain management specialists and anesthesia practice administrators. We look forward to providing you with many more years of practice management news through the Communiqué and our weekly Alerts. Please log on to ABC’s web site at www.anesthesiallc.com and click on the “Publications” link to view the electronic version of the Communiqué online or to see copies of our previous Alerts.

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Heard Here First: He was laid off. How long would it take to find a job? What about the kids and their education?

October 2013

The five most-viewed articles last month on AnesthesiologyNews.com

What would his wife say?

1. Four Strategies To Help Anesthesiologists Boost Their Income (Blog post) 2. Anesthesiologists Have a Big PR Problem (Blog post) 3. Calif. Ruling on CRNA Practice Promises Nationwide Tremors

That he should never have

4. ICD-10 Changeover Poses Risks and Rewards For Anesthesiologists

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5. When Settled Isn’t Settled: An Anesthesiologist’s Guide To Medical History

in the first place?

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1. Punjasawadwong Y, Boonjeungmonkol N, Phongchiewboon A. Bispectral index for improving anaesthetic delivery and postoperative recovery. Cochrane Database of Systematic Reviews. 2007;17(4):CD003843. 2. Murkin JM, Adams SJ, Novick RJ, et al. Monitoring brain oxygen saturation during coronary bypass surgery: a randomized, prospective study. Anesth Analg. 2007;104(1):51-58. 3. Casati A, Fanelli G, Pietropaoli P, et al. Continuous monitoring of cerebral oxygen saturation in elderly patients undergoing major abdominal surgery minimizes brain exposure to potential hypoxia. Anesth Analg. 2005;101(3):740-747. 4. FDA 510(k) K082327. 5. American Society of ExtraCorporeal Technology Standards and Guidelines for Perfusion Practice, July 2013. COVIDIEN, COVIDIEN with logo, Covidien logo and positive results for life are U.S. and internationally registered trademarks of Covidien AG. Other brands are trademarks of a Covidien company. ©2013 Covidien. 13-PM-0271

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NPO: Never Precisely Originated, Not Prudently Ordered

he American Society of Anesthesiologists updated its preoperative NPO guidelines in 2011, advising that patients “fast from intake of a light meal … six hours or more before elective procedures” and “fast from intake of clear liquids at least two hours before elective procedures” ((Anesthesiology, March 2011). These recommendations, and others

in the guideline, have caused ongoing controversy as institutions revise their NPO policies, and individuals protest them. See for instance, “Saying No to NPO” (Anesthesiology News, March 2013) and “NPO before surgery is nonsense” (allnurses.com). ASA guidelines are systematically developed and based on recent literature and expert opinions, but some

physicians complain the NPO guidelines, in particular, are variable and inconsistent with their practices. One anesthesiologist pled, “I have been in the practice of anesthesia for over 30 years and have rewritten NPO guidelines for my institutions at least once for every year in practice” (CSA Bulletin, Spring 2012). Some have decried patient complications from “forced

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starvation” (JAMA ( , May 22, 2013). How can NPO guidelines, repeatedly studied and revised over so many years, generate so much disagreement? One reason is the NPO acronym. No one knows what it actually stands for, so individuals use it idiolectically, applying their unique meanings to this ill-defined and imprecise term. Some NPO-rule conflicts probably arise from its varying application among different patient groups, clinical situations and practice sites. Even considering this, however, the real problem seems to be that no one knows what NPO really stands for. Numerous Perceived Options Among anesthesiology texts, one can find NPO referenced as nil, non, nunquam, ne, not, nihil, or nothing per os, oris, ora, ossa, orem, or oram. The Numerous Perceived Options for NPO muddle its clinical application, a case of term imprecision causing usage uncertainty, and a scientific imbroglio. The first uses and original definition of NPO, the classic bedrocks for meaning, are unfortunately Not known and Philologically Obscure. Senior anesthesiologists remember the term NPO from their training, used colloquially, but not in print. Journal editors generally banned acronyms and abbreviations until about three decades ago. The term first appeared in The New England Journal of Medicine in 1970 in the correspondence section as “patients … who were probably in relative fasting state (n.p.o.) ….” NPO first appeared, without definition, in the Journal of the American Medical Association in 1987 in the personal essay section, Piece of My Mind. NPO may not have appeared in the journal Anesthesiology until 1990, decades after its widespread informal use, when Cote used “NPO after midnight” in the title of an editorial. In sync with most subsequent commentators, Cote did not define NPO but did “encourage further investigation of this sacred caveat … (and) large prospective investigations to scientifically decide this issue,” a possible definition of babel, and reinforcement of some practitioner views of scientific research. Anesthesia textbooks by Seldin in 1947 and Alexander in 1949 do not use NPO, although the term was probably in clinical use then. The

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COMME N TA R Y famous article by Curtis Mendelson in 1946 that identified aspiration of stomach contents into the lungs as a complication of obstetric anesRobert E. Johnstone, MD thesia similarly avoided the term. Collins’ 1976 textbook, “Principles of Anesthesiology,” contains NPO, which it generally defined as “no food on the day of surgery.” So NPO seems to have gained use in speech years before it would appear in print, where definitiveness would generally be expected, but the opportunity was already lost.

‘Finding the first use of NPO with a precise health care definition, to settle its meaning, seems a search worthy of a word maven, but too much for me, after numerous false trails.’ Early studies of NPO concepts and results used ambiguous phrases, such as “preoperative fasting.” Finding the first use of NPO with a precise health care definition, to settle its meaning, seems a search worthy of a word maven, but too much for me, after numerous false trails. I have discovered NPO means nonprofit organization, nano-particle ontology, and Nashville Philharmonic Orchestra. Governments use the term for National Program Office, National Productivity Organization, Neighborhood Police Officer and National Public Observatory. Internet slangers use npo as short-cut for never pull out. Even among clinicians, NPO stands for Northern Physicians Organization and Nurse Practitioners of Oregon. No wonder no one knows what NPO actually means. The use of NPO as a shorthand term for preoperative fasting seems to have arisen during the mid-20th century when physicians who had taken more science than language classes attempted to convert their inchoate orders into Greek and Latin, the classic languages of science and medicine. They were driven, but not up to Latinizing such phrases as “don’t swallow

anything solid tomorrow morning before surgery.” Multiple translation attempts by various individuals of their personal phrases, in an era before standardization and Englishonly communications, have left us with their Nonliterate and Palaveric Officialese. The concept of advising patients not to eat before anesthesia, as a means of reducing the risk for pulmonary aspiration of stomach contents, undoubtedly began soon after the

introduction of anesthesia into medical practice in 1846. John Snow in his book published in 1858, “On Chloroform and Other Anesthetics: Their Actions and Administration,” advised, “avoid taking a meal previous to the inhalation.” Preoperative fasting makes sense. But the rise of nutrition science in the past century led to observations that wound healing requires energy and that surgical patients do better when they take in calories. Ordering fasting

and then feasting requires some precision of timing, content and method. The best implementation for this is to communicate clearly and avoid illdefined terms. Those in agreement can join my acronym Non Proliferation Organization. —Robert Johnstone, MD Dr. Johnstone is professor of anesthesiology at West Virginia University in Morgantown, and a frequent contributor to Anesthesiology News.

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The following advertorial has been provided by Spacelabs Healthcare and is designed to support the advertisement presented to the right.

Doctors Rush To Corporate Employment … as Corporate America Lays off Workers He was laid off. How long would it take to find a job? What about the kids and their education? What would his wife say? That he should never have taken that job with the hospital in the first place?

n the economy in general, businesses are rushing to cut fulltime employment. They are using temps. They are outsourcing. They are replacing workers with technology. Yet physicians are turning to hospital and hospital-affiliated medical groups employment at a rapid rate. From my discussions with anesthesia residents, work with anesthesiologists on their careers and experience with groups considering disbandment to become hospital employees, this phenomenon is not simply a trend for office-based physicians—it’s affecting the world of anesthesia, too. And many anesthesiologists are leaving truly private practice for jobs with large national and regional groups and other anesthesia staffing companies. So why the disconnect? Why do many physicians believe that employment in hospitals, hospital-captive medical groups or large staffing-model groups provides safety or stability when the world around them for other employees—unskilled, skilled and professional—is in turmoil? Corporations 101 Corporations exist to make a profit. There’s nothing wrong with that. It’s a fact of life. But because all corporations, and that includes hospitals and especially staffing service model groups, exist to make a profit, they will always seek to lower their costs. Of course, costs include employment costs, which includes salaries. ... Welcome to the Team … but Not Really It makes little difference whether it’s the added burden of providing health insurance imposed by Obamacare, the overall uncertainty in the economy or the harsh new employment reality,

employers across the country, from large corporations to smaller entities, are turning to part-time and temporary workers. Full-timers are retiring or being laid off. In the several weeks before writing this article, a small sample of announced layoffs included Merck: more than 100 employees; Heinz: 600 employees; and Cisco: 4,000 workers. At the same time, the number of involuntary part-time employees—that is, those who would rather have fulltime jobs—remains high. Part-time workers enable employers to escape the coming Obamacare burden and, in general, many of the employee benefit expenses that employers incur in connection with full-time workers. And, as to temporary workers, the key is that they can be terminated almost immediately. That flexibility is an advantage in the marketplace akin to that gained by the lower costs of offshore personnel and the fact that employers do not have to pay nearly as much for personnel-related costs such as health insurance and other benefits. If business expands, hire temps; if business contracts, fire temps. According to a recent Associated Press article, employers are increasingly reliant on temps and part-time labor. Nearly 17 million people, or approximately 12% of everyone with a job, is either a temporary worker or a contracted worker or consultant. That represents a 50% increase in the number of temporary workers since the end of the recession. And, despite the government’s touting of the upswing in employment, only 23% of the approximately 950,000 jobs the economy added from January to July 2013 are full-time. The see corporate page 10

Spacelabs Healthcare Q. Who is Spacelabs Healthcare? A. Spacelabs Healthcare is a comprehensive perioperative solutions provider developing, manufacturing and distributing medical equipment and services throughout the world. We provide solutions for patient monitoring and connectivity, anesthesia delivery and ventilation, diagnostic cardiology and supplies and accessories, selling to hospitals, clinics and physician offices. Spacelabs’ world headquarters is in Snoqualmie, Wash., where we develop and manufacture anesthesia, patient monitoring and cardiology products. Spacelabs provides various perioperative solutions from low to high acuity, covering simple to complex cases and pediatric to geriatric patients--offering you the choices you need in anesthesia delivery, patient monitoring and supplies and accessories. What’s more, you can configure solutions to satisfy your individual practices and preferences. Our product line is continually developing and expanding with some exciting new additions coming in the near future. Spacelabs Healthcare has more than 50 years of innovation and service and began as the innovator of life support systems for the Gemini and Apollo space missions. Always endeavoring to meet our customers’ unmet needs, the result is the complete rethinking of the anesthesia delivery system experience.

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C OMM E NT A R Y CORPORATE

• There is no need to compete for the exclusive contract. • I may earn less, but at least I’ll have stability. Sure, running your own medical practice or group may be complicated. It is easy just working and collecting a paycheck. But health care employers are not substitute parents. Sure, parents may kick you out of the house, but employers fire you or lay you off and never invite you back for the holidays.

The same trends affectSystem in California and ing industry in general, leadSamaritan Medical Center ing to layoffs, part-time and in New York, to name just a remaining 730,000 of those jobs are temp work, also are affecting few. part-time positions. health care. Although physicians were Physicians not included in those layAgain, in the several-week Many anesthesiologists and other period preceding this writoffs, the fact is that hosphysicians see advantages in hospital ing, layoffs were reported Mark F. Weiss, JD pitals are employers, too. at Crestwood Medical Although the health care or large-group employment. Here are a Center in Alabama, Baptist Memo- sector of the economy is more vibrant few of the usual reasons: • It’s less complicated than running a rial Health Care in Tennessee, King’s than some others, it’s not immunized group. Daughters Health Systems in Kentucky, against downturns or against the need • My employer will find work for me. Maine Medical Center, Alameda Health to reduce costs. With more physicians employed by large organizations, it is only a matter of time before they, too, are affected by cutbacks. The fact that many hospitals are nonprofit does not alter the equation. Nonprofit corporations are corporations, too. And, remember that they are not really nonprofit. They are simply about not paying taxes. These organizations are under the same pressure as employers in general to cut expenses, and that means cutting employment costs. Look at the rest of the corporate world: If robots can build cars, the number of factory workers goes down. If robot doctors can treat your patients, you involuntarily go part-time, or are unemployed. The urge to seek security is entirely human and virtually universal. But what appears safe in today’s health care economy, what appears less complicated in today’s health care economy and what is clearly the trend in today’s economy— employment by hospitals—is far more risky than it appears. There is no real security in depending on a pseudo-parent employer. So why are so many physicians falling for this same story in regard to hospital employment? Unfortunately, the answer is simple. They’re not fooling you. You’re fooling yourself. The reality is that the only safety that exists is within you. The reality is that you are selff employed no matter whether your paycheck comes from the largest hospital chain in the nation or from your solo practice. The only difference is who can tell you when to stop working. The new experience you’ll gain as a member of the U.S. Army Reserve will help —Mark F. Weiss, JD you remember why you became a physician. By practicing in your community A frequent contributor to Anesthesiology News, and serving when needed, you could receive up to $250,000 in student loan Mr. Weiss is an attorney who specializes in the repayment and up to $75,000 in Special Pay. You’ll feel an increased sense of business and legal issues affecting physicians and pride when you care for our Soldiers and their families. CONTINUED FROM PAGE 8

THE STRENGTH TO HEAL

and rediscover my passion for medicine.

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physician groups on a national basis. He holds an appointment as clinical assistant professor of anesthesiology at USC’s Keck School of Medicine and practices with Advisory Law Group (dba The Mark F. Weiss Law Firm in Texas), a firm with offices in Los Angeles, Santa Barbara and Dallas representing clients across the country. He can be reached by email at markweiss@advisorylawgroup.com.

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Operating Room Noise May Pose Risks to Clinicians, Patients San Diego—It may be time to suggest that your facility take steps to take the volume down a few notches. A new sudy suggests that noise in the OR frequently exceeds guidelines set by various workplace and patient safety organizations. The study, from the University of Kentucky (UK), found that nearly 90% of anesthesiologists, and an even greater share of nurses, reported having trouble hearing in the OR. “We have established enough evidence and data here at the University of Kentucky to state that the noise level does, in fact, exceed health regulatory guidelines, and that most OR staff do perceive that elevated noise levels may have a negative impact on communication and, therefore, on performance,” said Rosalind Ritchie, MD, who presented the findings at the 2013 annual meeting of the Society for Ambulatory Anesthesia (abstract 37). Many groups have issued guidance on health levels of noise in hospitals, including the Occupational Safety and Health Administration, the Joint Commission, the World Health Organization and the National Institute for Occupational Safety and Health. But these evidently are not closely observed. In her role as medical director of the Center for Advanced Surgery at UK Healthcare, in Lexington, Dr. Ritchie received a patient comment regarding the noise level in the OR, which prompted her to survey surgical staff to determine their level of comfort with the noise, and whether OR noise ever interfered with their ability to perform their jobs effectively. She also measured noise levels in the OR at critical times during a variety of operations. Perceptions of noise levels may vary by the different roles individuals play in the surgery, Dr. Ritchie explained, and their location in the OR relative to other team members. Of those who responded to the survey, 88% of anesthesiologists and 92% of nurses reported difficulty hearing in the OR— far more than the 35% of surgeons who reported trouble hearing. Similarly, 53.5% of anesthesiologists and 46.2% of nurses compared with 4.3% of surgeons reported that OR noise levels were too high in general. Noise in the OR also has implications for patient safety, Dr. Ritchie

said. “When you add multiple contributing factors such as beepers, cell phones, overheard pages, monitors and music, conversations and instruments, the ability to communicate effectively becomes impaired—critical communications about the patient’s care may be heard incorrectly or not heard at all.”

OR staff in her survey stated that they handicapped by the noise level,” said had misheard comments ranging from Edward Nemergut, MD, associate requests about the positioning of a bed professor of anesthesiology and neuor table to the type and dose of local rosurgery at the University of Virginia anesthetic. Health System, in Charlottesville. “It is my experience that the OR is “When communication is adversely way too loud, and communication affected, patient care can suffer.” between health care practitioners is see OR noise page 12

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Telemedicine Program Gives U.S. Doctors Glimpse Of Care in Rwanda—and Vice Versa

he patient was in terrible shape. She had been stabbed by her husband in the neck and had lost her voice, indicating the knife had gone through her airway. Air was rushing the wound. The biggest concern for the anesthesiologist on duty was to find a way to secure the woman’s airway during surgery, knowing that placing a breathing tube down her throat might worsen the injury. But this wasn’t Europe or North America. It was Rwanda. It took the patient three days to get to the hospital because she lived so far away. And there was no fiber-optic endoscope to perform intubation and to examine her vocal cords. The hospital did not even have a range of anesthetics at hand—only halothane. This summer, Marcel Durieux, MD, PhD, and a group of anesthesia residents at the University of Virginia (UVA) sat quietly around a rectangular table in a windowless conference room, listening to anesthesia residents in Rwanda describe the patient—part of a new program in which residents on either side of the globe schedule monthly teleconferences to consult on difficult cases. The program, which began about eight months ago, helps both groups of doctors, said Dr. Durieux, professor of anesthesiology at UVA, in Charlottesville. Medical residents in the United States learn creative ways to deal with cases without the latest tools of modern medicine, and Rwandan residents obtain additional training. “The whole country has 11 anesthesiologists, and it’s just not enough to train more residents,” Dr. Durieux told Anesthesiology News. “It’s difficult for us to understand how isolated physicians in developing countries tend to work. You may not have Internet access; you cannot go to conferences; you cannot subscribe to journals.”

even defending your rationale for a certain treatment plan is very valuable for any trainee, and the Rwandan residents don’t get this opportunity in many

Left: Typical OR in Rwanda.

other areas of their training.’

Above: Resident Kristi Rose teaching regional anesthesia in Rwanda.

—Julia Weinkauf, MD

Credit for all images: Marcel Durieux, MD, PhD.

Residents in the United States, on the other hand, constantly are learning from cases and encounterAlthough the UVA telemedicine program pering new tools and practices. “Anything we can do forms distance medicine for rural Virginia and to break that isolation [Rwandan doctors face], to other locations, Dr. Durieux said it is the first anesexchange ideas and discuss complex cases, both thesiology telemedicine program for Africa. The sides will learn from,” Dr. Durieux said. see Rwanda page 14

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Dr. Nemergut moderated a sesLoud Volume Medium Volume sion on patient safety at the 2013 Anesthesia Staff (Nurses/Techs) 12 16 annual meeting of the International Anesthesia Research Society, where 14 10 Dr. Ritchie’s abstract also was named 12 best in category. 30.0% 53.3% 8 54.5% To combat excessive noise levels and 33.3% 10 increase awareness, Dr. Ritchie and her 6 8 76.9% 30.0% colleagues have implemented a number of interventions at UK Health6 41.7% 4 25.0% 33.3% care. They now have tracking lights in 4 45.5% the entrance hallway to the operating 40.0% 2 2 75.0% suites that change from green to yel23.1% 25.0% 13.3% low to red when noise levels reach pre0 0 set decibel limits, and signs posted in the OR remind staff that noise should be kept to a minimum during critical points in surgery. She noted that UK Healthcare also has implemented Table 1. Causes of Problems Hearing in the OR

OR NOISE

‘The experience of verbalizing and

educational programs and formed a task force to help ensure that the OR environment is optimal for all OR team members. Dr. Ritchie urged her colleagues around the country to look critically at OR noise levels in their institutions. “I am most confident that this is a growing national problem. I have discussed this with many of my colleagues, and many have indicated that they too perceived noise levels in the operating suite as a growing hazard to patient safety and personnel health. I think guidelines should be instituted by an executive level committee at each hospital.” —Keely Savoie

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CONTINUED FROM PAGE 12

group patterned it after a similar program set up by UVA surgeons. Alternating Perspectives During the calls, both sides take turns. One month, Rwandan doctors present a case; the following month, it’s the U.S. residents’ turn. They try to pick cases that might happen in Rwanda and include technology the doctors might one day have access to. For instance, earlier this year, the American team described a closed head injury they managed using an arterial line, IVs and a computed tomography scan. Marcel Durieux, MD, PhD, teaching in Rwanda. Clinicians reviewed how they dealt with a patient experienc- Dr. Weinkauff told Anesthesiology News. ing increased intracranial pressure, indiRwandan students have plenty of cating bleeding inside the brain. “They printed materials to learn from, added may not be able to do all this now, but Dr. Weinkauf,f who also is on the facat least it gets them thinking about ulty of the Department of Anesthesia what they would do if more money in the University Central Hospital of becomes available, and their system gets Kigali, in Rwanda. When international upgraded,” Dr. Durieuxx said. doctors and teachers give lectures and But international residents have a workshops, they frequently leave behind few resources doctors here don’t, noted PowerPoint files, books, articles and Jennifer O’Flaherty, MD, MPH, asso- other resources. “But what they need ciate professor of anesthesiology and most is guidance and mentoring on how pediatrics at Dartmouth-Hitchcock to become adult learners and mature, Medical Center, in Lebanon, N.H. For critically thinking, academic physicians,” instance, many other countries have she said. IV tramadol and IV acetaminophen, But those are skills that every docwhich are rare in the United States. “I tor needs to cultivate, so the Rwandon’t know of any similar programs” dan residents try to present cases they that enable anesthesiologists from know their U.S. colleagues will benefit other countries to discuss cases they from, as well, Dr. Weinkauff said. The managed with local resources, added wounded trachea case, for instance: Dr. O’Flaherty, who is not involved “Such a case is very infrequently seen in in the telemedicine effort but works the United States, so it provoked some with Dr. Durieux on a separate proj- interesting discussion.” ect to boost Rwanda’s capacity to train Indeed, the U.S. residents asked many residents, including in anesthesiology questions about the patient with the tra(http://hrhconsortium.moh.gov.rw/). cheal injury. “Each conference is schedIndeed, although learning about new uled for one hour, but in reality every technologies and treatment options is single one has run over because there’s helpful, the real benefit of the meet- too much to talk about,” Dr. Durieux ing comes from revisiting previous cases said. Would it be safe to attempt intuand decisions, said Julia Weinkauf, MD, bating the patient, or should she a faculty member in the Department of undergo an awake tracheostomy? What Anesthesiology in the UVA Health Sys- vascular access did you have? What flutem, who helped set up the telemedicine ids and blood products would you want program. “The experience of verbaliz- to have available? In the end, the patient ing and even defending your rationale did have a tracheostomy, and was found for a certain treatment plan is very valu- to have esophageal damage as well. Forable for any trainee, and the Rwan- tunately, she survived. dan residents don’t get this opportunity in many other areas of their training,” —Alison McCook

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Device Allows Off-Line Concentration of Residual Blood

he Hemobag, a modified ultrafiltration device from Global Blood Resources, can concentrate and salvage residual blood from the extracorporeal circuit after patients were disconnected from the cardiopulmonary bypass (CPB) machine, a new study has found. Compared with preprocessing samples, the postprocessing product showed significant improvement in prothrombin time (PT) and international normalized ratio (INR) and significant increases in levels of all clotting factors and natural anticoagulants. “In cardiac surgery, it’s always been controversial what to do with the residual blood in the CPB machine,” said David Moskowitz, MD, director of cardiothoracic anesthesia at Englewood Hospital and Medical Center, in Englewood, N.J. Dr. Moskowitz was not involved in the research (Perfusion 2013;28:214-222) but was familiar with the technology.

cardiac surgery requiring CPB and clinicians used the Hemobag in each case. The authors, from hospitals in Oregon and Pittsburgh, found a reduction in PT from a sample taken before processing (mean 23.32) to a sample taken after processing (mean 15.02) (change of –8.30; P<0.01); similarly, INR fell from 2.03 to 1.28 (change of –0.75; P<0.01).

Activated partial thromboplastin times and platelet counts were not significantly different. On average, about 800 to 2,000 mL of whole blood was removed for processing from the extracorporeal circuit; after processing, about 300 to 950 mL of concentrated whole blood was salvaged for reinfusion. Platelet-derived and transforming growth factor concentrations were

found in the final product at levels comparable to normal blood. “I think it’s a no-brainer to concentrate blood post-cardiopulmonary bypass,” Dr. Moskowitz told Anesthesiology News. “If we can do it offf line while surgery continues, then it makes sense.” —George Ochoa Dr. Moskowitz reported no relevant financial conflicts of interest.

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“Some have argued that the residual blood is ‘garbage’ and prefer to dump it into the cell salvage machine, which only saves the red blood cells,” Dr. Moskowitz added. “Some directly reinfused the residual blood, which leads to excessive volume loading requiring diuretics and/ or vasodilators. Others perform modified ultrafiltration”—a technique for removing excess volume from the residual blood that preserves coagulation and clotting factors. Although effective, modified ultrafiltration is time-consuming, Dr. Moskowitz said, requiring the patient to remain heparinized and connected to the bypass machine. “The Hemobag is the same concept as modified ultrafiltration, except that the patients are not connected to the bypass machine and the surgery can continue without delay,” he said. The prospective study included two groups of 11 patients each from two institutions. All were scheduled for

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CONTINUED FROM PAGE 1

Chasing the Sun, Stethoscope in Hand For the past four years, Dr. Popovv has “chased the sun,” he said. But it is not quite that easy. During the six hours that the clinic is open each day, he sees 30 to 60 patients. The age range is 6 months to well over 100 years. The majority of cases involve traumarelated injuries resulting from mishaps on the various onboard entertainments: the rockk climbingg wall, the zip line, the flow rider. And older people tripping over children scuttling around the 17 passenger decks. Meclizine is available free in the waiting area for seasickness—which often isn’t enough for Dr. Popov, v who has been known to resort to ondansetron when his nausea becomes particularly acute. Crewmember injuries often involve the aerobatic divers, ice skaters, dancers and aerial performers. Other frequent ailments include strokes, myocardial infarctions (MIs) and complications of diabetes. Teams from shore can come aboard for dialysis patients. On one recent trip, 14 patients with endstage renal disease traveled with their nephrologist and nurse. Crewmembers undergo a biannual medical examination, especially for hepatitis, syphilis, AIDS and tuberculosis. Care of them involves ongoing management of diabetes and hypertension, for the most part. Although the hospital floats, all of the medical staff are expected to perform at the same level of medical care as a land-based facility but without the corresponding support structure: no referrals to cardiology or radiology—indeed, the ship lacks advanced imaging modalities like computed tomography or MRI—or more advanced laboratory investigations. A maximum number of 16 hands are available. In addition to medical care, the staff must oversee sanitization of the entire vessel, from management of medical waste and the distribution and collection of sharps containers to housekeeping. Purity of the water supply also must be ensured weekly. An outbreak prevention plan is also under their supervision as are plans for mass casualties. So far, the ship has not had an outbreak of norovirus, the bane of ocean liners, but anyone with any gastrointestinal symptoms is quarantined in his or her cabin for a minimum of 24 hours. Should an ailing guest attempt to leave, he or she is shuffled back. A refusal means walking the plank at the next port. A crew wellness program, including a crew gym and bar, is designed to provide help and comfort to these workers, especially as they are often away from home for seven months or more at a time. Because all medical issues must be reported to port authorities, ordering such items as medications and oxygen cylinders, and all shoreside health communications, involve a mountain of paperwork.

Christian Herbst, RN, in the Oasis’ treatment rooom.

The Oasis’ emergency room.

Alexander Popov, MD, in his office aboard the Oasis of the Seas.

administered. Just beyond the desk is the emergency room, fully equipped for resuscitation and monitoring. A ventilator is available, but there is no anesthesia machine. (Anesthesia is by block and/or IV.) Sterilizers and drug cabinets sit in a separate area. Equipment is ready to treat a case of pneumothorax, secure an airway, insert an arterial line, take x rays, sew up wounds and perform other emergency xprocedures. The ship’s modest laboratory allows for complete blood count, Piccolo xpress analyzer (lipid panel, liver enzymes), i-STAT (chem 8 cartridges), coagulation profiles and other common tests. Glycated hemoglobin also can be measured. Rapid tests for cardiac enzymes, DSM CAP-dimer, r AIDS, hepatitis, mononucleosis, Legionella, streptococcus, tuberculosis and pregnancy are on hand. A treatment room has an operating table, used mainly for resin-based splinting with back slabs. There are autoclaves, a dental box, ophthalmologic examination equipment, otoscopes, ear irrigation machines and oxygen concentrators. Guests may take this latter apparatus to their cabins. Fresh dried plasma is available, as are means to type blood. If a transfusion is required, the medical staff appeals to donors among the passengers, and direct transfer is made from guest to patient. In one feature that’s much like land-based hospiFirsthand Account tals, stretchers line the walls of the corridors, along On a recent cruise, Dr. Popov invited a group of with emergency bags. Eight defibrillators are disanesthetic care providers (this author included) to tributed around the hospital. Response time is bettour the medical facility. The area is remarkable for ter than on land, averaging two minutes. The nurse its size, scope, efficiency and flexibility. Two wait- on duty moves around the ship with an emergency ing areas accommodate guests and crewmembers. At bag on wheels containing all resuscitative equipment. the nurses’ station, patients are triaged, vital signs Three wards have a total of six beds with monitoring are recorded, and over-the-counter medications are capability.

Christian Herbst, RN, in the Oasis’ modest lab. Unfortunately, for some travelers, the ship’s hospital is the final port of call. The morgue has three trays—empty during this tour. The previous week, seven patients had been taken off the ship for emergency care, mostly MIs and strokes. During our trip, a young man had a seizure, arrested, was resuscitated and was awake after 10 hours, neurologically intact. On the day we visited, an 80-year-old man thrombosed his stent while climbing on the rock wall. After intubation, he was stable on a nitroglycerin infusion. Although the ship has a helicopter pad, its small size plus the sea swell and waves make airlifting a patient so perilous that the captain would rather turn the ship toward land, at a $100,000 expense—the same as when a passenger falls overboard. Attempts are made to examine the images from numerous cameras located around the vessel to determine the time and approximate location of a fall. While life as a ship’s doctor has a certain glamour, it comes with equal measures of stress and chaos. Dr. Popov is onboard for three- or four-month stretches, with two to three months of downtime. He uses his months off to go to England to maintain his anesthetic skills. But he would have it no other way. —Elizabeth A. M. Frost, MD Dr. Frost is professor of anesthesiology at the Icahn School of Medicine at Mount Sinai, in New York City, and a member of the editorial board of Anesthesiology News. She does not get seasick.

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By the Numbers:

Ambulatory Surgery

$7.5 billion Thatâ&#x20AC;&#x2122;s the amount ambulatory surgery centers (ASCs) saved the Medicare program between 2008 and 2011, according to a recent study by researchers at the University of California, Berkeley. Of that figure,

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Why I Use EZ-IO® Jens W. Krombach, MD Associate Professor of Clinical Anesthesia University of California, San Francisco San Francisco General Hospital

The PH insertion site is easy to identify in most patients. I initially hesitated to choose this site, but Vidacare’s training with clinical experts was extremely helpful to eliminate my concerns.

Vascular access via the intraosseous (IO) route has been an established method for more than 70 years, yet many paramedics, nurses and physicians have never considered placing one. I was one of them, with more than 20 years of practice as a paramedic and later an emergency physician and anesthesiologist, and despite multiple training sessions on chicken bones, trying to push or shoot a needle into my patient’s bone appeared to be battlefield medicine and not for my trauma patients. My view of IO access changed completely when Vidacare introduced the EZ-IO®, making IO placement smooth and almost effortless. The technique is extremely easy to learn and has an impressive safety record. The EZ-IO® is a tool I must have at my Level 1 trauma center and county hospital.

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Q. Can vascular access be attained within seconds in any situation? A. Facing an emergency situation, the EZ-IO® provides immediate intravascular access within seconds. Following skin preparation, I am usually able to administer drugs or fluids in less than 30 seconds.

Q. Is IO a resource for patients with difficult IV access for nonemergent procedures? A. The EZ-IO® is gaining increasing acceptance by anesthesia providers as an alternative for patients with difficult IV access (DVA), no matter the age. The majority of our faculty group considers the EZ-IO® to be a reasonable and safe alternative for DVA patients scheduled for nonemergent anesthesia. We regularly offer patients IO as an alternative whenever IV access is challenging, or the patient reports a history of DVA. In minor surgeries, it can be the sole line to provide general anesthesia. For major surgeries, the EZ-IO® can serve as a bridge to establish general anesthesia. A definitive, large-bore line can then be placed with the patient asleep. The proximal humerus is the preferred access site, especially for anesthesiology procedures: PH IO access is close to the anesthesia provider’s workplace where the site can be monitored easily; PH insertion and infusion is less painful; flow rates are usually significantly higher.

A. Many providers are concerned about pain associated with IO access in an awake, nonemergent patient with DVA. Insertion pain using the EZ-IO® is negligible, similar to placing an IV. First-attempt success rates close to 100% are

a selling point for patients presenting with prior multiple IV sticks. The initial flush may be painful. IO lidocaine administration before the flush should provide sufficient analgesia. Dr. Richard Hixson provides a weight-based guide to IO lidocaine (http://www.pawz.net/). For nonemergent anesthesia, a second option appears superior: the EZ-IO® is inserted after inhaled sedation. Confirm the established IO access via aspiration of blood and initiate inhaled induction. Immediately following loss of consciousness, flush the EZ-IO® and administer induction agents.

Q. What infusion rates are obtained with the EZ-IO® vascular access system? A. Published research shows 5 L per hour at the PH site. I regularly observe crystalloid infusion flow rates comparable to an 18 gauge IV. For massive volume resuscitation, consider placing two or more EZ-IO® needles. Dr. Krombach is a consultant for Vidacare Corporation. Potential complications may include local or systemic infection, hematoma, extravasations, or other complications associated with percutaneous insertion of sterile devices.

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Pain-Free Budget Cuts: a Case Study In Minimally Invasive Fiscal Surgery

frequently heard refrain is that 30% or more of U.S. spending on health care could be eliminated without any effect on patient health. Armed with this information, President Barack Obama originally set out to “bend the cost curve downward” with health care reform legislation. The Affordable Care Act (ACA) is the most farreachingg effort to contain health care costs to date. This sweeping federal legislation reforms payment and delivery systems to reward value and quality over quantity, and is catalyzing change down to the individual health care provider. Insurers, hospitals, employers and communities are taking the initiative and figuring out how to offer better care for less money. Many physicians say they already have felt a change in the environment and feel they have no choice but to cut back on health care spending, despite administration having little concern about whether fat or muscle is being cut. Anesthesiology departments are no exception. For example, our department was tasked to cut 3% from our lean budget while not affecting patient quality of care. As a framework, we used the guidelines set forth by the Center for American Progress’s convention of leading health policy experts and were able to achieve our goal. Here are six things we did that other departments can easily implement (Table 1).

Use Competitive Bidding For All Health Expenditures Medical suppliers also are beginning to feel the pressure of the ACA as hospitals look to supply expenses to decrease their budgets. The quickest and least painful way to reduce costs is to reduce the price of goods. As pricing becomes more transparent within the industry and hospitals have increased access to market pricing tools and databases, suppliers are forced to participate in competitive bidding. We have realized significant cost savings by bidding products to our incumbent supplier and competitors, and awarding business to the supplier with the best price. We have leveraged our product volume, length of agreement and supplier commitment to achieve the best market pricing. Table 1. Six Pain-Free Budget Cuts Use competitive bidding for all health care costs. Participate in tiered plans and standardization programs. Leverage bargaining power to secure the best premium rates/convert to contracted products. Simplify the supply chain administrative systems. Empower nonphysician providers to practice to the full extent of their training. Create an oversight committee.

Participate in Tiered Plans And Standardization Programs The effects of the ACA challenge hospitals to look at supply expenses through a lens outside the typical price of goods. The new law requires hospitals to focus more on product standardization and decreased use of supplies. Our anesthesiology department has partnered closely with supply chain personnel and others—purchasers, buyers, nursing and materials managers—to better understand the benefits our group purchasing organization (GPO) and contracting can play in the field of standardization and utilization. Typically GPOs negotiate aggressive contract pricing with suppliers by leveraging a hospital’s product volume and market share. We have aggressively promoted this concept within our anesthesiology department and have challenged our clinicians to standardize exclusively with one or two suppliers in various product categories in order to reach a higher commitment level and therefore a better price. For example, we saw a significant savings by standardizing our magnetic resonance imaging–compatible disposables, including electrocardiogram pads and temperature probes. We agreed to a 90% commitment with our incumbent supplier and achieved the best tier and contract price. In addition, our current GPO further empowers standardization through a unique program that allows hospitals to standardize with selected suppliers, and is rewarded through rebates from each respective supplier. We have actively pursued these programs, particularly by standardizing our anesthesia masks and circuits. We agreed to a 90% commitment with one supplier, thus entitling us to a 3% quarterly rebate on our total anesthesia mask and circuit spending.

ssyyst steem m leevveerraagg es es all ll voolluum me and aan nd barg bbaarg rg ai aini ning ng poow wer er oon n beh ehaallf ooff in nddiv ividua iduuaal ho id hosp spit ital alss.. How wev eveerrr,, be beca caus caus ussee of th of hee sppeeci cial aliz ized ed naatture ure of ur of ch hiild ldren’ ren’ re n’s ho hosp spit ital ital alss,, and nd the ffaact th act ct tha hat m moost st are re con onssiiddeerreed sttan nd-alon aalloon ne ins nsttiittuution ti onss,, th heese se faacciillitie iitties iiees ha have vee fouun ndd uni nique quue wa ways ys to le levveerr-age th ag thei eiirr bu buyyiing ng poow wer toogget ethe the her aass a gro roup oup up, uun nddeer tth the he C Ch hiilld ld He Heal alth th Ass ssoc ociia oc iattiiion on (CH HA) A)).. Ou Our ur G GP PO and CH an and C HA h haavvee agg ggrega rreeggaate t d voluume me and nd com ommi mittm mitm ment men ent en Renée J. Roberts, MD, in front of the “out of stock” tag. levels for all CHA hospitals to leverage best pricing with suppliers. Many contracts in which we participate, namely high-volume products such as needles and syringes or exam and surgical gloves, have been negotiated at the aggregate level and have enabled us to achieve the best price in the market.

Simplify Supply Chain Administration Before health care reform, our administrative staff would order any product or service that was requested by a health care practitioner. We would store everything in a central stock area with little organization and no concern about supply cost. Often, supplies expired before use, orders were unknowingly duplicated and there was zero standardization across product categories. The anesthetizing sites were likewise disorganized and there was limited focus on access and efficiency in locating products. The variability in how each site was configured limited storage space and it was difficult to find correct supplies safely and quickly, while restocking was laborious and time-consuming. Often we would even find many supplies still packaged Leverage Bargaining Power away in their original shipping boxes. Most contract negotiation begins with the leverSince the passage of health care reform, we have aging of bargaining power. Many adult hospitals expended major efforts in reorganizing and simplifyoperate within a larger health system, such as Med- ing our anesthesia supply chain. We created a master Star Health or INOVA in the Washington metro- anesthesia supply list; reorganized our carts for easy politan region, and benefit significantly as the health see cuts page 22

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access to frequently used items; and standardized and labeled cart contents across all anesthetizing sites. Similarly, we organized, labeled and unboxed all incoming products in our storage rooms. Products were slotted to a specific row and bin based on category and turnover rate and clearly labeled. This improved organization has allowed us to capture data on product volume that helps us better predict our use and rates of turnover for specific items. We waste fewer expired products and avoid common stockk outs of high-priorityy items and costly charges for overnight shipping. These time-consumingg but simple changes have allowed us to realize significant cost savings and significantly increase our operational efficiency. To further streamline our supply-chain ordering process, we implemented a system of stockk out tags. Once an anesthesia technician removes the last item from a bin, he or she flips the “out of stock” tag, creating a visual alert to our administrative purchasing team that an item is ready to be reordered.

When the administrative purchasing team places the order, the card is flipped to the “reordered” side, signaling the technician team that the product has been ordered for replenishment. A communication board with current “back orders” also is posted prominently and updated by the purchasing team to notify anesthesiology personnel. An automatic email is triggered from the purchasing team to designated anesthesiologists for a decision to find a clinically acceptable substitute or to indicate that stock is adequate until the back order is filled. Empower Nonphysician Providers To Make the Most of Their Training Similar to other hospitals, our support personnel had been minimal in number, trained only in basic turnover of the operating room (OR). They were responsible for supporting not only anesthesiologists but OR nurses and scrub technicians in case setups. They also were responsible for duties normally assigned to environmental services such as cleaning OR floors,

beds and equipment and removing trash. With increasing financial pressure to efficiently manage our ORs, we split our support personnel into two groups: one to support the nurses and one, the anesthesia technicians, to support anesthesiology. To improve education, we decided to implement an in-house anesthesia technician–training program. This program Table 2. Goals for Your Operating Room Oversight Committee value analysis and each surgical service. Organize all OR supplies into commonly used and service line–oriented. Standardize each service line (each anesthesiologist does a block with the same products). Establish a process for new equipment/supply approval. Systemize trials of new products and formalize the decision process.

includes multiple knowledge-based written tests and related skills-based manual demonstrations to challenge knowledge on where to retrieve specific supplies related to the respective procedure. For example, the written test for the “intraoperative complications” would ask questions about treatment for malignant hyperthermia (MH), while the demonstration would ask the technician to retrieve the dantrolene and supplies for mixing and administering it from the appropriate MH cart drawer. This program has now evolved to mirror American Society of Anesthesia Technicians and Technologists guidelines with the goal that most of our technicians will soon be certified. Our technicians now possess a standard knowledge and skill base that has allowed the anesthesiologists to depend on them for turnover and support during induction, extubation and line placement, thereby allowing anesthesiologists to dedicate more time exclusively to patient care. This program and education has resulted in timely and efficient turnovers that significantly affect our bottom line.

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PR N Create an Oversight 4. Systemizing trials of new products and The six painless initiatives dis- an opportunity to further reform our Committee cussed here have helped our OR save department into a cost-effective, profformalizing the decision process. Once more than $3 million over four years itable and efficient role model for our We also created an Operating Room cost and patient quality analyses for Products Committee comprised of repa requested product are completed, a and have obviated the need for lay- hospital. resentatives from each surgical line— formalized trial is conducted to adeoffs. During this economic crunch, otolaryngology, anesthesiology, general quately evaluate use of the product. we continue to find additional ways —Renée J. Roberts, MD, surgery—supply chain, OR business Trial results are then shared with the of cutting our costs while increasand Ashley E. Wilson, MHA and data analysts and the director of ing our revenue. In our latest step, committee and product approval is perioperative services (Table 2). This based on a majority vote. This prowe have begun to adopt the Lean Dr. Roberts is Director of Anesthesia Support and Six Sigma Methodology to pro- Services and assistant professor of anesthesiolcommittee has realized significant savcess has greatly enhanced the OR’s ings by establishing four factors: decision-makingg criteria, communica- mote new operational efficiencies ogy and pain medicine, and Ms. Wilson is value 1. Organizing OR supplies. Each service tion among all specialties and strong within our anesthesiology department. analysis manager, at Children’s National Medical We’ve come to view budget cuts as Center, in Washington, D.C. line was required to sort out speclinical support for all products. cialty products from common OR products that can be shared across all specialties. We discovered that each specialty might have ordered similar or exact products from vary® ing vendors. By standardizing products and creating a central shared area among all specialties, we were able to achieve better pricing from select suppliers, reduce an immense amount of duplication and prevent product expiration that was caused by products being stored in service areas that used them less frequently. 2. Standardizing each service line. We have greatly emphasized product standardization within and among service lines. Based on personal preference, we discovered that many anesthesiologists, for example, used three to four different brands of IV catheters. We were able to standardize nearly every product category to one brand and type by trialing then converting to the product that at least 70% of surgeons and anesthesiologists indicated by vote that they were willing to use in their clinical practice. 3. Establishing a process for new equipment/supply approval.l We also highly structured the process for new product requests and approval. For example, if an anesthesiologist requests a new type of LMA (LMA North America/Teleflex), the request is brought to the committee and analyzed against cost, efficiency, patient safety and quality. We require that any physician who requests or champions a product attend the committee meeting to justify the product’s clinical and financial benefits. When we launched the committee, we communicated to all clinicians that it would approve increases in product cost only if significant justification and supporting evidence of increases in patient safety, care and outcomes were provided. This new process established a checkk andbalance system for product requests KARL STORZ Endoscopy-America, Inc., 2151 E. Grand Ave, El Segundo, CA 90245, USA, Phone: (424) 218-8100, Fax: (800) 321-1304, E-Mail: info@karlstorz.com that significantly weighed benefits KARL STORZ GmbH & Co. KG, Mittelstraße 8, D-78532 Tuttlingen/Germany, Phone: + 49 7461 / 70 80, Fax: 07461 / 70 81 05, E-Mail: karlstorz-marketing@karlstorz.de KARL STORZ Endoscopy Canada, Ltd., 2345 Argentia Road, Suite 100, Mississauga, Ontario, Canada L5N 8K4, Phone: (800) 268-4880, Fax: (905) 858-0933 of cost and patient care.

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THE SCIENCE BEHIND POSITIVE PATIENT OUTCOMES

Part 3 of a 3-Part Series

Perioperative Patient Monitoring: Utilizing BIS in Total Intravenous Anesthesia Procedures Faculty TJ Gan, MD, MHS, FRCA Professor of Anesthesiology Vice Chair for Clinical Research and Faculty Development Department of Anesthesiology Duke University Medical Center Durham, North Carolina

Introduction In order to optimize short- and longterm outcomes, anesthesia providers typically monitor the level of drug delivery to best achieve the most appropriate depth of anesthesia while ensuring that incidence of adverse events (AEs) due to anesthetic administration will be low. Thus, the use of techniques, such as total intravenous anesthesia (TIVA), has expanded and increased the need for precise anesthetic monitoring. The BIS™ (bispectral index) Brain Function Monitoring System is designed to illustrate anesthetic depth even when specialized techniques like TIVA are employed.

Total Intravenous Anesthesia: Procedure and Outcomes In contrast to the use of inhalation agents for general anesthesia, TIVA involves the use of different IV drugs: one for the hypnotic effect (eg, propofol, ketamine, midazolam, dexmedetomidine) and another for analgesia (eg, remifentanil or other opioids).1-3 TIVA is often used in Europe—employing targetcontrolled infusion (TCI) devices—although

some countries outside of Europe require regulatory approval for the use of TCI devices and certain anesthesia medications in special populations (ie, pediatric patients).4 However, even without TCI, TIVA has been shown to be effective in establishing general anesthesia and may be associated with fewer AEs compared with inhalation agents.1,5 Particularly, TIVA has been shown to be useful for patients with a history of severe cardiovascular instability,6 patients with asthma,7 those who have a known susceptibility to malignant hyperthermia,4 or patients who experience frequent postoperative nausea and vomiting (PONV).4 In fact, multiple studies have shown that TIVA is associated with decreased PONV compared with inhalation agents: For example, Visser et al studied 1,447 elective inpatient surgeries and 563 outpatient surgeries, and reported that TIVA with propofol reduced the absolute risk for PONV up to 72 hours by 15% among inpatients (from 61% to 46%; P<0.001) and by 18% among outpatients (from 47% to 29%; P<0.001) compared with inhalation anesthesia.5 Furthermore, the median length of stay in the postanesthesia care unit was 135 minutes after isoflurane versus 115 minutes after TIVA for inpatients (P<0.001) and 160 minutes after isoflurane versus 150 minutes after TIVA for outpatients in the hospital day care unit (P=0.039).5 Other studies have shown a decreased rate of PONV with TIVA compared with inhalation agents in patients undergoing minor elective gynecologic or orthopedic interventions,8 robot-assisted laparoscopic radical prostatectomy,9 maxillofacial surgery,10 and laparoscopic cholecystectomy,11 among other surgical populations.

Table. Advantages of TIVA Can be administered to maintain anesthesia in patients undergoing airway procedures Improved quality of emergence from anesthesia Method of choice for some patients with muscle disorders (ie, Duchenne’s muscular dystrophy) Method of choice for patients at risk for malignant hyperthermia No risk for environmental pollution Possible use in off-site and office-based locations Rapid offset using propofol Rapid onset of action independent of alveolar ventilation Reduction in incidence of postoperative nausea and vomiting TIVA, total intravenous anesthesia Adapted from references 2 and 4.

ANESTHESIOLOGY NEWS • OCTOBER 2013

TIVA may have other advantages over inhalation agents (Table).2,4 Chandler et al reported that TIVA with propofol and remifentanil was associated with a lower rate of emergence delirium (38.3% vs 14.9%; P=0.018) and a lower median postoperative pain score (1 vs 3; P=0.033) compared with the use of sevoflurane in a study of 112 children undergoing strabismus repair.12 Hofer et al reported that measures of psychological well-being at 90 minutes after surgery were higher with TIVA than with inhalation anesthesia.8 Finally, in contrast to inhalation anesthetics, the use of TIVA does not result in operating room air pollution.2

recording EEG data from healthy adults who underwent repeated transitions between consciousness and unconsciousness using several different anesthetic regimens.15 The BIS monitor generates a number on a continuous scale of 0 to 100, with 100 representing alert cortical electrical activity and 0 indicating cortical electrical silence.16 Validation studies have demonstrated that a BIS value between 45 and 60 is considered suitable for surgical anesthesia and reflects a very low probability of consciousness.17

Monitoring Level of Consciousness During TIVA Procedures

Regarding the use of BIS to monitor intraoperative awareness during TIVA procedures, although some studies have found either no benefit18—or discovered a benefit after secondary analysis19—other studies have shown that BIS is effective in reducing awareness incidence in TIVA procedures.20 Zhang et al performed a prospective, double-blind, randomized controlled multicenter trial of BIS monitoring in 5,228 patients undergoing surgery with TIVA.20 The authors observed 4 cases of confirmed awareness (0.14%) reported in the BIS-guided group and 15 (0.65%) in the control group (odds ratio, 0.21; 95% confidence interval, 0.070.63; P=0.002). Overall, this study found that the incidence of awareness was reduced by 78% when TIVA was guided by BIS.20 Positive results have been found irrespective of agent used with TIVA. Researchers in Germany studied 42 patients scheduled for microlaryngoscopy. 21 Patients were randomly assigned to 1 of 2 groups: IV remifentanil or IV alfentanil; hypnosis was managed using propofol in both groups.21 The researchers noted that using BIS during the procedure provided a clear determination of how much propofol to administer in order to not only ensure adequate anesthesia, but also to achieve equal BIS values to investigate the difference in recovery from anesthesia between the 2 agents.21 Results showed that use of remifentanil/propofol with TIVA managed by BIS provides a more rapid recovery of ventilatory function.21 Khafagy et al reported that study coadministration of clonidine or magnesium as adjuvants to TIVA, guided by BIS, reduced anesthetic consumption and was associated with improved hemodynamic values and enhanced postoperative analgesia.22 Overall, Akçali et al reported that the use of BIS resulted in lower consumption of propofol and shorter time to extubation in patients undergoing lumbar discectomies under TIVA.23

Despite the benefits of using TIVA, the method can present a challenge when clinicians seek to measure anesthetic depth as effectively as possible. When using inhalation anesthetics, measures such as minimum alveolar concentration or end-tidal volatile anesthetic concentration supplement standard monitoring13; however, due to the form of administration, these methods are not applicable during TIVA procedures. The pharmacokinetic effects of certain TIVA drugs also can affect standard hemodynamic measurements including mean arterial pressure (MAP) and heart rate (HR). Guignard et al found noncranial patients exhibited a hemodynamic response (changes in MAP and HR) when receiving large doses of remifentanil with propofol.14 In this study, the authors also used BIS to monitor anesthetic depth and found no change in BIS levels to correspond with changes found in MAP and HR. Therefore, the study authors concluded that measuring depth of anesthesia only using hemodynamic variables may be unreliable when opioids, hypnotics, and other drugs can alter these variables. Instead, the appropriate anesthesia amount was maintained with the help of BIS, which was unaffected by the specific drugs administered.14

BIS A statistically based, complex index, BIS is unique because it integrates several disparate descriptors from a single channel of frontal electroencephalographic (EEG) data into a single variable, based on a large volume of clinical data, to synthesize an index that correlates behavioral assessments of sedation and hypnosis,15 yet is insensitive to the specific anesthetic or sedative agent chosen. BIS was derived empirically by

BIS Monitoring During TIVA Procedures

Supported by

Case Study: 72-Year-Old Woman With Colon Cancer Scheduled for Colectomy With Planned Colostomy

he patient’s medical history included hypertension, type 2 diabetes, myocardial infarction 15 years ago, depression, and chronic back pain. The patient noted that her blood pressure (BP) was not very well controlled despite medication. Her American Society of Anesthesiologists (ASA) classification was 3. Surgical history included gynecological laparoscopy, total hip replacement, and laparoscopic cholecystectomy and appendectomy. She experienced postoperative nausea and vomiting (PONV) after each surgery, and she related that her anesthesiologist tried every antiemetic known without success. She is currently on atenolol for her hypertension; glipizide to control diabetes; sertraline for depression; and hydrocodone, pregabalin, and ibuprofen for back pain. The patient was scheduled for a colectomy with planned colostomy. She received a laxative as part of the routine bowel preparation that her surgeon ordered and did not have any fluid from midnight of the day of surgery. In view of her previous history of PONV, a total intravenous anesthesia (TIVA) technique with propofol was planned. Additionally, dexamethasone 4 mg IV was administered at induction of anesthesia and ondansetron 4 mg IV was planned for administration toward the end of the surgery. The patient received midazolam 2 mg and fentanyl 50 mcg as premedication. Anesthesia induction was accomplished with propofol 2 mg/kg with further 100 mcg

Conclusion TIVA is an effective strategy for the establishment of general anesthesia and may be associated with fewer AEs compared with inhalation analgesia.1,5 Use of the BIS Brain Monitoring System can help optimize delivery of anesthetics, including TIVA, and thereby may result in fewer AEs and improved outcomes.

References 1. Hogue CW Jr, Bowdle TA, O’Leary C, et al. A multicenter evaluation of total intravenous anesthesia with remifentanil and propofol for elective inpatient surgery. Anesth Analg. 1996;83(2):279-285. 2. Lerman J, Johr M. Inhalational anesthesia vs total intravenous anesthesia (TIVA) for pediatric anesthesia. Pediatr Anesth. 2009;19(5):521-534. 3. Mani V, Morton NS. Overview of total intravenous anesthesia in children. Paediatr Anaesth. 2010; 20(3):211-222. 4. Lerman J. TIVA, TCI, and pediatrics: where are we and where are we going? Paediatr Anaesth. 2010;20(3):273-278. 5. Visser K, Hassink EA, Bonsel GJ, et al. Randomized controlled trial of total intravenous anesthesia with propofol versus inhalation anesthesia with

of fentanyl. Neuromuscular blocking agent rocuronium 0.6 mg/kg was administered to facilitate tracheal intubation. Propofol infusion was initiated at 100 mcg/kg/min. Monitoring devices included ASA-recommended basic monitoring. Additionally, the patient had a BIS™ ™ (bispectral index) sensor placed before induction of anesthesia. Immediately following induction of anesthesia, her BP dropped precipitously to 60/40 mm Hg. At this point, the patient’s BIS value was 30, with no interference from electromyogram (EMG) and high signal quality index (SQI). Propofol was reduced to 30 mcg/kg/min and a dose of phenylephrine 100 mcg was administered. Ventilation was supported with a facemask while awaiting onset of rocuronium. Three minutes later, the patient was intubated with a size 7.5-mm orotracheal tube and taped. While a second IV catheter was being placed, the BIS value trended up and now was reading 73. A dose of propofol 50 mg was injected and propofol infusion rate was increased to 150 mcg/kg/min. A BIS value of more than 70 indicated a higher risk for patient awareness. Therefore, a bolus of propofol was appropriate to rapidly deepen anesthesia, and this was followed by a corresponding increase in propofol infusion rate to maintain adequate anesthesia. Following induction, an esophageal Doppler was placed in the mid-esophagus to guide fluid and hemodynamic

isoflurane-nitrous oxide: postoperative nausea with vomiting and economic analysis. Anesthesiology. 2001;95(3):616-626. 6. Suryaprakash S, Chakravarthy M, Muniraju G, et al. Myocardial protection during off pump coronary artery bypass surgery: a comparison of inhalational anesthesia with sevoflurane or desflurane and total intravenous anesthesia. Ann Card Anaesth. 2013; 16(1):4-8. 7. Radosic N, Nikolic J. Comparative study of two types of anesthesia (TIVA and balanced NLA) in asthmatic patients undergoing functional endoscopic sinus surgery (FESS). Presented at: Euroanaesthesia 2005: Annual Meeting of the European Society of Anesthesiologists; May 28-31, 2005; Vienna, Austria. Abstract A-262. 8. Hofer CK, Zollinger A, Büchi S, et al. Patient wellbeing after general anaesthesia: a prospective, randomized, controlled multi-centre trial comparing intravenous and inhalation anaesthesia. Br J Anaesth. 2003;91(5):631-637. 9. Yoo YC, Bai SJ, Lee KY, et al. Total intravenous anesthesia with propofol reduces postoperative nausea and vomiting in patients undergoing robot-assisted laparoscopic radical prostatectomy: a prospective randomized trial. Yonsei Med J. 2012;53(6):1197-1202. 10. Gecaj-Gashi A, Hashimi M, Sada F, et al. Propofol vs isoflurane anesthesia-incidence of PONV in patients at maxillofacial surgery. Adv Med Sci. 2010;55(2):308-312.

management. At 30 minutes, the patient’s BP increased to 190/100 mm Hg with a heart rate (HR) of 100 beats per minute (bpm), and propofol was being infused at 150 mcg/kg/ min. At this time, the patient’s BIS value was 45. As the BIS level range was consistent with general anesthesia range, adjustment of propofol infusion rate was not appropriate and the increased BP was treated with an antihypertensive. Following treatment with esmolol, her BP and HR reduced to 130/85 mm Hg and 85 bpm, respectively. After approximately 90 minutes into the surgery, her BP registered 80/50 mm Hg and her HR was 65 bpm. Propofol was infused at 150 mcg/kg/min. BIS values then were measured at 50, which indicated an adequate level of sedation. Therefore, causes of hypotension other than adjusting propofol infusion should be considered. For example, does the patient need plasma volume expansion with fluid? Could it be blood loss? What is the patient’s hemoglobin level? If fluid or blood loss is not an issue, hypotension may be treated with a vasoactive drug (eg, phenylephrine). On the other hand, if the BIS value was 30, with the presence of hypotension, propofol infusion rate could be reduced further to provide appropriate level of sedation, between 45 and 60. This case illustrates using information from the BIS monitor to better manage the patient’s hemodynamic response during anesthesia, and select the more appropriate strategy to treat hyper- and hypotension.

11. Khalid A, Siddiqui SZ, Aftab S, et al. Recovery profilea comparison of isoflurane and propofol anesthesia for laparoscopic cholecystectomy. J Coll Physicians Surg Pak. 2008;18(6):329-333. 12. Chandler JR, Myers D, Mehta D, et al. Emergence delirium in children: a randomized trial to compare total intravenous anesthesia with propofol and remifentanil to inhalational sevoflurane anesthesia. Paediatr Anaesth. 2013;23(4):309-315. 13. Sessler DI, Sigl JC, Kelley SD, et al. Hospital stay and mortality are increased in patients having a “triple low” of low blood pressure, low bispectral index, and low minimum alveolar concentration of volatile anesthesia. Anesthesiology. 2012;116(6):1195-1203. 14. Guignard B, Menigaux C, Dupont X, et al. The effect of remifentanil on the bispectral index change and hemodynamic responses after orotracheal intubation. Anesth Analg. 2000;90(1):161-167. 15. Sinha PK, Koshy T. Monitoring devices for measuring the depth of anaesthesia – an overview. Indian J Anaesth. 2007;51(5):365-381. 16. Covidien. BIS™ Brain Monitoring Technology. www.covidien.com/rms/pages.aspx?page=Our Products/BrainMonitoring/Technology. Accessed August 27, 2013. 17. Yeganeh N, Roshani B, Almasi A, et al. Correlation between bispectoral index and predicted effect-site concentration of propofol in different levels of targetcontrolled, propofol induced sedation in healthy volunteers. Arch Iran Med. 2010;13(2):126-134.

18. Avidan MS, Zhang L, Burnside BA, et al. Anesthesia awareness and the bispectral index. N Engl J Med. 2008;358(11):1097-1108. 19. Mashour GA, Shanks A, Tremper KK, et al. Prevention of intraoperative awareness with explicit recall in an unselected surgical population: a randomized comparative effectiveness trial. Anesthesiology. 2012;117(4):717-725. 20. Zhang C, Xu L, Ma YQ, et al. Bispectral index monitoring prevent awareness during total intravenous anesthesia: a prospective, randomized, doubleblinded, multi-center controlled trial. Chin Med J (Engl). 2011;124(22):3664-3669. 21. Wuesten R, Van Aken H, Glass PS, et al. Assessment of depth of anesthesia and postoperative respiratory recovery after remifentanil- versus alfentanil-based total intravenous anesthesia in patients undergoing ear-nose-throat surgery. Anesthesiology. 2001;94(2):211-217. 22. Khafagy HF, Ebied RS, Osman ES, et al. Perioperative effects of various anesthetic adjuvants with TIVA guided by bispectral index. Korean J Anesthesiol. 2012;63(2):113-119. 23. Akçali DT, Ozköse Z, Yardim S. Do we need bispectral index monitoring during total intravenous anesthesia for lumbar discectomies? Turk Neurosurg. 2008;18(2):125-133.

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Disclosures: Dr. Gan reported receiving honoraria from Baxter, Covidien, Edwards Lifesciences, and Merck; grant/research funding from Acacia, AcelRx, Covidien, Fresenius Kabi, Merck, and Purdue Pharma; and speaker fees from Baxter and Merck. Disclaimer: This monograph is designed to be a summary of information. While it is detailed, it is not an exhaustive clinical review. McMahon Publishing, Covidien, and the author neither affirm nor deny the accuracy of the information contained herein. No liability will be assumed for the use of this monograph, and the absence of typographical errors is not guaranteed. Readers are strongly urged to consult any relevant primary literature. Copyright © 2013, McMahon Publishing, 545 West 45th Street, New York, NY 10036. Printed in the USA. All rights reserved, including the right of reproduction, in whole or in part, in any form.

ANESTHESIOLOGY NEWS • OCTOBER 2013

26 I AnesthesiologyNews.com

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P OLI C Y & M A NAGEMENT U.S. Percent = 43%

VA CHANGE

anesthesiologists, and a similar number of CRNAs, work in the VA system. the language of the Nursing Handbook— a draft copy of which the ASA provided The VHA declined to make to reporters—is sufficiently vague to raise someone available to discuss some questions about the society’s interthe new policy. But Gina Jackson, a spokeswoman for the pretation of its intent and impact. agency, said current policy “rec‘In No Way Equivalent’ ommends that CRNAs and/ Jane Fitch, MD In a Sept. 9, 2013, conference call with or anesthesiologists work in a reporters, Jane Fitch, MD, the incoming team together with the other president of the society, said the ASA was nurses and physicians caring for “deeply disappointed” with the amended our veteran patients, and does handbook. Allowing nurses to practice not require physician superviunsupervised raises “significant” concerns sion of CRNAs. As a member for the safety of patients in the VA system, of the anesthesia team, CRNAs Percent of Veteran Population 65 Years and Older by Dr. Fitch said. are subject to the same profesState: Fiscal Year 2012 “The language of the policy indicates sional practice review, evaluation Source: Department of Veterans Affairs. independent practice,” said Roxanne Pipiand monitoring as all anesthesia tone, an ASA spokeswoman. “The handproviders.” book doesn’t get into procedure-specific Robert Katz, MD Ms. Jackson added, “The proposed Nursing HandActs under a set of approved privileges. scenarios for any of the four advanced pracAdvanced practice nursing education pro- book and APRN full practice policy support the anestice nursing roles,” which, along with CRNAs cover vides the foundation for APRN core privileges. Core thesia team–based model of care that fully utilizes the certified nurse-midwives, clinical nurse specialists and privileges as defined by the profession are those sets of knowledge, skills and abilities of CRNAs.” certified nurse practitioners. clinical practice, procedures or interventions that all VA Anesthesiologists Wary Dr. Fitch, who herself was a certified registered nurse APRNs are qualified to perform based on their educaHowever, the new policy evidently caught the VA’s anesthetist before receiving her medical degree, said tional background and training.” It then lists core privthe two positions “are in no way equivalent.” CRNAs ileges including the taking of a history and physical own anesthesia providers by surprise. An internal receive far less training—five to seven years compared examination, prescribing under an earlier VA directive, email from the department’s central anesthesia service with 12 to 14 for physician anesthetists, and one-tenth developing a care plan and ordering diagnostic and lab- sent after the ASA teleconference stated that the VA’s oratory studies. nursing service made the change “without input from the number of hours, she said. Although Dr. Fitch said CRNAs often do not have Dr. Fitch said the ASA first learned about the policy the National Anesthesia Service.” According to the even a college degree, according to the policy: “A change about five months ago. The group tried to meet email, several versions of the handbook are circulating, CRNA is an APRN who has completed a master’s or with VA officials to discuss the document on three although “all drafts we have seen propose an increase in doctoral degree and board certification in the specialty occasions but was rebuffed, she added. independence” over current policy. of anesthesia. CRNAs practice in all settings in which “With input from our Field Advisory Committee Vulnerable Patients anesthesia services are delivered including traditional (FAC) we have submitted several questions and conIn a July 2, 2013, letter to Robert Petzel, MD, the cerns to ONS [Office of Nursing Services] regarding hospital surgical suites and ambulatory surgical centers.” However, Ms. Pipitone said the society does not undersecretary for health in the Department of Vet- the proposed change in status. Concerns have also been “interpret this to mean that the VA will only allow erans Affairs, the ASA said it was “concerned about submitted by Primary Care Physicians. To date, ONS nurse anesthetists with advanced degrees to practice the impact of these policies on surgical anesthesia care has not responded to our questions,” according to the independently. There is nothing in the new handbook within the VHA. The policies are particularly trouble- email, which concludes, “At this point there are more that addresses segmenting nurse anesthetist by educa- some given the population serviced” by VA hospitals. questions than answers.” tion received, whether they have a two-yearr associate VA patients are nearly 15 times more likely to be in Robert Katz, MD, chief of the anesthesiology serdegree RN or three-yearr diploma RN. Regardless of poor health than the general population, according to vice at the North Florida/South Georgia VA, based in their education or training, they all practice as nurse the society—raising their risk for complications during Gainesville, said the new policy “will definitely have an anesthetists.” and after surgery. “We believe that physician involve- impact” if it goes through. The typical CRNA workSome people familiar with the issue said the ASA’s ment is in the best interest of all patients and is particu- ing independently handles ASA status 1 and 2 patients, aggressive response to what could be considered a mat- larly appropriate and necessary for VHA patients,” the Dr. Katz said. In his facility, three-quarters of patients ter of worst-case interpretation of an ambiguous policy letter stated. are ASA status 3 and 4, primarily elderly with many indicated Dr. Fitch’s desire to assert her political bona The ASA has been working with members of Con- medical problems. If the new policy simply means that CRNAs can fides as incoming president of the society on the eve gress—unsuccessfully, so far—to urge the VHA to of her ascension to the position. Dr. Fitch campaigned reverse the policy change. The ASA also issued a “Call work independently but don’t have to, and they are on a theme of “I didn’t know what I didn’t know” as to Action” to members urging them to contact their assigned to the healthier patients with an anesthesiola nurse anesthetist—a refrain she stressed more than Congressional representatives about the proposed pol- ogist nearby in case something goes wrong, “it probaonce during the conference call. Indeed, the email alert- icy change, which, it argues, is in conflict with the bly isn’t going to affect what we do all that much. But ing reporters to the call identified her as “President VHA’s anesthesia service handbook. if they are assigned to do really sick patients with no Elect of the American Society of Anesthesiologists and backk up from a physician, I think that would not be a Federal/State Conflict Former Nurse Anesthetist.” good idea. I would expect that a fair number of really Forty states currently allow CRNAs to practice with- sick patients might get into trouble.” Short on Specifics out physician supervision, while only one, New Jersey, CRNAs Respond The document does not highlight any new clini- mandates oversight by an anesthesiologist. But health cal duties for CRNAs in the VA system. But the ASA care providers who work in the VA system fall under Frank Purcell, senior director of federal governpoints to this passage as expanding nurses’ scope of federal licensing laws, which trump state regulations. ment affairs for the American Association of Nurse practice intolerably: As a result, a CRNA working at a VA hospital in a state Anesthetists (AANA), said the VA change, which “APRNs [advanced practice nurses] practice as inde- that required physician oversight would be permitted his group has been aware of for some time, is not a pendent providers without regard to State Practice the wider scope of practice. Approximately 700 to 800 see VA change page 34 -4 0. 0 -4 5. 45 0 .1 -5 4. 0 40 .1

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AnesthesiologyNews.com I 29

TE CH N OL OG Y

Designing Women Helping Shape the Future of Anesthesia

hen doctors run into problems in the middle of a procedure, they make do with the tools at hand. Most move on, but a few are inspired to find solutions for the problem that just left them bedeviled. But the path from inspiration to successful innovation is not for the faint of heart. More than genius, it requires what Thomas Edison, the world’s most famous inventor—and the one who holds the most patents—called “stickk to-it-iveness,” sometimes to a painful degree. To those with an inventor’s mindset, the desire to solve puzzles, create solutions and make their mark drives them forward. So it is for two women whose respective efforts to resolve a postoperative pain management dilemma and simplify the process of safely inflating a child’s endotracheal tube illustrate how anesthesiologists with an inventive spirit can turn clinical headaches into puzzles to solve. Inspiration for a new patientcontrolled analgesia (PCA) system struck inventor and anesthesiologist Pamela Palmer, MD, PhD, as she was fielding calls from malpractice lawyers. That role had fallen to her as head of the Acute Pain Management Center at the University of California, San Francisco Medical Center at Mount Zion, from 1995 to 2005. “I kept hearing about all these problems with postoperative IV PCA opioids,” Dr. Palmerr said. “Sometimes there was an obvious smoking gun, such as a misprogramming of the pump, but sometimes they didn’t know what went wrong. They couldn’t get data off the pump, or maybe data was missing. Sometimes a physician may have been writing inappropriate dosing orders for a patient.” In particular, there was the case of a 68-year-old, 4-foot 11-inch female patient found dead at 2 a.m. “I was peeling back the layers of the patient’s record like an onion,” Dr. Palmer recalled. “The patient was very anxious and opioid-naive. The physician kept increasing her morphine PCA dose and it all finally hit her in the middle of the night. In the end she hadn’t dosed the IV PCA since 10 p.m., but the delayed penetration of morphine and its metabolites into the brain are known to cause potential problems.” Dr. Palmer,r who earned her doctorate in neuroscience, said it made her think there had to be a better system for these patients. “There are better drugs than

morphine. And it’s silly to have people pushing around a pole with six feet of swinging tubing inserted into their arm. It’s archaic. No one has significantly improved patient-controlled analgesia in 40 years.” So that’s what Dr. Palmerr decided to do. In 2005, she cofounded AcelRx, a pharmaceutical company focused on innovative therapies for the treatment

of acute and breakthrough pain, where she is currently chief medical officer (see article, page 49). Inventing was not new to her. In 1994, Dr. Palmerr helped cofound Omeros, a biopharmaceutical company, where she helped develop perioperative irrigation solutions to address another flaw she had identified while still in medical school at Stanford University.

“I watched orthopedic surgeons run liters of salt water through joints as they operated on them and I thought, ‘Why don’t they put something therapeutic in the irrigation like an analgesic or an anti-inflammatoryy drug,’” she said. Inventing seems to come naturally to Dr. Palmer, r who has an undergraduate degree in electrical engineering. “I think see invent page 34

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T E C H NO L O G Y

Program Targets PGY-1 â&#x20AC;&#x2DC;Lostâ&#x20AC;&#x2122; Year

nesthesia interns who may fear losing basic anesthesia skills between graduating from medical school and starting their residency training now have an online tool that not only helps bridge the gap year but boosts confidence in the process. Successful Transition to Anesthesia Residency Training (START) is a 10-month program created by researchers at Stanford Universityâ&#x20AC;&#x2122;s Anesthesia Informatics and Media Lab that includes online video lectures, collaborative activities and feedback for interns. â&#x20AC;&#x153;We felt there was an opportunity to teach our interns some anesthesia during that internship year. Enough so that when they come to start residency training, they donâ&#x20AC;&#x2122;t feel like a deer in headlights,â&#x20AC;? said Larry Chu, MD, MS, co-directorr of START and director of the Anesthesia Informatics and Media Lab. â&#x20AC;&#x153;They have some view of the landscape; they come feeling more prepared to begin residency training in anesthesia.â&#x20AC;? A prospective, observational multicenter trial compared 14 basic anesthesia skills and selff reportedd confidence in 75 postgraduate year (PGY) 1 interns who participated in the 2011-2012 START program and 75 interns from the previous year who did not participate in the program. Test scores for interns across four universities improved 34.5%, according to research presented at the 2013 Society for Technology in Anesthesia (abstract 8). Not only did basic anesthesia skills improve, but in follow-up surveys of 37 START participants, the majority reported less stress at the beginning of their residency (81%) and said that their school cared more about their education (92%). â&#x20AC;&#x153;Internet learning is here to stay and it is going to integrate more and more into what we do. But it is not going to be a substitute; it is going to be in addition to other learning methods, specifically learning directly from patient care experiences,â&#x20AC;? said Alex Djuricich, MD, associate dean for continuing medical education at the Indiana University School of Medicine, in Indianapolis, who writes a blog called Mired in MedEd. Dr. Djuricich was not involved in the current study. Three factors drive Internet learning for interns in anesthesia or other specialties: the tech-savvy millennial generation, increased use of tablet devices and importantly, restrictions of 16-hour work days for PGYY 1 interns,

which take away an estimated 20% of hospital time to learn the same amount of material, Dr. Djuricich noted. Connecting START with resident training is a long-term goal for Dr. Chuâ&#x20AC;&#x2122;s team. â&#x20AC;&#x153;One of the things we hope to show someday is T1-level evidence [results achieved in an educational setting] that through this stimulation, our residents are performing better. But, itâ&#x20AC;&#x2122;s

very difficult to show T3-levell outcomes [improved patient and public health] from a research methodology point of view,â&#x20AC;? he said. Translating how START affects patients may be difficult to assess, but as the program rolls out, Dr. Chu and his colleagues will have additional data to examine the effects of START on residents and patients.

INDICATIONS ULTIVAÂŽ (remifentanil HCl) for Injection is indicated for intravenous administration: t "T BO BOBMHFTJD BHFOU GPS VTF EVSJOH UIF JOEVDUJPO BOE NBJOUFOBODF PG HFOFSBM BOFTUIFTJB GPS JOQBUJFOU BOE PVUQBUJFOU QSPDFEVSFT t 'PS DPOUJOVBUJPO BT BO BOBMHFTJD JOUP UIF JNNFEJBUF QPTUPQFSBUJWF QFSJPE JO BEVMU QBUJFOUT VOEFS UIF EJSFDU TVQFSWJTJPO PG BO BOFTUIFTJB QSBDUJUJPOFS JO B QPTUPQFSBUJWF BOFTUIFTJB DBSF VOJU PS JOUFOTJWF DBSF TFUUJOH t "T BO BOBMHFTJD DPNQPOFOU PG NPOJUPSFE BOFTUIFTJB DBSF JO BEVMU QBUJFOUT

START began in 2009, and a year later included Yale University, in New Haven, Conn., the University of California, Davis and Mount Sinai School of Medicine, in New York City. In 2012, the program grew to eight institutions and in 2013, the program will include two Canadian medical schools. In all cases, the institutions approached Dr. Chuâ&#x20AC;&#x2122;s team to be included. â&#x20AC;&#x153;Iâ&#x20AC;&#x2122;m very impressed with it. It looks like it was well thought out; it looks like they made a special effort to

6-5*7" JT B SFHJTUFSFE USBEFNBSL PG (MBYP (SPVQ -JNJUFE 5IF .ZMBO MPHP JT B SFHJTUFSFE USBEFNBSL PG .ZMBO *OD

IMPORTANT RISK INFORMATION $POUJOVPVT JOGVTJPOT PG 6-5*7" TIPVME CF BENJOJTUFSFE POMZ CZ BO JOGVTJPO EFWJDF *7 CPMVT BENJOJTUSBUJPO PG 6-5*7" TIPVME CF VTFE POMZ EVSJOH UIF NBJOUFOBODF PG HFOFSBM BOFTUIFTJB *O OPOJOUVCBUFE QBUJFOUT TJOHMF EPTFT PG 6-5*7" TIPVME CF BENJOJTUFSFE PWFS UP TFDPOET *OUFSSVQUJPO PG BO JOGVTJPO PG 6-5*7" XJMM SFTVMU JO SBQJE PGGTFU PG FGGFDU 3BQJE DMFBSBODF BOE MBDL PG ESVH BDDVNVMBUJPO SFTVMU JO SBQJE EJTTJQBUJPO PG SFTQJSBUPSZ EFQSFTTBOU BOE BOBMHFTJD FGGFDUT XJUIJO UP NJO VQPO EJTDPOUJOVBUJPO PG 6-5*7" BU SFDPNNFOEFE EPTFT %JTDPOUJOVBUJPO PG BO JOGVTJPO PG 6-5*7" TIPVME CF QSFDFEFE CZ UIF FTUBCMJTINFOU PG BEFRVBUF QPTUPQFSBUJWF BOBMHFTJB QBSUJDVMBSMZ XIFSF QPTUPQFSBUJWF QBJO JT BOUJDJQBUFE 7JUBM TJHOT BOE PYZHFOBUJPO NVTU CF DPOUJOVPVTMZ NPOJUPSFE EVSJOH 6-5*7" BENJOJTUSBUJPO 6-5*7" QSPEVDFT BEWFSTF FWFOUT UIBU BSF DIBSBDUFSJTUJD PG Ă§ PQJPJET

ÂŞ .ZMBO *OTUJUVUJPOBM

6-5 +"

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AnesthesiologyNews.com I 31

TE CH N OL OG Y â&#x20AC;&#x2DC;We felt there was an opportunity to teach our

Instead of creating a program to please everyone, â&#x20AC;&#x153;theyâ&#x20AC;&#x2122;re actually doing metrics to evaluate performance,â&#x20AC;? said Enough so that when they come to start residency Dr. Doyle, a member of the editorial board of Anesthesiology News. â&#x20AC;&#x153;They training, they donâ&#x20AC;&#x2122;t feel like a deer in headlightsâ&#x20AC;&#x2122; also started off with a needs assessment. Every big educational initiative should â&#x20AC;&#x201D;Larry Chu, MD, MS begin with a needs assessment because otherwise, you can end up solving the demonstrate that the plan works,â&#x20AC;? said Dr. Doyle was not involved in the cur- wrong problem. They appear to have John Doyle, MD, PhD, staff anes- rent study, and Cleveland Clinic inte- done that fairly well.â&#x20AC;? thesiologist at the Cleveland Clinic grates the internship with anesthesia Dr. Chu and his colleagues may apply the START model to other who has researched online education. training.

interns some anesthesia during that internship year.

On Off

when you want it. when you donâ&#x20AC;&#x2122;t.

Anesthesia providers identiďŹ ed more than 150 procedures for Remi*.1 Providers interviewed recommend Remi for more than 150 procedures.1 Where could Remi beneďŹ t your practice?

NEUROLOGICAL/ EVOKED POTENTIAL

ABDOMINAL

HEAD & NECK

ORTHOPEDIC

CARDIOTHORACIC

HIGH-RISK PATIENTS

Remi gives you predictable control of depth and duration of analgesia when you need it most2 t Rapid onset of 1 to 2 minutes2 t Rapid response to dose adjustment within 5 to 10 minutes2 t Rapid offset within 5 to 10 minutes results in rapid dissipation of effect and rapid recovery2 t Unique organ-independent metabolism provides rapid elimination with no accumulation2

Visit www.aboutULTIVA.com to see where Remi could work for you. Please see Indications and Important Risk Information below and accompanying brief summary of Prescribing Information on next page for all precautions, warnings, contraindications, and adverse events.

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Ăľ NDH LH NJO 'BJMVSF UP BEFRVBUFMZ DMFBS UIF *7 UVCJOH UP SFNPWF SFTJEVBM 6-5*7" IBT CFFO BTTPDJBUFE XJUI UIF BQQFBSBODF PG SFTQJSBUPSZ EFQSFTTJPO BQOFB BOE NVTDMF SJHJEJUZ VQPO UIF BENJOJTUSBUJPO PG BEEJUJPOBM n VJET PS NFEJDBUJPOT UISPVHI UIF TBNF *7 UVCJOH

%VF UP UIF QSFTFODF PG HMZDJOF JO UIF GPSNVMBUJPO ULTIVA is contraindicated for FQJEVSBM PS JOUSBUIFDBM BENJOJTUSBUJPO 6-5*7" JT BMTP DPOUSBJOEJDBUFE JO QBUJFOUT XJUI LOPXO IZQFSTFOTJUJWJUZ UP GFOUBOZM BOBMPHT 6-5*7" 4)06-% #& 64&% */ 5)& $"3&'6--: .0/*503&% 4&55*/( #: 41&$*'*$"--: 53"*/&% 1&340/4 /05 */70-7&% */ 5)& 463(*$"- 03 %*"(/045*$ 130$&%63& 09:(&/ 4"563"5*0/ *4 50 #& $0/5*/6064-: .0/*503&% 3&464$*5"5*7& "/% */56#"5*0/ &26*1.&/5 09:(&/ "/% "/ 01*0*% "/5"(0/*45 .645 #& 3&"%*-: "7"*-"#-& 3FNJGFOUBOJM JT DPNNPOMZ SFGFSSFE UP BT 3FNJ CZ BOFTUIFTJB QSPWJEFST References: 1. Data on ďŹ le. Canonsburg, PA: Mylan Institutional; 2012. 2. ULTIVA [package insert]. Rockford, IL: Mylan Institutional LLC; 2011.

specialties with â&#x20AC;&#x153;lost-yearâ&#x20AC;? internships, such as dermatology or radiology. For now, the researchers showed that the model not only works at Stanford, but across multiple institutions. â&#x20AC;&#x153;This is the first time, as far as we know, that anyone in any medical specialty, let alone anesthesia, has shown the benefit of an online distancelearningg program designed to prepare interns for postgraduate medical education specialty training,â&#x20AC;? Dr. Chu said. â&#x20AC;&#x201D;Trevor Stokes

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T E C H NO L O G Y

Robotic Esophagectomy: Tips To Optimize Pre-Op Assessment and Reduce Injury Risk Miami Beach, Fla.—Robotic assistance may offer distinct advantages for surgery to remove esophageal cancer, but robotic esophagectomy is so new that definitive trials supporting any superiority versus open resection are still under way.

ULTIVA® for Injection

In the meantime, Katherine Grichnik, MD, outlined some important perioperative considerations based on her experience with robotic esophagectomies in a presentation at the Society of Cardiovascular Anesthesiologists 2013 annual meeting.

(remifentanil hydrochloride) For IV Use Only Rx only Brief Summary: The following is a brief summary only. Before prescribing, see complete ULTIVA prescribing information. CONTRAINDICATIONS Due to the presence of glycine in the formulation, ULTIVA is contraindicated for epidural or intrathecal administration. ULTIVAA is also contraindicated in patients with known hypersensitivity to fentanyl analogs. WARNINGS AND PRECAUTIONS Continuous infusions of ULTIVA should be administered only by an infusion device. IV bolus administration of ULTIVA should be used only during the maintenance of general anesthesia. In nonintubated patients, single doses of ULTIVA should be administered over 30 to 60 seconds. Interruption of an infusion of ULTIVA will result in rapid offset of effect. Rapid clearance and lack of drug accumulation result in rapid dissipation of respiratory depressant and analgesic effects upon discontinuation of ULTIVA at recommended doses. Discontinuation of an infusion of ULTIVA should be preceded by the establishment of adequate postoperative analgesia. Injections of ULTIVA should be made into IV tubing at or close to the venous cannula. Upon discontinuation of ULTIVA, the IV tubing should be cleared to prevent the inadvertent administration of ULTIVA at a later point in time. Failure to adequately clear the IV tubing to remove residual ULTIVA has been associated with the appearance of respiratory depression, apnea, and muscle rigidity upon the administration of additional fluids or medications through the same IV tubing. USE OF ULTIVA IS ASSOCIATED WITH APNEA AND RESPIRATORY DEPRESSION. ULTIVA SHOULD BE ADMINISTERED ONLY BY PERSONS SPECIFICALLY TRAINED IN THE USE OF ANESTHETIC DRUGS AND THE MANAGEMENT OF THE RESPIRATORY EFFECTS OF POTENT OPIOIDS, INCLUDING RESPIRATORY AND CARDIAC RESUSCITATION OF PATIENTS IN THE AGE GROUP BEING TREATED. SUCH TRAINING MUST INCLUDE THE ESTABLISHMENT AND MAINTENANCE OF A PATENT AIRWAY AND ASSISTED VENTILATION. ULTIVA SHOULD NOT BE USED IN DIAGNOSTIC OR THERAPEUTIC PROCEDURES OUTSIDE THE MONITORED ANESTHESIA CARE SETTING. PATIENTS RECEIVING MONITORED ANESTHESIA CARE SHOULD BE CONTINUOUSLY MONITORED BY PERSONS NOT INVOLVED IN THE CONDUCT OF THE SURGICAL OR DIAGNOSTIC PROCEDURE. OXYGEN SATURATION SHOULD BE MONITORED ON A CONTINUOUS BASIS. RESUSCITATIVE AND INTUBATION EQUIPMENT, OXYGEN, AND AN OPIOID ANTAGONIST MUST BE READILY AVAILABLE. Respiratory depression in spontaneously breathing patients is generally managed by decreasing the rate of the infusion of ULTIVA V by 50% or by temporarily discontinuing the infusion. Skeletal muscle rigidity can be caused by ULTIVA and is related to the dose and speed of administration. ULTIVA may cause chest wall rigidity (inability to ventilate) after single doses of >1 mcg/kg administered over 30 to 60 seconds, or after infusion rates >0.1 mcg/kg/min. Single doses <1 mcg/kg may cause chest wall rigidity when given concurrently with a continuous infusion of ULTIVA. Muscle rigidity induced by ULTIVA should be managed in the context of the patient’s clinical condition. Muscle rigidity occurring during the induction of anesthesia should be treated by the administration of a neuromuscular blocking agent and the concurrent induction medications. Muscle rigidity seen during the use of ULTIVA in spontaneously breathing patients may be treated by stopping or decreasing the rate of administration of ULTIVA. Resolution of muscle rigidity after discontinuing the infusion of ULTIVA occurs within minutes. In the case of life-threatening muscle rigidity, a rapid onset neuromuscular blocker or naloxone may be administered. ULTIVA should not be administered into the same IV tubing with blood due to potential inactivation by nonspecific esterases in blood products. PRECAUTIONS Vital signs and oxygenation must be continually monitored during the administration of ULTIVA. General: Bradycardia has been reported with ULTIVA and is responsive to ephedrine or anticholinergic drugs, such as atropine and glycopyrrolate. Hypotension has been reported with ULTIVA and is responsive to decreases in the administration of ULTIVA or to IV fluids or catecholamine (ephedrine, epinephrine, norepinephrine, etc.) administration. Intraoperative awareness has been reported in patients under 55 years of age when ULTIVA has been administered with propofol infusion rates of ≤ 75 mcg/kg/min. Rapid Offset of Action: WITHIN 5 TO 10 MINUTES AFTER THE DISCONTINUATION OF ULTIVA, NO RESIDUAL ANALGESIC ACTIVITY WILL BE PRESENT. However, respiratory depression may occur in some patients up to 30 minutes after termination of infusion due to residual effects of concomitant anesthetics. Standard monitoring should be maintained in the postoperative period to ensure adequate recovery without stimulation. For patients undergoing surgical procedures where postoperative pain is generally anticipated, other analgesics should be administered prior to the discontinuation of ULTIVA. ULTIVA should not be used as a sole agent for induction of anesthesia because loss of consciousness cannot be assured and because of a high incidence of apnea, muscle rigidity, and tachycardia. Pediatric Use: The efficacy and safety of ULTIVA as an analgesic agent for use in the maintenance of general anesthesia in outpatient and inpatient pediatric surgery have been established in controlled clinical trials in pediatric patients from birth to 12 years. In clinical trials, the clearance rate observed in neonates was highly variable and on average was two times higher than in the young healthy adult population. While a starting infusion rate of 0.4 mcg/kg/min may be appropriate for some neonates, an increased infusion rate may be necessary to maintain adequate surgical anesthesia, and additional bolus doses may be required. The individual dose for each patient should be carefully titrated (see ULTIVA Prescribing Information [PI], DOSAGE AND ADMINISTRATION, Table 11). ULTIVA has not been studied in pediatric patients for use as a postoperative analgesic or as an analgesic component of monitored anesthesia care. Geriatric Use: Of the total number of subjects in clinical studies of ULTIVA, 486 were in the age range 66 to 90 years. While the effective biological half-life of remifentanil is unchanged, elderly patients have been shown to be twice as sensitive as the younger population to the pharmacodynamic effects of remifentanil. The recommended starting dose of ULTIVA should be decreased by 50% in patients over 65 years of age. Use in Morbidly Obese Patients: As for all potent opioids, caution is required with use in morbidly obese patients because of alterations in cardiovascular and respiratory physiology. Long-term Use in the ICU: No data are available on the long-term (> 16 hours) use of ULTIVA as an analgesic in ICU patients. Carcinogenesis, Mutagenesis, Impairment of Fertility: Animal carcinogenicity studies have not been performed with remifentanil. Remifentanil did not induce gene mutation in prokaryotic cells in vitroo and was not genotoxic in an in vivoo rat assay. No clastogenic effect was seen in hamster or mouse studies. In the in vitroo mouse lymphoma assay, mutagenicity was seen only with metabolic activation. Remifentanil has been shown to reduce fertility in male rats when tested after approximately 40 times the maximum recommended human dose (MRHD). The fertility of female rats was not affected at IV doses as high as 1 mg/kg when administered for at least 15 days before mating. Pregnancy Category C: Teratogenic effects were not observed in either rats or rabbits following administration of remifentanil at doses up to 400 times and 125 times the MRHD, respectively. Administration of radiolabeled remifentanil to pregnant rabbits

Robotic esophagectomy is “a technique that has arisen quickly, especially in the last two years,” said Dr. Grichnik, professor of anesthesia and critical care at Duke University School of Medicine, in Durham, N.C. Staff experience, preparation and patient positioning all

and rats demonstrated significant placental transfer to fetal tissue. There are no adequate and well-controlled studies in pregnant women. ULTIVA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Administration of remifentanil to rats throughout late gestation and lactation at IV doses up to 400 times the MRHD in terms of mg/m2 of body surface area, had no significant effect on the survival, development, or reproductive performance of the F1 generation. Animal Toxicology: Intrathecal administration of the glycine formulation without remifentanil to dogs caused agitation, pain, hind limb dysfunction, and incoordination. These effects are believed to be caused by the glycine. Glycine is a commonly used excipient in IV products and this finding has no relevance for IV administration of ULTIVA. Labor and Delivery: Respiratory depression and other opioid effects may occur in newborns whose mothers are given ULTIVA shortly before delivery. The safety of ULTIVA during labor or delivery has not been demonstrated. Placental transfer studies in rats and rabbits showed that pups are exposed to remifentanil and its metabolites. In a human clinical trial, the average maternal remifentanil concentrations were approximately twice those seen in the fetus. In some cases, however, fetal concentrations were similar to those in the mother. The umbilical arteriovenous ratio of remifentanil concentrations was approximately 30% suggesting metabolism of remifentanil in the neonate. Nursing Mothers: It is not known whether remifentanil is excreted in human milk. After receiving radioactive-labeled remifentanil, the radioactivity was present in the milk of lactating rats. Because fentanyl analogs are excreted in human milk, caution should be exercised when ULTIVA is administered to a nursing woman. ADVERSE EVENTS In controlled clinical trials in approximately 2770 adult patients, ULTIVA produced adverse events characteristic of μ-opioids, such as respiratory depression, bradycardia, hypotension, and skeletal muscle rigidity. These adverse events dissipated within minutes of discontinuing or decreasing the infusion rate of ULTIVA. Table 1: Adverse Events Reported in ≥ 1% of Adult Patients in General Anesthesia Studies* at the Recommended Doses† of ULTIVA Induction/Maintenance Adverse Event Nausea Hypotension Vomiting Muscle rigidity Bradycardia Shivering Fever Dizziness Visual disturbance Headache Respiratory depression Apnea Pruritus Tachycardia Postoperative pain Hypertension Agitation Hypoxia

ULTIVA (n=921)

Alfentanil/ Fentanyl (n=466)

Postoperative Analgesia ULTIVA (n=281)

Morphine (n=98)

After Discontinuation ULTIVA (n=929)

Alfentanil/ Fentanyl (n=466)

8 (<1%) 178 (19%) 4 (<1 % ) 98 (11%)‡ 62 (7%) 3 (<1%) 1 (<1%) 0 0 0

0 30 (6%) 1 (<1%) 37 (8%) 24 (5%) 0 0 0 0 0

61 (22%) 0 22 (8%) 7 (2%) 3 (1%) 15 (5%) 2 (<1%) 1 (<1%) 0 1 (<1%)

15 (15%) 0 5 (5%) 0 3 (3%) 9 (9%) 0 0 0 1 (1%)

339 (36%) 16 (2%) 150 (16%) 2 (<1%) 11 (1%) 49 (5%) 44 (5%) 27 (3%) 24 (3%) 21 (2%)

202 (43%) 9 (2%) 91 (20%) 1 (<1%) 6 (1%) 10 (2%) 9 (2%) 9 (2%) 14 (3%) 8 (2%)

1 (<1%) 0 2 (<1%) 6 (<1%) 0 10 (1%) 2 (<1%) 0

0 1 (<1%) 0 7 (2%) 0 7 (2%) 0 0

19 (7%) 9 (3%) 7 (2%) 0 7 (2%) 5 (2%) 3 (1%) 1 (<1%)

4 (4%) 2 (2%) 1 (1%) 0 0 3 (3%) 1 (1%) 0

17 (2%) 2 (<1%) 22 (2%) 10 (1%) 4 (<1%) 12 (1%) 6 (<1%) 10 (1%)

20 (4%) 1 (<1%) 7 (2%) 8 (2%) 5 (1%) 8 (2%) 1 (<1%) 7 (2%)

*Does not include adverse events from cardiac studies or the neonatal study. See ULTIVA PI, Tables 6, 7, and 8 for cardiac information. † See ULTIVA PI, Table 10 for recommended doses. Not all doses of ULTIVA were equipotent to the comparator opioid. Administration of ULTIVA in excess of the recommended dose (i.e., doses >1 and up to 20 mcg/kg) resulted in a higher incidence of some adverse events: muscle rigidity (37%), bradycardia (12%), hypertension (4%), and tachycardia (4%). ‡ Included in the muscle rigidity incidence is chest wall rigidity (5%). The overall muscle rigidity incidence is <1% when remifentanil is administered concurrently or after a hypnotic induction agent. In the elderly population (> 65 years), the incidence of hypotension is higher, whereas the incidence of nausea and vomiting is lower. DRUG ABUSE AND DEPENDENCE ULTIVA is a Schedule II controlled drug substance that can produce drug dependence of the morphine type and has the potential for being abused. OVERDOSAGE As with all potent opioid analgesics, overdosage would be manifested by an extension of the pharmacological actions of ULTIVA. Expected signs and symptoms of overdosage include: apnea, chest-wall rigidity, seizures, hypoxemia, hypotension, and bradycardia. In case of overdosage or suspected overdosage, discontinue administration of ULTIVA, maintain a patent airway, initiate assisted or controlled ventilation with oxygen, and maintain adequate cardiovascular function. If depressed respiration is associated with muscle rigidity, a neuromuscular blocking agent or a μ-opioid antagonist may be required to facilitate assisted or controlled respiration. Intravenous ﬂuids and vasopressors for the treatment of hypotension and other supportive measures may be employed. Glycopyrrolate or atropine may be useful for the treatment of bradycardia and/or hypotension. Intravenous administration of an opioid antagonist such as naloxone may be employed as a speciﬁc antidote to manage severe respiratory depression or muscle rigidity. Respiratory depression from overdosage with ULTIVA is not expected to last longer than the opioid antagonist, naloxone. Reversal of the opioid effects may lead to acute pain and sympathetic hyperactivity. ULTIVA is a registered trademark of Glaxo Group Limited. US Patent Nos. 5,019,583; and 5,866,591 Version C, 07/2011 Manufactured for Mylan Institutional LLC, Rockford, IL 61103 Manufactured by Hospira, Inc. Lake Forest, IL 60045

are important considerations. After the training, investment—the cost of the robot alone can reach $1.5 million or more, atop which come annual service fees—and other preoperative preparation for robotic-assisted esophagectomy, it’s important to consider the experience of the perioperative team, including the surgeon and the operating room (OR) staff. For example, preoperative placement of an epidural catheter is not usually indicated but may be considered when working with less-experienced robotic surgeons as the potential for conversion to an open procedure is greater, Dr. Grichnikk told Anesthesiology News. “Know your surgeon and where they are on the learning curve for robotic esophagectomy,” Dr. Grichnikk said. “If the surgeon has a high conversion rate, then a preoperative thoracic epidural may be appropriate.” This strategy obviates the need to place a thoracic epidural postoperatively, after the patient is awake, in the event of conversion to an open procedure, she explained. “It’s not just the surgeon. There is a learning curve for the whole team,” Dr. Grichnik said. “We have a team of people taking care of these patients, including the OR personnel, nursing team and anesthetic team.” Concerns about patient safety, of course, do not stop at induction. The unique OR environment for robotic esophagectomy requires anesthesiologists and all OR staff to be prepared for adverse events during the procedure, said Dr. Grichnik, who also directs the Center for Educational Excellence at the Duke Clinical Research Institute. Injury prevention, for example, becomes more challenging when the robotic arms or other components of the da Vinci Surgical System (Intuitive Surgical, Inc.) limit access to the patient. “Be knowledgeable about and prepared for untoward events from the procedure itself, such as organ injury, fire or instrument failure,” Dr. Grichnik said. “This primarily means being prepared to resuscitate or participate in solving a problem such as electrical arcing.” She added, “Yes, believe it or not, a fire in the abdomen has been reported.” More common potential problems include injury to nearby organs,

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AnesthesiologyNews.com I 33

TE CH N OL OG Y hemodynamic instability, the effects from a pneumoperitoneum and endoscopic malfunctions, Dr. Grichnikk said. Clinicians should anticipate unique complications related to minimally invasive surgery, including the possibility that a patient might develop subcutaneous emphysema from CO2 insufflation. Precise patient positioning is important to minimize injuries—corneal abrasions and nerve and crush injuries have been reported, she said. It is important to “anticipate the changes to the patient physiology due to positions such as lateral, prone or Trendelenberg, especially in patients with multiple comorbid diseases,” Dr. Grichnik added. “Once the robot is in place, the table and [patient] position cannot change.” Clinicians also should pay strict attention to securing the endotracheal tube well in the correct position, Dr. Grichnikk advised. They also should check to ensure that IV lines are placed appropriately and function well once the patient is in his or her final position for robotic esophagectomy. An arterial line is advised and all patients are candidates for a central line. Advantages of a robotic-assisted approach to esophagectomy for the surgeon include enhanced dexterity and articulation, motion stability and scaling, as well as the ability to see structures up to 10 times larger with the three-dimensionall camera, Dr. Grichnik said. “However, patients really chose robotics for the perception of an improved quality of life, less scarring and being able to get back to activities of daily living more quickly,” she noted. The stage, and not the specific type of esophageal cancer, generally dictates survival, Dr. Grichnik said. “Overall

da Vinci Surgical System (Intuitive Surgical, Inc.)

survival at five years is miserable: 11% to 18%. Thus, this is one type of cancer where we have to pay a lot of attention to quality of life.” Proponents of robotics also point to equal or better resection of esophageal squamous cell carcinoma or adenocarcinoma compared with open surgery. Generally less blood loss during surgery is another advantage. Dr. Grichnik’s clinical tips are “very insightful,” said James Clark, MD, of the Department of Surgery and Cancer

at the Royal College of London, in England. “These issues are relevant not only to robotic esophagectomy, but also to prostatectomy and robotic TME [total mesorectal excision].” Many unanswered questions regarding the clinical advantages of robotic-assisted versus open esophageal resection might be answered by a direct comparison under way at University Medical Center Utrecht in The Netherlands (Trials 2012;13:230). The researchers plan to randomize

112 patients to either robotic or open resection in this single-center controlled trial. All participants will receive a thoracic epidural preoperatively, Dr. Grichnik noted. The primary aim of the study, which began in January 2012, is to compare oncologic outcomes and quality of life over five years of follow-up. —Damian McNamara Dr. Grichnik is a consultant for online course educational material provided by Intuitive Surgical, Inc. Dr. Clark had no relevant financial disclosures.

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T E C H NO L O G Y INVENT

‘It’s important to check that

groups to address the details to make it fully operational and to make molds the idea can be viable from the training I have from that degree means that when I for mass production. During this time, see something that is logically intuitive and improves she also secured domestic and interbeginning to end and to get something, it drives me crazy not to follow it up to a national patents. Finally, she said, the conclusion.” finish line is within sight. “Beta proa patent review to make sure She also credits her educational and professional totypes are finished, and I’m working environment as being fundamental to her career path. there’s not another product like on a sublicense agreement right now “It’s really the community that you’re brought up in. As with a sole provider. The next steps a medical student at Stanford, we were almost bred left are validating studies and to see it it, even in other countries.’ to invent things. Many of my fellow students started Joan Spiegel, MD on the market.” companies.” But it’s not all sunshine. “I call this the unpredictable project of a thouOther successful inventors from her time at StanDr. Spiegel founded Beaver Medical—named for ford include Wesley Sterman, MD, and John Stevens, the mascot of her alma mater, the Massachusetts Insti- sand paper cuts,” she said. “Inventing is fraught with MD, who started Heartport, Inc., to develop a system tute of Technology—which makes safety products pitfalls and unexpected manufacturing and finanfor minimally invasive cardiac surgery; George Tid- for anesthesia and critical care. Like Dr. Palmer, r she cial problems. While developing ideas is exciting, marsh, MD, PhD, founder or top executive at several has been heavily involved in every step of the devel- when one decides to take it from beginning to end, it biotechnology firms including Threshold Pharma- opment of her invention, a syringe used to simultane- requires a lot of tenacity and financial support. There ceuticals, Horizon Pharma and La Jolla Pharmaceuti- ously inflate the cuff of a patient’s endotracheal tube are unexpected events like patent infringement and cal Co.; and Gregory Demopulos, MD, who helped and measure the pressure within. there are a lot of what-ifs?” Dr. Palmerr launch Omeros. Dr. Spiegel’s interest in inventing has been bolstered Dr. Spiegell doesn’t identify any kind of institutional Although she has partnered with experts in business, by her professional community. “This is a path that gender-related roadblocks, but she acknowledged engineering, finance and regulatory affairs to develop is recognized by Harvard and by medical schools. It’s that between her full clinical load and demands in and promote her ideas, Dr. Palmer remains closely a way to be promoted academically. There is a collab- her personal life, she has to push herself hard to build involved in all aspects of the invention process, from orative infrastructure in place, awards, and a template her business in whatever spare time she can scrape engineering and property rights to financing. AcelRx encouraging innovation.” together. “I think women feel guilty in every place went public in 2011 and has been through two rounds In late 2009, she submitted her concept to a compe- they are physically not present, whether it’s with their of funding since then. She is the first author on many tition at MIT. Although it was possible to submit just husband, child or work. I feel the guilt as a mother.” of her products’ patents. “We have them throughout an idea, she came in with drawings. “This was a wellDr. Spiegel, a member of the Anesthesiology News the world at this point, and because it is quite novel, known class where you enter your seed-like potential editorial board, recommends that would-be inventors there is quite broad coverage from a drug and device medical ideas,” she explained. “The project was sim- get good advice and protection from an intellectual standpoint,” she said. plistic enough for a group of grad students to finish it property expert early in the process. “It’s important to In an industry dominated by men, Dr. Palmerr said in three months, which was very appealing to them. So check that the idea can be viable from beginning to end and to get a patent review to make sure there’s not she has not felt any particular challenges in terms of they chose me and they ran with that ball.” her gender: “I don’t think I’ve been another product like it, even in other countries,” she hurt or helped by being a woman. said. “Also, talk with others who’ve done this.” ‘I think the training I have Maybe this is because I’m living in Another thing to consider is whether the market the Bay Area with so many smart will be willing to pay for a new product. Anesthesiolfrom [engineering] means that people around me. People get ogists are not rewarded for doing procedures that add excited about the merit of scientific any cost. For example, she said, “We don’t get reimwhen I see something that is ideas and not necessarily who they bursed for using a lot of devices and for the difficulty come from.” of the procedure. We get paid by our time spent with logically intuitive and improves the patient rather than what it took to have the same Engineering a something, it drives me crazy not outcome. There is a huge incentive to be frugal.” Safer Airway That’s not to say there isn’t opportunity for a device to follow it up to a conclusion.’ Pamela Palmer, MD, PhD that can save lives or reduce pain or discomfort. “If Across the country, another anesthesiologist-inventor is simithere is a need, there’s always room for a device but it has to be cross-referencedd with cost,” Dr. Spiegel said. larly drawing on her clinical experience to come up with new solutions. “I’ve always had The support of the grad students, who gave her “Devices are becoming commoditized unless they are a book of ideas,” said Joan Spiegel, MD, of Beth Israel extra encouragement, was a logistical and emotional very unique or improve outcomes. They can’t just be Deaconess Center and assistant professor at Harvard boost. Their work left Dr. Spiegel with an initial pro- cool or new.” Medical School, both in Boston. totype, which she then took to private engineering —Jennifer Hanawald CONTINUED FROM PAGE 29

VA CHANGE

CONTINUED FROM PAGE 26

change at all but a “confirmation of what advanced practice nurses do”— not only in the VA system but elsewhere. Mr. Purcell said the draft document implicitly endorses a call from the Institutes of Medicine to allow CRNAs and other APRNs to practice independently. “This is something that physicians and nurses, some of the most distinguished experts in

health care, have recommended.” And Mr. Purcell disputed the notion that the nursing handbook disbands the care team in VA hospitals. “Nurse anesthetists would be continuing to serve in the interests of the veterans who are under their care and serve as part of a group of expert health care professionals. In the VA system, no provider of any type, physician or nurse, is an island.” In an Aug. 30, 2013, letter to the VHA, the AANA and the Association

of Veterans Affairs Nurse Anesthetists praised the new handbook while objecting to what the groups said were “inaccurate and misleading statements” from the ASA about the document. For example, the letter states, “neither the VHA draft Nursing Handbook nor the term ‘Licensed Independent Practitioner’ [LIP] suggest that CRNAs and other APRNs would be ‘required’ to function without physician involvement should the VHA designate APRNs

as LIP. Understanding that the VHA looks to the Department of Defense for information and healthcare delivery standards, the agency should be aware that branches of our U.S. Armed Forces have recognized CRNAs as LIP for a decade or more, and that those military CRNAs have compiled an outstanding safety record delivering care in major stateside hospitals and in the most austere conditions in theater.” —Adam Marcus

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C LIN I C A L A N ES THES IO LO G Y ERAS

at Duke University, in Durham, N.C., who led the work. the novel program had significantly Dr. Gan and his colleagues studreduced lengths of stay and 30-day ied 236 patients undergoing elective readmission rates, as well as potentially colorectal surgery. Patients within the lower hospital costs, than those who ERAS program (n=137) were comreceived conventional care. pared with a historical cohort of 99 “Enhanced recovery after surgery is consecutive patients who did not go a concept that integrates a number of through the program. evidence-based practices into proto“Patient education is important colized care, in this case into colorectal with the ERAS program, so we edusurgery patients,” said Tong Joo (T.J.) cate our patients about their care and Gan, MD, vice chair of anesthesiology what they’ll be going through,” said CONTINUED FROM PAGE 1

Dr. Gan, whose group presented its findings at the 2013 annual meeting of the International Anesthesia Research Society (abstracts S-124 and S-152) and the 2013 annual meeting of the American Society of Anesthesiologists (abstract 4293). “Preoperatively, instead of starving them for six to eight hours, we actually give them a carbohydrate drink up to two hours before surgery. We use an epidural for every case, whether the procedure is open or laparoscopic, plus multimodal analgesia

with IV acetaminophen and [nonsteroidal anti-inflammatoryy drugs].” As part of the program, patients undergo esophageal Doppler monitoring (Cardio Q, Deltex) to track their fluid management. Patients are encouraged to start consuming fluids the night of surgery, and solid food the following day. Early ambulation is also a key component of the ERAS program. The investigators found that mean length of stay was 8.4 days in nonERAS patients compared with six days for those who went through the ERAS program (P<0.001). Rates of readmission 30 days after surgery were 20.2% and 8.8%, respectively (P=0.012). Median postoperative crystalloid consumption was 10.5 L in non-ERAS patients and 4.6 L in ERAS patients (P<0.001) (Table). Use of opioids after surgery was significantly greater among non-ERAS patients (196±191 mg) than their counterparts (85±175 mg). Perhaps not surprisingly, mean total hospitalization costs were $3,640 (15.8%) lower for ERAS patients ($19,344) than non-ERAS patients ($22,984). These differences reached statistical significance with respect to costs for lab tests ($856 vs. $1,172; P=0.011) and chest x-rays ($135 vs. $262; P=0.046), but not overall. The investigators also examined the level of practitioner compliance with ERAS protocols, and the effect, if any, between full and partial compliance on patient outcomes. They found that 74 of the 137 ERAS patients had full compliance. Patients who received fully compliant care were in the hospital for a mean of 5.7 days compared with 6.3 days for those who received partially compliant care. Thirtydayy readmission rates were 5.4% and 12.7%, respectively. Median consumption of postoperative crystalloids was greater in patients who received Table. Adherence to the Early Recovery After Surgery (ERAS) Program Significantly Improved Patient Outcomes

Length of stay (mean, median) 30-day readmission Postoperative crystalloid use (median, L) Postoperative colloid use (median, L)

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AnesthesiologyNews.com I 37

CLINICAL ANESTHESI OLOGY

TemporalScannerâ&#x201E;˘

â&#x20AC;&#x2DC;Given that the ERAS protocol was associated with shorter length of stay and less cost, we are beginning to extend the program to other proceduresâ&#x20AC;&#x2122; â&#x20AC;&#x201D;Tong Joo (T.J.) Gan, MD fully compliant care (4.7 L vs. 3.8Â L), whereas mean postoperative morphine equivalent consumption was comparable. â&#x20AC;&#x153;Given that the ERAS protocol was associated with shorter length of stay and less cost, we are beginning to extend the program to other procedures,â&#x20AC;? Dr. Gan said. Clinicians Failing To Heed Fluid Message Elizabeth A.M. Frost, MD, professor of anesthesiology at the Carl Icahn School of Medicine at Mount Sinai, in New York City, said that although the benefits of fluid restriction have been understood for at least a decade, few clinicians have heard the message. â&#x20AC;&#x153;Physicians are very slow to change and still cling to fluid resuscitation,â&#x20AC;? said Dr. Frost, a member of the Anesthesiology News editorial board. â&#x20AC;&#x153;The DukeÂ researchers are reemphasizing the point of the need for fluid restriction rather than continuing with Shireâ&#x20AC;&#x2122;s old concept of replacing the third spaceâ&#x20AC;&#x201D;which asÂ we know, does not exist,â&#x20AC;? Dr. Frost said. Although the patient population is small, the findings are statistically significant and agree with multiple recent, and not so recent,Â studies, she added.

â&#x20AC;&#x153;The nextÂ step is to get TEE [transesophageal echocardiography] capability into all operating rooms and train all anesthesiologists in interpretation of theÂ findings. We are a long way from that point. Another useful technique is the several computerized machines that are now available that display stroke volume variationÂ or pulse pressure variation along with cardiac output on a single screen.â&#x20AC;? However, these technologies are expensive and require both arterial cannulation and controlled ventilation, which may not be feasible in an awake patient in the ICU. Another way to assess fluid requirementsÂ is by measuring lung water, a simple and noninvasive scanning technique. â&#x20AC;&#x153;It would be interesting to find out howÂ well ERAS protocol compliance has increased and/or infiltrated surgical management at this major academic center, perhaps as a benchmark for otherÂ institutions,â&#x20AC;? Dr. Frost concluded. â&#x20AC;&#x153;I think this is the way most hospitals are going to go, especially with the new health care system,â&#x20AC;? Dr. Gan said. â&#x20AC;&#x153;In fact, following this study, our hospital administration asked our other surgeons to incorporate ERAS into their practice. And I think thatâ&#x20AC;&#x2122;s probably going to spread.â&#x20AC;? â&#x20AC;&#x201D;Michael Vlessides

ERAS

P Value

Non-ERAS

Total ERAS

Fully/nearly Compliant

Partially Compliant

Non-ERAS vs. Total ERAS

8.4 (7)

6.0 (5)

5.7 (4.5)

6.3 (5)

<0.001

20.2%

8.8%

5.4%

12.7%

0.012

10.5

4.6

4.7

3.8

<0.001

0.25

0.15

>0.05

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C LIN I C A L A N ES THES IO LO G Y

Newer Oral Anticoagulants: Advice for Anesthesiologists Miami Beach, Fla.â&#x20AC;&#x201D;The newer oral anticoagulant agents come with distinct advantages for patients with atrial fibrillation (A-Fib) compared with traditional therapies like warfarin or lowmolecular-weight heparin, but their use also comes with some caveats. In addition to the convenience of oral dosing, treatment with dabigatran (Pradaxa, Boehringer Ingelheim),

rivaroxaban (Xarelto, Janssen) or apixaban (Eliquis, Bristol-Myers Squibb) can mean a relatively fast onset, no need for monitoring and rapid clearance for most patients with normal renal function, said Jerrold H. Levy, MD, professor of anesthesiology and co-director of the Cardiothoracic Intensive Care Unit at Duke University Medical Center, in Durham, N.C.

â&#x20AC;&#x153;The advantage of these agents is you donâ&#x20AC;&#x2122;t have to monitor them,â&#x20AC;? said Dr. Levy, y who gave a presentation on the drugs at the 2013 annual meeting of the Society of Cardiovascular Anesthesiologists. â&#x20AC;&#x153;What I find so useful in the ICU is the patient who develops A-Fib, you start a dose of dabigatran or rivaroxaban, and after two to four hours, they are therapeutic. The

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new oral agents, the direct thrombin inhibitor dabigatran and the [factor] Xa inhibitors rivaroxaban and apixaban, provide a whole new coagulation perspective.â&#x20AC;? These oral anticoagulants are indicated only for patients with A-Fib but without valve disease, Dr. Levyy emphasized. Rivaroxaban also is approved for treatment of and reduction in the risk for recurrent deep vein thrombosis (DVT) and pulmonary embolism and for DVT prophylaxis after knee or hip replacement surgery. Clinicians should use the drugs with caution in patients with renal dysfunction and adjust the doses as recommended. Dr. Levyy admitted that the newer oral anticoagulants are not without their critics. â&#x20AC;&#x153;Everyone complains about the new oral anticoagulants because they are not reversible. Well, in 2013, other agents that are widely used are not reversible,â&#x20AC;? he said. â&#x20AC;&#x153;And one of the biggest problems in a critically ill patient I see, on occasion, is lowmolecular-weight heparin [LMWH].â&#x20AC;? â&#x20AC;&#x153;With renal dysfunction, LMWH can be dangerous; the halff life is greatly prolonged, and if the patient bleeds you have to measure antiXa levels, because the prothrombin, PTT [partial thromboplastin time] and other standard tests are normal,â&#x20AC;? Dr. Levyy said. â&#x20AC;&#x153;Despite what is suggested, you cannot completely reverse LMWH with protamine. You canâ&#x20AC;&#x2122;t dialyze it; you canâ&#x20AC;&#x2122;t get rid of it and itâ&#x20AC;&#x2122;s a major concern.â&#x20AC;? The halff life of dabigatran is approximately eight hours. The agent is dosed 150 mg twice daily for patients with A-Fib with normal renal function. That changes, however, in the setting of renal dysfunction. â&#x20AC;&#x153;This drug is exquisitely sensitive to renal impairment,â&#x20AC;? Dr. Levyy said. â&#x20AC;&#x153;Alternative dosing of 75 mg twice daily is used for renal impairment.â&#x20AC;? Rivaroxaban and apixaban also are eliminated by the kidneys, but to a lesser extent than dabigatran. Only about 5% to 7% of dabigatran is actively absorbed, which means the remaining 95% gets passed through the gastrointestinal tract. â&#x20AC;&#x153;This may be why there is a potentially higher risk for gastrointestinal bleeding, although rivaroxaban has a similar effect,â&#x20AC;? Dr. Levyy said. In the setting of A-Fib, rivaroxaban is dosed once daily at 15 to 20 mg and apixaban, a more potent agent, is dosed at 5 mg twice a day.

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AnesthesiologyNews.com I 39

CL IN ICA L A N E STH E SIOL OG Y ‘What I find so useful in the ICU is the patient who develops atrial fibrillation, you start a dose of dabigatran or rivaroxaban, and after two to four hours, they are therapeutic. The new oral

… unlike warfarin,” which takes five to seven days, even with administration of vitamin K.

bleeding, avoid neuraxial procedures and follow the guidelines.” If a patient experiences bleeding related to dabigatran, hemodiDelays and Testing alysis can remove 60% of the agent For urgent procedures in patients over four hours. For bleeding associat high risk for bleeding, Dr. Levy ated with rivaroxaban, prothrombin advised delaying the surgery 24 to 48 complex concentrates based on curhours and ordering laboratory test- rent data (studies such as Circulation ing to further determine the extent of 2011;124:1573-1579 http://www.ncbi. anticoagulation. In addition, “if you nlm.nih.gov/pubmed/21900088 and have to go to ER for emergency sur- recent data presented by Dr. Levyy and gery, think about the increased risk for colleagues) are useful, but this strategy

f label, Dr. Levyy emphasized. is offMore advice regarding management of these agents perioperatively and in the ICU setting can be found in a recent issue of Anesthesiology (2013;118:1466-1474). —Damian McNamara Dr. Levy receives research support from ViroPharma; receives other financial support from The Medicines Company; and is a consultant to CSL Behring, Boehringer Ingelheim, Johnson & Johnson and Merck. Drs. Singh and Vetter had no relevant disclosures.

agents, the direct thrombin

inhibitor dabigatran and

the [factor] Xa inhibitors rivaroxaban and apixaban,

US G

Y™

provide a whole new

AT 20 13

coagulation perspective.’ —Jerrold H. Levy, MD Saket Singh, MD, a staff cardiac anesthesiologist at West Penn Allegheny Health System, in Pittsburgh, said “the use of newer anticoagulants is increasing rapidly and it is important that anesthesiologists familiarize themselves with these newer agents.” Thomas Vetter, MD, professor of anesthesiology and director of the Preoperative Assessment, Consultation, and Treatment Clinic at the University of Alabama at Birmingham, said, “With the implementation of the perioperative surgical home, anesthesiologists, serving as the patient’s primary perioperativist, can play a key, active role in the management of all anticoagulants, including these newer drugs for atrial fibrillation.” Because the FDA approved apixaban in December 2012, clinical experience with this agent is more limited. However, regarding dabigatran and rivaroxaban, Dr. Levyy said, “both drugs are effective in two to four hours. It’s pretty dramatic … [especially] if you have ever ‘warfarinized’ a patient postoperatively and spent days trying to obtain a therapeutic INR [international normalized ratio].” Clinicians can stop administration one day before procedures with a low risk for bleeding—such as an electrophysiologic intervention—and usually two days with normal renal function before those carrying a higher risk. This represents another advantage for the newer oral anticoagulants, Dr. Levyy said. “With normal renal function, dabigatran and rivaroxaban are rapidly cleared

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Correcting A-Fib in the ICU Doable, but Difficult

any critically ill patients who develop acute atrial fibrillation (A-Fib) in the ICU can be returned to regular heart rhythms— but the fix is not easy. In a recent study, Missouri researchers found the incidence of acute A-Fib at their hospital to be 3.4%, with an associated mortality rate of 33.3% and stroke rate of 5.6%. Following treatment received in the ICU and during hospitalization, 88% of surviving patients converted back to normal sinus rhythm by hospital discharge. “The treatment of A-Fib is well described, but the surprising finding in this study was that most patients required two, three or four medications” to control their arrhythmias, said Steven Trottier, MD, lead author of the study and vice chairman of the Department of Critical Care Medicine at St. Louis University School of Medicine. “That’s important, and it’s not well described in the literature.” In the study, 77% of patients needed two or three medications; 15% needed four medications; and some needed as many as five or six medications. The difficulty controlling this arrhythmia in

ICU patients may relate to its underlying cause, such as major surgery, trauma or infection, Dr. Trottier said. The rhythm is difficult to control until the precipitating etiology improves, he said. Acute A-Fib can increase the risk for stroke, heart failure or death. People with A-Fib are five times more likely to have a stroke than those without the rhythm anomaly, according to the National Stroke Association. And they are nearly 2.5 times more likely to suffer sudden cardiac death, according to a recent meta-analysis by researchers at the University of Minnesota ((JAMA Intern Medd 2013;173:29-35). Dr. Trottier and his colleagues reviewed patient records for the years 2009 to 2011 at their large, universityy affiliated hospital using the APACHE outcomes database. They monitored the number of ICU admissions, incidence of A-Fib, mortality, acute cerebrovascular accident, A-Fib treatment, hospital discharge rhythm and medications prescribed for A-Fib on discharge. During the study period, 4,772 ICU patients were entered into the database. Of these patients, 162 (3.4%) developed acute A-Fib. Nine (5.6%) A-Fib patients

developed an acute cerebrovascular accident compared with 1.9% of patients without A-Fib. The average age of patients with the condition was 74 years. Acute medical therapy was provided to 160 patients, with 82.7% receiving amiodarone alone or in combination with metoprolol or diltiazem. Eighty patients (49%) converted to normal sinus rhythm in the ICU. The average duration of A-Fib was 3.5 days. Hypotension developed in 49 patients (30%); full-dose anticoagulation (heparin, enoxaparin) was administered to 106 patients (65%). Six patients (3.7%) underwent cardioversion, of whom five had their sinus rhythm restored to normal. At the time of discharge, 13 of 108 surviving patients (12%) remained in A-Fib; medications for A-Fib were prescribed to 58 of the patients (54%). The others had returned to normal sinus rhythm. Dr. Trottier said more follow-up is warranted for patients discharged with A-Fib and related medications. Paul Marik, MD, professor and chief of pulmonary and critical care medicine at Eastern Virginia Medical School, in

Norfolk, said the study was “solid, with expected results.” He wrote about managing A-Fib in the ICU in a 2000 paper published in the Journal of Intensive Care Medicinee (15;184-190). “Unlike ambulatory patients in whom A-Fib is likely to be short-lived, in the critically ill these arrhythmias are unlikely to resolve until the underlying disease process has improved,” the paper stated. “Urgent cardioversion is indicated for hemodynamic instability. Treatment in hemodynamically stable patients includes correction of treatable precipitating factors, control of the ventricular response rate, conversion to sinus rhythm, and prophylaxis against thromboembolic events in patients who remain in A-Fib. Diltiazem is the preferred agent for rate control, while amiodarone is generally considered” to be an antiarrhythmic agent of choice. Today, Dr. Marikk said, many physicians load patients with IV magnesium to ensure adequate blood levels. The researchers reported their findings at the 2013 annual meeting of the Society of Critical Care Medicine (abstract 286). —Karen Blum

Interscalene Blocks Reduce Pain, Nausea After Shoulder Surgery

nterscalene nerve blocks diminish morphine consumption for 12 hours after shoulder surgery and also reduce pain and postoperative nausea and vomiting, according to a pilot study by Canadian researchers. “As anesthesiologists, our job is to do the best thing possible for controlling patients’ pain,” said Meggie Raymond, MD, an anesthesiology resident at the University of Sherbrooke Hospital Center near Montreal. “This study was to investigate in a systematic way the optimum block regimen for shoulder surgery.” Patients undergoing shoulder surgery are at high risk for severe postoperative pain. Previous studies have reported that interscalene (IS) blocks for ambulatory shoulder surgeries reduce postoperative nausea and vomiting (PONV), pain, unplanned hospitalizations and narcotic consumption (Anesth ( Analg 2005;101:1663-1676). Compared with general anesthesia, IS blocks also can decrease discharge time ((Anesth Analgg 1998;87:816-826). The placebo-controlled, double-blind study compared morphine consumption, postoperative pain and PONV between three groups of shoulder surgery patients who were prospectively randomized to receive either IS block alone (group 1), IS block with

subacromial (SA) block (group 2) or SA block alone (group 3). The investigators tracked each group for 48 hours postsurgery. Although the primary end point—morphine consumption at 48 hours—did not differ between groups, at 12 hours postsurgery there were clear differences in morphine consumption. Those who had received the IS block alone or in combination with the SA block consumed an average of 10 and 0 mg, respectively. Patients who received the SA block alone, in contrast, consumed an average of 48 mg. Pain scores in the postanesthesia care unit (PACU) were significantly lower in the IS groups, as was PONV. The results were to be presented at the Canadian Anesthesiologists’ Society annual meeting (abstract 1627638), which was cancelled due to flooding. “In the light of our study, which found no statistical difference between groups 1 and 2, the single-shot postoperative subacromial block doesn’t seem to add any benefit,” Dr. Raymondd said. Dr. Raymondd suggested that the lack of difference in morphine consumption at 48 hours reflected the fact that the groups required pain management at different times. “Patients without the IS block had more pain in the PACU and had their morphine loading there, but

people with th he IS block probably loadded themselves at homee when the effect of the block disappeared,” Dr. Raymond said. “We should ould keep in mind that patients must be well informed to deal with their narcotics at home to prevent rebound pain by taking appropriate analgesics before the blocks end.” “This confirms what we know from the literature; there is no reason not to do this block unless the patient has a breathing problem,” said Marie Hanna, MD, associate professor and director of the Acute Pain Service and Regional Anesthesia at Johns Hopkins Medicine, in Baltimore. “Because shoulder surgery is so painful, there is still much to do in this area,” Dr. Raymondd said. “But review studies [[Anaesthesia 2010;65:608-624; Can J Anesth 2004;51:886-891] indicate that a continuous IS block incorporating a basal local anesthetic infusion with patient-controlledd boluses is the most effective analgesic technique following both major and minor shoulder surgery.” —Keely Savoie

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PONV Drug Tarred by Fraudulent Studies Less Effective Than Bogus Data Showed

he antiemetic agent ramosetron, the subject of many of the 170-odd retractions by the disgraced Japanese anesthesiologist Yoshitaka Fujii, MD, still appears to prevent postoperative nausea and vomiting, but with somewhat less effectiveness than the previous literature (some fraudulent) had shown. Previous meta-analyses of the effect of ramosetron suggested that it reduced the risk for postoperative nausea and vomiting (PONV) by 70%. But when Takahiro Mihara, MD, PhD, staff anesthesiologist at Kanagawa Children’s Medical Center, in Japan, and his colleagues re-reviewed the literature, removing the randomized controlled trials (RCTs) by Dr. Fujii, they found that ramosetron was closer to 40% effective in reducing nausea in these patients. This is roughly equivalent to other drugs on the market, which many anesthesiologists may pass over for ramosetron, believing it to be more effective, said Dr. Mihara, presenting the results at the annual Euroanaesthesia meeting (abstract 168). “Thus, we consider that our meta-analysis may give important information mainly to those who use ramosetron as a first-line drug, hoping for its very strong effect.”

Anesthesiologists who do use ramosetron as their first choice—the drug is approved only in parts of Asia—“should consider changing their firstline drug to other drugs with similar effect, such as dexamethasone.” The purpose of the latest study, which also appeared in June in Anesthesia & Analgesia (Epub June 11), was to enable a group of Japanese anesthesiologists to “repair the vast damage” to the literature caused by Dr. Fujii’s actions, Dr. Miharaa said. “Actually, I was not interested in the effect of ramosetron because the use of ramosetron to prevent PONV is not covered by [health] insurance in Japan, and thus we cannot use ramosetron.” Last year, the Japanese Society of Anesthesiologists concluded that Dr. Fujii—who had published extensively on PONV—falsified data in the vast majority of more than 200 papers published between 1993 and 2011, most of which described RCTs. The inquiry concluded that his co-authors were unaware of the misconduct, and he even may have forged their signatures to the research, in some cases. For the new study, the researchers reviewed double-blind RCTs from MEDLINE, the Web of

Science and other sources, excluding all those authored by Dr. Fujii. They included data from 734 patients. Although analyses includ- Yoshitaka Fujii, MD ing Dr. Fujii’s work estimated that the drug reduces PONV by 70%, the new report showed its effectiveness was closer to 40%. This was not a surprise, Dr. Miharaa said. “We had considered that the effectiveness of ramosetron was overstated because of Dr. Fujii’s fabricated works.” In 2012, a consortium of 23 journals declared it would retract any falsified data from Dr. Fujii. Steven Shafer, MD, editor in chief of Anesthesia & Analgesia, who helped lead the consortium, said he was not surprised to see that ramosetron works. “It is a 5-HT3 antagonist, like ondansetron. We know that drugs in the class provide effective treatment for PONV, and are also effective as prophylaxis for PONV.” Furthermore, to obtain approval for the drug, its maker had to conduct highly scrutinized clinical trials, said Dr. Shafer, professor of anesthesiology, perioperative and pain medicine at Stanford University

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CL IN ICA L A N E STH E SIOL OG Y

Topical Anesthetic Better Than Block for Cataract Surgery

atients undergoing cataract surgery report less pain if they receive topical anesthesia instead of a retrobulbar block, researchers have found. Although a retrobulbar block (RBB) provides effective anesthesia, the procedure has been linked to several complications, including blindness, anesthesia of the brainstem and local anesthetic toxicity. In the new study, Yuna Rapoport, MD, of Vanderbilt Eye Institute in Nashville, Tenn., and colleagues reviewed patient records from 110 cataract surgeries performed at the local Veterans Affairs medical center. Of those procedures, seven involved general anesthesia, 50 an RBB, 34 topical anesthesia (with tetracaine drops) with sedation, and 19 topical anesthesia without sedation. Patients who underwent the surgery with an RBB reported experiencing more pain, as rated on a 10-point visual analog scale, than those who received a topical regimen (P=0.01), P according to the researchers.

in Stanford, Calif. “Fujii could not have contributed to the trials used for drug registration because the monitoring for drug registration trials tracks the data back to individual patient medical records. It would be impossible for any study site to fabricate the results.” Although doctors in the United States do not use ramosetron, they should be reassured that “the process that brings new drugs to the market is unlikely to be influenced by fraud,” Dr. Shafer said. But many issues remain to be addressed, he added. The study compared ramosetron with ondansetron, and showed the former to be slightly more effective against PONV. But it’s unclear whether these results apply to the clinic, because researchers would need to treat many patients before the true difference between the two drugs, administered in equal doses, emerges. “The interesting question is whether ramosetron is more clinically effective than other 5-HT3 antagonists. That is not part of the meta-analysis ... However, it is a clinically relevant question: What drug, at what dose, provides the best prophylaxis against PONV?”

Intraoperative pain was significantly associated with increases in blood pressure and heart rate, supporting the validity of the pain assessment rubric. Surgeries that used RBBs lasted significantly longer than those in which anesthesiologists administered a topical anesthetic (P=0.0002). P

“RBB is a common method of anesthesia for ophthalmology training programs because it allows for the operation to proceed without the eye moving,” Dr. Rapoport said. “We are in the process of collecting more data prior to changing policies, but are considering the risks and benefits of RBB as compared with other types of

anesthesia during cataract surgery,” as a result of the findings. Dr. Rapoport presented the results at the 2013 annual meeting of the Association for Research in Vision and Ophthalmology (abstract 1609706) and will be presenting further results in the future.

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n the first study to evaluate celecoxib as a postsurgical analgesic in children, Canadian researchers have found that the drug provides effective pain relief after adenotonsillectomy. The randomized controlled trial, from Children’s Hospital of Eastern Ontario Research Institute, in Ottawa, Ontario, found that a short course of oral celecoxib (Celebrex, Pfizer) reduced early pain and consumption of acetaminophen in children undergoing adenotonsillectomy, although it had no effect on functional recovery. The drug did not appear to increase the risk for bleeding. “The fact that no one has used celecoxib in kids to treat perioperative pain is a bit of a surprise,” said Kimmo Murto, MD, director of pediatric cardiac anesthesia and director of research at the institution, who led the research team. “This is the first study that has looked at it, in surgery in general and specifically for postadenotonsillectomyy pain in kids.” Dr. Murto was scheduled to present the findings at the 2013 annual meeting of the Canadian Anesthesiologists’ Society (abstract 1651722) before the meeting was cancelled because of flooding. The study randomized 282 children between ages 2 and 18 years to preoperatively receive a loading dose of 6 mg/kg of celecoxib or placebo. Postoperatively, patients received either 3 mg/kg of celecoxib or placebo twice daily for five doses. Morphine and acetaminophen were given as needed; dosing was not scheduled but was monitored. Age-appropriate diaries were completed by parents and Equivalent Pain on a 100 mm Scale

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Oral Celecoxib Effective For Pain after T & A in Peds children to record recovery on postoperative day (POD) 0 to 7. The primary outcome was “worst pain” over the previous 24 hours on POD 0 to 2. Other outcomes included use of analgesia, side effects, parental satisfaction regarding pain and side effects, hospital contact for bleeding and need for intervention. The researchers also compared functional recovery—quality of life and fatigue— at baseline and on POD 7. Genotype for cytochrome P450 enzyme 2C9 (CYP2C9), which is responsible for celecoxib metabolism, also was determined. Celecoxib significantly reduced “worst pain” on POD 0 (P=0.03) and POD 1 (P=0.01). However, no significant difference was seen on POD 2 (P=0.66). Celecoxib also significantly reduced pain with swallowing on POD 0 (P=0.04) and POD 1 (P=0.01). Pain at rest was only reduced in the evening of POD 0 (P=0.02). Patients who received celecoxib consumed significantly less acetaminophen on PODs 0 to 2 (P=0.04). However, although their consumption of morphine trended lower, the reduction was not statistically significant (P=0.06). Dr. Murto suggested an even greater effect in analgesia response might have been seen if the use of acetaminophen had been scheduled. No difference was reported in distribution of CYP2C9 genotypes, parent satisfaction, functional recovery at seven days after surgery or incidence of side effects. Dr. Murto also reported that the slow metabolizer CYP2C9 genotype was not associated with increased analgesic efficacy or adverse

Placebo Celecoxib

70 65 60 55 50 45 0

Postoperative Day

Figure. “Worst pain” experienced during the first three postoperative days. Children in the celecoxib group experienced significantly less pain at days 0 (P=.03) P and 1 (P P=0.01) but not day 3 (P=0.66). P

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CL IN ICA L A N E STH E SIOL OG Y for a non-narcotic drug that can provide excellent analgesia and antiinflammatory effects with the least amount of side effects after adenotonsillectomy in children is similar to the quest for the holy grail. Every researcher is hoping to find this drug.” Dr. Murto said he and his colleagues plan to perform more studies in this patient population with celecoxib at higher doses, for a longer duration and combined with scheduled acetaminophen. events in those children who received celecoxib. The researchers reported “minimal” difference in hospital visits for tonsil bleeds, six among children receiving celecoxib compared with five among those given placebo, or in additional surgery, three patients who took celecoxib and two who received placebo. Although the only FDA-approved indication for celecoxib in the pediatric population is juvenile idiopathic arthritis, the drug “seems to have some value in managing postoperative surgical pain in kids,” Dr. Murto said. Because adenotonsillectomy is associated with postoperative bleeding and respiratory events, “celecoxib seems to be an ideal analgesic to manage pain in kids after their tonsil surgeries because it’s potentially opioid-sparingg and preserves platelet function.” According to Jerrold Lerman, MD, clinical professor of anesthesiology at Women and Children’s Hospital of Buffalo, in New York, “the difficulty in treating pain after tonsillectomy would be well served by including [celecoxib] in the regimen. However, if it’s going to be used, we need to know the pharmacokinetics of the drug in children, as well as the appropriate dosing. It appears that only one study has looked at the pharmacokinetics of celecoxib in kids, and I don’t think anyone has performed a dose–response study. A dose– response study should be performed to determine the appropriate dose before it’s used as an opioid-sparingg agent.” Susan Verghese, MD, professor of anesthesiology and pediatrics at the George Washington University Medical Center, and staff anesthesiologist at Children’s National Medical Center, both in Washington, D.C., found it interesting that the oral medication was tolerated after adenotonsillectomy. However, said Dr. Verghese, “any drug that can provide analgesia, decrease tissue inflammation at the surgical site and therefore decrease the amount of narcotics used postoperatively is a good drug. The quest

This abstract won the first-place award in the clinical science category at the Society of Anesthesia and Sleep Medicine 2013 annual meeting in October. —Mandy Armitage, MD Funding for this trial was provided by the University of Ottawa Department of Anesthesia and the Children’s Hospital of Eastern Ontario Research Institute. Dr. Verghese is a member of the editorial board of Anesthesiology News.

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Study Suggests Need for Practice Change in Ankle Surgeries Boston—A study conducted in cadavers has found that both a sciatic and saphenous nerve block should be used during ankle surgeries. The dissection study demonstrated that the saphenous nerve contributes to the sensory innervation of bony structures

in the medial ankle. Anesthesiologists not involved in the study applauded the research, saying it answered a long-standingg question. “I have questioned the commonly held understanding of the sensory distribution of the saphenous nerve, so I found

this poster particularly interesting. Traditional thinking has been that this nerve provides more cutaneous rather than deep sensation. Clinically, we have not found this to be the case,” said Eugene Viscusi, MD, professor of anesthesiology and director of acute pain

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management at Jefferson Medical College of Thomas Jefferson University, in Philadelphia, and a member of the editorial board of Anesthesiology News. This is, in fact, why researchers at the Oregon Health & Science University (OHSU), in Portland, conducted the study. Their clinical experience indicated that adding a saphenous nerve block to a sciatic nerve block is necessary to obtain complete anesthesia and/or analgesia of the ankle, even if the overlying skin is undisturbed. Jean-Louis Horn, MD, an anesthesiologist at OHSU, led the study, which was presented at the 2013 spring meeting of the American Society of Regional Anesthesia and Pain Medicine (abstract 48). To clarify the role of the saphenous nerve in the innervation of the distal tibia and medial ankle joint capsule, the researchers dissected 25 lower legs from 13 embalmed cadavers, five men and eight women. The specimens were taken from patients who died between the ages of 59 and 100. The investigators opened the lower legs with a superficial skin flap that extended distally from the lateral border of the proximal tibia to the dorsum of the foot and then reflected medially.

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CL IN ICA L A N E STH E SIOL OG Y This approach exposed the medial and anterior portions of the lower leg and allowed for the identification of the saphenous vein and nerve. The researchers then followed the saphenous nerve along its distal course and dissected branches deep under the subcutaneous tissue. They discovered that each ankle had at least one branch springing off the saphenous nerve that dove deep and medial and became continuous with the distal tibia’s periosteum. The branches split off from the saphenous nerve between 4 and 8 cm above the medial malleolus. All of the ankles also had identifiable branches that became continuous with the capsule of the ankle joint located near the medial malleolus. “The saphenous nerve innervates the periosteum of the distal tibia and medial ankle joint capsule,” said Nicholas Eglitis, BS, a medical student at OHSU, who presented the findings at the meeting. The researchers concluded that regional anesthesia for the medial ankle should add a saphenous nerve block to a sciatic nerve block, which is one standard of care. “This study shows a consistent innervation of the ankle joint by the saphenous nerve. Literature and textbooks have been inconsistent in describing the exact distribution of the saphenous nerve—some show only cutaneous innervation above the ankle,” said Kishor Gandhi, MD, MPH, associate

professor of anesthesiology and director of regional anesthesia at Jefferson Medical College. “This study shows that the nerve may innervate a significant part of the medial part of the ankle. Both sciatic and saphenous nerve blocks may be needed for 100% anesthesia and analgesia for ankle surgeries.” —Kate O’Rourke

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Drs. Horn, Viscusi and Gandhi and Mr. Eglitis have no relevant disclosures.

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CLINICAL ANESTHESI OLOGY

Patient-Controlled Oral Pain System Averts Need for IV Boston—An experimental, noninvasive device preprogrammed to deliver a standard dose of oral sufentanil provides postoperative analgesia that is superior to traditional IV patient-controlled morphine, researchers have found. The product, the Sufentanil NanoTab patientcontrolledd analgesia (PCA) system (SNPS; AcelRx; above), delivers 15-mcgg microtablets of sublingual sufentanil with a 20-minute lockout period. The device incorporates a security access card and locking system to prevent illegal access to the drug. The Phase III study was one of two pivotal trials required for FDA approval of the device. “A patient-controlled device that is pre-programmed with a standard drug, does not interfere with patient movement, and is noninvasive may have great implications for the paradigm of postoperative pain management,” said study investigator Eugene Viscusi, MD, professor of anesthesiology and director of acute pain management at Thomas Jefferson University, in Philadelphia. Intravenous PCA has been a mainstay of postoperative pain management for almost 30 years. However, programmable pumps, particularly PCA, have a high incidence of programming and medication errors, which can lead to significant patient harm. Hospital personnel spend considerable amounts of time preparing drugs, programming, replacing drugs and maintaining IV access. The large pumps also may interfere with physical therapy and activities of daily living. Sufentanil has a high therapeutic index compared with morphine (26,000:1 vs. 70:1) and rapid equilibrium between plasma and the central nervous system—the halff life for equilibrium with sufentanil is six minutes compared with 2.8 hours for morphine. Sufentanil, however, redistributes rapidly from plasma following IV administration and has a short duration of action, characteristics that make it less than ideal for IV PCA. The new study, conducted at 26 sites across the United States, enrolled adults scheduled for open abdominal or major orthopedic surgery under general or

spinal anesthesia without intrathecal opioids. Patients were randomized to receive pain control with SNPS (n=177) or IV PCA with 1 mg morphine sulfate, with a lockout every six minutes (n=180). The primary end point was patient global assessment with method of pain control over the 48-hourr study period. Success was defined as the proportion of patients who responded “good” or “excellent.” More patients in the SNPS arm had successful pain control than patients who received morphine (78.5% and 65.6%; P=0.007). Both patients and nurses were more likely to report being satisfied with the sublingual device. Patients receiving pain control through SNPS were less likely to drop out of the study because of adverse events (7.3% vs. 10%), lack of efficacy (7.3% vs. 8.9%) or other reasons (2.8% vs. 5.6%). “The sufentanil NanoTab PCA system was not only equally efficacious to IV PCA morphine, it had a faster onset (statistically significant by one hour), and was better tolerated in the sense that fewer patients had oxygen desaturation events,” said Mike Royal, MD, JD, MBA, chief of clinical affairs at AcelRx and an author of the study, presented at the 2013 spring meeting of the American Society of Regional Anesthesia and Pain Medicine (abstract 73). “Given that the patient can be unchained from the heavy PCA pumps and IV poles, we think our easyy to-use handheld preprogrammable system will be welcomed by health care practitioners,” he said. “This is a very novel system,” said Christopher Wu, MD, professor of anesthesiology and critical care medicine at Johns Hopkins University School of Medicine, in Baltimore, who was not involved with the trial. “Oral is always preferable to IV if we can afford it.” Additional data from 35 sites were to be presented at the 2013 annual meeting of the American Society of Anesthesiologists (abstract 3238). The company expects to file a new drug application for the device in the third quarter of 2013. —Kate O’Rourke Dr. Viscusi is a member of the editorial board of Anesthesiology News.

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Revisiting Environmental Hygiene And Hospital-Acquired Infections BRIAN CURRIE, MD, MPH Professor of Clinical Medicine Division of Infectious Diseases Albert Einstein College of Medicine Assistant Dean for Clinical Research Montefiore Medical Center New York, New York

he role of environmental hygiene in preventing hospital-

acquired infections (HAIs) has

been a controversial topic.1,2 It was

widely accepted that the bulk of HAIs were the result of transmission from one patient to another via the contaminated hands of caregivers or contaminated equipment that was sequentially used on patients.

However, the role of noncritical environmental of key environmental surfaces in frequent con- patients who did not occupy such rooms.3,13 Bacsurfaces as a reservoir for nosocomial pathogens tact with patients and health care workers such terial strain typing often confirmed this chain of to contaminate the hands of health care providers as bed rails, door knobs, etc.5-7 Subsequent stud- transmission. These findings strongly supported and subsequently infect patients remained unde- ies have documented that routine cleaning and terminal cleaning, the practice of cleaning and fined. Of note, a literature survey published less disinfection substantially reduces contamination disinfecting all room surfaces following patient than 10 years ago concluded that there was no evi- and could be useful in controlling outbreaks.3,8-11 transfer or discharge before use by a new patient. dence to support environmental hygiene practices A landmark study published in 2013 reported that Current guidelines now encourage hospitals to as a method for reducing HAIs.3 the risk for nosocomial infections could be sub- develop programs for cleaning and disinfectThe past 10 years have seen a progressive accu- stantially reduced by the use of environmental ing high-touch surfaces as part of terminal room mulation of evidence that clearly established envi- hygiene strategies that reduce the bacterial bio- cleaning using a properly applied, Environmental ronmental reservoirs of nosocomial pathogens as burden on high-touch room surfaces.12 Protection Agency (EPA)-approved germicide.14,15 a cause of HAIs, and this information was used to A number of recent studies have documented shape what has become the foundation of cur- that patients who were placed in rooms previously Monitoring Compliance rently recommended hospital-based environmen- occupied by individuals infected or colonized with Establishing a monitoring program for periodic tal hygiene practices. VRE, MRSA, C. difficile, or Acinetobacter were 73% or ongoing assessments of environmental hygiene It had long been appreciated that shortly after more likely to acquire the same pathogens than practices has been shown to significantly improve being placed into a patient room, individuals shed bacterial organisms that contaminated environmental surfaces, including those thought to be Table 1. Objective Methods to Evaluate Environmental Hygiene Practice involved in horizontal transmission and HAIs such as methicillin-resistant Staphylococcus aureus Method Difficulty Confirms Pathogens Assesses Cleaning (MRSA), vancomycin-resistant enterococci (VRE), Acinetobacter and other gram-negative bacteDirect observation High No Yes ria, and Clostridium difficile spores.2,3 Additional Swab culture Low Yes Possibly research also documented that these organisms can persist on environmental surfaces for weeks Agar slide culture Medium Limited Possibly or even months.4 Culture sampling demonstrated Fluorescent markers Low No Yes that certain surfaces carried a much higher bacterial bioburden than others, a consequence of Adenosine triphosphate bioluminescence Low No Possibly more frequent contact with patients. A conceptual model of â&#x20AC;&#x153;high-touchâ&#x20AC;? surfaces evolved from Based on reference 14. these findings, which included the identification

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CL IN ICA L A N E STH E SIOL OG Y compliance with hospital policies and protocols. Table 2. Disinfectants and An environmental cleaning toolkit released in 2010 Cleaning Tools by the Centers for Disease Control and Prevention encouraged hospitals to create such programs as • Demand-release chlorine disinfectants an adjunct to terminal room cleaning to ensure • Chlorine dioxide 14 high-touch surfaces are thoroughly cleaned. The • Sodium dichloroisocyanurate toolkit further advocates for an objective assess• Chloramine-T7 ment of hygiene practices and outlines a variety of • Superoxidized water approaches and technologies to accomplish this 14 task (Table 1). • Microfiber mops Covert direct observation can provide an objec• Microfiber wipes tive assessment of compliance with cleaning protocols and is the most frequently used monitoring tool in US hospitals. The process is labor intensive, should employ a checklist, and in actuality is Assessing Current Practice quite difficult to accomplish in a covert fashion. As Despite existing recommendations for hospia result, data generated from this method is not tals to establish environmental hygiene programs likely to reflect or measure true hygiene practices. and monitor their effectiveness, suboptimal pracSerial swab cultures of environmental surfaces tices are common.13,17 Studies have established that also can be used as a monitoring tool. Although terminal cleaning is about 49% effective; however, samples are easy to acquire, processing costs and success rates for high-touch surfaces show sigturnaround delays limit the practicality of this nificant variation, ranging from 30% to more than method as a monitoring tool. Furthermore, given 75%.13 A recent survey of infection preventionists the lack of established, concrete cutoffs to serve documented that many continue to rely on direct as a baseline for acceptable results, precleaning observation to monitor environmental cleaning contamination levels must be determined for each practices (employed by 70% of respondents on surface to assess compliance with environmental a daily, weekly, or monthly basis) as well as poor cleaning policy. uptake of fluorescent gel or ATP systems (used by Agar slide cultures have been adapted for envi- 26% to 28% of respondents on a daily, weekly, or ronmental surface monitoring in hospitals and monthly basis).13 are capable of quantifying aerobic colony counts Other recent studies have documented that (ACCs) per cm2. This technique is largely limited even when aggressive interventions are employed, to culturing large flat surfaces and also requires including intensive staff education and the use measurements of precleaning contamination lev- of newer, objective-based evaluation techniques els in order to assess the efficacy of environmen- with performance feedback, efficacy rates for high-touch surface cleaning remain in the range tal cleaning practices. Fluorescent markers also have been developed of 77% to 82%.13 Although these studies have docto assess hygiene practices.14,16 This commercially umented that cleaning and disinfection need to available method involves the application of a flu- be improved in US health care settings as part of orescent gel to target surfaces, which becomes efforts to prevent nosocomial infections, they also transparent after drying. Following room cleaning, have resulted in the development and introduction ultraviolet (UV) light will expose any areas that of a variety of new technologies. were not adequately cleaned. There is widespread hospital experience with the use of these markers, Emerging Technologies and a number of studies have demonstrated their The past 5 years have seen the rapid develaccuracy for objectively evaluating environmental opment of emerging technologies designed to enhance environmental hygiene practice. The prohygiene practices.16 A second commercially available solution is the liferation of products is almost bewildering, and the adenosine triphosphate (ATP) bioluminescence pace at which new technologies are being introassay, which measures ATP on surfaces using a duced is accelerating rapidly. This section is not luciferase assay and luminometer.14 A specialized intended to provide an all-inclusive overview of swab is used to sample a targeted surface area, every technology in development; instead, it will which is then analyzed using a portable handheld provide a broad overview of currently available luminometer. The total amount of ATP, both micro- technologies and the level of evidence supportbial and nonmicrobial, is expressed as relative light ing their use. Infection control practitioners should units. Low readings have shown a reasonable cor- appreciate the need to revisit emerging technolorelation with low ACCs, but very high readings may gies on an ongoing basis and should stay abreast indicate bacterial contamination, organic debris of the burgeoning amount of literature that concontaining dead bacteria, or both. Moreover, high tinues to surface regarding their performance and concentrations of liquid bleach disinfectant can effectiveness. It also should be stressed that current interfere with the assay and may result in reduced recommendations and guidelines consider these signal strength. Again, the lack of a threshold products as adjuncts, rather than replacements, to cutoff value requires an assessment of preclean- existing environmental hygiene programs and pracing ATP levels to properly interpret results. ATP tices. Products and strategies have been divided systems have proven effective for documenting into 4 categories for discussion: disinfectants and improvements in daily cleaning practices for high- cleaning tools; soft-surface disinfection; hard-surtouch surfaces.14 face disinfection; and whole-room disinfection.

DISINFECTANTS

AND

CLEANING TOOLS

Products in this category are summarized in Table 2. The development of new disinfectants is largely driven by a desire to decrease the long wetcontact time required with the use of iodine-based or quaternary disinfectants (ie, up to 10 minutes) and their apparent inability to optimally disinfect C. difficile spores. Current recommendations for C. difficile disinfection rely on the use of a 5% to 6% sodium hypochlorite solution (ie, household bleach), which is corrosive to environmental fixtures, bleaches fabrics, and carries occupational exposure risks. The advantage of slow-release chlorine products is that, although they are fast acting, they exert a prolonged bactericidal effect.15 Unfortunately, they still retain the potential to damage equipment and facilities. Another option is superoxidized water, which is created when saline is electrolyzed to produce a solution of hypochlorous acid and chlorine, with free chlorine the active microbicide.15 Point-of-use production systems are commercially available, but they are expensive and complicated to operate.15 The solutions appear to have a 48-hour shelf life.15 The product is FDAapproved for high-level disinfection, but further study of its application as an environmental disinfectant is required. Microfiber mops and microfiber wipe cloths have a long history of use in hospitals. Both products are made of a blend of microscopic polyester and polyamide fibers, which are split to create microscopic hooks that collect and retain dust, dirt, and bacteria. Microfiber mops have been demonstrated to have superior efficacy in reducing microbial levels on floors compared with conventional, cotton string mops, and achieved 95% efficacy.18 Furthermore, performance did not improve when they were used with a disinfectant. Microfiber mops are less work intensive than conventional mops, eliminate issues of cross contamination during environmental cleaning, and drastically reduce the use of water and chemicals due to more efficient cleaning and disinfection. Similarly, microfiber cleaning cloths have consistently outperformed conventional cloths in their ability to decontaminate across all surfaces, even when bacteria were coated on to the surfaces with phosphate-buffered saline (PBS) or PBS–containing horse serum.19 Designed to be used without detergents or biocides, they have been shown to effectively decontaminate hard surfaces seeded with S. aureus, Escherichia coli, and C. difficile spores under simulated conditions. An additional study compared the efficacy of 10 different microfiber cloths (9 reusable) under simulated conditions and found comparable performance among the products, even after 150 washes.20 Although the Joint Commission and the EPA have advocated for these products, continued research to evaluate their performance in real-world clinical settings is required, as well as to determine if their use can reduce HAI rates.

SOFT-SURFACE DISINFECTION Soft-surface disinfection strategies include fabric impregnation with copper or silver to take see HAIs page 52

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advantage of their intrinsic antimicrobial properties, citric acid impregnation of cotton cloth, and organosilane-based quaternary ammonium impregnation of fabric materials (Table 3).21 These materials have been used to produce scrubs, uniforms, linens, and privacy curtains. A double-blind, randomized controlled trial (RCT) evaluating the use of antimicrobial-impregnated privacy curtains in the ICU setting showed a significant delay in time to colonization and an 8-fold reduction in the risk for VRE contamination compared with standard fabric curtains.21 Similarly, an ICU-based, blind, randomized crossover trial evaluating the efficacy of organosilane-based quaternary ammoniumimpregnated scrub suits reported a significant reduction in MRSA contamination, with little effect on the burden of VRE or gram-negative rods.22 Further investigation is warranted to demonstrate the ability of these products to consistently perform under clinical conditions, followed by clinical trials to measure their effect on HAI rates.

HARD-SURFACE DISINFECTION Hard-surface disinfection technologies are summarized in Table 4. Copper and copper alloy cladding of high-touch hard surfaces takes advantage of the natural antimicrobial properties of copper to significantly reduce high bacterial bioburden within 2 hours.23 Copper and copper alloy surfaces have demonstrated activity against a broad spectrum of bacteria, including nosocomial pathogens known to be transmissible from environmental reservoirs. Furthermore, copper technologies provide continuous bacterial disinfection on all surfaces where it is employed. More than 200 publications have documented its potent antimicrobial activity in both simulated and actual clinical conditions. A recent RCT conducted in 3 hospitals reported a significant reduction in HAIs when copper technologies were used in conjunction with an aggressive environmental hygiene program.12 A variety of copper-based products are commercially available, including countertops, IV poles, handles, support railings, bed rails, and sinks. The principal factor that limits the widespread adoption of this technology is its high cost. Similarly, silver iodide and silver nanoparticles also are being used to develop hard surfaces with intrinsic antimicrobial activity. Silver iodide–based coatings will need to demonstrate the ability to persist after repeated washings, and they also need to verify their disinfection efficacy in both simulated and actual clinical conditions. Silver nanotechnology products are still in early development stages. Disinfectant-based hard-surface technologies include the incorporation of triclosan into surfaces and the use of quaternary ammonium salt surfactants as a coating on hard surfaces. Triclosan-based products already have been proven to have limited application in the health care environment.23 Triclosan has a limited spectrum of antimicrobial activity and there is mounting evidence that bacteria can become triclosan-resistant in the setting of continued exposure. Triclosan-impregnated

Table 3. Soft-Surface Technologies • Copper oxide impregnation • Citric acid impregnation • Organosilane-based quaternary ammonium impregnation • Silver-impregnated yarn

Table 4. Hard-Surface Technologies • Copper and copper alloy cladding • Silver iodide and modified polyhexamethlyene biguanide coating • Silver nanoparticle incorporation • Triclosan incorporation • Quaternary ammonium salt surfactant coating • Microtopography surface • Light-activated antimicrobial coatings • Cellulose acetate–containing toluidine blue O and rose Bengal • Silicon polymer–containing methylene blue and gold nanoparticles • Titanium dioxide coating

Table 5. Whole-Room Technologies UV light • Combination of ozone/UV light/ hepafiltration • Hydrogen peroxide vapor or aerosolization • Titanium dioxide spray UV, ultraviolet

products are now primarily marketed for household use. Quaternary ammonium salt surfactants are in early development and, like all surface-coating technologies, they will need to demonstrate durability as well as efficacy. The final category of hard-surface disinfectants includes a group of light-activated antimicrobial compounds. Titanium dioxide is the most developed product, with considerable prior use in food, toothpaste, and tooth-whitening preparations, and as a disinfectant in Japanese health care environments. Titanium dioxide is produced by crystallizing titanic iron ore into a nanoliquid form. When exposed to UV light in the sub-400 nm range, it becomes a photocatalyst oxidizer that produces hydroxyl radicals and superoxide ions with potent antimicrobial activity. Patented technologies now allow for the nanoliquid to penetrate and form

permanent bonds with the surface that last for years. Titanium dioxide has required exposure to sunlight or UV light for maximum antimicrobial activity, and it has shown a broad spectrum of antibacterial activity, although this effect is slower in decontaminating spores. The addition of zinc to the preparation has now provided effective antimicrobial action after exposure to indoor lighting of any type, which provides continuous disinfection as long as room lighting is in use. A single application remains active on heavily used surfaces even after 1 year. Now marketed in the United States for disinfection in the health care setting, it will be interesting to see what efficacy information becomes available.

WHOLE-ROOM DISINFECTION Table 5 summarizes approaches to environmental disinfection using whole-room technology. As a group, they (with the exception of titanium dioxide) employ devices placed in patient rooms and all use toxic technologies that prohibit patient or staff occupancy during the disinfection process. As a result, they all are limited to use as adjunct disinfection technologies during terminal room cleaning between patients. Disinfection cycle duration times will effect room turnover times, and this should be a consideration in addition to disinfection efficacy rates. UV light room disinfection is probably the most studied of the whole-room technologies, and the products build on a long history of the use of UV light to disinfect well water, circulating dialysis fluid, and room air for tuberculosis control. Numerous products are commercially available and all employ the use of low-pressure mercury or xenon vapor lamps to generate UV light in the germicidally active wavelength range of 200 to 320 nm.24,25 Shortwave UV-C radiation, primarily at 254 nm, kills by damaging DNA. Photon absorption leads to formation of pyrimidine dimers between adjacent thymine bases in DNA, rendering the microbe incapable of replication. These technologies offer broad-spectrum microbicidal activity, including C. difficile spores.24 A typically sized hospital patient room can be disinfected within 10 minutes, minimally affecting room turnaround times during terminal cleaning. The principal issue with UV light disinfection is that it provides for “line-of-sight” killing—meaning it does not work in shadowed areas and does not penetrate fabrics well—and there is no evidence that lack of a proper room cleaning before UV light disinfection can markedly reduce its efficacy.24 Line-of-sight killing has been addressed through the use of careful device placement in the room, rotating the light source, and UV-reflective shields and wall paint.24,27 One manufacturer provides indicators that can be placed in potential problem areas in the room and are capable of monitoring for appropriate UV light exposure. UV light has proven effective as a hospital room disinfectant, reliably reducing the bacterial bioburden of a wide spectrum of pathogens under simulated and real-time clinical situations (provided the room is cleaned first). However, its ability to reduce HAI rates has yet to be studied. see HAIs page 54

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Several systems have been developed that produce hydrogen peroxide vapor, aerosolized dry-mist hydrogen peroxide, or vaporized hydrogen peroxide for whole-room disinfection. Hydrogen peroxide is converted by catalysis after bacterial contact to generate free oxygen radicals with rapid bactericidal activity. Under simulated and real-time clinical conditions, hydrogen peroxide

has demonstrated broad-spectrum activity as a disinfectant, including the rapid decontamination of spores. Whole-room treatment leaves no residue.28 When used as a follow-up to bleach disinfection, whole-room disinfection is extremely effective. In a retrospective study conducted in 334 patient rooms previously occupied with individuals infected with C. difficile, use of hydrogen peroxide vapor within the terminal cleaning program reduced nosocomial infection rates

from 0.88 to 0.55 cases per 1,000 patient-days.29 Of note, the hydrogen peroxide intervention was only used in 54% of rooms. Additional evidence suggests that hydrogen peroxide room disinfection can reduce VRE infection rates, but 2 studies have now identified that the process may not be as effective in reducing MRSA infection rates.30,31 It has been suggested that this may be related to the fact that MRSA are catalase-producing organisms. Similar

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to UV room disinfection technologies, hydrogen peroxide room disinfection carries a significant capital expenditure cost and requires the removal of surface debris before use. Finally, titanium dioxide/zinc technologies have been developed and marketed as methods of wholeroom disinfection. The technologies and means of action already have been discussed above. Beyond hard surfaces, the products also can be sprayed onto soft surfaces and brushed into fabrics to provide a long-lasting, broad-spectrum biocidal coating. A single room application would cost less than $650 and last for 1 year. The room only needs to be vacant during the application process, and these products offer continuous room disinfection whenever room lights are on, providing a biocidal disinfectant action far beyond a terminal cleaning technology. This product is in clinical testing and efficacy data should be available in the near future. A combined ozone/UV light/hepafiltration technology product also is commercially available and requires further evaluation.

Conclusion

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Accumulating evidence has established that bacterial contamination of the physical hospital environment can serve as a reservoir for transmission to patients and can contribute to the acquisition of HAIs. Study findings have been used to shape current recommendations for environmental hygiene interventions, but achieving a high degree of compliance with guidelines has proven difficult. Emerging environmental hygiene technologies may provide important adjunct interventions in helping to achieve these goals.

References 1.

Rutala WA, Weber DJ. Surface disinfection: should we do it? J Hosp Infect. 2001;48(suppl A):S64-S68.

2. Donskey C. Does improving surface cleaning and disinfection reduce health care-associated infections? Am J Infect Control. 2013;41(5 suppl):S12-S19.

Catheter with needle removed.

Needle and catheter.

3. Hota B. Contamination, disinfection and cross colonization: are hospital surfaces reservoirs for nosocomial infection? Clin Infect Dis. 2004;39:1182-1189. 4. Kramer A, Schwebke I, Kampf G. How long do nosocomial pathogens persist on inanimate surfaces? A systematic review. BMC Infect Dis. 2006;6:130.

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5. Carling PC, Briggs JL, Perkins J, et al. Improved cleaning of patient rooms using a new targeting method. Clin Infect Dis. 2006;42(3): 385-388. 6. Huslage K, Rutala W, Sickbert-Bennett E, et al. A quantitative approach to disinfecting “high-touch” surfaces in hospitals. Infect Control Hosp Epidemiol. 2010;31(1):850-853.

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CL IN ICA L A N E STH E SIOL OG Y 7. Moore G, Muzlay M, Wilson A. The type, level, and distribution of microorganisms within the ward environment: a zonal analysis of an intensive care unit and a gastrointestinal surgical ward. Infect Control Hosp Epidemiol. 2013;34(5):500-506. 8. Sitzlar B, Deshpande A, Fertelli D, et al. An environmental disinfection odyssey: evaluation of sequential interventions to improve disinfection of Clostridium difficile isolation rooms. Infect Control Hosp Epidemiol. 2013;34(5):459-465. 9. Weber DJ, Rutala WA. Understanding and preventing transmission of healthcare-associated pathogens due to the contaminated hospital environment. Infect Control Hosp Epidemiol. 2013;34(5): 449-452. 10. Weber DJ, Rutala WA, Miller MB, et al. Role of hospital surfaces in the transmission of emerging health care-associated pathogens: norovirus, Clostridium difficile, and Acinetobacterr species. Am J Infect Control. 2010;38(5 suppl):S25-S33. 11. Goodman E, Platt R, Bass R, et al. Impact of an environmental cleaning intervention on the presence of methicillin-resistant Staphylococcus aureus and vancomycin-resistant enterococci on the surfaces in intensive care unit rooms. Infect Control Hosp Epidemiol. 2008;29(7):593-599.

24. Rutala WA, Gregen MF, Weber DJ. Room decontamination with UV radiation. Infect Control Hosp Epidemiol. 2010;31(10):1025-1029. 25. Levin J, Riley L, Parrish C, et al. The effect of portable pulsed xenon ultraviolet light after terminal cleaning on hospital-associated Clostridium difficile infection in a community hospital. Am J Infect Control. 2013;41(8):746-748. 26. Andersen DJ, Gergen MF, Smathers E, et al. Decontamination of targeted pathogens from patient rooms using an automated ultraviolet-C-emitting device. Infect Control Hosp Epidemiol. 2013;34(5):466-471. 27. Rutala WA, Gregen MF, Tande BM, et al. Rapid hospital room decontamination using

ultraviolet (UV) light with a nanostructered UV reflective wall coating. Infect Control Hosp Epidemiol. 2013;34(5): 527-529.

stearothermophilus biological indicators. J Hosp Infect. 2012;80(1):41-45.

28. Rutala W, Weber D. Disinfectants used for environmental disinfection and new room decontamination technology. Am J Infect Control. 2013;41(5 suppl):S36-S41. 29. Manian F, Griesnauer S, Bryant A. Implementation of hospital-wide enhanced terminal cleaning of targeted patient rooms and its impact on endemic Clostridium difficile infection rates. Am J Infect Control. 2013;41(6):537-541. 30. Pottage T, Macken S, Walker J, et al. Methicillin-resistant Staphylococcus aureus is more resistant to vaporized hydrogen peroxide than commercial Geobacillus

high in botic risk is When throm thrombin deficiency ti hereditary an

31. Passaretti CL, Otter JA, Reich NG, et al. An evaluation of environmental decontamination with hydrogen peroxide vapor for reducing the risk of patient acquisition of multi-resistant organisms. Clin Infect Dis. 2013;56(1):27-35.

Dr. Currie reported that he serves on the advisory board for Clorox and has received grant support from the Agency for Healthcare Research and Quality.

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12. Salgado CD, Sepkowitz KA, John JF, et al. Copper surfaces reduce the rate of healthcare-acquired infections in the intensive care unit. Infect Control Hosp Epidemiol. 2013;34(5):479-486. 13. Pyrek K. Environmental cleaning and monitoring for infection prevention. http://www. infectioncontroltoday.com/reports/2013/05/ importance-of-environmental-cleaning.aspx?endpointurl=/lib/download. ashx?id=1190. Accessed August 14, 2013. 14. Centers for Disease Control and Prevention. Options for evaluating environmental cleaning. http://www.cdc.gov/HAI/pdfs/toolkits/ Environ-Cleaning-Eval-Toolkit12-2-2010.pdf. Accessed August 14, 2013. 15. Centers for Disease Control and Prevention. Guideline for disinfection and sterilization in healthcare facilities, 2008. http://www.cdc. gov/hicpac/pdf/guidelines/Disinfection_ Nov_2008.pdf. Accessed August 14, 2013. 16. Boyce JM, Havill NL, Havill HL, et al. Comparison of fluorescent marker systems with 2 quantitative methods of assessing terminal cleaning practices. Infect Control Hosp Epidemiol. 2011;32(12): 1187-1193. 17. Carling PC, Parry MF, Von Beheren SM; Healthcare Environmental Hygiene Study Group. Identifying opportunities to enhance environmental cleaning in 23 acute care hospitals. Infect Control Hosp Epidemiol. 2008;29(1):1-7. 18. Rutala WA, Gergen MF, Weber DJ. Microbiologic evaluation of microfiber mops for surface disinfection. Am J Infect Control. 2007;35(9):569-573. 19. Wren MV, Rollins MS, Jeanes A, et al. Removing bacteria from hospital surfaces: a laboratory comparison of ultramicrofibre and standard cloths. J Hosp Infect. 2008;70(3):265-271. 20. Smith D, Gillanders S, Holah J, et al. Assessing the efficacy of different microbibre cloths at removing surface micro-organisms associated with healthcare-associated infections. J Hosp Infect. 2011;78(3):182-186. 21. Schweizer M, Graham M, Ohl M, et al. Novel hospital curtains with antimicrobial properties: a randomized, controlled trial. Infect Control Hosp Epidemiol. 2012;33(11):1081-1085. 22. Bearman G, Rosato A, Elam K, et al. A crossover trial of antimicrobial scrubs to reduce methicillin-resistant Staphylococcus aureus burden on healthcare worker apparel. Infect Control Hosp Epidemiol. 2012;33(3):268-275. 23. Weber DJ, Rutala WA. Self-disinfecting surfaces. Infect Control Hosp Epidemiol. 2012;33(1):10-13.

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Important Safety Information Thrombate III® (antithrombin III [human]) is indicated for the treatment of patients with hereditary antithrombin deficiency in connection with surgical or obstetrical procedures or when they suffer from thromboembolism. In clinical studies with Thrombate III, the most common side effects were dizziness, chest discomfort, nausea, and dysgeusia. The anticoagulant effect of heparin is enhanced by concurrent treatment with Thrombate III in patients with hereditary AT-III deficiency. Thus, in order to avoid bleeding, reduced dosage of heparin is recommended during treatment with Thrombate III. Thrombate III is made from human plasma. Plasma products carry a risk of transmitting infectious agents, such as viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent, despite steps designed to reduce this risk. No cases of transmission of viral disease or CJD have ever been identified for Thrombate III. Please see brief summary of Thrombate III complete Prescribing Information on adjacent page. Reference: 1. Thrombate III® (antithrombin III [human]) [prescribing information]. Research Triangle Park, NC: Grifols Inc; 2012. © 2013 Grifols Inc.

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Very Obese Patients Consume Greater Share of Hospital Resources

atients who are morbidly obese use more hospital resources in the perioperative period, including longer operating room times and more time spent under anesthesia, a pair of new studies shows. Although more research is needed to

tease out the reasons for the increase, experts said, hospitals may want to consider booking additional OR time for patients who are morbidly obese or have more personnel on hand to help position these patients for surgery. Both studies were presented at

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III®

Antithrombin III (Human) BRIEF SUMMARY CONSULT PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION

FOR INTRAVENOUS USE ONLY DESCRIPTION Antithrombin III (Human), THROMBATE IIIw is a sterile, nonpyrogenic, stable, lyophilized preparation of purified human antithrombin III (ATIII). THROMBATE III is prepared from pooled units of human plasma from normal donors by modifications and refinements of the cold ethanol method of Cohn. When reconstituted with Sterile Water for Injection, USP, THROMBATE III has a pH of 6.0–7.5, a sodium content of 110–210 mEq/L, a chloride content of 110–210 mEq/L, an alanine content of 0.075–0.125 M, and a heparin content of not more than 0.1 IU heparin/IU ATIII. THROMBATE III contains no preservative and must be administered by the intravenous route. Each vial of THROMBATE III contains the labeled amount of antithrombin III in international units (IU) per vial. The potency assignment has been determined with a standard calibrated against a World Health Organization (WHO) antithrombin III reference preparation. The capacity of the THROMBATE III manufacturing process to remove and/or inactivate enveloped and non-enveloped viruses has been validated by laboratory spiking studies on a scaled down process model using a wide range of viruses with diverse physicochemical properties. There are two dedicated virus inactivation/removal steps included in the THROMBATE III manufacturing process: a heat treatment step at 60°C ± 0.5°C for not less than 10 hours for virus inactivation and a nanofiltration step for effective removal of viruses as small as 18 nm. The manufacturing process was also investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the vCJD and CJD agents. An individual production step in the THROMBATE III manufacturing process has been shown to decrease TSE infectivity of that experimental model agent. The TSE reduction step is the Effluent I to Effluent II + III fractionation step (6.0 log10). These studies provide reasonable assurance that low levels of CJD/vCJD agent infectivity, if present in the starting material, would be removed. CLINICAL PHARMACOLOGY Antithrombin III, an alpha2-glycoprotein of molecular weight 58,000, is normally present in human plasma at a concentration of approximately 12.5 mg/dL and is the major plasma inhibitor of thrombin. Inactivation of thrombin by ATIII occurs by formation of a covalent bond resulting in an inactive 1:1 stoichiometric complex between the two, involving an interaction of the active serine of thrombin and an arginine reactive site on ATIII. ATIII is also capable of inactivating other components of the coagulation cascade including factors IXa, Xa, XIa, and XIIa, as well as plasmin. The neutralization rate of serine proteases by ATIII proceeds slowly in the absence of heparin, but is greatly accelerated in the presence of heparin. As the therapeutic antithrombotic effect in vivo of heparin is mediated by ATIII, heparin is ineffective in the absence or near absence of ATIII. The prevalence of the hereditary deficiency of ATIII is estimated to be one per 500 to 5000 in the general population. The pattern of inheritance is autosomal dominant. In affected individuals, spontaneous episodes of thrombosis and pulmonary embolism may be associated with ATIII levels of 40%–60% of normal. These episodes usually appear after the age of 20, the risk increasing with age and in association with surgery, pregnancy and delivery. The frequency of thromboembolic events in hereditary ATIII deficiency during pregnancy has been reported to be 70%, and several studies of the beneficial use of Antithrombin III (Human) concentrates during pregnancy in women with hereditary deficiency have been reported. In many cases, however, no precipitating factor can be identified for venous thrombosis or pulmonary embolism. Greater than 85% of individuals with hereditary ATIII deficiency have had at least one thrombotic episode by the age of 50 years. In about 60% of patients thrombosis is recurrent. Clinical signs of pulmonary embolism occur in 40% of affected individuals. In some individuals, treatment with oral anticoagulants leads to an increase of the endogenous levels of ATIII, and treatment with oral anticoagulants may be effective in the prevention of thrombosis in such individuals. In clinical studies of THROMBATE III conducted in 10 asymptomatic subjects with hereditary deficiency of ATIII, the mean in vivo recovery of ATIII was 1.6% per unit per kg administered based on immunologic ATIII assays, and 1.4% per unit per kg administered based on functional ATIII assays. The mean 50% disappearance time (the time to fall to 50% of the peak plasma level following an initial administration) was approximately 22 hours and the biologic half-life was 2.5 days based on immunologic assays and 3.8 days based on functional assays of ATIII. These values are similar to the half-life for radiolabeled Antithrombin III (Human) reported in the literature of 2.8–4.8 days. In clinical studies of THROMBATE III, none of the 13 patients with hereditary ATIII deficiency and histories of thromboembolism treated prophylactically on 16 separate occasions with THROMBATE III for high thrombotic risk situations (11 surgical procedures, 5 deliveries) developed a thrombotic complication. Heparin was also administered in 3 of the 11 surgical procedures. Eight patients with hereditary ATIII deficiency were treated therapeutically with THROMBATE III as well as heparin for major thrombotic or thromboembolic complications, with seven patients recovering. Treatment with THROMBATE III reversed heparin resistance in two patients with hereditary ATIII deficiency being treated for thrombosis or thromboembolism. During clinical investigation of THROMBATE III, none of 12 subjects monitored for a median of 8 months (range 2–19 months) after receiving THROMBATE III became antibody positive to human immunodeficiency virus (HIV-1). None of 14 subjects monitored for ⱖ 3 months demonstrated any evidence of hepatitis, either non-A, non-B hepatitis or hepatitis B. INDICATIONS AND USAGE THROMBATE III is indicated for the treatment of patients with hereditary antithrombin III deficiency in connection with surgical or obstetrical procedures or when they suffer from thromboembolism.

the 2013 annual meeting of the American Society of Anesthesiologists (ASA). In the first study (2056), researchers from Weill Cornell Medical College and the Hospital for Special Surgery, both in New York City, reviewed records from 131,541 patients

Subjects with ATIII deficiency should be informed about the risk of thrombosis in connection with pregnancy and surgery and about the inheritance of the disease. The diagnosis of hereditary antithrombin III (ATIII) deficiency should be based on a clear family history of venous thrombosis as well as decreased plasma ATIII levels, and the exclusion of acquired deficiency. ATIII in plasma may be measured by amidolytic assays using synthetic chromogenic substrates, by clotting assays, or by immunoassays. The latter does not detect all hereditary ATIII deficiencies. The ATIII level in neonates of parents with hereditary ATIII deficiency should be measured immediately after birth. (Fatal neonatal thromboembolism, such as aortic thrombi in children of women with hereditary antithrombin III deficiency, has been reported.) Plasma levels of ATIII are lower in neonates than adults, averaging approximately 60% in normal term infants. ATIII levels in premature infants may be much lower. Low plasma ATIII levels, especially in a premature infant, therefore, do not necessarily indicate hereditary deficiency. It is recommended that testing and treatment with THROMBATE III of neonates be discussed with an expert on coagulation. CONTRAINDICATIONS None known. WARNINGS Because THROMBATE III is made from human plasma, it may carry a risk of transmitting infectious agents, e.g. viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. No cases of transmission of viral diseases or CJD have ever been identified for THROMBATE III. Inform patients that THROMBATE III is made from human plasma and may contain infectious agents that can cause disease. While the risk that THROMBATE III can transmit an infectious agent has been reduced by screening plasma donors for prior exposure, testing donated plasma, and by inactivating or removing pathogens during manufacturing, patients should report any symptoms that concern them. ALL infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Grifols Therapeutics Inc. [1-800-520-2807]. The anticoagulant effect of heparin is enhanced by concurrent treatment with THROMBATE III in patients with hereditary ATIII deficiency. Thus, in order to avoid bleeding, reduced dosage of heparin is recommended during treatment with THROMBATE III. PRECAUTIONS General 1. Administer within 3 hours after reconstitution. Do not refrigerate after reconstitution. 2. Administer only by the intravenous route. 3. THROMBATE III, once reconstituted, should be given alone, without mixing with other agents or diluting solutions. 4. Product administration and handling of the needles must be done with caution. Percutaneous puncture with a needle contaminated with blood can transmit infectious virus including HIV (AIDS) and hepatitis. Obtain immediate medical attention if injury occurs. Place needles in sharps container after single use. Discard all equipment including any reconstituted THROMBATE III product in accordance with biohazard procedures. The diagnosis of hereditary ATIII deficiency should be based on a clear family history of venous thrombosis as well as decreased plasma ATIII levels, and the exclusion of acquired deficiency. Laboratory Tests It is recommended that ATIII plasma levels be monitored during the treatment period. Functional levels of ATIII in plasma may be measured by amidolytic assays using chromogenic substrates or by clotting assays. Drug Interactions The anticoagulant effect of heparin is enhanced by concurrent treatment with THROMBATE III in patients with hereditary ATIII deficiency. Thus, in order to avoid bleeding, reduced dosage of heparin is recommended during treatment with THROMBATE III. Pregnancy Category B Reproduction studies have been performed in rats and rabbits at doses up to four times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to THROMBATE III. It is not known whether THROMBATE III can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Pediatric Use Safety and effectiveness in the pediatric population have not been established. The ATIII level in neonates of parents with hereditary ATIII deficiency should be measured immediately after birth. (Fatal neonatal thromboembolism, such as aortic thrombi in children of women with hereditary antithrombin III deficiency, has been reported.) Plasma levels of ATIII are lower in neonates than adults, averaging approximately 60% in normal term infants. ATIII levels in premature infants may be much lower. Low plasma ATIII levels, especially in a premature infant, therefore, do not necessarily indicate hereditary deficiency. It is recommended that testing and treatment with THROMBATE III of neonates be discussed with an expert on coagulation. ADVERSE REACTIONS In clinical studies involving THROMBATE III, adverse reactions were reported in association with 17 of the 340 infusions during the clinical studies. Included were dizziness (8), chest discomfort (3), nausea (3), dysgeusia (3), chills (2), pain (cramps) (2), dyspnoea (1), chest pain (1), vision blurred (1), intestinal dilatation (1), urticaria (1), pyrexia (1), and wound secretion and hematoma (1). If adverse reactions are experienced, the infusion rate should be decreased, or if indicated, the infusion should be interrupted until symptoms abate. CAUTION & only U.S. federal law prohibits dispensing without prescription.

Grifols Therapeutics Inc. Research Triangle Park, NC 27709 USA U.S. License No. 1871

08941115-BS

undergoing anesthesia at NewYork Presbyterian Hospital (part of the Cornell campus) from December 2007 to February 2013, looking at comorbidities, time spent in the OR and blood pressure. They divided patients by body mass index (BMI), with 56,776 patients in the normal range of 18.5 to 24.9 kg/m2; 43,925 patients considered overweight with BMI of 25 to 29.9 kg/ m2; 25,407 patients considered obese with BMI of 30 to 39.9 kg/m2; and 5,433 patients considered morbidly obese with BMI of at least 40 kg/m2. More obese patients (28%) had hypertension—a measure of health before surgery—than overweight patients (23%) or those with a BMI in the normal range (16%; P<0.0001). Obese patients were more likely to be ranked as ASA class 3 (31% vs. 24% for overweight patients and 21% for normal BMI patients; P<0.0001). Obese and overweight patients also were more likely than patients with a normal BMI to have inpatient rather than ambulatory procedures. Among patients who were obese, 42% had inpatient procedures and 51% were treated on an outpatient basis; among overweight patients 40% were inpatients, whereas 53% were outpatients; and among patients in the normal BMI range, 30% had inpatient procedures whereas 65% were treated on an outpatient basis (P<0.0001). Obese patients also had longer overall operating time (96.8 vs. 89.8 minutes for overweight patients and 74.5 minutes for patients with a normal BMI; P<0.0001) and spent more time under anesthesia (176 vs. 168 minutes for overweight patients and 131 minutes for the normal BMI group; P<0.0001). “Although we cannot conclude this from our specific data, longer OR times have been associated with higher infection rates, for example,” said Stavros Memtsoudis, MD, PhD, clinical professor of anesthesiology and public health at Weill Cornell, who helped conduct the study. In a smaller study (2270), researchers at Stanford Medical Center, in Stanford, Calif., found that patients who are morbidly obese and undergoing primary hip arthroplasty required significantly more OR time than did patients with normal BMI. The investigators reviewed charts

O C TO B E R 2 0 1 3

AnesthesiologyNews.com I 57

CL IN ICA L A N E STH E SIOL OG Y Table. Rising Obesity Linked to Prolonged Surgeries and Hospital Stays BMI Range

35-35.9 (n=113)

40-50 (n=70)

Variables

Mean

P Value

Mean

P Value

Total Time in OR, min

156.3

0.000

167.9

0.000

Induction Time, min

26.3

0.000

28.2

0.000

Operation Time, min

97.6

0.000

103.0

0.000

Emergence Time, min

9.5

0.452

10.9

0.006

Recovery Time, min

184.9

0.994

174.6

0.474

Total Hospital Stay, days

3.6

0.233

3.9

0.001

from 1,332 patients scheduled for primary hip arthroplasty at the medical center from February 2008 to Jan. 1, 2013. The morbidly obese group had a total OR time of 168 minutes compared with 146 minutes for obese patients and 139 minutes for the normal BMI cohort. Patients who were morbidly obese also had longer operation times—103 versus 86 minutes for those with a normal BMI—and longer induction times, 28 versus 24 minutes for obese patients and 21 minutes for patients with normal BMI. Prospective research is needed to investigate what factors account for these differences, said Dr. Memtsoudis, who also is an attending anesthesiologist at the Hospital for Special Surgery, in New York City. Anesthesia and OR times might be longer for morbidly obese patients because of difficulty performing various procedures, positioning them for surgery or higher rates of complications, Dr. Memtsoudis said. But it could be instead that the health care team is being more careful with this population to avoid adverse events. Paradoxically, previous reports have suggested that obese patients have better outcomes following surgery, he said, although it’s not clear why. Nevertheless, “these studies are important because they help us understand that these patients use resources,” Dr. Memtsoudis said. He and his colleagues screen obese patients more thoroughly “to make sure there are no surprises” during sur surprises surgery. And the hospital ensures more staff members are available to help with patient positioning.

Two authors from the Stanford study, Bassam Kadry, MD, a clinical assistant professor of anesthesiology, perioperative and pain medicine, and Christopher Press, MD, a secondyear anesthesiology resident, also called for research to determine which procedures require extra time for obese patients. A linear relationship between procedure duration and obesity does not necessarily exist, Dr. Kadryy said, but understanding the connection “can potentially be used

to more accurately predict procedure duration.” For now, the medical center has modified the surgery schedule to allow more time for some operations on obese patients. For hospitals that treat a high percentage of obese patients, Dr. Kadryy said, “it’s worth considering creating dedicated service lines to help with transportation, positioning and peripheral IV placement for morbidly obese patients.” —Karen Blum

Protect your hard-earned reputation by managing risk. Since 1987, Preferred Physicians Medical (PPM) has exclusively insured anesthesiologists and their practices. Our policyhold ders also own PPM, so helping our physician owners manage their risk is a cornerstone of what makes us unique. PPM maintains a substantial database of more than 11,000 adverse anesthesia events and uses this information to identify areas of risk, monitor developing loss trends, and provide cutting-edge, timely and praactical anesthesia-specific risk management advice and strategies like: On-site risk management seminars for our po olicyholders and their staff presented by PPM in-house claims attorneys.. Exclusive online access to best practice proto ocols and documentation; white papers; current and archived issues of Anesthesia & Law, our risk management newsletter; and other useful infformation. Immediate email notification via Anesthesia Alerts of issues such as widespread drug contamination, dru ug shortages and significant changes to ASA standards. 24/7/365 telephone access to our experienced d attorneys and claims specialists for the expert risk man nagement advice you need, whenever you need it. Call PPM today to learn more about how our extensivve risk management program can help you protect your reputation.

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OCTOBER 2013

Lesson 306: Management of the Patient at Risk For an Operating Room Fire: Part 1 Daniel Charles Kolinsky, MD Resident in Emergency Medicine Washington University, St. Louis St. Louis, Missouri

PROFESSIONAL GAPS Fires in the OR are preventable and should never occur when health care personnel have proper education and system performance. Nevertheless, approximately 400 of these potentially fatal incidents occur annually in the United States. Anesthesiologists are key players in implementing safety programs for this issue. Many health care providers are unaware of the major elements of safety and how to avoid or treat a patient involved in an OR fire.

Alan David Kaye, MD, PhD Professor and Chairman, Department of Anesthesiology Louisiana State University Health Sciences Center New Orleans, Louisiana

LEARNING OBJECTIVES

REVIEWED BY: James Riopelle, MD Department of Anesthesiology Louisiana State University School of Medicine New Orleans, Louisiana

DISCLOSURE STATEMENT: The authors have no relationships with pharmaceutical companies or products to disclose, nor do they discuss off-label or investigative products relevant to this lesson.

At the end of this activity, the participant will be able to: 1. Name the 3 components of the “Fire Triad.” 2. Understand the importance of how a fire is fueled. 3. Provide examples of each component of the “Fire Triad” in the perioperative setting. 4. Describe the anesthesiologist’s role in preventing fires. 5. Appreciate the prevalence of an oxygen-enriched atmosphere in surgical fires. 6. Appreciate appropriate preoperative patient directions in fire prevention. 7. Identify the situations or surgical procedures that increase fire risk. 8. Outline preoperative risk preparation methods. 9. Understand the pre-assigned tasks, especially those of the anesthesiologist. 10. Describe currently available fire extinguishers.

TARGET AUDIENCE

CASE HISTORY

Anesthesiologists In this 2-part lesson, current recommendations for the prevention and management of operating room fires are reviewed. In Part 1, the incidence of operating room (OR) fires is noted and the efforts by the Anesthesia Patient Safety Foundation (APSF) and the American Society of Anesthesiologists (ASA) to prevent such incidents are described. The “Fire Triad” is explained and the respective roles of OR personnel are delineated. Preparation to prevent fires is outlined. Part 2 discusses the prevention and management of OR fires.

A 64-year-old Mexican immigrant was scheduled for a resection of an area around his left jaw for removal of a malignant amelanotic lesion, measuring approximately 3 x 3 x 2.5 cm. The patient had a history of high blood pressure and was taking lisinopril orally (20 mg per day). The patient had limited understanding of English and did not comprehend all of the instructions he was given during preoperative assessment. He had applied an aftershave after being admitted to day surgery the morning of his procedure. In the OR, routine monitors were placed, supplemental nasal oxygen at 4 L/min was delivered, and a combination of IV midazolam (3 mg) and propofol (85 mcg/kg per min) was administered, resulting in a titrated deep plane of anesthesia. Lidocaine 2% was injected into the left jaw and after the initial incision, cautery was used to assist in hemostasis. The patient’s entire face caught fire in a matter of seconds.

CALL FOR WRITERS If you would like to write a CME lesson for Anesthesiology News, please send an email to Elizabeth A.M. Frost, MD, at ElzFrost@aol.com.

Introduction

he APSF, in 2010, offered a fire safety video. A survey of the 587 anesthesia care responders who requested the video indicated that viewing the program prompted a change in their practice.1 With more than 70,000 anesthesia care providers in the United States, the response rate was clearly low. The ASA has released an updated Practice Advisory that presents the most recent information on the prevention and management of OR fires.2

Fires in the Operating Room The practicing anesthesiologist faces many potential hazards in the OR. One of the most serious of these

PREANESTHETIC ASSESSMENT Dr. Elizabeth A.M. Frost, who is the editor of this continuing medical education series, is clinical professor of anesthesiology at the Icahn School of Medicine at Mount Sinaii in New York City. She is the author off Clinical Anesthesia in Neurosurgery (Butterworth-Heinemann, Boston) and numerous articles. Dr. Frost is past president of the Anesthesia History Association and former editor of the journal of the New York State Society of Anesthesiologists, Sphere. She is also editor of the book series based on this CME program, Preanesthetic Assessment, Volumes 1 through 3 (Birkhäuser, Boston) and 4 through 6 (McMahon Publishing, New York City).

A COURSE OF STUDY FOR AMA/PRA CATEGORY 1 CREDIT Read this article, reflect on the information presented, then go online (www.mssm.procampus.net) and complete the lesson posttest and course evaluation before September 30, 2014. (CME credit is not valid past this date.) You must achieve a score of 80% or better to earn CME credit. TIME TO COMPLETE ACTIVITY: 2 hours RELEASE DATE: October 1, 2013 TERMINATION DATE: September 30, 2014 ACCREDITATION STATEMENT The Icahn School of Medicine at Mount Sinai is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

dangers is the outbreak of fire. Although OR fires are uncommon, they are among the most potentially lethal complications that anesthesiologists may encounter. No national standard requires the reporting of OR fires, nor is there a single database that records the number of fire events. Furthermore, malpractice settlements with confidentiality clauses make it even harder to quantify fire occurrences.3 As a result, accurate statistics on the incidence of surgical fires are difficult to ascertain.4 Figures range between 100 and 650 fires per year in the United States.5-6 Of these, 20 to 30 fires lead to injury and 1 to 2 fires cause death of the patient or a clinician, or both.5 Fires in the OR also are a significant source of liability for anesthesiologists. A 2006 study found that 17% of anesthesia malpractice claims stem from cases in which

CREDIT DESIGNATION STATEMENT The Icahn School of Medicine at Mount Sinai designates this enduring material for a maximum of 2.0 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. It is the policy of the Icahn School of Medicine at Mount Sinai to ensure objectivity, balance, independence, transparency, and scientific rigor in all CME-sponsored educational activities. All faculty participating in the planning or implementation of a sponsored activity are expected to disclose to the audience any relevant financial relationships and to assist in resolving any conflict of interest that may arise from the relationship. Presenters must also make a meaningful disclosure to the audience of their discussions of unlabeled or unapproved drugs or devices. This information will be available as part of the course material.

CONTINUING MEDICAL EDUCATION

This lesson is available online at www.mssm.procampus.net

the patient suffered burns in a surgical fire.7 An analysis of the ASA Closed Claims database found that just over 2% of claims relate to burns.8-9 Burn claims were associated more often with inappropriate care than claims not involving burns (P<0.01). One death was reported following a laser burn in the airway and 2 airway fires resulted in permanent disabling injuries. Payment was made more often in burn claims (72%) than in other claims in the database. Injuries from laser-related fires in the airway were the most severe. These cases not only had the highest payouts, but were also paid 100% of the time.9 The fact that most OR fires are easily preventable makes the resulting malpractice claims essentially indefensible.10 Several case reports suggest that the lack of knowledge of fire safety has led to injury and even death from OR fires.11-12 A working knowledge of fire prevention, safety, and awareness is indispensable for the practicing anesthesiologist. This article addresses the proper precautions that clinicians should take to avoid an OR fire, as well as what should be done during such an incident.

Table 2. Pre-Assigned Tasks in the Event of OR Fire Anesthesiologist Turn off oxygen/nitrous oxide and maintain ventilation with mask respirator (ie, Ambu bag). Communicate with the circulator to turn off the medical gas shut-off valves. Disconnect all electrical equipment on the anesthesia machine. Disconnect any leads, lines, or other equipment that may anchor the patient. Maintain the patient’s anesthesia during transport. Surgeon Remove from the patient materials that may be on fire. Control bleeding and prepare the patient for evacuation. Conclude the procedure as soon as possible. Place sterile towels or covers over the surgical site. Scrub Nurse Remove from the patient materials that may be on fire and help put out the fire. Obtain sterile towels or covers for the surgical site and instruments; gather a minimal number of instruments onto a tray or basin and place it with the patient for transport. Assist with patient transfer from the OR table to a stretcher/bed for transport out of the OR. Circulating Nurse

The Fire Triad For a fire to occur, 3 specific components are necessary: an ignition source, a fuel supply, and an oxidizing agent.13 Together, these 3 elements compose the “Fire Triad.” Reducing any of these parts results in a smaller fire, and removing any 1 element eliminates the possibility of a fire altogether. In the OR, many different factors can contribute to each part of the triad. Therefore, it is important to recognize which factor serves as the igniter, fuel, or oxidizing agent in the OR to prevent the assembling of a combustible combination (Table 1). Ignition comes from a concentrated source of heat or a spark. Examples of commonly used tools in the OR that can produce these situations are electrosurgical/electrocautery units, lasers, and light sources.13 A survey of practicing otolaryngologists found that 91% of fires in which they were involved were started by either electrocautery units or lasers.14 An analysis of Closed Claims data found that the percentage of fires started by cautery units has increased since 1985.15 Even after these tools are turned off, enough heat may be stored to cause ignition; thus, it is important to ensure that these probes are not directed at or in contact with a fuel supply. Anything that is flammable is considered a fuel. Many things in the OR serve this purpose. One would normally associate flammability with linens, prepping agents, and dressings.13 Other items that one might not consider are the patient’s body or contents within the body—methane

Ensure the patient’s safety by remaining with him or her and comforting him or her. Activate the fire alarm system and call the fire code to alert all necessary personnel. Extinguish small fires or douse them with liquid if appropriate. Remove any burning material from the patient or sterile field, and extinguish it on the floor. Collaborate with the anesthesia provider on the need to turn off the medical gas shut-off valves. Carefully unplug all equipment if the fire is electrical. Be aware of the safest route for escape. Obtain a transport stretcher if necessary. Remove IV solutions from poles and place them with the patient for transport out of the OR. OR, operating room Adapted from reference 20.

gas in the gastrointestinal tract—ointments, and medical equipment. In the past, flammable anesthetic agents such as ether or cyclopropane were more commonplace and often served as a fuel source. By halogenating alkanes in the late 1950s to early 1960s, scientists developed nonflammable, less toxic anesthetics—isoflurane, sevoflurane, desflurane—that now are the agents of choice.16,17 In fact, flammable agents are banned in ORs in the United States. Oxygen is the main oxidizing agent to which surgical teams are exposed. Oxygen is found in room air at 21% but also can be delivered directly to the patient at higher concentrations in oxygen-enriched mixtures, creating an oxygen-enriched atmosphere (OEA).13 In an OEA, ignition occurs more easily, fires burn hotter and are more difficult to extinguish, and items that normally do not burn can

Table 1. Commonly Found “Fire Triad” Items in the OR Electrocautery devices, lasers, heated probes, drills, burrs, argon beam coagulators, fiberoptic light cables, defibrillator pads, overhead surgical lights, electrical equipment Fuels

Tubes, sponges, drapes, gauze, alcohol-based prepping solutions, hand sanitizer, degreasers such as ether and acetone, masks, patient’s hair or skin or tissue, dressings, ointments/ tinctures, gowns, gastrointestinal tract gases, bed linens, gloves, packaging materials, and endotracheal tubes

Oxidizing agents

Oxygen, nitrous oxide

Adapted from reference 13.

OCTOBER 2013

combust.18 For example, a study that assessed the flammability of surgical drapes found that the time to ignition was inversely proportional to the ambient oxygen concentration.18 Furthermore, the authors observed no difference in time to ignition of flammable drapes versus nonflammable surgical drapes in an OEA.18 In addition, nitrous oxide can decompose into nitrogen and oxygen in the presence of heat, thereby increasing oxygen concentrations in ambient air. Therefore, it is important to note that although it is not considered an oxidizing agent, nitrous oxide can produce oxygen, forming an OEA.

Division of Labor and the Role of the Anesthesiologist The division of labor in the OR also leads to an inherent separation of responsibility for fire safety. The anesthesiologist is chiefly responsible for monitoring the oxidizers that are in and around the patient; the surgeon typically is responsible for controlling the surgical instruments that can cause ignition; and the nurses are in charge of combustible materials.13 It is important that each member of the team is cognizant of his or her respective responsibility for the Fire Triad and keep the elements from combining and potentially resulting in combustion or explosion. Although there is a division of responsibility for the parts of the triad, in the event of a fire, surgeons, nurses, and anesthetic care providers should act in an organized and

CONTINUING MEDICAL EDUCATION

OCTOBER 2013

Table 3. Fire Classes and Fire Extinguishers

Table 4. Types of Surgeries With High Risk For Fires

National Fire Protection Association Classes of Fires Class A

Fires involving ordinary combustible materials (eg, wood, paper, cloth, and most plastics)

Class B

Fires involving flammable liquids or grease

Class C

Fires involving energized electrical equipment

Class D

Fires involving combustible metals (eg, magnesium, titanium, potassium, and sodium)

Class K

Fires involving combustible cooking oils and fats

Oropharyngeal surgery: tonsillectomy, adenotonsillectomy Facial surgery: removal of lesions on head, face, or neck; cataract or other eye surgery Endoscopic laser surgery: removal of laryngeal papillomas Cutaneous/Transcutaneous surgery

Approved Coverage of Fire Extinguishers for Fire Class

Tracheostomy

Air pressurized water

Class A

CO2

Class B, C, and limited Class A

Dry chemical (sodium bicarbonate or potassium bicarbonate)

Class B and C

Multi-purpose dry chemical (monoammonium phosphate)

Class A, B, and C

Burr hole surgery Adapted from reference 2.

CO2, carbon dioxide Compiled from reference 25.

Figure. A CO2 fire extinguisher.

The division of labor allows the anesthesiologist to focus mainly on the oxygen (or nitrous oxide) that is delivered to the patient. In relation to fire prevention, the anesthesiologist’s main goal is to titrate the inspired oxygen to the lowest amount necessary to maintain the patient’s oxygenation within safe levels.19 This level will vary depending on the particular patient and the procedure being performed. Furthermore, as both oxygen and nitrous oxide are colorless and odorless, it is the anesthesiologist’s responsibility to communicate ongoing use and/ or presence in the surgical field to the surgeons. An OEA is present in approximately 75% of OR fires.23 The anesthesiologist, therefore, must play close attention to the selected method of oxygen delivery and the gas flow rate because he or she can dramatically reduce the likelihood of a fire, if not completely eliminate it. The Joint Commission recommends: “As a general policy, use air or fraction of inspired oxygen (FiO2) at or less than 30% for open delivery to prevent surgical fires.”22 The anesthesiologist must choose which method is most appropriate based on the surgical procedure being performed.

Steps to Fire Safety: Preparation coordinated fashion to extinguish the fire as soon and as safely as possible. The division of responsibility among OR personnel leads different groups to focus on a single part of the triad as opposed to the triad as a whole.19 This challenge underscores the need for team planning before the case and clear communication during the case.20 In 2011, a survey of 22 hospitals was conducted to determine which staff members participate in the fire safety and prevention workshops.21 Although the fact that many institutions are holding these seminars should be encouraging, the workshops were being conducted for the surgeons, surgical nurses, and anesthetists separately. As suggested above, in developing institutional policies to reduce the risk for fire outbreak, a multidisciplinary approach including all involved health care professionals is critical to the success of such policies.22

The first step to decreasing the morbidity and mortality of OR fires is preparation. Preparation is the precautions taken before a patient is brought to the OR. Fire safety equipment should be checked for availability and functional status. The hallways leading to the OR should be kept clear of patient beds, surgical machinery, and anything else that may obstruct access to fire safety equipment, medical gas valves, or in the worst case, impede evacuation of an OR altogether.24 The location of fire extinguishers, sterile saline, fire alarms, medical gas valves, self-inflating Ambu bags, and flashlights should be clearly marked and easily accessible.24 Items that must be readily available in the OR at all times include sterile saline, a carbon dioxide (CO2) fire extinguisher (Figure), replacement intubation and airway equipment (laryngoscope, endotracheal tubes, breathing circuit tubing, etc.), drapes, and sponges.21

All members of the OR staff—surgeons, anesthetic care providers, surgical technicians, nurses, and students— should be properly trained in fire safety practices with the pre-assigned roles explained to each member of the team in the event that a fire occurs (Table 2).20 When a fire occurs, if members complete their pre-assigned tasks, they should then help others complete their respective tasks.2 Team members should be taught rescue methods and evacuation protocols including turning off the medical gases to the room, activating the fire alarm, and initiating a hospital-wide alert often termed a “Code Red.” Members of the OR team also should be educated on the different classes of fires, the appropriate choice of a fire extinguisher, and how to use it properly (Table 3). The mnemonic “PASS” can be used to remember the steps of fire extinguisher activation. First, pull the pin at the handle and then aim at the base of the fire. Next, squeeze the handle (or trigger) and sweep back and forth across the base of the fire.19 Carbon dioxide fire extinguishers are recommended for the OR.19 Approved for Class B, Class C, and limited Class A fires, their broad spectrum of coverage enables them to extinguish fires of many different types. Furthermore, they extinguish fires by displacing the ambient oxygen with CO2, thereby removing the oxidizer component of the Fire Triad, making them the better choice when the patient is the fuel source.21,25 Although dry chemical extinguishers have the broadest spectrum of coverage, they leave a corrosive residue after use that can contaminate the field or cause tissue damage, and thus are not preferred in the OR setting.21 Afterward, a fire drill may be conducted to evaluate the proficiency of the OR team in fire safety and help familiarize them with the exits, evacuation routes, location of the extinguishers, and shut-off valves for medical gas and electrical supply. A case report explains that an OR fire drill enhanced the team’s response to fire outbreak.26 While these drills should be performed at regular intervals in accordance with local, state, and Joint Commission guidelines, the ASA recommends that they take place outside of patient care hours and have dedicated educational time set aside for them.2 Some procedures are deemed high-risk because the surgery will require bringing together the 3 components of the Fire Triad into close proximity, greatly increasing the probability of combustion (Table 4). The risk is particularly acute in facial or oropharyngeal surgeries, as high concentrations

CONTINUING MEDICAL EDUCATION

This lesson is available online at www.mssm.procampus.net

of oxygen are flowing through a plastic endotracheal tube immediately adjacent to a cautery. Approximately 21% of OR fires involve these sites.23 Therefore, preoperative discussion should take place among all members of the surgical team to determine the risk for fire based on the surgery being performed, as well as a list of surgical tools and materials to be used during the procedure.2 The Fire Risk Assessment Score is a simple assessment27 that can be performed in seconds during the surgical time-out. The scale ranges from 0 (very low risk) to 3 (high risk), with 1 point allotted for each of the following: • Surgical site above the xiphoid; • Presence of an open oxygen source, such as a face mask or nasal cannula; • Use of an ignition source, including a cautery or laser. In cases of high risk for OR fires (score 3), the team should outline the plan to minimize the risk by taking the proper precautions.

References 1.

Stoelting RK. Survey suggests viewing the APSF fire safety video changed practice among anesthesia professionals. APSF Newsletter. 2012;27(1):1.

Apfelbaum JL, Caplan RA, Barker SJ, et al. Practice advisory for the prevention and management of operating room fires. Anesthesiology. 2013;118(2):271-290.

OCTOBER 2013

Sosis MB. Anesthesiologists must do a better job of preventing operating room fires. J Clin Anesth. 2006;18(2):81-82.

15. Mehta SP. Cautery fires in the operating room. ASA Newsletter. 2012;76(2):16-18.

Rinder CS. Fire safety in the operating room. Curr Opin Anaesthesiol. 2008;21(6):790-795.

16. Yardley IE, Donaldson LJ. Surgical fires, a clear and present danger. The Surgeon. 2010; 8:87-92.

New clinical guide to surgical fire prevention. Patients can catch fire—here’s how to keep them safer. Health Devices. 2009;38(10): 314–332.

17. Wolf GL. Danger from OR fires still a serious problem. ASA panel reports risks. J Clin Monit Comput. 2000;16(3):237-238.

Daane SP, Toth BA. Fire in the operating room: principles and prevention. Plast Reconstr Surg. 2005;115(5):73e-75e.

Bhananker SM, Posner KI, Cheney FW, Caplan RA, Lee LA, Domino KB. Injury and liability associated with monitored anesthesia care: a closed claim analysis. Anesthesiology. 2006;104(2):228-234.

http://depts.washington.edu/asaccp/projects/anesthesia-closedclaims-project.

Kressin KA. Burn injury in the operating room: a closed claims analysis. ASA Newsletter. 2004;68(6):9-11.

10. Gorney M, Lofsky AS, Charles DM. Playing with fire. The Doctors Company Risk Management Advisory. 2002. http://www.thedoctors.com/risk/bulletins/fireinor.asp. 11. Anonymous. Use of wrong gas in laparoscopic insufflators causes fire. Health Devices. 1994;23(10-11):456-457.

18. Golderberg J. Brief laboratory report: surgical drape flammability. AANA J. 2006;74(5):352-354. 19. Ehrenwerth J, Seifert HA. Electrical and fire safety. In: Barash PG, Cullen BF, Stoelting RK, et al, eds. Clinical Anesthesia. 6th ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2009: 165-191. 20. AORN Guidance Statement: Fire prevention in the operating room. Perioperative Standards and Recommended Practices. Denver, CO: 2008; 171-179. 21. Hart SR, Yajnik A, Ashford J, Springer R, Harvey S. Operating room fire safety. The Ochsner J. 2011;11(1):37-42. 22. Joint Commission on Accreditation of Healthcare Organizations. Sentinel Event Alert. Issue 29; June 24, 2003. 23. ECRI Institute. Surgical fire safety. Health Devices. 2006;35:45-66. 24. Steelman VM, Hottel RA. Where there’s smoke, there’s … AORN J. 2009;89(5):825-827.

12. Stouffer DJ. Fires during surgery: two fatal incidents in Los Angeles. J Burn Care Rehabil. 1992;13(1):114-117.

25. US Occupational Safety and Health Administration. http:// www.osha.gov/SLTC/etools/evacuation/portable_about. html#drychem

13. ECRI Institute. Devastation of patient fires. Health Devices. 1992; 21:3-39.

26. Halstead MA. Fire drill in the operating room. Role playing as a learning tool. AORN J. 1993;58(4):697-706.

14. Smith LP, Roy S. Operating room fires in otolaryngology: risk factors and prevention. Am J Otolaryngol. 2011;32(2):109-114.

27. Mathias JM. Scoring fire risk for surgical patients. OR Manager. 2006;22(1):19-20.

Visit www.mssm.procampus.net today for instant online processing of your CME post-test and evaluation form. There is a registration fee of $15 for this non–industry-supported activity. For assistance with technical problems, including questions about navigating the Web site, call toll-free customer service at (888) 345-6788 or send an email to Customer.Support@ProCEO.com.

For inquiries about course content only, send an email to ram.roth@mssm.edu. Ram Roth, MD, is director of PreAnesthetic Assessment Online and assistant professor of anesthesiology at the Icahn School of Medicine at Mount Sinai,i New York, NY.

Post-Test 1.

The number of fires in the operating room (OR) in the published literature ranges from ______ with approximately ______ of them leading to death. a. 100 to 200, 1 to 2 b. 100 to 650, 1 to 2 c. 100 to 650, 5 to 10 d. 200 to 650, 1 to 2

All of the following supplies are replacement items that must be available in the OR at all times, except ______. a. fire blanket b. sterile saline c. CO2 fire extinguisher d. replacement intubation and airway equipment

The 3 components of the “Fire Triad” are ______. a. fire, igniter, fuel b. fire, fuel, oxidizer c. Igniter, fire, oxidizer d. Igniter, fuel, oxidizer

A survey conducted among otolaryngologists found that the most common ignition sources leading to surgical fires are ______. a. lasers and electrocautery units b. lasers and surgical lights c. electrocautery units and fiber-optic light cables d. electrocautery units and drills

All of the following are pre-assigned tasks of the anesthesiologist except: a. Turn off oxygen/nitrous oxide and maintain ventilation with mask respirator (ie, Ambu bag). b. Activate the fire alarm system and call the fire code to alert all necessary personnel. c. Communicate with the circulator to turn off the medical gas shut-off valves. d. Disconnect all electrical equipment on the anesthesia machine.

What are the criteria that determine if a surgery is high-risk for fire? a. Surgical site below the xiphoid, open oxygen system, and use of ignition source b. Surgical site below the xiphoid, open oxygen system, and use of a fuel source c. Surgical site above the xiphoid, closed oxygen system, and use of ignition source d. Surgical site above the xiphoid, open oxygen system, and use of ignition source

The recommended type of fire extinguisher for the OR is ______ which is approved for ______ fires. a. water, Class A b. water, Class A and B c. CO2, Class B and C d. CO2, Class B, C, and some A

In the division of labor in the OR, anesthesiologists are mostly responsible for the ______ whereas surgeons are mostly responsible for the ______. a. fuel, sources of ignition b. fuel, oxidizers c. oxidizer, sources of ignition d. oxidizer, fuel An oxygen-enriched atmosphere is present in ______ of surgical fires that have occurred. a. less than 60% b. 60% to 70% c. 70% to 80% d. more than 80%

10. All of the following procedures are considered to present a high risk for fire except ______. a. burr hole surgery b. endoscopic laser removal of laryngeal papillomas c. tonsillectomy d. wisdom teeth extraction

Different situations require different sedative solutions Important Precedex Safety Information

The first and only alpha2 agonist indicated for sedation1-2

Clinically significant episodes of bradycardia, sinus arrest and hypotension have been associated with Precedex infusion and may necessitate medical intervention.

Nonintubated patients prior to and during surgical and other procedures.1 Initially intubated and mechanically ventilated patients during treatment in an intensive care setting.1

Moderate blood pressure and heart rate reductions should be anticipated when initiating sedation with Precedex.

Administer Precedex™ by continuous infusion not to exceed 24 hours.1

Prolonged exposure to dexmedetomidine beyond 24 hours may be associated with tolerance and tachyphylaxis and a dose-related increase in adverse events.

Learn more at www.Precedex.com A right fit for today’s sedation management practices Please see the brief summary of Prescribing Information on adjacent page. References: 1. Precedex [package insert]. Lake Forest, IL: Hospira, Inc; 2008. 2. Kamibayashi T, Maze M. Clinical uses of α2-adrenergic agonists. Anesthesiology. 2000;93:1345-1349.

Hospira, Inc. 275 North Field Drive, Lake Forest, IL 60045 P12-3639, 10.5x13-May, 12. Printed in the USA.

For more information on Advancing WellnessTM, contact your Hospira representative at 1-877-9HOSPIRA (1-877-946-7747) or visit www.hospira.com.

Table 2 (continued): Adverse Reactions With an Incidence >2%—Intensive Care Unit Sedation Population <24 hours*

BRIEF SUMMARY CONSULT PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION

Precedex®

Rx only

(dexmedetomidine hydrochloride) injection

Adverse Event

For Intravenous Use 1 INDICATIONS AND USAGE 1.1 Intensive Care Unit Sedation Precedex® is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. Precedex should be administered by continuous infusion not to exceed 24 hours. Precedex has been continuously infused in mechanically ventilated patients prior to extubation, during extubation, and post-extubation. It is not necessary to discontinue Precedex prior to extubation. 1.2 Procedural Sedation Precedex is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures. 4 CONTRAINDICATIONS None 5 WARNINGS AND PRECAUTIONS 5.1 Drug Administration Precedex should be administered only by persons skilled in the management of patients in the intensive care or operating room setting. Due to the known pharmacological effects of Precedex, patients should be continuously monitored while receiving Precedex. 5.2 Hypotension, Bradycardia, and Sinus Arrest Clinically significant episodes of bradycardia and sinus arrest have been reported with Precedex administration in young, healthy volunteers with high vagal tone or with different routes of administration including rapid intravenous or bolus administration. Reports of hypotension and bradycardia have been associated with Precedex infusion. If medical intervention is required, treatment may include decreasing or stopping the infusion of Precedex, increasing the rate of intravenous fluid administration, elevation of the lower extremities, and use of pressor agents. Because Precedex has the potential to augment bradycardia induced by vagal stimuli, clinicians should be prepared to intervene. The intravenous administration of anticholinergic agents (e.g., glycopyrrolate, atropine) should be considered to modify vagal tone. in the treatment of most episodes of In clinical trials, glycopyrrolate or atropine were effective f Precedex-induced bradycardia. However, in some patients with significant cardiovascular dysfunction, more advanced resuscitative measures were required. Caution should be exercised when administering Precedex to patients with advanced heart block and/or severe ventricular dysfunction. Because Precedex decreases sympathetic nervous system activity, hypotension and/or bradycardia may be expected to be more pronounced in patients with hypovolemia, diabetes mellitus, or chronic hypertension and in elderly patients. In clinical trials where other vasodilators or negative chronotropic agents were co-administered with Precedex an additive pharmacodynamic effect was not observed. Nonetheless, caution should be used when such agents are administered concomitantly with Precedex. 5.3 Transient Hypertension Transient hypertension has been observed primarily during the loading dose in association with the initial peripheral vasoconstrictive effects of Precedex. Treatment of the transient hypertension has generally not been necessary, although reduction of the loading infusion rate may be desirable. 5.4 Arousability Some patients receiving Precedex have been observed to be arousable and alert when stimulated. This alone should not be considered as evidence of lack of efficacy in the absence of other clinical signs and symptoms. 5.5 Withdrawal Intensive Care Unit Sedation With administration up to 7 days, regardless of dose, 12 (5%) Precedex subjects experienced at least 1 event related to withdrawal within the first 24 hours after discontinuing study drug and 7 (3%) Precedex subjects experienced at least 1 event 24 to 48 hours after end of study drug. The most common events were nausea, vomiting, and agitation. Tachycardia and hypertension requiring intervention in the 48 hours following study drug discontinuation occurred at frequencies of <5%. If tachycardia and/or hypertension occurs after discontinuation of Precedex supportive therapy is indicated. Procedural Sedation Withdrawal symptoms were not seen after discontinuation of short term infusions of Precedex (<6 hours). 5.6 Tolerance and Tachyphylaxis Use of dexmedetomidine beyond 24 hours has been associated with tolerance and tachyphylaxis and a dose-related increase in adverse reactions [see Adverse Reactions (6.1)]. 5.7 Hepatic Impairment Since Precedex clearance decreases with severity of hepatic impairment, dose reduction should be considered in patients with impaired hepatic function [see Dosage and Administration (2.2)]. 6 ADVERSE REACTIONS 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in practice. Use of Precedex has been associated with the following serious adverse reactions: • Hypotension, bradycardia and sinus arrest [see Warnings and Precautions (5.2)] • Transient hypertension [see Warnings and Precautions (5.3)] Most common treatment-emergent adverse reactions, occurring in greater than 2% of patients in both Intensive Care Unit and procedural sedation studies include hypotension, bradycardia and dry mouth. Intensive Care Unit Sedation Adverse reaction information is derived from the continuous infusion trials of Precedex for sedation in the Intensive Care Unit setting in which 1007 patients received Precedex. The mean total dose was 7.4 mcg/kg (range: 0.8 to 84.1), mean dose per hour was 0.5 mcg/kg/hr (range: 0.1 to 6.0) and the mean duration of infusion of 15.9 hours (range: 0.2 to 157.2). The population was between 17 to 88 years of age, 43% ≥65 years of age, 77% male and 93% Caucasian. Treatment-emergent adverse reactions occurring at an incidence of >2% are provided in Table 2. The most frequent adverse reactions were hypotension, bradycardia and dry mouth [see Warnings and Precautions (5.2)]. Table 2: Adverse Reactions With an Incidence >2%—Intensive Care Unit Se dation Population <24 hours*

Adverse Event

All Precedex (N = 1007) (%)

Randomized Precedex (N = 798) (%)

Placebo (N = 400) (%)

Propofol (N = 188) (%)

Hypotension Hypertension Nausea Bradycardia Atrial fibrillation Pyrexia Dry mouth Vomiting Hypovolemia Atelectasis Pleural effusion Agitation Tachycardia Anemia Hyperthermia

25% 12% 9% 5% 4% 4% 4% 3% 3% 3% 2% 2% 2% 2% 2%

24% 13% 9% 5% 5% 4% 3% 3% 3% 3% 2% 2% 2% 2% 2%

12% 19% 9% 3% 3% 4% 1% 5% 2% 3% 1% 3% 4% 2% 3%

13% 4% 11% 0 7% 4% 1% 3% 5% 6% 6% 1% 1% 2% 0 – continued

Chills Hyperglycemia Hypoxia Post-procedural hemorrhage Pulmonary edema Hypocalcemia Acidosis Urine output decreased Sinus tachycardia Ventricular tachycardia Wheezing Edema peripheral

All Precedex (N = 1007) (%)

Randomized Precedex (N = 798) (%)

Placebo (N = 400) (%)

Propofol (N = 188) (%)

2% 2% 2% 2% 1% 1% 1% 1% 1% <1% <1% <1%

2% 2% 2% 2% 1% 1% 1% 1% 1% 1% 1% 0

3% 2% 2% 3% 1% 0 1% 0 1% 1% 0 1%

2% 3% 3% 4% 3% 2% 2% 2% 2% 5% 2% 2%

Procedural Sedation Adverse reaction information is derived from the two trials for procedural sedation in which 318 patients received Precedex. The mean total dose was 1.6 mcg/kg (range: 0.5 to 6.7), mean dose per hour was 1.3 mcg/kg/hr (range: 0.3 to 6.1) and the mean duration of infusion of 1.5 hours (range: 0.1 to 6.2). The population was between 18 to 93 years of age, 30% ≥65 years of age, 52% male and 61% Caucasian. Treatment-emergent adverse reactions occurring at an incidence of >2% are provided in Table 6. The most frequent adverse reactions were hypotension, bradycardia, and dry mouth [see Warnings and Precautions (5.2)]. Pre-specified criteria for the vital signs to be reported as adverse reactions are footnoted below the table. The decrease in respiratory rate and hypoxia was similar between Precedex and comparator groups in both studies. Table 6: Adverse Reactions With an Incidence > 2%—Procedural Sedation Population

* 26 subjects in the all Precedex group and 10 subjects in the randomized Precedex group had exposure for greater than 24 hours.

Adverse reaction information was also derived from the placebo-controlled, continuous infusion trials of Precedex for sedation in the surgical intensive care unit setting in which 387 patients received Precedex for less than 24 hours. The most frequently observed treatment-emergent adverse events included hypotension, hypertension, nausea, bradycardia, fever, vomiting, hypoxia, tachycardia and anemia (see Table 3).

Randomized Dexmedetomidne (N = 387) 28% 16% 11% 7% 5% 4% 4% 4% 3% 3% 3% 3% 2% 2% 2% 2% 2% 2% 2% 2% 2%

Adverse Event Hypotension Hypertension Nausea Bradycardia Fever Vomiting Atrial Fibrillation Hypoxia Tachycardia Hemorrhage Anemia Dry Mouth Rigors Agitation Hyperpyrexia Pain Hyperglycemia Acidosis Pleural Effusion Oliguria Thirst

3 4

Placebo (N = 379) 13% 18% 9% 3% 4% 6% 3% 4% 5% 4% 2% 1% 3% 3% 3% 2% 2% 2% 1% <1% <1%

5 6

Respiratory depression2

37%

32%

Bradycardia3

14%

Hypertension4 Tachycardia5 Nausea Dry mouth Hypoxia6 Bradypnea

13% 5% 3% 3% 2% 2%

24% 17% 2% 1% 3% 4%

Hypotension was defined in absolute and relative terms as Systolic blood pressure of <80 mmHg or ≤30% lower than pre-study drug infusion value, or Diastolic blood pressure of <50 mmHg. Respiratory depression was defined in absolute and relative terms as respiratory rate (RR) <8 beats per minute or > 25% decrease from baseline. Bradycardia was defined in absolute and relative terms as <40 beats per minute or ≤30% lower than pre-study drug infusion value. Hypertension was defined in absolute and relative terms as Systolic blood pressure >180 mmHg or ≥30% higher than pre-study drug infusion value or Diastolic blood pressure of >100 mmHg. Tachycardia was defined in absolute and relative terms as >120 beats per minute or ≥30% greater than pre-study drug infusion value. Hypoxia was defined in absolute and relative terms as SpO2 <90% or 10% decrease from baseline.

Table 7: Adverse Reactions Experienced During Post-approval Use of Precedex

Table 4: Key Treatment-Emergent Adverse Events Occurring in Dexmedetomidineor Midazolam-Treated Patients in the Randomized Active Comparator Continuous Infusion Long-Term Intensive Care Unit Sedation Study* Adverse Event Hypotension1 Hypotension requiring intervention Bradycardia2 Bradycardia requiring intervention Systolic Hypertension3 Tachycardia4 Tachycardia requiring intervention Diastolic Hypertension3 Hypertension3 Hypertension requiring intervention† Hypokalemia Pyrexia Agitation Hyperglycemia Constipation Hypoglycemia Respiratory Failure Renal Failure Acute Acute Respiratory Distress Syndrome Generalized edema Hypomagnesemia

Placebo N = 113 (%) 30%

6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of Precedex. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Hypotension and bradycardia were the most common adverse reactions associated with the use of Precedex during post approval use of the drug.

In a controlled clinical trial, Precedex was compared to midazolam for ICU sedation exceeding 24 hours duration. Key treatment emergent adverse events occurring in dexmedetomidine or midazolam treated patients in the randomized active comparator continuous infusion long-term intensive care unit sedation study are provided in Table 4. The number (%) of subjects who had a dose-related increase in treatment-emergent adverse events by maintenance adjusted dose rate range in the Precedex group is provided in Table 5.

Dexmedetomidine (n=244) 56% 28% 42% 5% 28% 25% 10% 12% 11% 19% 9% 7% 7% 7% 6% 5% 5% 2% 2% 2% 1%

1 2

Table 3: Treatment-Emergent Adverse Events Occurring in >1% Of All Dexmedetomidine-Treated Patients in the Randomized Placebo-controlled Continuous Infusion <24 Hours ICU Sedation Studies

Precedex N = 318 (%) 54%

Adverse Event Hypotension1

Midazolam (n=122) 56% 27% 19% 1% 42% 44% 10% 15% 15% 30% 13% 2% 6% 2% 6% 6% 3% 1% 1% 6% 7%

† Includes any type of hypertension. 1 Hypotension was defined in absolute terms as Systolic blood pressure of <80 mmHg or Diastolic blood pressure of <50 mmHg or in relative terms as ≤30% lower than pre-study drug infusion value. 2 Bradycardia was defined in absolute terms as <40 bpm or in relative terms as ≤30% lower than pre-study drug infusion value. 3 Hypertension was defined in absolute terms as Systolic blood pressure >180 mmHg or Diastolic blood pressure of >100 mmHg or in relative terms as ≥30% higher than pre-study drug infusion value. 4 Tachycardia was defined in absolute terms as >120 bpm or in relative terms as ≥30% greater than pre-study drug infusion value.

The following adverse events occurred between 2 and 5% for Precedex and Midazolam, respectively: renal failure acute (2.5%, 0.8%), acute respiratory distress syndrome (2.5%, 0.8%), and respiratory failure (4.5%, 3.3%).

Body System

Preferred Term

Body as a Whole

Fever, hyperpyrexia, hypovolemia, light anesthesia, pain, rigors

Cardiovascular Disorders, General

Blood pressure fluctuation, heart disorder, hypertension, hypotension, myocardial infarction

Central and Peripheral Nervous System Disorders

Dizziness, headache, neuralgia, neuritis, speech disorder, convulsion

Gastrointestinal System Disorders

Abdominal pain, diarrhea, vomiting, nausea

Heart Rate and Rhythm Disorders

Arrhythmia, ventricular arrhythmia, bradycardia, hypoxia, atrioventricular block, cardiac arrest, extrasystoles, atrial fibrillation, heart block, t wave inversion, tachycardia, supraventricular tachycardia, ventricular tachycardia

Liver and Biliary System Disorders

Increased gamma-glutamyl transpepsidase, hepatic function abnormal, hyperbilirubinemia, alanine transaminase, aspartate aminotransferase

Metabolic and Nutritional Disorders

Acidosis, respiratory acidosis, hyperkalemia, increased alkaline phosphatase, thirst, hypoglycemia

Psychiatric Disorders

Agitation, confusion, delirium, hallucination, illusion

Red Blood Cell Disorders

Anemia

Renal Disorders

Blood urea nitrogen increased, oliguria

Respiratory System Disorders

Apnea, bronchospasm, dyspnea, hypercapnia, hypoventilation, hypoxia, pulmonary congestion

Skin and Appendages Disorders

Increased sweating

Vascular Disorders

Hemorrhage

Vision Disorders

Photopsia, abnormal vision

10 OVERDOSAGE The tolerability of Precedex was studied in one study in which healthy subjects were administered doses at and above the recommended dose of 0.2 to 0.7 mcg/kg/hr. The maximum blood concentration achieved in this study was approximately 13 times the upper boundary of the therapeutic range. The most notable effects observed in two subjects who achieved the highest doses were first degree atrioventricular block and second degree heart block. No hemodynamic compromise was noted with the atrioventricular block and the heart block resolved spontaneously within one minute. Five patients received an overdose of Precedex in the intensive care unit sedation studies. Two of these patients had no symptoms reported; one patient received a 2 mcg/kg loading dose over 10 minutes (twice the recommended loading dose) and one patient received a maintenance infusion of 0.8 mcg/kg/hr. Two other patients who received a 2 mcg/kg loading dose over 10 minutes, experienced bradycardia and/or hypotension. One patient who received a loading bolus dose of undiluted Precedex (19.4 mcg/kg), had cardiac arrest from which he was successfully resuscitated.

Table 5. Number (%) of subjects who had a dose-related increase in Treatment Emergent Adverse Events by maintenance adjusted dose rate range in the Precedex group Precedex mcg/kg/hr ≤ 0.7* N = 95

> 0.7 to ≤ 1.1* N = 78

> 1.1* N = 71

Constipation

14%

Agitation

14%

Anxiety

Oedema peripheral

Atrial fibrillation

Respiratory failure

10%

Acute Respiratory Distress Syndrome

Adverse Event

* Average maintenance dose over the entire study drug administration

Manufactured and Distributed by: Hospira, Inc. Lake Forest, IL 60045 USA Licensed from: Orion Corporation Espoo, Finland Printed in USA Hospira, Inc., Lake Forest, IL 60045 USA

O C TO B E R 2 0 1 3

AnesthesiologyNews.com I 65

CL IN ICA L A N E STH E SIOL OG Y

Studies Find Sugammadex Does Not Raise Risk for Serious Bleeding San Diego—Sugammadex does not appear to promote bleeding or blood loss, according to a new study that contradicts previous results indicating the novel reversal agent could delay clotting. The international multicenter trial found that sugammadex (Merck) did not appear to prolong activated partial thromboplastin time (aPTT) and prothrombin time (PT) in surgical patients. Meanwhile, more new data suggest the drug, which is available in Europe, Asia and elsewhere but not in the United States, is at least as safe as, and more effective than conventional reversal agents. “In vitro studies and a small volunteer study showed a small transient rise in aPTT and PT, so we needed to see if this was translated to surgical patients or not,” said Tiffany Woo, MSc, director of clinical research for anesthesia at Merck Research Laboratories in Whitehouse Station, N.J., who led the study. “So we designed this fairly extensive study of almost 1,200 patients at 22 sites, where we examined the effect of sugammadex on postsurgical bleeding and coagulation parameters.” Patients in the randomized, doubleblindd trial were undergoing hip fracture surgery or hip/knee joint replacement and receiving thromboprophylaxis. Patients received either 4 mg/kg of sugammadex or usual care for reversal of rocuronium- or vecuronium-induced neuromuscular blockade. “In the usual-care group, anesthesiologists who normally reverse were allowed to continue, which meant using neostigmine with glycopyrrolate or atropine,” Ms. Woo said. “If they didn’t reverse and did spontaneous recovery, that was also included in the usual-care group.” As Ms. Woo reported at the 2013 annual meeting of the International Anesthesia Research Society (abstract

S-48), 1,184 patients were treated, 596 with sugammadex and 588 with usual care. Among usual-care patients, 52% received neostigmine while 48% recovered without medication. Patients given sugammadex experienced prolongation of both aPTT (5.5%) and PT (3%) relative to usual care 10 minutes after receiving the drug. “These levels both returned to baseline by 60 minutes” after receiving the agent, Ms. Woo said. Adjudicated bleeding events within 24 hours were reported in 17 patients receiving sugammadex (2.9%) and 24 usual-care patients (4.1%; relative risk [RR], 0.70 95% confidence interval [CI], [0.38-1.29]). These results were consistent with those obtained in a sensitivity analysis for 24-hour bleeding events (RR, 0.64 95% CI [0.37-1.11]), as well as other bleeding endpoints. “The main issue here is the relative risk is quite low,” Ms. Woo said. No relevant differences were observed between groups with respect to other hemodynamic parameters. Post-treatment transfusion was required in 37% and 39% of the sugammadex and usual-care patients, and average 24-hour drain volumes were 0.46 and 0.48 L, respectively. The average drop in hemoglobin using the bleeding index was –15.7 and –17.4 g/L, respectively,

and incidences of postoperative anemia were 20.8% and 22.4% for sugammadex and usual-care patients. None of the other safety end points— including risk for venous thromboembolism—demonstrated clinically relevant differences for the patients who received sugammadex. And no patient experienced anaphylaxis requiring care. “There were less treatment-emergent adverse events with sugammadex than with usual care,” Ms. Woo added. Pooled Analysis Reaches Similar Conclusion That finding agrees with results of a pooled analysis of 1,850 patients who received sugammadex as part of Phase 2 and 3 trials, which found that the drug was not associated with an increased risk for bleeding or other adverse events, including hypersensitivity. That study, by researchers in The Netherlands, was presented at the 2013 annual meeting of the American Society of Anesthesiologists (ASA; abstract 4013). And in another study presented at the ASA meeting (abstract 4012), researchers at Massachusetts General Hospital, in Boston, reported that sugammadex appears to be as safe as conventional care in patients undergoing abdominal surgery. The study also found that patients who received sugammadex experienced fewer

Table. Administration of Sugammadex Led to Shorter Time Intervals In Several Measures Compared With Usual Care Geometric mean times, min

Sugammadex

Usual care

P Value

Study drug administration to extubation

11.0 (median, 11)

15.2 (median, 14)

0.014

Study drug administration to OR discharge ready

14.7 (median, 13.5)

18.6 (median, 17)

0.021

Study drug administration to actual OR discharge

19.9 (median, 19)

24.1 (median 23)

0.020

drug-related adverse events than those given neostigmine with glycopyrrolate. Meanwhile, the drug seemed to perform well, completely eliminating cases of residual neuromuscular blockade in the postanesthesia care unit, compared with a rate of 43% for this complication among patients who received the other reversal agents, according to the researchers. “The results from this study suggest that sugammadex versus neostigmine/glycopyrrolate decreased the time between reversal and patient being considered OR discharge ready, which should help maximize operational efficiency in the OR in a high throughput setting,” the Boston researchers wrote (Table). Sorin J. Brull, MD, professor of anesthesiology at the Mayo Clinic College of Medicine, in Jacksonville, Fla., praised the Merck study for its design and sample size, and said he was confident that sugammadex was not the cause of excess bleeding. “The increase in the coagulation parameters was clinically insignificant,” Dr. Brull told Anesthesiology News. “A 5.5% increase in any of these parameters is highly unlikely to result in actual hemorrhage. Second, the small prolongation in these parameters was shortlived, the values returning to baseline within 60 minutes of administration of sugammadex. Considering that sugammadex is administered at the end of the surgical procedure—most likely even after closure of the surgical incision— the likelihood of clinically significant bleeding is further decreased.” That is not to say that there will not be bleeding associated with sugammadex, he added. “But it will be an association, not a cause. Similarly, there is bleeding associated with the use of the standard reversal agent, but this is not to say that neostigmine has caused bleeding.” —Michael Vlessides Dr. Brull serves as a global advisory board member for Merck, and has participated in studies of sugammadex on behalf of the company.

Study Probes Anesthesia–Erection Link en who undergo urologic surgery on occasion experience an erection during the procedure—unwitting arousal that can force the delay, and even cancellation, of the operation. Now researchers in China have found that certain anesthetics used during urologic surgery are more likely to be associated with erections.

The study, by a group from West China Hospital in Chengdu, compared rates of erection in nearly 300 men who received sevoflurane, propofol or isoflurane as general anesthetic for elective urologic surgery. Sixteen of the men (5%) developed an erection in the operating room. But the breakdown was uneven. Only one

of the men given isoflurane had an erection compared with four in the sevoflurane group and 11 of the men who received propofol, according to the researchers (P=0.003). P But there’s a happy ending. In a finding that might cure many a late-night headache, too, administering isoflurane at an end-tidal

concentration of 1 to 1.3 minimum alveolar concentration quickly reversed the tumescence, the investigators reported. The researchers presented their results at the 2013 annual meeting of the American Society of Anesthesiologists (abstract 3066). —AN Staff

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Algorithm Helps Curb Opioid Use for Headache Care in ED

to discharge, time from evaluation to treatment, and time from treatment to discharge—also remained constant. Based on the ED doctors’ feedback on the algorithm, Dr. Bamford and her colleagues removed unnecessary elements and created one that has three simple steps to treatment. Each step is used in sequence if the previous one does not result in halving of the

patient’s pain within two hours. Brad Uren, MD, clinical assistant professor of emergency medicine at the University of Michigan, in Ann Arbor, and president of the Michigan College of Emergency Physicians, who was not involved in the study, said further validation of the algorithm will show whether it will hold up in various ED settings.

“This proposed treatment algorithm and others like it are useful adjuncts to the treatment of headaches in the emergency department,” he said. “Narcotic misuse is becoming a great concern in this country, and evidencebasedd treatment protocols that represent safe, appropriate and timely patient care are of great interest.” —Rosemary Frei, MSc

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mergency and pain physicians from the Cleveland Clinic in the process of refining an algorithm for headache management in the emergency department (ED) report that it has resulted in an 82% reduction in both treatment with opioids or narcotics in the ED and in discharge with prescriptions for these types of medications. The researchers also hope to reduce the amount of imaging, number of consults and number of admissions related to headache, all while continuing to maintain or increase patients’ pain relief. “We were astonished at how much we were able to diminish the use of opiates,” said lead investigator Cynthia Bamford, MD, after she and her colleagues presented the details of the algorithm implementation in poster form at the 2013 International Headache Congress, held recently in Boston. “The director of the emergency department really worked hard with his team to get them to utilize this algorithm, and to educate them about opiate use—and it really made a difference.” The initial version of the algorithm was tested in the ED of Lakewood Hospital in Lakewood, Ohio. According to the investigators, it was quite dense and complex, with lists of “red flags” such as fever and chills, “yellow flags” such as recurrent ED visits without appropriate follow-up care, and detailed criteria for migraine without aura and cluster headache. Nonetheless, the ED physicians were able to significantly reduce opiate use after implementation of the algorithm in February 2013. Two-thirds of patients were treated with opiates or narcotics between October 2012 and January 2013, compared with only 12% in the post-implementation period of February to April 2013. Furthermore, the percentage of patients discharged with prescriptions for opiates or narcotics fell from 44% to 8%. The percentage of patients undergoing imaging remained relatively constant, at 48% pre- and 54% postimplementation, as did the number of patients for whom consults were called (8% and 6%, respectively), and admissions (8% in both periods). Pain relief did not suffer during the drop in opioid use, with 63% of preimplementation patients experiencing greater than 50% pain relief and 68% having this amount of pain relief after the ED doctor implemented the algorithm. Three other metrics the team measured—time from arrival at the hospital

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Genetic Advances Could Alter Perception of Postoperative Pain Miami—Backed by encouraging initial study findings, anesthesiology researchers at the University of Miami Miller School of Medicine are forging ahead with genetic trials that could considerably change the way some clinicians perceive patients with high postoperative analgesia requirements. “Clearly there has been a longstandingg belief that patients who use

more opioids, relative to other patients, are often considered ‘weaker.’ Many patients are in fact accused of having other dependencies that are believed to be affecting their pain tolerance,” Keith A. Candiotti, MD, told Anesthesiology News. Dr. Candiotti said he hopes the research will obviate the automatic labeling of patients with high

patient-controlled analgesia (PCA) requirements as substance abusers. “Doctors should give patients the benefit of the doubt. Our research has demonstrated that significant variations in opioid consumption can often be attributed to genetic factors and may have little to do with conscious control,” said Dr. Candiotti, professor of clinical anesthesiology and vice chair of clinical

research at the University of Miami. “While environmental factors will obviously affect the pain phenotype, much of it is directly related to a patient’s genetics.” The research suggests even a single gene could explain as much as 50% of pain response variation among patients, as well as differences in 24-hour PCA usage, but the etiology is multifactorial. “I still feel there is no one gene or trait that will clearly predict the pain phenotype, but it is interesting to find genes or factors that are such strong predictors,” said Dr. Candiotti, who also is chief of perioperative medicine. Genetic polymorphisms discovered in the cytochrome P450 metabolism system that significantly alter bioavailability of postoperative analgesics are among the more prominent findings so far. Genetic differences in some receptors also can predict individual variation in postoperative pain responses. In terms of clinical implications, remain flexible and avoid one standard approach to treating pain in all patients, Dr. Candiotti advised. “Clear and strong patient variations in opioid and pain medication use clearly exist. We need to recognize that not all patients are OK with a standard PCA setting.” Current genetic testing offers some insight, but remains expensive and time-consuming, Dr. Candiotti said. A clinically useful, rapid assay could someday help to predict postoperative pain management in many patients. But in the meantime, he offers a simpler solution: ask. “We have also found that if we just ask a patient: ‘Will you use a lot of pain medication after surgery?’ they can often predict their consumption fairly accurately.” David J. Clark, MD, PhD, professor of anesthesia at Stanford University, in Stanford, Calif., said, “It is clear that postoperative analgesic requirements vary greatly between patients. The question is can we predict who will require greater opioid doses?” Genetic differences between patients can affect opioid requirements in several ways, Dr. Clarkk said. “First, patients with certain genetic characteristics may have different pain sensitivities. Another way genetics might contribute is by altering how people respond to opioids,” he said. “The group at the University of Miami is poised to discover how genetically determined differences in drug metabolism and action come into play in our postoperative patients. Such advances may provide

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PA IN M E D ICIN E novel insights into drug mechanisms of action and allow us to predict analgesic requirements preoperatively.” “Dr. Candiotti’s research is further evidence that we need to individualize therapy,” said Lynn R. Webster, MD, president of the American Academy of Pain Medicine. “People who seem to need more medication may not be abusers, as often they are labeled, but may indeed require more medication.” “Understanding the role genetics plays in determining efficacy of opioids may lead to more effective treatment, but more importantly, to safer therapies. If we can use genetics to identify individuals who are sensitive to small doses of opioids, then we may save lives from inadvertent overdoses,” said Dr. Webster, r who is also chief medical director of CRI Lifetree Salt Lake City Research Center in Utah. Pain Response Multifactorial Reaction to pain is likely a mix of genetic, environmental and behavioral factors. “As I’ve done more and more research, I’ve found a huge proportion [of pain response variability] is due to physiology,” Dr. Candiotti added. “For example, we know smokers require more morphine after surgery. This could be a difference in gene expression.” Smoking is one of two factors that Dr. Candiotti and his colleagues found to be significantly associated with more severe postoperative pain in a study of 236 women (Pain Med 2012;13:604-609). They found smokers had a significantly increased frequency of acute severe postoperative pain compared with nonsmokers (P=0.014). Having a poor CYP2D6 metabolizer genotype is another factor. Compared with patients who have genes that code for intermediate, extensive or ultra-rapid endogenous morphine biosynthesis, Dr. Candiotti’s team found those with a poor metabolizer genotype were significantly more likely to report severe postoperative pain (P=0.007, 0.002 and 0.050, respectively). “I did not anticipate that smokers would have such increased morphine consumption for acute injury compared to nonsmokers,” Dr. Candiotti said. “You can add this to the list of reasons not to smoke!” The research at the University of Miami aligns well with work done by other investigators. For example, in a study of 45 mothers with post-cesarean delivery pain, the poor metabolizers of codeine into morphine were more likely to report no analgesic effect

(Ther Drug Monitt 2011;33:425-432). Again, researchers identified variations in the cytochrome P450 CYP2D6 genotype as the explanation. Interestingly, this research showed that the other extreme—an ultrarapid metabolizer genotype—may be less than ideal as well. These women reported immediate pain relief but also were more likely to experience dizziness and constipation. Anesthesiology researchers at Tongji Medical College in Wuhan, China, discovered

a different cytochrome P450 polymorphism, CYP3A4*1G, that alters fentanyl metabolism—and therefore could predict individual pain relief — among 176 patients undergoing lower abdominal surgery (Clin Chim Acta 2011;412:755-760). Dr. Candiotti and his colleagues also discovered genetic alterations in the interleukin-1 receptor antagonist gene, one that corresponds with serum levels of this antagonist and with postoperative opioid consumption in a study

of 96 nephrectomy patients ((Anesthesiology 2011;114:1162-1168). Specifically, they discovered that whether a patient is homozygous or heterozygous for specific receptor alleles could determine variability in 24-hour postoperative opioid requirements. —Damian McNamara Dr. Candiotti is a member of the editorial board of Anesthesiology News. Dr. Webster is a consultant and an advisor to several companies developing opioid drugs.

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The following advertorial has been provided by Origin Healthcare Solutions and is designed to support the advertisement presented below.

AnesthesiaRCM™, from Origin Healthcare Solutions Q. What is Origin AnesthesiaRCM™? A. Origin Healthcare Solutions provides a comprehensive suite of services tailored to meet the specific needs of anesthesia and pain management providers. Origin is committed to providing solutions that help to build patient–provider trust and contribute to building an environment in which our anesthesia and pain management clients can provide patient-centered care. Origin offers a dedicated accounts receivable team and provides experienced staff who are

specifically trained in the areas of credentialing, coding and claims processing. Origin’s portfolio of services includes the following: • Integrated full-service anesthesia billing • Provider education • Compliance updates and training • Anesthesia dashboards, benchmarking and analytics • Fee schedule optimization • Documentation analysis • Certified procedure coding

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Neostigmine Prolongs Postoperative Pain Relief in Pediatric Patients

ediatric patients experience better and more durable postoperative pain relief after groin surgery when the muscle relaxant neostigmine is caudally injected with bupivacaine compared with bupivacaine alone, a new study has found. The findings were scheduled to be presented at the annual meeting of the Canadian Anesthesiologists’ Society, which was cancelled due to flooding. “We found that caudal neostigmine in the doses 2 mcg/kg increases the postoperative analgesic duration and reduces analgesic consumption,” said Sachinanad J. Bharati, MD, assistant professor at the All India Institute of Medical Sciences, in New Delhi. At higher doses, neostigmine is associated with potentially severe side effects, including hypotension, bradycardia and respiratory depression. “But when used in lower doses, it is free of these side effects,” Dr. Bharati said. The researchers recruited 40 children undergoing hypospadias surgery, congenital hernia repair or clubfoot (CTEV) correction surgery. The patients were assessed for American Society of Anesthesiologists physical status classification and divided into two groups. Group 1 received 0.5 mL/kg of 0.25% bupivacaine caudally; group 2 received 0.5 mg/kg of 0.25% bupivacaine with 2 mcg/kg neostigmine caudally. The investigators monitored duration of analgesia and total analgesic consumption for both groups. Group 2, which received the adjunctive neostigmine, had significantly longer analgesia (423±30.1 vs. 242.75±16.42 minutes) and consumed significantly less additional analgesia (160±113.8 vs. 703±246.12 mg). “Neostigmine coadministered with bupivacaine through caudal route offers an advantage over bupivacaine alone for postoperative pain relief, without increasing the effect of adverse effects in children undergoing groin surgeries,” Dr. Bharati said. The additional pain relief associated with neostigmine may be attributed to its mode of action, which is distinct from bupivacaine. “The analgesic effects of caudal neostigmine observed in our study may be attributed to the direct action at the spinal cord level after transdural diffusion to the cerebrospinal fluid,” Dr. Bharati said. “Spinal delivery of neostigmine inhibits the

breakdown of the endogenous spinal neurotransmitter acetylcholine, which has been shown to produce analgesia.” Dr. Bharati also pointed out that neostigmine is relatively inexpensive and readily available, making it a good choice for adjunctive analgesia.

“[Relative to its potential benefits], neostigmine is underused with local anesthetics because of fear of side effects such as hypotension, bradycardia and respiratory depression,” he said. “However, when used in lower doses, it is free of these side effects.

The greatest advantage is that it is cheap, readily available in operating theater settings, stable at room temperature and stable when mixed with other drugs.” —Keely Savoie

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Catastrophic Thinking Worsens Post-Op Pain, Study Shows Washington—Patients may have the ability to dictate the course of their postoperative pain, according to preliminary results of an ongoing study. The researchers have found that catastrophic thinking significantly predicted, and was positively related

to, acute postoperative pain intensity. “Catastrophizing is a psychological construct where a person focuses irrationally and illogically on the worst possible outcomes, regardless of the situation,” said Mario Moric, MS, research coordinator in

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pain is significant. Previous research concluded that pain catastrophizing was a psychological predictor of worse long-term pain outcomes after TKA (Clin Orthop Relat Res 2010;468:798-806), and Mr. Moric and his colleagues sought to determine if similar catastrophizing also could predict acute postoperative pain. The researchers enrolled 31 patients into the trial, each of whom was scheduled to undergo primary TKA with a standardized anesthetic regimen. The Pain Catastrophizing Scale (PCS; Psychol Assess 1995;7:524-532) was used during the month before surgery where higher scores indicated greater use of catastrophic thinking. Pain scores (0-10 numeric rating scale [NRS]) on the operative knee were recorded every four hours for 72 hours after surgery, then twice daily thereafter until patient discharge. Patients’ average at-rest pain scores were calculated for each postoperative day, from day 1 to day 5. Preoperative PCS scores were found to be a significant predictor of postoperative acute pain, with a positive and significant regression coefficient (P=0.0399). This finding indicated that higher preoperative PCS scores predict higher postoperative acute pain scores. The mean PCS score was 16.4±12.0, whereas the mean acute postoperative NRS at-rest pain score was 2.7±1.7. “Although there are only 13 items on the PCS scale, it can be broken down into different types of catastrophizing: rumination, magnification and helplessness,” Mr. Moric explained.

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PA IN M E D ICIN E associate professor of anesthesiology at the University of Toronto, Canada, said it was not a particular surprise that catastrophizing predicted acute pain, but nonetheless suggested a way that its effects may be diluted. “Preoperative screening and psychological therapy may be a very good idea, and patients who improve significantly may ultimately decide not to have surgery,” he said. “Yet even if patients decide to go forward with their surgery, I would imagine that the

‘We want to see if we can modify the psychological risk factors up front, and if we can do that, we may be able to prevent acute and chronic postoperative pain.’ —Mario Moric, MS “Helplessness is where patients feel they don’t have any power to change their pain. Magnification occurs when a patient magnifies the amount of pain they feel; they think it’s going to get worse and worse. Finally, rumination occurs when a patient becomes fixated on their pain,” Mr. Moric said. The researchers analyzed these three subscales for their relationship to postoperative pain. They found that rumination was the most highly correlated with acute postoperative pain. Although the study is ongoing, the researchers are planning another investigation to see if patients’ catastrophizing behaviors can be altered. “We want to see if we can modify the psychological risk factors up front,” said Mr. Moric, “and if we can do that, we may be able to prevent acute and chronic postoperative pain.” Colin J.L. McCartney, MBChB, director of anesthesia research at Sunnybrook Health Sciences Centre and

preoperative therapy would still help with postoperative coping strategies.” “It is well known that anxiety plays a role in acute pain and the development of chronic pain” (Expert Rev Neurother 2009;9:723-744), said Brittany Rosenbloom, BA, a psychiatry researcher at The Hospital for Sick Children in Toronto. “As such, a more comprehensive investigation of how pain catastrophizing interacts with anxiety and the experience of pain would better inform

future researchers and clinicians about the greatest area for intervention. Mr. Moric’s study, however, supports the need for psychological interventions before TKA—and potentially following TKA—to reduce pain intensity.” Mr. Moric presented the findings at the 2012 annual meeting of the American Society of Anesthesiologists (abstract 033) —Michael Vlessides

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P A IN M E D I C I NE Examining the Evidence Few studies have examined the use of PNS for either RLP or PLP. There treatments may differ depending on is some evidence suggesting PNS may the underlying mechanism. Broadly, be a viable option for the treatment the pain can be categorized as either of RLP. Previously, the use of PNS for residual limb pain (RLP), also known post-amputation pain has been limited as stump pain, or phantom limb pain due to the surgically invasive nature of (PLP). Neuromodulation treatments the procedure and the necessity of prefor pain include peripheral nerve stim- cise lead placement. A recent case study ulation (PNS), spinal cord stimulation found that percutaneous and remote (SCS) and transcutaneous electrical placement of the lead resulted in 60% reduction in selfnerve stimulation (TENS). f reported RLP at the end of a two-weekk home trial.2 A lead was placed remotely (>1 cm from the femoral nerve). Stimulation was continued for two weeks, during which the patient experienced a 60% reduction in selff reported pain. Although this evidence is promising, particularly given relief without close proximity to the nerve, it is limited in that only a single episode of RLP was examined. This patient also rarely experienced PLP, leaving the efficacy of PNS for PLP unclear. Similarly, SCS has been shown to have sustainable benefits in some patients with amputation-related pain, although results have been variable.3-5 In a recent study, 10 of 12 patients experienced worthwhile benefits, determined by the patients reporting that their pain reduction was

Neuromodulation for Post-Amputation Pain Dear Arizona Pain Specialists, Some of my patients suffer from chronic pain after limb amputations. I have considered treating their pain with neuromodulation devices, but I am not sure if such treatments are effective for this type of pain. Is neuromodulation an appropriate treatment for post-amputation pain? —Missing Pain Relief

Dear Missing Pain Relief, istorically, post-amputation pain has been notoriously difficult to manage. Considering the prevalence of pain after amputation, sometimes reported as high as 95%,1 it is an area that merits increasing attention. It is important to classify what type of post-amputation pain the patient is experiencing, as the best

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PA IN M E D ICIN E meaningful and worthwhile. Although the amount of pain relief varied, the mean pain reduction was 65%.4 In all of these patients, quadripolar paddle electrodes were implanted epidurally by laminectomy and stimulator parameters were adjusted to fit each patient. Patients then reported their benefit as a percentage of pain relief at subsequent follow-up visits. Interestingly, patients experiencing PLP reported relief in the phantom limb as well as the residual limb, but only if the sensation of the stimulation proceeded past the stump and into the phantom limb. These studies indicate that PNS and SCS may be viable options for patients in whom alternative treatment modalities have failed, but the lack of randomized controlled trials determining the efficacy of this treatment makes it difficult to conclusively recommend either procedure.6 Although peripheral neuromodulation may be sufficient for RLP, it is widely believed that PLP is due to supraspinal mechanisms.6 Based on this reasoning, treatments such as motor and parietal cortex stimulation, rather than stimulation of the spinal or peripheral nerves, have been seen as the most intuitive treatment options.7 However, a recent pilot study found that TENS provided both RLP and PLP relief.8 This study examined 10 individuals with trans transtibial amputations and persistent modderate to severe PLP or RLP. The effectt of TENS on the patients’ pain was th hen observed both at rest and with moveement. Following 60 minutes of TENS therapy, the mean reduction in pain wiith movement was 3.9 on a numerical rating scale of 0 to 10. Again, the lack off more rigorous evidence prevents any conclusive recommendation from bein ng made concerning TENS therapy foor PLP, but this study found promisin ng results that merit additional reesearch. Conclusion Thee various forms of neuromodulatioon have the potential to treat both RLP and PLP, but the evidencee is currently limited by small sampple sizes and the lack of control ggroups. More studies, including randomized controlled trials, are needed to provide strongger conclusions regarding the eeffectiveness of these therapies. Nonetheless, the promising results observed so far suggest the potential for neuromodulation treatments to relieve post p -amputation pain, including both R RLP and PLP.

—Paul Lynch, MD, Tory McJunkin, MD, Andrew Wallmann, BS, and Edward Swing, PhD Drs. Lynch and McJunkin own and operate Arizona Pain Specialists, a comprehensive pain management practice that provides minimally invasive, clinically proven treatments, with three locations in the greater Phoenix area. They also provide consulting services to other pain doctors around the country through their partner company, Boost Medical. For more information, visit ArizonaPain.com and BoostMedical.com.

References 1. Ephraim PL, Wegener ST, MacKenzie EJ, et al. Phantom pain, residual limb pain, and back pain in amputees: results of a national survey. Arch Phys Med Rehabil. 2005;86:1910-1919. 2. Rauck RL, Kapural L, Cohen SP, et al. Peripheral nerve stimulation for the treatment of postamputation pain—a case report. Pain Pract.t 2012;12:649-655. 3. Krainick JU, Thoden U, Riechert T. Pain reduction in amputees by long-term spinal cord stimulation. Long-term follow-up study over 5 years. J Neurosurg. 1980;52:346-350. 4.

McAuley J, van Groningen R, Green C. Spinal cord stimulation for intractable pain following limb

amputation. Neuromodulation. 2012 Sep 25. [Epub ahead of print]. 5. Miles J, Lipton S. Phantom limb pain treated by electrical stimulation. Pain. 1978;5:373-382. 6. Hsu E, Cohen SP. Postamputation pain: epidemiology, mechanisms, and treatment. J Pain Res. 2013;6:121-136. 7. Bolognini N, Olgiati E, Maravita A, et al. Motor and parietal cortex stimulation for phantom limb pain and sensations. Pain. 2013 Apr 19. [Epub ahead of print]. 8. Mulvey MR, Radford HE, Fawkner HJ, et al. Transcutaneous electrical nerve stimulation for phantom pain and stump pain in adult amputees. Pain Pract. 2013;13:289-296.

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Patient Opioid Disengagement Dear Arizona Pain Specialists, I have several patients who are not compliant with the opioid prescriptions I’ve written them. I want to help all of my patients, but I’m concerned about the safety issues these patients present. How should I deal with patients who aren’t able to take their opioid medications responsibly? —Struggling with Noncompliance

Dear Struggling with Noncompliance, his is a great question and one that we frequently hear. Managing opioid compliance is an essential piece of the practice and begins with the development of a robust management plan. This plan is intended to improve the quality of life for the patient by meeting his or

her pain management needs, as well as meeting the regulatory requirements of the practice. In an attempt to prevent noncompliance in your practice, it is best to develop a protocol designed to optimize patient selection and set the foundation for prescription opioid therapy compliance.

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Why Monitor Opioid Compliance? In the past 20 years, the use of prescription opioid therapy has significantly increased.1 Coupled with the increased use of opioids, clinicians and regulatory officials have seen an increase in prescription opioid abuse, diversion, overdose and deaths. Opioids are responsible for more overdoses in the United States than all other illicit drugs combined.2 It is our responsibility as clinicians to help our patients with the best and safest treatments available to them. This implies that we screen for and identify patients who are at high risk and/ or poor candidates for opioid therapy. A thorough patient interview including psychosocial history must accompany the physical exam and review of past medical records. Further patient evaluation and clinical consideration must be conducted in patients with histories of aberrant drug-related behaviors.1 Patients who are typically considered poor candidates for opioid therapy include those with a history of illicit drug abuse as well as a personal or family history of illicit drug or alcohol abuse. It’s also important to look at their overall condition. Do they have pathology that warrants the risk associated with long-term use of opioids? How active are they? What are their short, moderate and longterm goals for their pain? Tools for Compliance Monitoring An appropriate opioid therapy program for your practice should be understood by all and documented. You should employ the use of the monitoring tools available to clinicians. These tools include the following: Opioid Therapy Agreements (Contracts). An opioid therapy agreement is a written and signed contract between the patient and the clinical

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practice that outlines the goals of treatment as well as the stipulations required by the patient in order to continue prescription opioid therapy. The agreement should lay out all the common and worst-case problems that can occur. You may want to include an agreement that the patient will not receive prescriptions for pain medications from any other providers while under your care. This can help reduce the chances of the patient receiving prescriptions from multiple providers that add up to dangerously high doses of opioids. This agreement should be discussed at length with the patient so that he or she fully understands the real risks involved with opioid therapy. Regular Pharmacy Board Review. Currently, 48 U.S. states and one territory either have active prescription monitoring programs or are in the process of implementing such a program.3 Once registered, clinicians will have access to patients’ prescription histories. This report will include name of opioid prescribed, the date prescribed and filled, the prescriber’s name, the quantity dispensed and the dispensing pharmacy.4 This is a very helpful tool that allows clinicians to see if patients are honest, have received medications from multiple providers, the dosages the patients have received and whether the patients have a history of polypharmacy. Regular Urine Drug Screens. Regular urine drug screens (UDS) must be consistent with the prescription opioid therapy established for the patient. Discovering an absence of prescribed opioids or the presence of nonprescribed opioids during the UDS could indicate noncompliance. And, an inconsistent UDS may reveal a patient’s use of illicit drugs, a serious discovery that must trigger a review and modification of the patient’s plan of care.

When To Disengage A Patient From Opioids Making the decision to disengage a patient from prescription opioid therapy should be conducted on a caseby-case basis and should follow your standard protocol. You should take all factors of noncompliance into consideration when making a decision. You must thoroughly discuss with the patient anytime he or she violates your opioid compliance program. The clinical consequences of the violation must be documented in the patient’s record, as well as expectations for future patient behavior. Violations that are clear indicators of threat to patient safety and/or that place you or your practice in a medicolegal risk (e.g., prescription forgery) are grounds for immediate disengagement. For example: Patient Jones currently receives opioids for chronic back pain. He went to a hospital emergency department and was admitted for a kidney stone. Patient Jones received a short prescription for an opioid. This outside prescription violated the opioid contract. In this case, however, you might determine that issuing the patient a warning, educating that patient about contacting you in advance when receiving an outside prescription and documenting the exchange in Patient Jones’ medical record is sufficient. Patient Smith received a warning several months ago for failing to take medications as prescribed. This patient then tests positive for several illicit drugs in a UDS and this result is confirmed in outside testing. This patient is a clear risk to himself and should be disengaged from opioids. How Do You Disengage A Patient From Opioids? Once the decision has been made to disengage a patient from opioid therapy, the patient must be informed. The communication can be accomplished through an office visit discussion and/or through a detailed patient letter delivered via certified mail. We like to meet face to face with a patient in the office and explain that he or she has violated our agreement and we can no longer prescribe chronic opioids for the condition. Usually we explain that we are happy to have the patient continue receiving care in our practice, but with treatments other than narcotics. Appropriate referrals to an addictionologist, in-patient treatment center, counselor and/or psychiatrist are considered at this time. It is also important to notify the patient’s referring physician and/or primary care physician of this update so that they are aware of the patient’s condition. As clinicians, we

have a responsibility to prevent harm to our patients. If the patient feels that he or she must continue opioid medications, a list of clinical providers and their contact information should be provided to the patient to arrange future care. Providing a final 30-dayy opioid prescription or a tapering dose to the patient may be appropriate to prevent withdrawal symptoms. This also should provide the patient adequate time to locate and establish care with a new provider, so that they cannot make “abandonment claims.” This 30-dayy continuation of treatment after a patient leaves a practice is considered standard of care in Arizona. Consider the standards in your state when establishing your disengagement policies. If your practice uses opioid therapy, it is imperative that your patients are aware of the great risk this therapy holds. It also is important that your practice has well-thought-out guidelines for prescribing, monitoring and withdrawing patients from this therapy. As always, it’s important to follow all Drug Enforcement Administration recommendations, state guidelines and society “best practices.” We also recommend you

discuss this issue and other common occurrences with a qualified health care attorney in your area. —Tory McJunkin, MD, Paul Lynch, MD, Leila Micklos, MS, FNP-BC, and Edward Swing, PhD Drs. Lynch and McJunkin own and operate Arizona Pain Specialists, a comprehensive pain management practice that provides minimally invasive, clinically proven treatments, with five locations in the greater Phoenix area. Drs. Lynch and McJunkin also provide consulting services to other pain doctors around the country through their partner company, Boost Medical. For more information, visit ArizonaPain.com and BoostMedical.com.

References 1. Chou R, Fanciullo GJ, Fine PG, et al. Clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain. J Pain. 2009;10(2):113-130. 2. Paulozzi LJ, Jones CM, Mack KA, et al. Vital signs: overdoses of prescription opioid pain relievers—United States, 1999-2008. MMWR. 2011;60:1487-1492. 3. Alliance of States with Prescription Monitoring Programs. (2013). About the Alliance. http://www. pmpalliance.org/node/2. Accessed July 25, 2013. 4. Lynch PJ, McJunkin TL, Anderson JK, et al. Responsible use of opioids for chronic pain. Pain Medicine News. 2012;10(10):10-11.

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Experts: Medical Marijuana Not for Teens in Pain

esearchers from Mayo Clinic warn in a recent commentary in the clinicâ&#x20AC;&#x2122;s medical journal that physicians should refrain from prescribing medical marijuana to adolescents with chronic pain. Although acknowledging the potentially devastating effects of chronic pain in this hard-to-diagnose and treat populationâ&#x20AC;&#x201D;including impaired

socialization, quality of life, activities of living and physical activityâ&#x20AC;&#x201D;the researchers write in Mayo Clinic Proceedings (2013 Jun 20. [Epub ahead of print]) that the potential risks associated with marijuana use in adolescents can far outweigh the potential benefits. â&#x20AC;&#x153;The consequences may be very, very severe, particularly for adolescents who may get rid of their painâ&#x20AC;&#x201D;or

notâ&#x20AC;&#x201D;at the expense of the rest of their life,â&#x20AC;? said co-author J. Michael Bostwick, MD, professor of psychiatry at Mayo Clinic, in Rochester, Minn., in a statement. The authors of the new piece stress there are little data on the potential safety and efficacy of medical marijuana in adults, and well-conducted research is even scarcer in adolescents.

Rationale, Reversal, and Recovery of Neuromuscular Blockade Part 1: Framing the Issues Case Study Harold is a 74-year-old man undergoing a video-assisted right upper lobectomy for stage I non-small cell lung cancer. Current Symptoms Â&#x2021; Dyspnea Â&#x2021; Coughing with hemoptysis Â&#x2021; Chest pain Vital Signs Â&#x2021; Height: 177.8 cm (70â&#x20AC;?) Â&#x2021; Weight: 65 kg (143 lb) 6LJQLÂż FDQW 0HGLFDO +LVWRU\ Â&#x2021; Hypertension Â&#x2021; Chronic obstructive pulmonary disease (moderate) &XUUHQW 0HGLFDWLRQV Â&#x2021; Metoprolol succinate ER 50 mg/d Â&#x2021; Tiotropium bromide inhalation powder Laboratory Results Â&#x2021; 2-cm lesion in right upper lobe revealed on chest computed tomography (CT) scan; PDOLJQDQF\ FRQÂż UPHG ZLWK QHHGOH ELRSV\ Â&#x2021; No abnormal bronchopulmonary or mediastinal lymph nodes; brain CT, isotopic bone scan, abdominal ultrasonography negative for distant metastases Â&#x2021; )RUFHG H[SLUDWRU\ YROXPH LQ WKH Âż UVW second: 43.6% of predicted value (1.44 L) Â&#x2021; Carbon monoxide diffusing capacity: 71.7% of predicted values (20.19 mL/min/mmHg) Â&#x2021; Cardiac ultrasonography: normal pulmonary artery pressure (22 mm Hg) At induction, Harold receives propofol 1.5 mg/kg and rocuronium 0.6 mg/kg. During the procedure, movement of the diaphragm interferes with surgery. This activity is jointly sponsored by Global Education Group and Applied Clinical Education. Supported by an educational grant from Merck.

Applied Clinical Education is pleased to introduce a new interactive 3-part CME series featuring challenging cases in neuromuscular blockade. Each month, weâ&#x20AC;&#x2122;ll present a clinical scenario that you face in your daily practice. After reading the introduction to the case, consider the challenge questions, and then visit www.CMEZone WR Âż QG RXW KRZ \RXU DQVZHUV VWDFN up against those of our multidisciplinary faculty panel. Access the activities on your desktop, laptop, or tablet to explore the issues surrounding safe, effective, neuromuscular blockade and reversal via a unique multimedia learning experience and earn 1.0 AMA PRA Category 1 Credit.â&#x201E;˘ Participate in November and December as well to complete the whole series and earn a total of 3.0 AMA PRA Category 1 Credits.â&#x201E;˘ This monthâ&#x20AC;&#x2122;s distinguished faculty: -RQ *RXOG 0' *OHQQ 6 0XUSK\ 0' Chief, Division of General Surgery Alonzo P. Walker Chair in Surgery Associate Professor of Surgery Medical College of Wisconsin Senior Medical Director of Clinical Affairs Froedtert Hospital Milwaukee, Wisconsin

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They point out the potential adverse events associated with marijuana use, including anxiety, fatigue, decreases in reaction times, concentration problems, reduced motivation, and dizziness and confusion, adding that potential problems are compounded in younger individuals. For example, research has shown that marijuana use in individuals under the age of 16 has been linked to an increased risk for schizophrenia ((J Clin Psychiatry 2013;74:e08), poorer cognitive performance, higher rates of addiction and greater levels of depression ((Arch Pediatr 2011;18:737-744; Drug Alcohol Depend 2003;69:303-310). â&#x20AC;&#x153;If youâ&#x20AC;&#x2122;re a pain patient, and youâ&#x20AC;&#x2122;re using this drug or other narcotics as well, one of the side effects is to be out of it, and out of it when the goal of a pain rehab program is actually to get you into it,â&#x20AC;? Dr. Bostwickk said in the press statement. â&#x20AC;&#x153;The whole point is function restoration, not further functional decline.â&#x20AC;? Although the legalization of medical marijuana in some states has been anecdotally linked to increased recreational use among adolescents, a new study conducted by University of Florida researchers and published in the American Journal of Health Policy using data from the Youth Risk Behavior Survey (2013 Jun 13. [Epub ahead of print]) showed that medical marijuana laws had no significant effects on use among adolescents following the first few years of their enactment, but posited that longer-term studies might show different results. Teens in pain should be screened for marijuana use, said the researchers of the Mayo Clinic study, and those testing positive should be considered for nonpharmacologic treatments such as acupuncture, biofeedback and physical therapy. They called for further research to determine how many adolescent pain patients are using medical marijuana as well as how it is affecting their functioning. â&#x20AC;&#x201D;AN Staff

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New Criteria Suggested for Defining Postdural Puncture Headaches After Epidurals

iagnosis of headache after placement of an epidural catheter improves with the use of specifically created criteria, a group of researchers in Canada have found. In comparison, the International Classification of Headache Disorders (ICHD-2) was insufficient for assessing postdural puncture headache (PDPH) following epidural catheter placement. “Since at least one-third of dural punctures that result in PDPH postepidural are unrecognized, we need better tools to help us identify patients developing PDPH early so that we can assess the impact of early intervention in aborting PDPH,” said Pamela Angle, MD, associate professor of anesthesiology at the University of Toronto. Epidural catheters are commonly used to manage labor and delivery pain in women during childbirth. In 1% to 2% of these procedures, the epidural needle punctures the dural sac, leading

to leakage of cerebrospinal fluid (CSF) that causes the debilitating headaches and related symptoms of PDPH. “Women with severe PDPH are often in agony,” Dr. Angle said. “They have a new baby, but may not even be able to lift their heads off of the bed. ICHD-2 criteria were developed for diagnosis of PDPH after spinal needle insertion, not epidural insertion.” Multicenter Trial As part of a multicenter randomized controlled trial that assessed smaller epidural needles and catheters versus traditional ones, modified criteria were used as an assessment tool for post-epidural PDPH. Dr. Angle developed the criteria based on the literature and her own years of clinical and research experience. The study criteria widened ICHD-2 criteria to include patients who may or may not have had a recognized dural puncture following epidural needle

placement in the spine. “Epidural procedures seek to avoid dural puncture, and the epidural needle’s curved tip may reduce recognition of dural sac injury and CSF leak,” she explained. The study criteria included postural neck ache, with or without headache, and alternative symptoms such as dizziness, tinnitus and muffled hearing. “There are a significant number of patients who don’t get a headache but develop a postural neck ache and symptoms that suggest PDPH but don’t meet ICHD-2 criteria,” Dr. Angle said. “Some patients only develop a clearly postural neck ache without other symptoms.” Finally, the study criteria extended the period of symptom onset from five to 14 days. A blinded group of external adjudicators (one neurologist/headache specialist matched to one of three different senior anesthesiologists)

independently assessed each woman who developed symptoms suggestive of possible PDPH within the first 14 days of epidural placement using both Dr. Angle’s criteria (primary outcome) and ICHD-2 criteria. To establish a clinical gold standard, an independent neurologist blinded to the previous diagnoses also evaluated each of the 184 cases of possible PDPH. The study found that 38% of the women ultimately diagnosed as positive by the clinical gold standard for CSF leakage symptoms developed postural symptoms after the five-day window. “These women would be missed by both ICHD-2 and the new ICHD-3-betaa criteria,” Dr. Angle said. The study criteria also had high reliability between adjudicators, with 93% agreeing on the first-pass diagnosis versus 70% using the ICHD criteria. The study criteria were also almost twice as see PDPH page 80

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sensitive as the ICHD criteria (71% vs. 36%) and had a higher positive predictive value (88% vs. 69%). “Dr. Angle’s definitions of PDPH are a big improvement over the ICHD criteria,” said Barbara Scavone, MD, president of the Society for Obstetric Anesthesiology and Perinatology and professor in anesthesia and critical care, and obstetrics and gynecology at the University of Chicago.

“They will be especially useful for future research by providing high interrater reliability and sensitivity in defining PDPH, which causes a great deal of morbidity in our patients,” Dr. Scavone said. “Clinically, they will be a good guide, but most clinicians will continue to rely on their clinical judgment, just as Dr. Angle’s research used a clinician as the gold standard.” “Our findings suggest that our diagnostic criteria for PDPH should be adopted and explored in future

research related to post-epidural PDPH,” Dr. Angle said. “Additional analyses comparing PDPH trial criteria versus ICHD-3 criteria against the study gold-standard test are planned.” The research was scheduled for presentation at the 2013 meeting of the Canadian Anesthesiologists’ Society in Calgary, Alberta, which was cancelled due to flooding (abstract 1652641). —Keely Savoie

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Webinar

Monograph

Webinar

Co-Chairs

Charles E. Argoff, MD

Bill H. McCarberg, MD

Professor of Neurology Albany Medical College Director, Comprehensive Pain Management Center Albany Medical Center Albany, New York Yo

Founder Chronic Pain Management Program Kaiser Permanente Adjunct Assistant Clinical Professor University of California, San Diego SSchool h l off Medicine d San Diego, California

www.REMEDIESCME.com Release Date: May 9, 2013

Expiration Date: May 9, 2014

Each part of this activity has been approved for 1.25 AMA PRA Category 1 CreditsTM For information about the accreditation of this program, please contact Global at (303) 395-1782 or inquire@globaleducationgroup.com and Applied Clinical Education

Supported by an educational grant from

Doctor Shoppers Make Up Nearly 1% Of Patients Buying Prescription Opioids octor shopping” accounted for nearly 2% of opioid prescriptions in 2008, a recent national study found. Doctor shoppers are individuals who obtain multiple opioid prescriptions from several prescribers for nonmedical use. The average doctor shopper in the new study obtained 32 opioid prescriptions from 10 different physicians in the last 10 months of 2008. Doctor shoppers obtained an estimated 1.9% (4.3 million) of the 223 million opioid prescriptions dispensed in 2008. When the authors of the study (PLoS ONE E 2013;8:e69241), all affiliated with Abt Associates, a public policy and business research and consulting group, considered the quantity of drugs prescribed, the doctor shoppers’ share was even greater: an estimated 4% of the total amount of opioid drugs dispensed each year, or about 11.1 million g, the equivalent of about 5.4 million g of morphine. That would be enough to provide a very high daily dose (109 morphine equivalent mL per patient) for every day of the year. The probability of being a doctor shopper was highest among patients in their 30s. The opioid most likely to be abused by doctor shoppers, as a percentage of all prescriptions dispensed, was oxycodone (2.8%), followed by oxymorphone (2.3%), tramadol (2%), buprenorphine (1.9%) and hydrocodone (1.8%). The lowest risks were for codeine/dihydrocodeine (1.2%), fentanyl (1.2%), methadone (1%) and propoxyphene (1%). Using data from IMS Health Inc., the investigators analyzed records for opioid prescriptions dispensed in 2008 by 76% of American retail pharmacies. Data were linked to individual patients, but all patient-identifying information had been removed. “Ultimately,” the authors wrote, “the front lines of defense against drug diversion by deceptive patients are manned by physicians and other health care providers who are authorized to prescribe scheduled drugs.” The authors named prescription drug monitoring programs, practice guidelines, addiction screening instruments and monitoring of treatment adherence as tools for such health care providers.

”D

—George Ochoa

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Civil War Medicine, Through the Lens of Mathew Brady

he United States is currently celebrating the sesquicentennial of the nation’s Civil War, fought from April 1861 to April 1865. Many of the mental images we have of that war have been shaped by the contemporary photographs of Mathew Brady and his assistants, as well as the various sketch artists whose work appeared in the newspapers and magazines of the day. The photographs are especially riveting, and the ones reproduced here relate to hospitals and medicine during the war. Brady had established his studio and fame before the war; many famous individuals sat for his portraits. As the war began, Brady sent more than 20 of Wounded soldiers under trees at Marye’s his assistant photographers into the field with porta- Heights, in Fredericksburg, Va., after the battle ble darkrooms to document the fighting. Brady, whose of Spotsylvania, 1864. eyesight was fading by this time, did some work in the field, but often remained in Washington, D.C., to coordinate their work. Wars can accelerate or create improvements in medical care, and the Civil War was certainly an excellent example. Young physicians who had little or no experience with surgery had plenty of opportunities for practice. Anesthesia with ether or chloroform, and often both, was widely used during the conflict (see Anesthesiology News, March 2013, page 1). Demands of the battlefield and care of the wounded required new thinking in movement of the injured, nursing care and the design and construction of hospitals. Sanitation became a major concern, and commissions were formed to address that issue. Recordkeeping was emphasized, and on the Union side resulted in the publication of the multivolume “Medical and Surgical Interior view of Carver Hospital, in History of the War of the Rebellion.” Washington, D.C., sometime during the war. As we remember the events, personalities and great sacrifices of the Civil War, we also can recall its numerous and important medical advances. Many of the photographs taken by Brady and his assistants can be found online at the U.S. National Archives Archival Research Catalog at http:// arcweb.archives.gov. A new biography of Brady is Robert Wilson’s “Mathew Brady: Portraits of a Nation” (Bloomsbury, 2013). Maj. Horace R. Wirtz served as medical director of the —A.J. Wright U.S. Army’s Department of the South for six months in 1863.

Hospital near Washington, D.C., ca 1860.

Scene at a hospital complex sometime during the war.

Dr. Mary Walker in the 1860s.

General Hospital at Point of Rocks, Md., 1860s.

Wounded soldiers in a hospital.

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