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THE INDEPENDENT MONTHLY NEWSPAPER FOR ANESTHESIOLOGISTS AnesthesiologyNews.com • D e c e m b e r 2 0 1 2 • Volume 38 Number 12

40th Anniversary 1972-2012

Prolonged Hypotension In Surgery Linked To Poor Outcomes Washington—The total time patients in surgery spend with low blood pressure may be a stronger predictor of serious postoperative complications than the depth of the hypotensive troughs they hit during the procedure, researchers have found.

The researchers, from the Cleveland Clinic in Ohio, have used their analysis to create an algorithm to guide the management of blood pressure in the operating room.

“This research attempted to address a seemingly simple question, yet one many of us might find difficult to answer: What really constitutes hypotension, especially when it comes to long-term see pressure page 30

CMS Ruling Exposes Organizational Rift Between Anesthesiologists, CRNAs

A

mid the 1,3362 pages of the Medicare Physician Fee Schedule for 2013, issued by the Centers for Meddicare & Medicaid Services (CM MS) on Nov. 1, 2012, are 13 paages relating to a bitterly fouught battle over benefits paid to certified registeredd nurse anesthetists. The fin nal rule, which takes effect Jaan. 1, 2013, will allow CRNAs to bill Medicare directly for perform ming chronic pain see CMS page 24

Ohio Physicians Deal Setback To Push for Broader Licensing Rules

INSIDE 06 | COMMENTARY How to survive the Affordable Care Act.

Foes of plan decry ‘intrusions’ by medical boards, advocates see need

12 | PAIN MEDICINE

O

28 | CLINICAL ANESTHESIOLOGY

pponents of the nationwide Society of Anesthesiologists. Critics initiative to expand the have called the system burdensome requirements for physicians and unnecessary. to keep their medical licenses current “The State Medical Board of Ohio’s were heartened by a recent decision rejection of MOL [maintenance of by the State Medical Board of Ohio licensure] proves that it is not inevto pull out of a pilot project to evalitable or impossible to stop,” said Cleveland anesthesiologist Paul Kemuate the new program.

The decision to withdraw from pen, MD, PhD, a vocal opponent of the pilot, which is being developed by the Federation the program. “It requires only a handful of commitof State Medical Boards (FSMB), was recommended ted individuals to investigate these matters and the by 11 Ohio medical societies and associations, includ- medical boards’ intrusions, expose the lies, educate ing the Ohio State Medical Association and the Ohio see MOL page 22

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4 I AnesthesiologyNews.com

DECEMBER 2012

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Heard Here First: For years, people have talked about how delirium can be influenced by

December 2012

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

the way we do things in the hospital, which is typically designed for the

1. Tablet-Based Technology Gauges Surgical Blood Loss 2. New Data Bolster Concept of Surgical Homes Led

By Anesthesiologists 3. Seeking Solutions to Failed Extubation

convenience of staff

4. Strange Stories in the Papers: The History of Anesthesia’s Future

and not necessarily the patient. It’s only

5. As Liposuction Deaths Mount, Study Exposes Cracks In Safety

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6 I AnesthesiologyNews.com

DECEMBER 2012

COMMENTA RY

Two Rules for Surviving The Affordable Care Act

H

ealth care regulamoney, it can also improve the quality of medical care” tors need our help.

They are churn(NY Times, Nov. 16, 2011). ing out rules and demonImproving care simply by stration projects as the cutting payments—the phiAffordable Care Act (ACA) losophy behind bundled authorizes, but some of payment projects—makes these new provisions are perfect sense to the regincreasing payments to hosulatory royalty of Alice’s pitals and physicians. This wonderland. situation is undesired and Robert E. Johnstone, MD This mindset is why awkward, an embarrassKathleen Sebelius, secment to reformers, whose goal is to retary of the Department of Health and Human Services (HHS) and regreduce such outlays to physicians.

Reformers speak of improving the ulation churner chief, was offf withefficiency and quality of health care their-heads mad when she discovered while reducing waste and costs, which recently that hospitals adopting her regulators generally understand are newly required electronic records were code phrases for paying less. As Eze- getting paid more. “There are troukiel Emmanuel, an influential reformer, bling indications that some providrecently explained, “With one-third of ers are using this (newly required) total health care expenditures spent on technology to … obtain payments,” hospital care and about 20% spent on Ms. Sebelius observed. She described physician services and specialists each better documentation as possible year, this is where the big money is— “upcoding” and “fraud” and vowed and where it can be saved. … Control- to crack down on doctors and hosling costs can do more than simply save pitals that benefit financially from

DECEMBER 2012

AnesthesiologyNews.com I 7

COMME N TA R Y health care reform (NY Times, Sept. 24, 2012:B1). After all, if the government pays too much to physicians and hospitals, it might not be able to afford its growing legion of workers, an important government effort to improve the economy. Employment at HHS grew from 64,750 workers in 2008 to 83,745 in 2011, but further growth could stall if its bureaucrats cannot master the complexities of paymentreduction regulation writing.

Anesthesiologists can help. They work at the intersection of patients, technology, administrators and regulations. They have learned to deal with non-clinical staff, practice revisionists and forced inefficiencies. Locked anesthesia drug carts, checklists of checklists and labeling of spinal kit drug syringes are daily fare. Hospital administrators, institutional accreditors and state inspectors frequently force anesthesiologists to cope with complex policies, unintended consequences and less money.

Since regulation churning is difficult work, and real regulators are distracted trying to figure out what an accountable care organization is and how to bundle all health care payments into one check, anesthesiologists have something to offer. Here are two free proposals for regulators to improve anesthesia care while growing their own ranks and avoiding unintentional increases in physician payments. Other anesthesiologists, I’m sure, can suggest many more.

1. More bells and whistles. Surgical suites have busy corridors, packed with stored equipment. Patients and personnel use these corridors to travel to and from operating rooms (ORs), risking stretcher collisions and trauma. For corridor safety, surgical personnel could blow whistles before each corner, just as trains do when approaching intersections. Backk up horns on patient stretchers, like those mandated by the Occupational Safety and Health Administration, could also prevent retrograde collisions when backing into ORs. Since everyone is already familiar with the pleasant sound of these backk up horns, implementation of this retrograde program would be easy. To win public support, regulators could announce their whistle-and-horn program as extraordinarily sound, and government agencies could promote harmonized policies.

2. SPAWN (Staying Power: Acronyms Work Nicer). Most government agencies that have survived

from one federal budget to the next have used acronyms to enhance their staying power. Review any list of money-suckingg military projects or efficiency-disruptingg postal programs and you will find impressive strings of capital letters. Hospitals and anesthesiologists have been slow to use acronyms and govspeak, still referring to surgical suites as “surgical suites” and Departments of Anesthesiology as “Departments of Anesthesiology.” HHS should

require all departments of anesthesiology to form Acronym Adoption Committees (ACADCOMs) to generate Properly Identified Government Titles (PIG-Ts). Departments of anesthesiology could then have the killer title, DOA, populated with physicians known as SLPRDOCS. One potential downside is HHS might mistakenly send larger payments to the DOAs, overvaluingg their importance.

Everyone can help write regulations.

Just forward your proposals to the HHSCMMI—the Center for Medicare and Medicaid Innovation. Be careful, though, about unintended consequences. I proposed one new project myself, the Center for Revising Anesthesia Programs, until I discovered its unintended acronym.

—Robert E. Johnstone, MD Dr. Johnstone is professor of anesthesiology at West Virginia University. This commentary expresses his personal opinions.

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P A IN M E D I C I NE

HIPAA: Issues of Health Information Privacy and Security Dear Arizona Pain Specialists,

M

y group emails appointment reminders to patients and we are considering emailing test results and other treatment information to patients. Are there any HIPAA issues we should be concerned about?

Signed, Emailing in the Dark

Dear Emailing in the Dark, he answer is yes. If your practice is a covered entity under HIPAA, emailing a patient or emailing patient information involves both the HIPAA Privacy and Security rules. The content of the email, including the patient’s email address, constitutes protected health information (PHI).

The first question you always must ask yourself before you disclose PHI, whether via email, telephone or in person, is if the disclosure is permitted by the Privacy Rule. Thankfully for you, disclosures for treatment purposes are always permitted. However, the second question is how much PHI you need to disclose, since the Privacy Rule requires the PHI disclosed to be the minimum necessary for the disclosure. For example, if you are emailing an appointment reminder to a patient, the minimum PHI necessary for the disclosure would probably be the date, time and location of the appointment. Including the purpose of the appointment (e.g., follow-up appointment regarding your lumbar epidural) probably would not comply with the minimum necessary requirement.

Next, the Privacy Rule requires your practice to implement safeguards to protect PHI from intentional and unintentional disclosures that violate the Privacy Rule. And because PHI sent via email is in electronic form, it constitutes electronic protected health information (ePHI) and is subject to the Security Rule, which only applies to ePHI. Generally speaking, the Security Rule requires your practice to analyze and implement technical, physical and administrative safeguards to protect the

T

confidentiality, integrity and availability of ePHI. In layman’s terms, this means you need to make sure you have done everything you can to ensure no one other than the patient accesses the email.

Earlier this year, the Office for Civil Rights (OCR), the agency of the U.S. Department of Health and Human Services that enforces the Privacy and Security rules, entered into a resolution agreement and corrective action plan with a small physician practice that OCR believed violated the rules. The information in the agreement and plan are revealing regarding OCR’s interpretation and enforcement of these rules.

For example, one of the ways in which OCR believed the group violated the rules was that the group’s employees emailed ePHI among themselves.

Specifically, the agreement states that the group “failed to conduct an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity and availability of the ePHI held by the” group. In addition, the group’s employees used Internet-based public email providers (e.g., Yahoo!, Hotmail, gmail, etc.) to email the ePHI. The agreement states that the group permitted these providers “to receive, store, maintain and transmit ePHI on the [group’s] behalf without obtaining satisfactory assurance in a business associate agreement … .”

If your practice is a covered entity under HIPAA, emailing a patient or emailing patient information involves both the HIPAA Privacy and Security rules. The content

Consequently, if you use Yahoo! or any other Internet-based email provider to email ePHI, you should make sure you have a business associate agreement with the provider.

Among other things, the corrective action plan requires the group to perform a risk assessment of all of its ePHI and implement a “risk management plan that implements security measures sufficient to reduce risks and vulnerabilities to ePHI identified by the risk assessment … .” The plan also requires the group to ensure that all “ePHI transmitted over an electronic communications network” is “encrypt[ed] or otherwise adequately safeguard[ed]” against unauthorized access. Incidentally, the plan requires the group to “submit evidence to satisfy this obligation that includes text messaging of ePHI.” In other words, the plan requires all of the group’s emails and text messages containing ePHI to be encrypted.

In addition to complying with all of the obligations in the plan, the group paid $100,000 to OCR to resolve the matter. That may seem like a lot (and it is); however, OCR could have imposed significantly higher financial penalties.

In summary, it would be wise for your practice to stop emailing any ePHI for any purpose until it has confirmed its compliance with the Privacy and Security rules. Based on the aforementioned resolution agreement and corrective action plan, if your practice hasn’t performed a risk assessment and implemented a risk management plan, which includes encryption of all ePHI that is emailed or texted, or if your practice’s employees use Internet-based email providers to email ePHI and the practice does not have business associate agreements in place with these providers, it is fair to say that you won’t be in compliance with OCR’s interpretation of the rules.

Signed, Arizona Pain Specialists

of the email, including the patient’s email address, constitutes protected health information.

Dear Arizona Pain Specialists, ne of our MAs had written patient records that she was transporting between offices stolen from her car. Do we have to notify the patients whose records were stolen (we’d rather not)?

O

Signed, Desperately Seeking Records Dear Desperately Seeking Records, our story is all too common—and preventable.

The short answer is: probably. And if you must notify the patients whose records were stolen, you also must notify OCR. Moreover, if more than 500 patients’ records were stolen, then you also must notify the media in your area.

The Health Information Technology for Economic and Clinical Health (HITECH) Act, which was passed in 2009 as part of the economic stimulus legislation, provides grants to physicians who implement certified electronic health record systems and satisfy the meaningful use criteria. The act

Y

see privacy page 10

10 I AnesthesiologyNews.com

DECEMBER 2012

P A IN M E D I C I NE PRIVACY

and addresses, this would present a significant risk for financial or other also requires covered entities to notify harm to the patients. Moreover, if the patients, OCR and possibly the media records contained sensitive or potenwhen there is a breach of “unsecured tially embarrassing medical information, then there would be a significant protected health information.”

A breach occurred if the stolen risk for reputational or other harm. patient records contained informaThe HITECH Act contains certain tion that presents “a significant risk exceptions to the breach definition of financial, reputational or other that, if applicable, would not require harm” to the patients. For example, if notice. Unfortunately, none of those the records contained patients’ names, exceptions applies to stolen patient dates of birth, social security numbers records. However, even if there were a CONTINUED FROM PAGE 8

breach, you would not have to provide notice unless the patient records constitute “unsecured PHI.” “Unsecured PHI” is PHI “that is not rendered unusable, unreadable or indecipherable to unauthorized individuals through the use of a technology or methodology specified by the Secretary [of the Department of Health and Human Services] in guidance issued under [the HITECH Act] on the HHS website. Since the patient records were written records, they were

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usable, readable or decipherable to whoever has them. Consequently, they constitute “unsecured PHI.” The HITECH Act requires you to document your breach analysis, and the commentary to the regulations implementing the HITECH Act identifies a number of factors that should be considered. Make sure your analysis includes these factors.

If you determine that a reportable breach occurred, you must notify the affected patients as soon as reasonably possible, but not later than 60 days after the date you discovered the breach, and notify OCR within 60 days following the end of the calendar year. If you must notify patients, the notice must be written in plain language and, to the extent possible, include the following: • A brief description of what happened, including the date of the breach and the date of the discovery of the breach, if known; • A description of the types of unsecured PHI that were involved in the breach (such as whether full name, Social Security number, date of birth, home address, account number, diagnosis, disability code or other types of information were involved); • Any steps patients should take to protect themselves from potential harm resulting from the breach; • A brief description of what the covered entity involved is doing to investigate the breach, to mitigate harm to patients and to protect against any further breaches; and • Contact procedures for patients to ask questions or learn additional information, which shall include a toll-free telephone number, an email address, website or postal address.

DECEMBER 2012

AnesthesiologyNews.com I 11

PA IN M E D ICIN E The notice must be sent to the patient by first class mail to the patient’s last known address or, if the patient agreed to electronic notice and the agreement has not been withdrawn, by email. If additional information becomes available, it may be provided in more than one mailing.

If there is insufficient or out-off date contact information that precludes written notice, you must provide a substitute form of notice as specified in the Code of Federal Regulations (45 C.F.R. §164.404(d)(2)). If you believe there is a possibility of imminent misuse of a patient’s unsecured PHI, you may provide the required information by telephone.

With respect to the notice to OCR, the notice must be submitted electronically by a breach report form that is available on OCR’s website: http:// www.hhs.gov/ocr/priXYZy/hipaa/ administrative/breachnotificationrule/ brinstruction.html.

Signed, Arizona Pain Specialists Dear Arizona Pain Specialists, ur practice wants to include patient testimonials on our website. Are there any issues we should be aware of beforehand?

O

expressly authorizes the practice to disclose the patient’s PHI. Since the HIPAA Privacy Rule generally prohibits indefinite authorizations, you will need to make sure you have a policy and system in place to get an updated authorization as previous authorizations expire.

Also, because your testimonials will identify the patient in some way, it is a good idea to have the patient sign a separate consent form documenting the patient’s willingness to use himself

Signed, Arizona Pain Specialists —Bryan Bailey, Esq, Tory McJunkin, MD, Paul Lynch, MD, and Edward Swing, PhD

Bryan Bailey is an attorney at Milligan Lawless, P.C., specializing in health care law and business transactions. Drs. Lynch and McJunkin own and operate Arizona Pain Specialists, a comprehensive pain management practice that provides minimally invasive, clinically proven treatments, 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.

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OFIRMEV reduces opioid consumption*1 • OFIRMEV 1 g (Q6h) + PCA morphine significantly reduced morphine consumption vs placebo + PCA morphine (–46% over 6 h, P<0.01; –33% over 24 h, P<0.01)1 • The clinical benefit of reduced opioid consumption was not demonstrated

OFIRMEV from the start • Consider administering the first dose of OFIRMEV PreOp or post-induction • Schedule OFIRMEV Q6h for first 24 h and continue as clinically warranted

Signed, Testimonially Naive Dear Testimonially Naive, atient testimonials are a great thing; they’re also PHI. Consequently, even if a patient consents to posting a testimonial, you should not do so unless the patient executes a HIPAA-compliant authorization that

or herself and his or her statements for promotional purposes. Otherwise, the practice risks a patient claiming it not only violated the patient’s right to privacy but his or her intellectual property rights.

P

Indiccation OFIRMEV is indicated for the management of mild to moderate pain; the management of moderate to severe pain with adjunctive opioid analgesics; and the reduction of fever.

Important Safety Information OFIRMEV is contraindicated in patients with severe hepatic impairment, severe active liver disease or with known hypersensitivity to acetaminophen or to any of the excipients in the formulation. Acetaminophen should be used with caution in patients with the following conditions: hepatic impairment or active hepatic disease, alcoholism, chronic malnutrition, severe hypovolemia, or severe renal impairment.

Do not exceed the maximum recommended daily dose of acetaminophen.

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Discontinue OFIRMEV immediately if symptoms associated with allergy or o hypersensitivity occur. Do not use in patients with acetaminophen allergy.

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The antipyretic effects of OFIRMEV may mask fever in patients treated for postsurgical pain.

To report SUSPECTED ADVERSE REACTIONS, contact Cadence Pharmaceuticals, Inc. at 1-877-647-2239 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.com.

Please see Brief Summary of Prescribing Information on adjacent page or full Prescribing Information at OFIRMEV.com.

OFIRMEV should be administered only as a 15-minute intravenous infusion. *Randomized, double-blind, placebo-controlled, single- and repeated-dose 24-h study (n=101). Patients received OFIRMEV 1 g + PCA morphine or placebo + PCA morphine the morning following total hip or knee replacement surgery. Primary endpoint: pain relief measured on a 5-point verbal scale over 6 h. Morphine rescue was administered as needed. †SPID24=sum of pain intensity differences, based on VAS score, from baseline, at 0 to 24 h.

References: 1. Sinatra RS, Jahr JS, Reynolds LW, Viscusi ER, Groudine SB, Payen-Champenois C. Efficacy and safety of single and repeated administration of 1 gram intravenous acetaminophen injection (paracetamol) for pain management after major orthopedic surgery.

Anesthesiology. y 2005;102:822-831. 2. Data on file. Cadence Pharmaceuticals, Inc.

©2012 Cadence Pharmaceuticals, Inc. All rights reserved.

OFIRMEV and the OFIRMEV dot design are trademarks of Cadence Pharmaceuticals, Inc.

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12 I AnesthesiologyNews.com

DECEMBER 2012

P A IN M E D I C I NE

The Great Opioid Debate: PROP Versus PROMPT

S

hould the reins be tightened on the use of long-term opioid therapy for patients with chronic noncancer pain (CNCP)?

That question is at the heart of a controversy that has boiled over since July when 37 physicians in pain management, public health, psychiatry and other specialties issued a citizen petition calling on the FDA to require

opioid label changes that would strike the word “moderate” from CNCP opioid treatment indications and limit the drug’s use solely to severe pain—and then only for a maximum of 90 days at no more than the equivalent of 100 mg of morphine daily.

The petition from Physicians for Responsible Opioid Prescribing (PROP) cited growing U.S. rates of

opioid addiction and overdose deaths along with what it said was a lack of evidence for the safety and effectiveness of long-term opioid use for CNCP as the main reasons for the group’s action.

“Unfortunately,” the petition stated, “many clinicians are under the false impression that chronic opioid therapy (COT) is an evidence-based treatment

for chronic noncancer pain and that dose-related toxicities can be avoided by slow upward titration. These misperceptions lead to overprescribing and high dose prescribing.”

Pharmacists and physicians opposed to PROP’s proposed label restrictions were quick to respond. Professionals for Rational Opioid Monitoring and Pharmacotherapy (PROMPT), a group of 26 physicians, sent a letter to the FDA expressing its own concerns about the safety of chronic opioid use, but suggesting an alternative approach emphasizing “clinician education, proactive risk stratification and appropriate therapeutic monitoring.”

PROMPT also endorsed the lengthier and more heated response from the American Academy of Pain Medicine, which called the PROP proposals “seriously flawed, potentially harmful to patients with debilitating pain conditions for whom opioid therapy is indicated, and without substantive scientific foundation.”

Interviews with the principals of both PROP and PROMPT revealed a depth of conviction on both sides of the issue.

PROP’s Kolodny: More Opioid Oversight Needed Andrew Kolodny, MD, president of PROP and chairman of the Department of Psychiatry at Maimonides Medical Center in New York City, spoke about a decade of rising addiction and overdose death rates “fueled by overprescribing of opioids” mostly for “people with a diagnosis of chronic noncancer pain.”

“What caused this increase,” Dr. Kolodnyy said, “was a very effective marketing and education campaign to convince doctors that we were underutilizing opioids.” Physician, he said, were told incorrectly that “we didn’t have to worry about getting patients addicted and that opioids were effective.

“This increase in prescribing,” he continued, “has led to this public health crisis. We think it’s now time for the FDA to communicate clearly to the medical community that longterm use of opioids for chronic noncancer pain has not been proven safe and effective.”

According to Dr. Kolodny, y “the best available evidence does not suggest that they’re safe and effective. In the United States, where we’re consuming a large portion of the world’s opioid supply, there’s absolutely no evidence

DECEMBER 2012

AnesthesiologyNews.com I 13

PA IN M E D ICIN E that we’re doing any better a job of treating chronic pain than in countries where opioids are prescribed more cautiously.

“In fact,” he said, “the best available epidemiologic data that’s looked at this question comes from Denmark. What they found in a very large study [Pain 2006;125:172-179] was that people who are on opioids long-term for chronic pain were doing very poorly compared with people who were having their pain treated with nonopioid analgesics. There are other studies from the United States that have replicated that.”

He added: “So I don’t believe a reduction in prescribing of opioids for chronic pain will worsen the problem of untreated chronic pain. In fact, because I don’t believe that opioids are effective for most people with chronic pain, I think it exacerbates the problem of untreated chronic pain and to some extent we’re undertreating pain by overprescribing opioids.”

PROMPT’s Dr. Fudin: A More Rational Solution Needed Jeffrey Fudin, PharmD, associate professor of pharmacy practice and pain management at Albany College of Pharmacy and Health Sciences, in New York, offered a number of objections to PROP’s proposals. First, he said, it was “absurd” of PROP to ignore the multiplicity of therapeutic options required to treat all of the “unique disorders” that cause CNCP. Moreover, he said, “a lot of patients [with chronic pain] can’t take [other] analgesics for one reason or other.”

Also, limiting opioid dosages to the equivalent of 100 mg of morphine per day disregards the variability in conversion calculations that can occur among different opioid products. He pointed to one study of accepted conversion charts that showed variations in calculations ranging “all the way from –50% to +245%.”

As for adverse events associated with chronic analgesic treatment, Dr. Fudin said many more are linked to nonsteroidal anti-inflammatory drugs than to opioids, including bleeding disorders, kidney dysfunction and death. He also said that most opioid deaths occur in patients on multiple sedating agents including alcohol, and in those abusing multiple medications, not in patients being treated by knowledgeable pain management clinicians and who take the medication as prescribed.

Moreover, he noted that the largest contributor to rising opioid mortality

rates was methadone. A recent report by the Centers for Disease Control and Prevention, he said, found that although 2% of all opioid prescriptions are written for methadone, 33% of opioid-related deaths involve the synthetic opioid. “That’s huge,” Dr. Fudin said. “Methadone pharmacokinetics are very complex and a lot of prescribers don’t have experience and should not be prescribing it.”

A clear example of this, he noted, was seen in Washington state, where

“the state’s decision to list methadone as a preferred painkiller to cut costs contributed to increasing numbers of overdoses among patients covered by Medicaid” ((JAMA 2012;8:749-750).

So what is the answer to the problems that PROP is addressing?

Dr. Fudin said the FDA’s Risk Evaluation and Mitigation Strategies (REMS) program for extended-release opioids “is a step in the right direction,” but regulations “should go further and make education mandatory

for all people who prescribe opioids.

“It doesn’t matter if [the opioids] are extended-release or not,” he continued. “[Prescribers] need to learn about risk stratification, and they need to be trained in how to do urine drug screens and how to interpret them. They also need to know that if the urine screen shows something unusual, they have to take the next step to order a qualitative confirmation or perhaps follow up with see debate page 14

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14 I AnesthesiologyNews.com

DECEMBER 2012

P A IN M E D I C I NE

Despite Risks, Blacks Prescribed Morphine for Cancer Pain

B

lacks with cancer pain are more likely than whites to receive morphine, which forms toxic metabolites, despite the fact that they have a higher rate of kidney disease.

According to a new study, health care practitioners prescribed morphine more often to black patients than to white patients (47.2% vs.

18.5%, respectively), whereas they prescribed oxycodone more often to white patients than to black patients (81.5% vs. 52.8%, respectively).

“The clinical management of pain is not as good for African Americans as it is for whites,” said Salimah H. Meghani, PhD, MBE, associate professor at the University of Pennsylvania School of Nursing, in Philadelphia, and lead author of the study. She presented the findings at the 2012 annual meeting of the American Pain Society (abstract 12).

The three-month, longitudinal, observational study looked at black and white patients diagnosed with cancer who were prescribed at least one around-theclockk analgesic. Patients were recruited from three outpatient oncology clinics in the mid-Atlantic region.

accounting for these factors, the racial disparity persisted. For example, 64.5% of blacks earning more than $20,000 per year received morphine instead of oxycodone, compared with only 54.5% of whites in the same category.

Dr. Meghani said these findings may be explained, in part, by racial bias on the part of health care providers, or by the fact that providers do not fully understand the data concerning which racial groups are more likely to abuse prescription drugs. “Some doctors have told me they prescribe morphine more often to their patients than oxycodone because it’s considered to have less of a street value,” said Dr. Meghani. “The prescription patterns may in part stem from health care providers’ belief that African Americans are more likely than whites to abuse prescription opioids, when the findings from the National Survey on Drug Use consistently point otherwise.”

Although previous studies have shown disparities in pain treatment between black and white patients, Karen Anderson, PhD, MPH, associate

professor in the Department of Symptom Research at the University of Texas MD Anderson Cancer Center, in Houston, said Dr. Meghani’s study is groundbreaking. “It’s novel that she identified the differences in medications that physicians are prescribing to black and white patients, and how, in spite of the fact that African Americans are more likely to have kidney dysfunction, they’re given pain medicine that’s not optimal for them,” Dr. Anderson said.

The study could potentially influence the way physicians decide which drugs to prescribe, she added. “Hopefully, oncologists who see this study will become more aware and look at the kidney function of their patients before deciding which pain medication to give to them.”

Dr. Meghani said that these findings are preliminary, adding that the next step is to conduct another study with a larger sample to explore racial disparities in patterns of opioid prescription in greater detail.

—Dana Hawkins-Simons

50 CONTINUED FROM PAGE 13

a [serum analysis], and they need to know how to evaluate those serums.”

If prescribers had that knowledge, he said, “outcomes would be much better.”

The PROP proposal is on the FDA docket, and the agency has until January 2013 to respond.

Dr. Kolodnyy noted that even if the agency decided to require label changes, individual physicians would not be restricted from prescribing offf label for longerterm opioid therapy at higher doses for patients with CNCP. “The FDA doesn’t regulate the practice of medicine. It regulates drug companies,” he said.

Dr. Fudin said that although physicians would be able to prescribe offf label, the presence of label restrictions could dissuade many from doing so because of liability concerns, thus denying relief to patients needing more potent analgesics. What’s more, he said, many health insurers including Medicare and Medicaid likely would withhold payments for opioid prescriptions not adhering to label indications, a potential financial hardship for people unable to work because of painful disabilities.

He cited Florida’s experience with the so-called “Pill Mill” legislation. The new law, he said, is causing many doctors to fear prescribing opioids and pharmacies unwilling to fill prescriptions, leaving many

40

Incidence, %

DEBATE

Although analgesics with toxic metabolites, specifically M3G and M6G, do not cause renal insufficiency, they tend to accumulate in patients with chronic kidney disease (CKD) and result in more side effects.

For example, black patients with CKD who were prescribed morphine reported more severe opioid-induced side effects than whites (31% vs. 22%, respectively). The side effects included constipation, nausea, vomiting, drowsiness and dizziness.

Patients who experience negative side effects are more likely to stop taking their medications. In fact, the study showed that blacks were significantly less likely than whites to adhere to the proper dosage of prescribed aroundthe-clock analgesics (53% vs. 74%, respectively).

Dr. Meghani said prescription patterns were influenced by the income and insurance status of patients. Both black and white patients were more likely to be prescribed oxycodone, which is more expensive than morphine, when they had an income greater than $20,000 per year, and also when they had private insurance. But even

33 30

22 20

14.3 9.1

10

8.7

7.7 0.8

0

Methadone

Morphine

Hydrocodone Hydromorphone

Oxycodone

Fentanyl

Buprenorphine

Figure. Drug-related deaths involving opioids by drug type.

Source: Centers for Disease Control and Prevention.

elderly patients with chronic pain syndromes not only in pain but also going through withdrawal. “If Florida represents even a small percentage of what we can expect countrywide from the PROP petition, it will be a disaster.”

Dr. Kolodnyy said the assertion that medical insurers would withhold payments from physicians prescribing opioid therapy offf label was “just plain wrong,” adding that psychiatrists like himself “do a lot of prescribing for offf label indications” and

encounter no payment problems with Medicare and Medicaid or other insurers. He also maintained that the reluctance of many legitimate retail pharmacies in Florida and other states to fill prescriptions for opioids like oxycodone was due not to state laws seeking to curb illicit “pill mills,” but to their fear of robberies and because “they just don’t want to be caught in the middle of all this.”

—Bruce Buckley

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DECEMBER 2012

AnesthesiologyNews.com I 17

PR N

New Regional Technique Controls Post-TKA Pain San Diego—A new nerve block called the “iPACK” may provide an effective option for controlling posterior knee pain following knee replacement surgery.

The brainchild of a research team at St. Francis Hospital and Medical Center in Hartford, Conn., the iPACK is an ultrasound-guided infiltration of the interspace between the popliteal artery and the capsule of the knee with a local anesthetic solution that provides an alternative analgesic when combined with a femoral nerve block.

“Patients who are having total knee arthroplasty [TKA] need something for controlling pain in the back of the knee,” said Sanjay Sinha, MD, director of regional anesthesia at St. Francis and assistant clinical professor of anesthesiology at the University of Connecticut. “The problem with doing a sciatic nerve block is that it causes foot drop, and may mask surgically induced peroneal nerve injury.

“We had a solution where we performed a selective tibial nerve block, which spares the peroneal nerve and seems to work just as well as the sciatic nerve block for controlling pain,” he continued.

“The problem with the tibial nerve block is that the sole of the foot is numbed, and approximately 20% of the patients experience weakness in the peroneal nerve distribution from the proximal spread of the local anesthetic, which is undesirable because it can be a marker for nerve injury.”

Dr. Sinha and his colleagues hypothesized that the iPACK would spare the main trunk of the tibial and peroneal nerves and block only the terminal branches innervating the posterior knee joint. Using the method, they scanned the popliteal fossa just proximal to the popliteal crease to visualize the femoral condyles.

The ultrasound probe was then moved proximally until the condyles disappeared and the shaft of the femur became visible. At this level, the needle was inserted in a medial to lateral direction between the popliteal artery and the femur, until the needle tip was 2 to 3 cm beyond the lateral edge of the popliteal artery, the researchers said. They then injected 30 mL of 0.2% ropivacaine with epinephrine as they gradually withdrew the needle.

To determine the safety and efficacy of the iPACK method, the investigators so far have enrolled 14 patients in a pilot study comparing the approach with tibial nerve block. All patients were premedicated with a multimodal analgesic regimen and had a femoral nerve catheter inserted. Patients were then positioned prone, and either an iPACK or tibial nerve block was performed (n=7 in each group). Ultrasound-guided tibial nerve blocks used a maximum of 15 mL of 0.2% ropivacaine.

“We are comparing the presence or absence of foot drop, as well as postoperative pain scores, and opioid consumption,” said Dr. Sinha, who reported the findings at the 2012 annual spring meeting of the American Society of Regional Anesthesia and Pain Medicine (abstract P52).

The researchers observed no statistically significant difference between treatment groups in pain scores in the first 48 hours after surgery, although

Table. Median Opioid Consumption iPACK Group (n=7)

Tibial Group (n=7)

P-Value

Hydromorphone, mg

0.60

0.40

0.87

Fentanyl, mcg

100

100

0.56

0.0

0.2

0.46

POD 1 oxycodone, mg

11.0

17.0

0.49

POD 2 oxycodone, mg

0.0

10.0

0.63

Intraoperative narcotics

PACU narcotics Hydromorphone, mg Floor narcotics

PACU, postanesthesia postanesthesia care unit; POD, postoperative p p dayy

‘It’s a safe procedure. It’s quick

between providing targeted analgesia to the posterior knee or minimizing foot drop and missing a and easy and works really well.’ diagnosis of nerve injury.

“The sciatic nerve block has always been a some—Sanjay Sinha, MD what imperfect strategy in this regard,” Dr. Gadsden said. “These results are not only promising, but they trended higher in patients who received tibial they intuitively appear safer in that the pericapsular nerve blocks. Opioid consumption also was compa- injection is visualized, which is not usually the case rable between groups (Table). No patient in either when performed by surgeons. I’m very interested to see what effect this has on patient mobility postopgroup developed a foot drop.

As a second part of the study, the investigators eratively compared with a traditional tibial or sciatic also simulated the iPACK technique in two fresh nerve block.” cadavers to determine the spread of injectate. Dissection of the popliteal fossa showed that the dye —Michael Vlessides spread adequately in the tissue plane between the popliteal artery and the posterior knee capsule, Advertisement sparing the tibial and peroneal nerve.

Although Dr. Sinha noted that the study is in its NEW PRODUCT early stages, he was encouraged by these preliminary results. “It’s a safe procedure,” he added. “It’s quick and easy and works really well.”

Not for Patients With Odd Physiologies Nevertheless, the iPACK is not for all patients.

Dr. Sinha said it would be contraindicated in patients with an anatomic deformity of the knee, such as a cyst or aneurysm of the popliteal artery, and in those in whom the space cannot be well defined under ultrasound. “Otherwise, we’ve been doing it in most of our patients,” he said.

The iPACK also may help relieve surgeons of the responsibility of blindly injecting local anesthetic into the knee joint. “This is a more predictable approach,” said co-investigator Jonathan Abrams.

“The reality is we’re asking surgeons to do a blinded procedure, when we don’t even do blinded blocks anymore. And some of the surgeons are uncomfortable; they don’t want to do it. So why should we force them to do something we wouldn’t do ourselves?”

Jeff Gadsden, MD, director of regional anesthesia at St. Luke’s-Roosevelt Hospital in New York City, said the iPACK technique represents a thoughtful solution to a problem that frustrates many orthopedic anesthesiologists: managing the tradeoff

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18 I AnesthesiologyNews.com

DECEMBER 2012

PRN

Appendectomy Delay Increases Surgical Site Infection Risk

A

delay of more than six hours from the time of admission to the time of appendectomy was associated with an increased risk for surgical site infection (SSI) among patients with nonperforated appendicitis, according to a study in Annals of Surgery (2012;256:538-543).

The paper’s lead author, Pedro G. Teixeira, MD, a surgical critical care

fellow at the University of Southern California (USC), Los Angeles County (LAC) + USC Medical Center, in Los Angeles said, “As a surgical community, we’ve attempted to decrease the rate of complications.

SSIs have been used as a marker of quality care delivery. Identifying something that we do that increases the rate of SSIs is very relevant.”

In the retrospective study, the to appendectomy was not associated records of patients admitted with with a higher perforation rate. appendicitis to LAC+USC Medical Center from July 2003 to June 2011 were reviewed. Over the eight‘Our paper suggests year period, 4,529 patients were admitted with appendicitis and 4,108 (91%) that expediting underwent appendectomy. Perforation surgical intervention is occurred in 23% (942) of the patients who received appendectomy. A delay

appropriate. It may not be appropriate to wait more than six hours.’

—Pedro G. Teixeira, MD

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After adjusting for age, leukocytosis, sex, surgical technique (open vs. laparoscopic) and perforation, the time from admission to appendectomy greater than six hours was independently associated with an increase in SSI (odds ratio [OR], 1.54; 95% confidence interval [CI], 1.01-2.34; P=0.04). Time to appendectomy did not significantly increase SSI risk in patients with perforated appendicitis, but it did so in patients without perforation. A delay of greater than six hours resulted in a significant increase in SSI from 1.9% to 3.3% in patients with nonperforated appendicitis (OR, 2.16; 95% CI, 1.03-4.52; P=0.03], and the incidence of SSI in nonperforated appendicitis reached a level similar to that with perforation (3.3% vs.

3.9%; P=0.47).

The average time from admission to appendectomy was 11 hours and 50 minutes. Dr. Teixeira noted that this was “a little long,” although 36% of patients were operated on within six hours.

“There are several reasons for a delay,” he said. “Because some data show that a delay is acceptable, some see delay page 20

DECEMBER 2012

AnesthesiologyNews.com I 19

PR N

When Is Best To Operate on a Small Bowel Obstruction?

Within three days may be optimal, study finds Patients who underwent surgery usually had their operations within the first few days, with 80% having had surgery by the end of the third day of admission.

For the patients having surgery, 19% experienced complications; 25% required resection of intestine;

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ever let the sun rise or set on a small bowel obstruction.”

Although this adage is more than 100 years old, some surgeons still believe it as gospel. But recent studies show that about 75% of patients with a small bowel obstruction will get better without surgery. So how many sunsets should you wait to operate?

A paper presented at the 2012 annual meeting of the American Association for the Surgery of Trauma suggests that surgeons probably should wait no longer than three days.

Senior author Frederick H. Millham, MD, chair of surgery at Newton– Wellesley Hospital, in Newton, Mass., and associate professor of surgery at Harvard Medical School, in Boston, said, “[Small bowel obstruction] is a complex problem. Some patients need surgery right away; some need it eventually; and some don’t need it at all.

The first group tells us they need surgery. It’s challenging to try to distinguish the second group from the third in some cases. We need to figure out where to draw the line.”

Dr. Millham and his group reviewed the Nationwide Inpatient Sample for 2009. The large database is sponsored by the Agency for Healthcare Research and Quality and contains information from 44 states. Patients undergoing gynecologic procedures and those in the category of early postoperative small bowel obstruction were excluded.

There were more than 27,000 patients with adhesive small bowel obstruction, with some 4,800 patients (18%) who underwent surgery for the condition.

The main outcomes studied were complications, number of resections, deaths and postoperative length of stay (LOS) longer than seven days. The ages of the patients were similar in the nonoperative and operative groups, but the average LOS was three days longer for those who had surgery (P<0.001).

About 60% of the patients managed nonoperatively were discharged by the end of day 3, with 91% discharged by the end of day 7.

Women comprised 60% of those admitted with a small bowel obstruction and 66% of those who had surgery (P<0.001 for both). The authors speculated that more women required surgery because of pelvic adhesions that probably did not resolve as easily as generalized abdominal adhesions.

3% died; and 32% stayed longer than seven days in the hospital postoperatively. A delay of four or more days until surgery resulted in a complication rate of 25%, a resection rate of 28% and a mortality rate of 5%, with 43% of patients hospitalized longer than seven days after surgery. All of these

differences were statistically significant compared with earlier surgery. But after multivariate analysis, only the risk for death (increased by 60%) and postoperative LOS longer than seven days remained significantly related to delaying surgery. see obstruction page 20

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PRN DELAY

CONTINUED FROM PAGE 18

surgeons are reassured that it wouldn’t negatively affect the outcomes. Also, we have a very busy hospital, and even though it is open 24/7, in some cases multiple trauma patients might affect the timing and cause a delay.”

John E. Mazuski, MD, PhD, professor of surgery at Washington University School of Medicine, in St. Louis, who was not associated with the study, called it “an important paper from several standpoints. A key point is that it is a very large, albeit retrospective study.” The important conclusions, he stated, are “that appendiceal perforation is not directly related to timing of appendectomy” and “that there was an important consequence to a delay in appendectomy, which is an increase in infectious risk.”

Dr. Mazuski noted several limitations of the study, including the use of a composite end point for SSI that “does intermix complications which may be of different importance” as well as the restriction to the experience of a single public hospital.

“Another limitation with the paper is the way in which delay of appendectomy was measured,” he said. “The time recorded is that between hospital admission and appendectomy, but neither of these is precisely characterized. Another major potential

OBSTRUCTION

CONTINUED FROM PAGE 19

Rao R. Ivatury, MD, chair of trauma, critical care and emergency surgery at Virginia Commonwealth University, in Richmond, asked Dr. Millham if he could explain why the delayed group had a higher mortality rate considering that the rate of resection was similar.

Dr. Millham said that it was possible that there was a bias toward higher physiologic acuity in the early surgery group, due to the large percentage of that group who underwent surgery on the day of admission.

“When the early and delayed [surgery] groups are compared, the patients in the early group may mask the patients in the delayed group who physiologically deteriorated,” he said.

Dr. Millham acknowledged a few limitations of the study. For one, physiologic data and the indications for surgery were not available in the National Inpatient Sample, which is

limitation is the lack of data on antibiotic usage relative to the delay. Were the patients experiencing a significant delay (>6 hours) being treated with antibiotics?”

Regarding how the study should affect clinical practice, Dr. Teixeira said, “Our paper suggests that expediting surgical intervention is appropriate. It may not be appropriate to wait more than six hours.”

“I think it would be premature to suggest that practice patterns should be altered based on the findings of this study,” Dr. Mazuski countered. “To bring the performance of appendectomy down to the suggested six-hour time point would probably require a significant increase in resources just for this one disease process.” The “role of antibiotics in permitting a safe delay in appendectomy” needs to be addressed with further research, he said.

Dr. Teixeira reported no relevant financial conflicts of interest. Dr. Mazuski reported receiving research funding and serving as a consultant and speaker for several pharmaceutical companies making antibiotics that can be used in the treatment of intra-abdominal infections, including AstraZeneca, Forest Laboratories, Merck and Pfizer.

—George Ochoa

composed of administrative data only.

“It is possible that the lack of effect of delay on resection results from the high resection rate in patients operated on at the time of admission,” he said.

Also, a possible increase in the percentage of resections in the delayed group might not be readily apparent in the data. Dr. Millham saw this study as hypothesis-generating and thought a prospective study that included indications for surgery would sort this out.

“We can definitely say that patients stay longer and are more likely to die with delay, but are left looking for additional data,” Dr. Millham said. “I hope this work will stimulate a multicenter trial to get a better answer.”

Dr. Ivaturyy echoed this and said, “I agree that these answers cannot come from a large database but from a multicenter, prospective study.”

—James E. Barone, MD

DECEMBER 2012

AnesthesiologyNews.com I 21

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22 I AnesthesiologyNews.com

DECEMBER 2012

P OLI C Y & M A NAGEMENT MOL

CONTINUED FROM PAGE 1

colleagues and engage state medical societies to unite in opposition,” Dr. Kempen told Anesthesiology News.

The FSMB, which represents approximately 70 medical and osteopathic boards in the United States and its territories, recommended a new MOL framework in April 2010.

The framework requires physicians to pass periodic tests of their knowledge and skills and to demonstrate performance standards using patient data from their own practices. The licensing boards of Ohio and most other states now require renewing doctors to provide proof of their continuing medical education (CME), update information about their certifications, training and malpractice claims, and pay a fee.

Ohio requires physicians to complete 100 CME hours every two years.

Nearly all providers of CME activities also require physicians to document that they are meeting selff assessment benchmarks.

“Requiring physicians to submit to additional medical board regulations

regarding competency would be redundant and unnecessary,” the 11 Ohio medical associations and societies wrote in a letter dated Oct. 5, 2012, to the state board. “Implementing additional MOL requirements would be a waste of the medical board’s time and resources.”

The Ohio medical board’s decision to withdraw from the FSMB pilot was made after “extensive discussion” during the past two years with local physicians, said Jennifer Hayhurst, the association’s director of regulatory affairs, in a recent posting on the group’s online message board.

“This is an encouraging and empowering first step in the right direction,” said Ron Benbassat, MD, an internist in Beverly Hills, Calif., who runs a website (www.changeboardrecert.com) that encourages physicians to work to reform or abolish MOL and maintenance of certification (MOC) requirements. “Physicians must band together in every state to put an end to this MOC and MOL nonsense once and for all,” Dr. Benbassat said. “We must unite and take back control of our profession,” he said.

MOL Pilots Continuing Proponents of MOL were unbowed by the Ohio rejection. “Ohio’s decision does not impact the MOL initiative, which is moving forward in nine other states,” said FSMB President Humayun J. Chaudhry, MD. Those states are California, Colorado, Delaware, Iowa, Massachusetts, Mississippi, Oregon, Virginia and Wisconsin, he said. “We remain committed to the initiative and remain confident that over time, the system will continue to evolve and eventually serve patients and the medical community very well,” Dr. Chaudhryy said.

Lance A. Talmage Jr., MD, president of the Ohio Society of Anesthesiologists, said specific elements of the proposed pilot had not been determined but would have been based on FSMB’s proposed framework. “We felt that Ohio physicians were already providing competency through board-required CMEs and following government quality measures reporting and credentialing activities through our hospitals and health plans,” Dr. Talmage said. “So with all those quality measures already being followed, we thought it would

be best to support the other medical societies and the Ohio State Medical Association in not initiating the MOL procedures.”

The American Board of Anesthesiology (ABA) had “no response” to the Ohio decision, said J. Jeffrey Andrews, MD, ABA treasurer. “MOL is an initiative of the FSMB and the state medical boards (SMBs). It is not an initiative of the ABMS [American Board of Medical Specialties] or the ABA,” Dr. Andrews said. “Since its adoption of MOL policy, FSMB has been working to provide SMBs with resources, and the pilots were designed to provide an infrastructure to support the MOL requirements. If MOL is ever implemented in any state, the ABA’s primary interest is to make certain that the state medical boards accept MOC as fulfillment of the requirements for MOL.” Although opposing MOL, Dr. Talmage said the Ohio Society of Anesthesiologists remains “highly supportive” of the ABA’s maintenance of certification in anesthesiology (MOCA) initiative. Enhanced MOC requirements, enacted in 2000

Read the #1 anesthesiology publication in the country anywhere, anytime.

DECEMBER 2012

AnesthesiologyNews.com I 23

POL ICY & M A N A G E ME N T by the 24 medical and surgical specialty boards belonging to the ABMS, have elicited mixed reviews, ranging from grudging acceptance to vehement opposition (see Anesthesiology News, October 2011, page 1).

Anesthesiologists who became board-certified during the previous decade must pass a closed-book “cognitive examination” consisting of 200 multiple-choice questions. Of those, 150 are general, and the rest are specific to pediatrics, cardiothoracic care, neuroanesthesia, critical care, obstetrics/ gynecology and pain medicine. They also must complete a medical practice performance assessment and improvement program.

The four-step process includes collecting clinical outcomes data or feedback from patients over an extended period of time, comparing that information with approved guidelines to determine areas for improvement, designing and implementing an improvement plan, and collecting and analyzing new data to determine improvement. Anesthesiologists also must obtain CME credits and complete an anesthesia simulation course at a center certified by the American Society of Anesthesiologists (ASA).

The ASA produces educational programs to help diplomates meet the MOCA requirements. Concerning MOL, Norman A. Cohen, MD, ASA’s vice president for professional affairs, said such initiatives “are best managed by those directly impacted” at the state and local levels. Although ASA provides assistance to state anesthesiology societies, Dr. Cohen said the Ohio chapter had not requested guidance in this case.

Supporters claim MOCA keeps physicians up to date in knowledge and practice and improves patient safety.

Critics complain that the testing methodology does not represent current practice because it prohibits access to reference materials. It also forces anesthesiologists to spend unnecessary time and money cramming for tests in specialty areas where they do not practice and have no intention of doing so, opponents said.

Back Door to Mandatory?

Many physicians also have expressed concern that conditions for maintaining board certification may become unofficial requirements for maintaining state licensure, turning what has been voluntary into something that is mandatory to practice medicine. They also worry about having to duplicate the expensive and time-consuming

MOC requirements in order to retain their medical licenses.

But according to the FSMB, physicians who successfully complete a MOC program in their field should be considered to have successfully met MOL requirements in any state.

In addition, MOL will not require a “high-stakes examination as part of its structure,” Dr. Chaudhryy said.

Nevertheless, physicians remain wary. For the second year in a row, members of the American Medical

®

Association’s House of Delegates expressed concern that MOC/MOL requirements might be overly burdensome or negatively affect the physician workforce. “We don’t want [doctors] to lose their license because they don’t have maintenance of certification,” Doug Myers, MD, president of the Washington State Medical Association, told delegates in June, according to an AMA report.

Lance Talmage, MD, chair of the FSMB board of directors, told an

AMA committee in June that it will be some time before most states implement the new MOL rules. “This is not something that is going to be in full force for five to seven years, so there is time to look at it,” Dr. Talmage said.

Dr. Talmage supports MOL, but his son, Dr. Lance Talmage Jr., the Ohio anesthesiologist, opposes it. “I guess we understand each other’s position,” the younger Dr. Talmage said. “That’s all I’m going to say.”

—Ted Agres

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P OLI C Y & M A NAGEMENT CMS

‘Let’s be clear that the only things CRNAs “extend” for CONTINUED FROM PAGE 1

anesthesiologists are their A) time in the break room, B) time in

management services such as nerve blocks, pain injections and maintenance of implanted devices in states where medical scope-off practice laws allow them to perform these services. Currently, only Louisiana restricts the administration of chronic pain services to physicians.

CMS said the determination would not significantly affect the federal budget because Medicare had not prohibited CRNAs from furnishing these services, only from billing the government directly for them. CRNAs have been paid at the same rate as physicians for the care, the agency said, but payments are made only on an assignment-related basis, meaning that they must accept the amount Medicare approves as final payment, and with supervision required in certain circumstances.

Perhaps more importantly for CRNAs, CMS expanded its definition of “anesthesia and related

6 · SEPTEMBER 2012

the call room, C) time on vacation and D) compensation, since anesthesiologists can direct up to four CRNAs at once, yet we all know it’s impossible to be in four places at the same time.’

—Debra P. Malina, CRNA, AANA past-president care” to include “those services that a certified registered nurse anesthetist is legally authorized to perform in the state in which the services are furnished.”

CMS removed an earlier proposed caveat that such care would be limited to “medical and surgical services that are related to anesthesia.” The new ruling clarifies that CMS will leave it to the states to determine which services CRNAs can legally provide, and CMS will pay them accordingly.

Tony Mira, president and CEO of Anesthesia Business Consultants (ABC), based in Jackson, Mich., said the rule likely would not have a significant financial impact—at least initially—on anesthesiologists.

“Most of the practices that ABC serves are owned and managed by anesthesiologists. It is possible that some of our physicians will make greater use of well-qualified CRNAs in providing pain medicine

AN INDEPENDENT SUPPLEMENT BY MEDIAPLANET TO USA A TOD DAY

NEWS For Certified Registered Nurse Anesthetist Jackie Rowles, developing a comprehensive treatment program for pain management is crucial, no matter the patient.

FACTS

Certified Registered Nurse Anesthetists (CRNAs) s at a Glance ■ Nurse anesthetists have been providing anesthesia care to patients in the United States for 150 years.

■ CRNAs are anesthesia professionals who safely administer more than 33 million anesthetics to patients each year in the United States.

■ CRNAs are the primary providers of anesthesia care in rural America, enabling healthcare facilities in these medically underserved areas to offer obstetrical, surgical, pain management and trauma stabilization services. In some states, CRNAs are the sole providers in nearly 100 percent of the rural hospitals.

■ According to a 1999 report from the Institute of Medicine, anesthesia care is nearly 50 times safer than it was in the early 1980s.

■ Managed care plans recognize CRNAs for providing highquality anesthesia care with reduced expense to patients and insurance companies. The cost-efficiency of CRNAs helps control escalating healthcare costs.

■ According to a recent survey, nine out of 10 Americans believe it is crucial that Medicare protect patient access to pain management delivered by CRNAs. ■ A minimum of 7-8 years of education and experience are required to become a CRNA, and 40 hours of continuing education is required every two years for recertification. editorial@mediaplanet.com

Pain knows no boundaries

Janice J. Izlar, CRNA, DNAP President, AANA

“I care for teens, students, executives, farmers, construction workers, professional athletes, mothers, fathers, retirees, nursing home patients, and disabled patients. Pain knows no boundaries.”

Rowles, a longtime registered nurse, works at Meridian Health Group in Carmel, Indiana and has specialized in chronic pain management care for 10 years. As a trained CRNA, Rowles can pro-

vide diagnostic and therapeutic injections which are sometimes done using fluoroscopy or ultrasound visualization.

“To watch someone’s pain lessen to where he/she can become more active and involved in life again because their pain has been managed enough to get them back to work, or allow them to play with their children or exercise again, is just amazing.

“CRNAs administer more than 32 million anesthetics to patients each year in the U.S. and are the primary provider of anesthesia care in rural America, according to Janice Izlar, President of the American Association of Nurse Anesthetists. In fact, nurses were the first professional group to provide anesthesia services, as far back as the 1800’s.

CRNA John Kane runs a pain office in Wolfeboro, New Hampshire and has the authority to

TYPES OF PAIN TREATED BY CRNAs

NECK PAIN

HEADACHE

SHOULDER PAIN POSTHERPETIC PAIN

MUSCLE/ TENDON PAIN

LOWER BACK PAIN

HIP PAIN

SCIATICA

STUMP PAIN

PERIPHERAL VASCULAR DISEASE

write prescriptions in his state.

He points out, “In the 30 years I’ve been doing anesthesia, I’ve seen the profession go from a certificate program to doctorate level. We’re taught techniques in placing epidural catheters to take mom’s pain away during labor and delivery or post-op pain in a patient having abdominal or joint replacements.”

Kane adds “These homegrown New Englanders are blind when it comes to the letters after my name. They live in a world where doctors are few, and to get their care they see Physician Assistants and Advanced Registered Nurse Practitioners.”

TENDONITIS

SOURCE: AMERICAN ASSOCIATION OF F NURSE ANESTHETISTS

CINDY RILEY editorial@mediaplanet.com

MANAGING PAIN, BUILDING RELATIONSHIPS

■ Question: How can a nurse anesthetist make a difference in a patient’s life?

■ Answer: By providing pain relief while also forming a personal relationship.

It was a Good Friday Dan Flachmeyer will never forget. Just 14-years-old, he was trying to remove a fish hook from a power line using a stack of aluminum tent poles. “ The pole hit the line and I lost both my arms and some toes, “ explains the 46-year-old Montana native. “I was smoldering on the

ground, with smoke coming out of my clothes. It was extremely painful. “ Flachmeyer spent nearly a year recovering, and was fitted with prosthetic arms. He eventually found work in the security field, married and raised three children.

But in 1999 he fell on a job site and suffered a serious neck injury. It wasn’t until he met CRNA Brian Bradley, years later, that he truly found relief from the pain.

Bradley explains, “Dan wears a prosthesis that crosses his neck.

The pressure on his neck broke down some of the spinal seg-

ments, resulting in considerable pain. We’ve been treating him with cervical epidurals with good success.”

Bradley, who works at a practice focusing on disc herniations, spinal stenosis and facet disease, says most of his patients are referred to him for treatment from local orthopedic spine surgeons and neurosurgeons.

“The work is very rewarding.

Chronic pain management provides me with the ability to establish relationships. I get to know the patients and their families on a much more intimate level.”

Flachmeyer, an avid fisherman and hunter says, “The difference going to Brian is like night and day. Within ten minutes of the first shot, I had no pain at all. Plus, I can go ten miles from where I live for treatment. Otherwise, I’d have to travel 110 miles to get treatment. Brian also has a great bedside manner and answers all my questions. I trust him, because he knows what he’s doing.”

CINDY C INDY RI R RILEY ILEY editorial@mediaplanet.com

A national advertising campaign from the American Association of Nurse Anesthetists earlier this year focused on chronic pain.

DECEMBER 2012

AnesthesiologyNews.com I 25

POL ICY & M A N A G E ME N T services in the states where Medicare will now pay nurses who perform these procedures, but it is impossible to predict any change in revenues as a result,” Mr. Mira said. “We count several CRNA-owned practices among our clients and we imagine that they will expand their offerings, consistent with staff availability and state law.”

However, Mr. Miraa added, “We do not expect that CRNAs will bill less for chronic pain services than do physicians. Medicare allows CRNAs 100% of the amount paid to physicians for anesthesia services, and we are not aware of any CRNAs who discount their fees below Medicare levels.”

“The AANA [American Association of Nurse Anesthetists] applauds the Centers for Medicare and Medicaid Services and the administration for ruling to preserve patient access to chronic pain management services administered by CRNAs,” Frank Purcell, the AANA’s senior director of federal government affairs, told Anesthesiology News.

Figure. The 16 states (green) that have opted out of Medicare’s requirement of physician supervision of nurse anesthetists.

But John M. Zerwas, MD, president of the American Society of Anesthesiologists (ASA), rebuked CMS for its “severely flawed and dangerous” decision. In a Nov. 1 statement, Dr. Zerwas said nurse anesthetists “lack the ability to safely and effectively treat patients with chronic pain using a comprehensive approach, and to appropriately manage the medical conditions contributing to their pain.”

The ASA maintains that chronic pain care is not a subset of anesthesia and that even anesthesiologists must complete a residency and pass an exam to become board-certified in pain medicine.

The AANA recently conducted a nationwide public relations and lobbying campaign about the CMS issue, including partial sponsorship of an advertising supplement in USA Today on chronic pain (left).

AANA portrayed the issue as potentially affecting pain care provided to elderly patients, especially in rural areas.

The issue has brought to the surface longstanding professional animosity between the ASA and the AANA, which represent 48,000 anesthesiologists and 44,000 anesthetists, respectively. Norman Cohen, MD, ASA’s vice president for professional affairs, called AANA’s chronic pain management campaign “part of a scope-off practice land grab, trying to expand the opportunities eventually for remuneration.

“It’s part of a multipronged strategy to achieve their goal to have through regulation what they haven’t been able to demonstrate through training and education—to be able to perform chronic pain services,” Dr. Cohen said in an interview.

AANA communications director Christopher Bettin declined to comment on the relationship between the two organizations. “Given the current sensitivities between the two organizations/professions at the moment, participating in an article of this nature would not be in our best interests.”

A New Chill?

The two groups have attempted to improve relations over the years. For example, during the late 1960s, an ASA–AANA Liaison Committee was formed to foster trust and cooperation. But relations deteriorated after only a few years, and the bad blood has continued off and on.

For example, in an interview with Medscape Today News published last February, Jeffrey S. Jacobs, MD, chair of ASA’s ethics committee, referred to nurse anesthetists as “anesthesiology extenders” who have a “narrower knowledge base” than anesthesiologists. This prompted then-AANA President Debra P. Malina, CRNA, to respond: “Let’s be clear that the only things CRNAs ‘extend’ for anesthesiologists are their A) time in the break room, B) time in the call room, C) time on vacation and D) compensation, since anesthesiologists can direct up to four CRNAs at once, yet we all know it’s impossible to be in four places at the same time.”

Both sides agree that patient safety should be the ultimate goal. “I’m in an academic practice in Oregon,” Dr. Cohen said. “We have a good working collegial relationship, working as a team. On a dayto-dayy basis, we work well together to care for our patients and when we work together as a team, we tend to have very good outcomes.”

Christine Zambricki, CRNA, AANA’s senior director of federal affairs strategies, said, “In settings where CRNAs and anesthesiologists work together on a daily basis, these anesthesia professionals share a common goal of patient safety and putting their patients first,” she told Anesthesiology News. “Issues that the professional associations deal with should not and typically do not get in the way of patient care.”

—Ted Agres

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

For ICU Patients, Quiet (If Not Quite Silence) Is Golden

M

anaging intensive care patients in quiet, private rooms with ready access to natural light can reduce their risk for postoperative delirium by nearly 50%, Canadian researchers have found.

The findings, reported at the 2012 annual meeting of the Canadian Anesthesiologists’ Society (abstract 1343666), confirm the suspicions of

many clinicians that the intensive care unit environment may play a role in the development of delirium.

“For years, people have talked about how delirium can be influenced by the way we do things in the hospital, which is typically designed for the convenience of staff and not necessarily the patient,” said Hilary Grocott, MD, professor of anesthesia and surgery at

the University of Manitoba, who led the study. “It’s only now that people are thinking about designing hospitals and ICUs around some of the factors that we know affect patients.”

Dr. Grocott’s institution recently renovated its intensive care rooms to incorporate certain features known to be appealing to patients, he said—creating a natural experiment. “We went from what we call an open design—no physical barriers between the different beds, no outside windows, small, loud space—to a unit that had all private rooms, wall-to-wall windows along one side and very little noise. Then we looked at the incidence of delirium before and after we moved, where the only thing that changed was the environment.”

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2. Stoelting R, Overdyk F. Anesthesia Patient Safety Foundation, Conclusions and Recommendations from June 08, 2011 Conference on Electronic Monitoring Strategies to Detect Drug-Induced Postoperative Respiratory Depression. http://www.apsf.org/announcementsphp?id=7. Accessed August 25, 2011.

3. Standards for Basic Anesthetic Monitoring. American Society of Anesthesiologists. http://www.asahq.org/For-HealthcareProfessionals/~/media/For%20 Members/documents/Standards%20Guidelines%20Stmts/Basic%20Anesthetic%20Monitoring%202005.ashx. Accessed June 20, 2011.

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The chart review comprised 286 patients who had undergone cardiac surgery at the institution between May 1 and June 15, 2010, or May 1 and June 15, 2011. Other than the change in environment, the groups were comparable, including age, operative risk or the medications they had been taking.

Delirium assessments were performed every 12 hours until postoperative day 7.

The analysis found that 44 patients (15.4%) had at least one episode of delirium during their time in the hospital. In people aged 65 years and older, the more patient-friendlyy ICU was associated with a significant reduction see delirium page 29

DECEMBER 2012

AnesthesiologyNews.com I 27

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

Trial Puts Sedative Dosing to the Test Effort to minimize hemodynamic anomalies from dexmedetomidine

T

o bolus or not to bolus? When it comes to dexmedetomidine, the answer has proved elusive.

But a multicenter team of Canadian researchers has found that although hemodynamic abnormalities occur in 40% to 60% of postsurgical patients receiving dexmedetomidine (Precedex, Hospira) in the intensive care unit, the incidence of such events is lower with a slower—or no—loading dose of the drug.

“The dosing recommendation for dexmedetomidine is to give it as a bolus over 10 or 20 minutes,” said C. David Mazer, MD, professor of anesthesia at the University of Toronto, Ontario, who helped lead the study.

“One of the problems with giving it as a bolus is its potential hemodynamic effects, so some practitioners just start it as an infusion. And although there is good documentation about the hemodynamic effects related to the bolus, there’s nothing in the literature about the hemodynamic effects with just the infusion.”

As Dr. Mazer and his colleagues reported at the 2012 annual meeting of the Canadian Anesthesiologists’ Society (abstract 1328069), 301 patients were enrolled in the open-label, nonrandomized trial. Patients with bradycardia, hypotension or heart block (Mobitz 2 or 3) were excluded from the study, which was supported by Hospira.

The investigators allocated patients to one of three loading-dose regimens: no dose (n=156), slow dose (1 mcg/kg over 20 minutes; n=82) and fast dose (1 mcg/kg over 10 minutes; n=63). In each group, the bolus was followed by an infusion of 0.2 to 0.7 mcg/kg per hour for two to 24 hours.

The primary outcome was the incidence of clinically meaningful hemodynamic abnormalities within the first two hours of receiving the sedative.

Anomalies were defined as slow heart rate (<50 beats per minute [bpm] requiring intervention or <40 bpm), low systolic blood pressure (<80 mm Hg), an increase in systolic blood pressure of more than 20% above baseline, the initiation of a pacemaker or the use of a vasoactive agent. Secondary outcomes included other adverse events, as well as use of sedatives and analgesics.

All three regimens were associated with hemodynamic abnormalities, Dr. Mazer told Anesthesiology

News. “The lowest rate of abnormalities was in patients who received no bolus, which is not surprising based on the characteristics of the drug.”

Nearly 43% of patients who did not receive a loading dose experienced hemodynamic abnormalities, compared with 49% of those in the slow

loading-dose group and 61.7% of those in the fast loading-dose group (P=0.015 vs. no loading dose).

The higher incidence of hemodynamic abnormalities in the group that received a rapid loading dose was accompanied by the increased use of vasoactive agents in this group: 8.5%

Mistify

your patients.

versus 25% among patients who did not receive a loading dose (P=0.003).

Furthermore, the time to first occurrence of hemodynamic abnormalities was significantly shorter in the bolus groups than the non-bolus group (P=0.013). The most common see bolus page 29

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

Hyperglycemia Tied to Death After Cardiac Surgery Boston—Patients undergoing cardiac surgery have double the risk for mortality if they experience severe hyperglycemia during the procedure, and have a 12-fold increase in the risk for death if they experience severe hyperglycemia in the perioperative period, researchers have found.

“A lot of people know that hyperglycemia in cardiac patients is associated

with mortality, but not to this level,” said Lance Holton, DO, a fellow in cardiothoracic anesthesia at the Cleveland Clinic, in Ohio, who led the large retrospective analysis.

Studies have shown that postoperative hyperglycemia in patients undergoing cardiac surgery can increase mortality by roughly eightfold ((J Diabetes Complications 2008;22:365-370).

Researchers also have shown that patients who are hyperglycemic during the intraoperative period have a nearly fivefold increase in death after the procedure (Anesthesiology 2005;103:687-694). Few studies, however, have looked at the risk that hyperglycemia presents in the combined perioperative period.

Presented at the 2012 annual

meeting of the Society of Cardiovascular Anesthesiologists (abstract 58), the study was designed to compare the risk for postoperative mortality associated with hyperglycemia in three periods: intraoperative, postoperative and perioperative (a combination of intraoperative and postoperative). The analysis included 4,302 patients categorized as being severely hyperglycemic if they had time-weighted average glucose of more than 200 mg/dL. Patients were considered mildly hyperglycemic if they had time-weighted average glucose of less than 200 mg/dL during each time period.

Severe hyperglycemia in the postoperative period increased the risk for postoperative mortality 7.3-fold. Postoperative mortality was increased 1.95fold for patients who were severely hyperglycemic in the intraoperative period and 12.23-fold for patients who were severely hyperglycemic in the perioperative period.

Dr. Holton said the new data suggest that effects of hyperglycemia differ during and after surgery. “The optimal glucose concentration for patients having heart surgery is not known,” he said.

“Trials are under way to evaluate the best glucose concentration for patients having heart surgery and will hopefully be useful in narrowing down a range.

Most of the data that we use intraoperatively for glucose control comes out of the intensive care unit. We are investigating to see whether there is an ideal range for the operating room and an ideal range for the ICU.” Athos Rassias, MD, an anesthesiologist at Dartmouth-Hitchcock Medical Center, in Lebanon, N.H., said that given the retrospective nature of the latest findings, “I’m not sure that the researchers can strongly support the fact that hyperglycemia per se was the causative main problem associated with increased mortality.”

Compared with patients who had mild hyperglycemia, those with severe hyperglycemia had higher rates of diabetes (45% vs. 19.6%; P<0.001) and were more likely to have had coronary artery bypass grafting (63% vs.

45.1%; P<0.001) and a history of congestive heart failure (30% vs. 25.6%; P=0.009). Perhaps, Dr. Rassias said, patients with severe hyperglycemia were sicker, which might have confounded the study results.

—Kate O’Rourke

DECEMBER 2012

DELIRIUM

CONTINUED FROM PAGE 26

in postoperative delirium (12.9% vs. 24.7%; P=0.048), a difference Dr. Grocott called “meaningful.”

Increasing age also was an independent risk factor for the occurrence of delirium (odds ratio [OR], 1.55 per 10 years of age; 95% confidence interval [CI], 1.11-2.17; P=0.0105). On the other hand, extubating patients in the operating room was associated with a reduction in the incidence of delirium (OR, 0.24; 95% CI, 0.10-0.59; P=0.0009).

Dr. Grocott recognized that most anesthesiologists do not have the luxury of a state-off the-art ICU. But there are ways older facilities can mimic newer hospitals to produce similar benefits, he said.

“We think right now that it’s the natural light, the quiet environment and the privacy that reduced delirium, but the missing link here may be improved patient sleep–wake cycles,” Dr. Grocott explained. “If that’s the case, then there probably are things that anesthesiologists can do pharmacologically to induce that more natural pattern.”

These measures include minimizing sedatives or incorporating agents such as clonidine or dexmedetomidine (Precedex, Hospira), which have been shown to improve sleep–wake cycles.

“It’s arguably a bit speculative because we don’t know for sure if it is the sleep– wake cycle,” Dr. Grocott added. “But certainly all those parameters that we adjusted by moving to a new ICU

AnesthesiologyNews.com I 29

SonoLong – The new revolutionary echogenic cathCLeter IN ICA A N E STH with E SIOL OG Y kit Lequipped “3D Cornerstone” reflectors fl

would be consistent with improving sleep–wake cycles.”

Charles S. Brudney, MBBCh, associate professor of anesthesiology and medicine at Duke University Medical Center in Durham, N.C., noted that the study supports existing research showing that the ICU environment affects patients’ sleep and delirium and the risk for developing post-traumatic stress disorder. “Some people have shown that if you improve the environment and make the nighttime seem more like nighttime, patients seem to have better outcomes and less delirium,” Dr. Brudneyy said.

“I think the quality of sleep also needs to be looked at,” he continued. “You could argue—as a lot of people do— that because these patients are sedated, it doesn’t matter if it’s night or day. But our goal is to sedate our patients less, so you’ve got to change the environment or they are not going to get particularly restful sleep.”

Changing the culture of an institution is not necessarily easy, however, particularly when health care personnel have jobs to do regardless of the time of day—or night. “I’ve historically tried to change my unit,” Dr. Brudney said. “I’ve banned food from the main nursing area in front of the patients and asked nurses to take their breaks in the back coffee room. But they still have all the lights on, take xx rays throughout the night, draw labs throughout the night and it’s all disruptive for the patient. No wonder they don’t get restful sleep.”

—Michael Vlessides

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BOLUS

CONTINUED FROM PAGE 27

adverse events in all groups were procedural pain (26.8%-37.8%), nausea (22.2%-30.5%), hypotension (15.9%-23.1%), pain (12.2%-14.3%) and hypertension (10.9%-14.6%).

Yet as Dr. Mazerr explained, the clinical scenario plays a critical role in determining which loading regimen of dexmedetomidine an anesthesiologist may choose. “If the patient needs rapid achievement of therapeutic levels without using any other agent, then I think a bolus may be the way to go,” he said. “In some patients, I might actually give the whole loading dose over a 10-minute period. In those who have pre-existing hemodynamic abnormalities, I might reduce the bolus or eliminate it.”

G. Burkhard Mackensen, MD, PhD, professor and chief of cardiothoracic anesthesia at the University of Washington, in Seattle, said he was not

particularly surprised by the results given the dosing regimens the researchers used in the study. “I certainly found the treatment allocation very interesting, because it was left to the individual anesthesiologist,” Dr. Mackensen said. “If anything, the effect size may be underestimated given the way treatment was allocated.”

Dr. Mackensen said he typically does not administer boluses of dexmedetomidine before starting an infusion. “I use smaller boluses in the operating room, but that’s without starting an infusion,” he said. “I keep a stick of the drug in my pocket, and use it at the time of weaning and extubation to smooth things out for the patient.

I have pretty good results with giving small boluses in these instances, although admittedly I’m not starting an infusion there, and it’s a different indication.”

—Michael Vlessides

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30 I AnesthesiologyNews.com

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

CONTINUED FROM PAGE 1

outcomes?” said Wolf H. Stapelfeldt, MD, chair of general anesthesiology and vice chair of surgical operations at Cleveland Clinic, who led the study. “From a practical point of view, we all have to draw the line somewhere. We’ve chosen to start out with drawing the line at a mean arterial pressure [MAP] of 60 mm Hg, but what does that mean? When should we start worrying? After two minutes? Five minutes? Fifteen minutes? Quite frankly, we don’t know, and this prompted our current study.”

The Cleveland Clinic team is now in the process of validating the algorithm, including, it hopes, by comparing its data to those from Mayo Clinic and Vanderbilt University Medical Center, in Nashville, Tenn.

“Depending upon the results of these validation steps, we anticipate an evolutionary practice change assuming that not all, but many patients’ outcome might be improved by minimizing hypotensive exposures,” Dr. Stapelfeldt said. “Depending upon the magnitude of the impact on patient outcome, the [decision support system] is principally designed to allow any such algorithm to either be pushed to every provider as a mandatory alert—i.e., a matter of departmental or institutional policy—versus functionality that is made available to individual providers via subscription at their discretion.” Any alert, whether global or individual, may be disregarded by the anesthesia care team using its best judgment, he added.

Dr. Stapelfeldt and his colleagues examined the institution’s registry for adult patients undergoing non-cardiac surgery between Jan. 1, 2009 and Sept. 30, 2010. They analyzed minute-to-minute MAP readings from more than 35,000 patient records for periods of time spent below hypotensive thresholds ranging from 75 to 45 mm Hg. Patients were considered to have dropped below a certain threshold if they spent at least one minute below that level. The investigators used logistic regression to determine the relationship between cumulative time spent below the various thresholds and 30-dayy mortality.

As Dr. Stapelfeldt reported at the 2012 annual meeting of the American Society of Anesthesiologists (abstract 074), spending any amount of time below a certain threshold was common, decreased in incidence with progressively lower hypotensive thresholds and was associated with increased 30-dayy mortality (Figure 1).

Several factors independently affected patient outcomes after surgery. These included patient age, Charlson comorbidity index and cumulative blood loss. “There was a 20% increase in mortality for each additional comorbidity,” Dr. Stapelfeldt said. “And every additional 20 years of age more than doubled a patient’s risk for dying within 30 days of surgery.”

But the most striking finding involved the cumulative amount of time spent below various blood pressure thresholds, he continued. “We found that as patients started spending even just a few minutes

Figure 1. Incidence, distribution of cumulative time spent and 30-day mortality for patients dropping below blood pressure thresholds.

Figure 2. Percentage increase in the odds ratio for 30-day mortality depending on the duration of hypotension below certain thresholds. (Figures courtesy of Wolf H. Stapelfeldt, MD.)

‘What’s most disconcerting is that many of our patients routinely exceeded a large number of these exposure limits by spending substantial amounts of time below their respective MAP thresholds, on the order of half an hour or longer in many instances.’

—Wolf H. Stapelfeldt, MD below an MAP of 55, there was a sharp increase in the odds ratio for mortality [Figure 2]. More importantly, similar increases in mortality were seen whenever patients exceeded other, longer exposure limits for time spent below any of the less severely hypotensive MAP thresholds.”

Indeed, as each additional exposure limit was exceeded, there was an incremental 4% to 7% increase in the risk for 30-dayy mortality. “What’s most disconcerting is that many of our patients routinely exceeded a large number of these exposure limits by spending substantial amounts of time below their respective MAP thresholds, on the order of half an hour or longer in many instances.”

These results suggest that long-term outcome may not only be affected by periods of severe hypotension, but also by extended periods spent at seemingly adequate intraoperative blood pressure levels. “Unlike conventional vital sign monitors—which alert only to blood pressure dropping below a certain threshold level—decision support systems can alert to a certain level of risk attributable to significant cumulative hypotensive exposure, something apparently very critical yet difficult for humans to keep track of, unlike the detection of any sudden changes in blood pressure.

“This information would be most useful if it is provided in real time, which decision support is now able to do,” Dr. Stapelfeldt said. “The idea is that once the anesthesia care team receives any first alerts to excessive hypotensive exposure, it might be able to adjust the anesthetic in such a way that the patient’s mean arterial pressure trends higher. One can choose how aggressive one wants to be with minimizing hypotension according to what level of attributable risk one might want to attempt to mitigate.”

Christian Apfel, MD, PhD, adjunct associate professor of anesthesia, perioperative care, epidemiology and biostatistics at the University of California, San Francisco, called the research fascinating and rigorous. “We still have procedures where surgeons are asking for ‘controlled’ hypotension,” Dr. Apfell said. “And that is actually something I’ve always been uncomfortable with.

“Dr. John Drummond from the University of California, San Diego is always warning against this kind of controlled hypotension,” Dr. Apfell continued. “And until now, we only had anecdotal evidence. This decision support system might help us in those kinds of situations.”

—Michael Vlessides

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32 I AnesthesiologyNews.com

DECEMBER 2012

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

History of Postpartum Bleeding Linked to Future Risk

W

omen who experience postpartum hemorrhage in their first pregnancies are three times as likely to have it in a second pregnancy as women without a history of the complication, according to a study of Swedish women directed by researchers in Massachusetts.

The study, one of the first to quantify the risk for postpartum

hemorrhage (PPH) in successive pregnancies, also showed that women with a history of the condition have a sevenfold risk for having it in a third pregnancy, compared with women who did not have PPH in previous pregnancies. These results should be generalizable to women in the United States, said lead researcher Brian Bateman, MD, assistant professor of

anesthesiology at Massachusetts General Hospital and Harvard Medical School, both in Boston.

The risk for PPH is highest among women with at least one previous PPH and among those with an earlier severe PPH, said Dr. Bateman, who presented the findings at the 2012 annual meeting of the Society for Obstetric Anesthesia and

Perinatology (abstract BP-6). “These women should be delivered in hospitals with the anesthesia, obstetric and blood bank resources to readily respond to a PPH, and the care team should anticipate an increased likelihood of bleeding.”

PPH is the leading cause of maternal mortality worldwide, complicating approximately one in 1,000 births, according to published reports. A history of PPH had been a recognized risk factor for PPH in subsequent pregnancies, but it was not well understood if the risk accumulated with multiple pregnancies or if the recurrence risk varied by PPH subtype, he said.

For the study, Dr. Bateman and his colleagues at Harvard and at the Karolinska Institutet in Stockholm, reviewed detailed records from the Swedish Medical Birth Register of 538,332 women who delivered between 1997 and 2009 (a total of 914,933 deliveries). They defined PPH using diagnostic codes based on an estimated blood loss of 1 L or more, and severe PPH if the woman received a blood transfusion.

‘These women should be delivered in hospitals with the anesthesia, obstetric and blood bank resources to readily respond to a [postpartum hemorrhage], and the care team should anticipate an increased likelihood of bleeding.’

—Brian Bateman, MD The risk for PPH was 5.5% in first pregnancies. Women with PPH in their first pregnancies had a greatly increased risk for PPH in subsequent pregnancies compared with women without a previous PPH. The risk for PPH was 12.8% in a PPH patient’s second pregnancy, compared with 3.8% among women who did not experience PPH previously (relative risk [RR], 3); among women with severe PPH in their first pregnancy, this risk showed a fourfold difference see PPH page 39

CONTINUING MEDICAL EDUCATION

DECEMBER 2012

Lesson 301: PreAnesthetic Assessment of the Patient With Amyotrophic Lateral Sclerosis WRITTEN BY:

TARGET AUDIENCE

Adam C. Adler, MD, MS Clinical Associate Tufts University School of Medicine Department of Anesthesiology and Pain Medicine Baystate Medical Center Springfield, Massachusetts

Anesthesiologists

Shaheen E. Lakhan, MD, PhD, MEd, MS Resident Physician, Department of Neurology Cleveland Clinic Cleveland, Ohio Shumei Man, MD, PhD Research Fellow, Department of Cell Biology Lerner Research Institute Cleveland Clinic Cleveland, Ohio

REVIEWED BY: Neil R. Connelly, MD Professor of Anesthesiology, Tufts University School of Medicine Director of Anesthesiology Research Department of Anesthesiology Baystate Medical Center Springfield, Massachusetts

DATE REVIEWED: November 2012

NEEDS STATEMENT Amyotrophic lateral sclerosis is one of the most commonly diagnosed neurodegenerative disorders and is encountered with significant frequency in anesthesia practice. Most anesthesiologists do not know when or which muscle relaxants are safe to use.

LEARNING OBJECTIVES At the conclusion of the lesson, the reader will be able to: 1. Describe the basic pathophysiology of amyotrophic lateral sclerosis (ALS).

2. Identify changes at the neuromuscular junction occurring in ALS. 3. List the issues with depolarizing neuromuscular blockers (NMBs) in ALS. 4. Identify nondepolarizing NMBs that can be used for patients with ALS. 5. Identify hyperkalemic-associated electrocardiographic changes.

6. Outline the treatment strategies of hyperkalemia.

7. List appropriate reversal agents for patients with ALS. 8. Tabulate the respiratory issues in ALS. 9. Present a plan for general anesthesia for a patient with ALS. 10. Anticipate postoperative complications of anesthesia.

DISCLOSURES

CASE HISTORY

The authors and reviewers have nothing to disclose. No funding was received in preparation of the manuscript.

A 65-year-old man with progressive amyotrophic lateral sclerosis (ALS) presented for anesthesia evaluation for laparoscopic placement of a gastrostomy tube. His medical history was consistent with progressive neuromuscular disease, chronic obstructive pulmonary disease, congestive heart failure, hypertension, type 2 diabetes mellitus, and depression.

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.

He had significant pharyngeal weakness with extremely limited ability to swallow or clear secretions. Vital signs included a blood pressure of 132/88 mm Hg, pulse of 76 beats per minute with sinus rhythm, temperature 93.3 °F, respiratory rate of 16 breaths per minute, O2 saturation of 93% on room air, height 175 cm, and weight 73.4 kg. The patient appeared cachectic and was trying to spit out his clear secretions. His mouth opening was extremely limited and 4 rotten teeth remained in the jaw. There were visible tongue fasciculations, and the Mallampati score was assessed as 3. The lungs had decreased air entrance bilaterally. There was significant weakness in all extremities. The patient had a 40-year 1- to 2-pack per day smoking history and was still smoking at the time of evaluation. He reported chronic clear sputum. The patient had multiple episodes of acute bronchitis, the last having cleared 2 weeks prior. He underwent distant open cholecystectomy under general anesthesia, which was reported to be uneventful. Chest x-ray showed flattening of the diaphragm, without significant abnormality. Computed tomographic scan of the chest was consistent with emphysematous changes and a stable pulmonary nodule. Pulmonary function tests dating 6 weeks prior revealed a forced expiratory volume in 1 second (FEV1) of 1.06 L or 58% of predicted, an FEV1/forced vital capacity of 0.78 L or 101% of predicted and forced expiratory flow 25% to 75% of 1.40 L per second or 59% of predicted, maximum voluntary ventilation of 53 L per minute or 57% predicted, and a residual volume/ total lung capacity of 65 or 166% of predicted. Medications included lisinopril, aspirin, loratadine, paroxetine, riluzole, tiotropium, fluticasone propionate plus salmeterol, trihexyphenidyl, and metformin. The patient remained in a sitting position as the recumbent position caused significant secretion buildup in the pharynx because of the inability to swallow. General anesthesia was required for the procedure and the issue of neuromuscular relaxation was discussed.

A

LS is a rapidly progressive neurodegenerative disease characterized by the degeneration and death of upper and lower motor neurons responsible for controlling voluntary muscles. Evidence suggests that this fatal disease is a proteinopathy secondary to accumulation of various aggregated proteins. It is one of the most common motor neuron diseases, affecting approximately 1.5 to 2.5 per 100,000 persons per year worldwide.1 ALS most commonly affects adults between the ages of 40 and 60 years. Individuals of all races and ethnic backgrounds are affected, men more often than women.

Although ALS is largely sporadic and of unknown etiology, a genetic basis has been linked to approximately 10% of cases (familial ALS).2 Discovered in 1993 by Rozen and

PREANESTHETIC ASSESSMENT Dr. Elizabeth A.M. Frost, who is the editor of this continuing medical education series, is clinical professor of anesthesiology at the Mount Sinai School of Medicine 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 December 31, 2013. (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: Dec. 1, 2012 TERMINATION DATE: Nov. 30, 2013 ACCREDITATION STATEMENT The Mount Sinai School of Medicine is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENT The Mount Sinai School of Medicine 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 Mount Sinai School of Medicine 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.

33

34

CONTINUING MEDICAL EDUCATION

DECEMBER 2012

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

colleagues, mutation of the enzyme superoxagonist and leads to larger potassium efflux, as ide dismutase 1 is responsible for about 20% of the channels are slower to close. familial cases. Since then, more than 10 genes Significantly lower concentrations of agohave been linked to ALS and motor neuron nist drugs or native Ach are required to depodiseases.3 larize immature receptors.8 The conformational 3 Upper motor neurons (UMNs) originate in change most probably imparts the susceptibilthe brain (primary motor cortex), whereas lower ity to agonists, whereas the extra junctional loca2 motor neurons (LMNs) stem from the spinal cord tions are in part responsible for the increased 1 Distal axonopathy-neuromuscular to target muscles. In ALS, both UMNs and LMNs resistance to the antagonist. junction altered mitochondria degenerate and cease to communicate properly A separate nicotinic α7ACh-R has been found 2 ER stress J unfolded protein with muscles. Ocular muscles and sensory neuto appear in times of skeletal muscle developresponse rons are never involved in ALS. ment and in denervation states (Figure 3). This 1 Signs of UMN involvement include motor homomeric receptor consists only of α receptors 3 Non-cell autonomy-inflammation microglia and T cells weakness, spasticity, hyperreflexia, and extensor arranged in a pentameric configuration. Choline, plantar response (Babinski’s sign—or extension a precursor to both Ach and succinylcholine, is of toes to a plantar stimulus). Symptoms of LMN a full agonist at this α7ACh-R, and only a partial Figure 1. The major themes in the pathogenesis of ALS.4 degeneration include muscle weakness, hypoagonist at the mature α,α,β,ε,σ receptors.7 tonia, hyporeflexia, and muscle atrophy. Patients Muscle α7ACh-Rs have a lower affinity for As, astrocyte; ER, endoplasmic reticulum; Mc, mitochondria have impairments in walking, swallowing (dysthe NDMR, imparting resistance. In the normal phagia), speaking (dysarthria), and eventually α,α,β,ε,σ receptors, binding of antagonists to breathing. Patients may feel twitches of muscles either a subunit renders the receptors inactive, as that can be seen under the skin (fasciculations). ventilation and surgery.6 These agents exert their effects Ach must bind both a receptors. In the α7ACh-Rs, antagoIn later stages of the disease, respiratory muscles are by inhibition at acetylcholine receptors (ACh-Rs); the nist binding to fewer than 4 subunits will leave 2 remaining affected, necessitating the use of nocturnal ventilatory relaxant effects can be predictably altered by disease α subunits available. Therefore, even with significant antagassistance such as positive airway pressure. Severe dysstates that interfere with the normal quantitative or qualonist presence, these receptors can still undergo depolarphagia eventually occurs requiring feeding tube placeitative properties of the receptors. States of increased ization—a mechanism suggested for resistance to NDMR.7 ment. Within 3 to 5 years from the onset of symptoms, quantity of ACh-R (upregulation) lead to exaggerated Succinylcholine, used since 1952, remains the only patients will usually lose the ability to breathe on their responses to depolarizing muscle relaxants (DMRs) and a ACh-R agonist clinically available in the United States.9 own and will need mechanical ventilation and support for resistance to nondepolarizing muscle relaxants (NDMRs).

Succinylcholine is formed by 2 molecules of Ach bonded survival. Unfortunately, no significant disease-modifying ACh-Rs at the NMJ are classified as nicotinic due to their by an ester linkage (Figure 4). It produces a fast and relitherapy is currently available. ability to bind nicotine. Normal adult ACh-R, located on able onset of paralysis for intubation with a short duration The pathogenic processes underlying ALS are not the muscle membrane, are pentameric, transmembrane of action. The NDMRs have more options classified mainly fully understood. However, the interaction between nonchannel-type receptors consisting of 5 subunits.7 The by duration of action and route of metabolism. They interneuronal cells and motor neurons play a key role in motor immature fetal ACh-R shares the same pentameric conforact with the ACh-R, binding to the α subunit, rendering neuron degeneration. The current understanding of ALS mation observed with denervation states and has the channel incapable of participating in muscle contracpathophysiology suggests that the microglia, the innate 5 subunits.7 tion. Certain disease states lead to up- or downregulaimmune cells of the central nervous system, maintain a In contrast with mature ACh-Rs, which are confined tion, increasing and decreasing the number respectively, balance between neuroprotection and cytotoxicity.4 to the motor endplate of the NMJ, immature recepof ACh-Rs. In addition, prejunctional (neuronal), and Although motor neuron degeneration is the pathologic tors can be found at aberrant locations throughout the postjunctional (muscle-related) changes can occur simulhallmark of ALS, a growing body of evidence suggests muscle membrane.6 Most studies of ACh-R in the NMJ taneously. Changes at the NMJ in denervation syndromes that the neuromuscular junction (NMJ) and the distal have occurred in burn patients or burn models. Followhave been well studied. axons are early and important pathologic targets of ALS.4 ing denervation injury, ACh-R undergoes conformaThe upregulation effect is not limited to ALS. It occurs Transgenic mice data suggest that the distal motor axons tional change from the adult subtype, with an ε-subunit in a variety of disease states such as disuse atrophy, burn undergo a process called dying back, k resulting in impaired to the immature, ACh-R subtype, containing a γ-subunit trauma, direct muscle trauma, infection, and chronic use synaptic function and axonal connectivity at the NMJ.5 (Figure 2). The immature channels have a low channel of NDMRs.8 Chronic occupation of ACh-Rs by NDMRs proSubsequently, faulty axonal transport hinders the clearconductance; low-amplitude currents, and a 2- to 10-fold motes upregulation, or increased receptor formation, ance of newly synthesized proteins exerting stress on the longer mean open-channel time.8 Therefore, opening of leading to a larger number of ACh-Rs on the muscle memendoplasmic reticulum and ultimately protein misfolding. the immature channels occurs with a far smaller dose of brane, which in turn imparts resistance. These changes Once proteins are synthesized by amino acid building arise following denervation of central or peripheral nerves blocks during translation, they are converted into tightly from stroke or injury, respectively. folded and highly complex structures essential for proper solubility, functioning, and disposal. (Although 20 different amino acids occur in nature, the number of different protein configurations exceeds the number of atoms in the universe.) Molecular chaperones, including heat shock proteins, protect against misfolding and rescue already misfolded proteins. In a complex and apparently obligatory interaction between microglia and the motor neuron, a biochemical shift from survival-promoting to deathpromoting signals initiates dying back (Figure 1).4

β α

γ α

ε

β α

γ α

δ

α7 α7 α7 α7 α7

The Neuromuscular Junction Neuromuscular blockers (NMBs; also called muscle relaxants) are commonly used in anesthesia, emergency medicine, and intensive care to facilitate conditions for tracheal intubation or to provide muscular relaxation for

Adult

Immature

Figure 2. Adult and immature nicotinic acetylcholine receptor conformation.

Figure 3. Conformation of the immature α7 acetylcholine receptor.

CONTINUING MEDICAL EDUCATION

DECEMBER 2012

In patients experiencing central or one-sided denervation, the contralateral and unaffected side with respect to motor function exhibits a similar pattern of resistance to NDMRs suggesting a mechanism aside from classic receptor-ligand as a factor.8 Prolonged immobility is not a denervation state itself but rather lends the muscle to disuse atrophy. The ACh-Rs are stimulated less frequently causing a secondary upregulation. In such cases, increased response to depolarizing drugs and resistance to NDMR drugs may be observed, although patients with ALS may exhibit prolonged responses to NDMR.10 Prolonged immobility in patients with advancing neuromuscular degeneration can contribute mechanistically to the predictable response to NDMR.

is not reduced until more than 70% of the receptors are occupied by NDMRs, imparting a margin of safety. However, in patients with significant neuromuscular degeneration, a 10% ACh-R blockade by NDMRs can lead to significant weakness and respiratory compromise.18 Extubation criteria in such patients can be difficult to assess as a result of baseline muscle weakness and altered pulmonary physiology. Neuromuscular blockade can further depress already diminished ventilatory muscle action. As a result, the requirement for muscle relaxation should be weighed against the potential increased likelihood of requiring postoperative ventilatory support.

Case reports have identified alternative anesthetic techniques, such as epidural placement and avoidance of muscle relaxants.19

Succinylcholine and Hyperkalemia Reversal Agents After denervation and prolonged immobilization, upregulation of the ACh-R occurs at the NMJ and along the muscle membrane. Succinylcholine, when administered in such states, can lead to activation of a large quantity of receptors and subsequent depolarization of the entire muscle. This large-scale depolarization leads to massive efflux of potassium from both ACh-R and potassium channels resulting in an unpredictable elevation of serum potassium, often to cardiac arrhythmogenic levels. Generally, serum potassium levels rise after administration of 0.5 mEq/L of succinylcholine.11 In patients with denervation injuries, the rise in serum potassium can be much greater, and more importantly unpredictable, as a larger number of channels are open to potassium flux. Neuromuscular changes can occur early in the disease course. In stroke patients, hyperkalemia can be demonstrated as early as 1 week following injury.12 Thus, a patient presenting with clinical signs and symptoms of denervation may exhibit an unpredictable hyperkalemic response.

The risk for hyperkalemia in recoverable injuries such as burns and immobility can be reversible; however, the time frame to recovery of a safe margin for administration has not been determined. In patients with chronic and progressive motor neuron disorders, the risk for hyperkalemia after succinylcholine has been demonstrated years following onset of illness.13 The use of pretreatment, such as a small dose of NDMR, prior to the use of succinylcholine has not proven effective at abolishing the hyperkalemic response.12 Hyperkalemia interferes with the normal cardiac action potential, and can alter or halt the cardiac cycle at extreme levels. Hyperkalemia, whether induced by succinylcholine or other means, has a stereotypical electrocardiographic pattern correlating with serum potassium concentration. Initial influx causes a conduction delay. The first changes observed on electrocardiography (EKG) are increased amplitude of the T waves or tenting resulting from accelerated ventricular repolarization and may occur with a potassium level of 5.5 mEq/L.14 With further increases in serum potassium concentration, atrioventricular transmembrane potentials are reduced, and sodium channels become deactivated.

With deactivation of membrane channels, atrial changes on EKG often are apparent, including flattening of the P wave and a lengthening of the PR interval, which typically occurs at potassium levels of approximately 6.5 mEq/L or greater. Eventually, the conduction through the sinoatrial and atrioventricular nodes becomes suppressed, and escape rhythms are generated with widening of the QRS

Figure 4. Structure of acetylcholine, succinylcholine, and rocuronium.

on EKG. As the QRS progressively widens and fuses with the T wave, the classical sinusoidal pattern can be identified. Without treatment, ventricular fibrillation or asystole will occur.

Treatment is aimed at temporizing measures focusing on shifting potassium intracellularly. Calcium chloride (10-20 mg/kg) antagonizes the effect of potassium at the cellular membrane. Sodium bicarbonate (1-2 mEq/kg) will increase the pH and shift potassium intracellularly.15 Change of pH by 0.1 units will result in a 0.5 to 1.5 mEq change in serum potassium opposite to the direction of the pH. Insulin shifts potassium intracellularly; it requires co-administration of glucose to prevent hypoglycemia. Use of β agonists, such as epinephrine and inhaled albuterol, also promotes intracellular shifting of potassium. These treatments all have unpredictably short-lived effects on serum potassium levels as the intracellular shifting of potassium can reverse, requiring redosing according to the patientâ&#x20AC;&#x2122;s responses. A potassium-binding agent (such as sodium polystyrene sulfonate) works in the intestinal lumen, exchanging 1 mEq of sodium ion for 1 mEq of potassium ion for each gram of agent given. Sodium polystyrene sulfonate has an onset of action of 1 to 2 hours and may be indicated if hemodialysis is to be delayed by more than 2 to 3 hours. Hemodialysis is the definitive and most effective treatment for hyperkalemia.16

Respiratory Issues in ALS Respiratory complications are a major cause of morbidity and mortality in patients with ALS. In patients with bulbar ALS, early tongue fasciculation and pharyngeal muscle weakness may lead to an increased risk for aspiration.10 In classic ALS, muscles of the tongue, pharynx, larynx, and chest become weakened and eventually atrophy.

These changes are associated with decreased vital capacity, maximum voluntary ventilation, and expiratory muscle reserve leading to respiratory failure and the need for ventilatory support.17 Inhalation anesthetics typically depress a multitude of respiratory parameters. In patients with ALS who have a limited pulmonary reserve, the need for postoperative ventilatory support following the use of inhalational agents is greater. In healthy individuals, twitch response

The use of reversal agents in patients with upregulation should be administered with caution. Cholinesterase inhibitors reversibly bind to acetylcholinesterase, promoting the binding of native Ach to the ACh-R and displacement of the nondepolarizing agents from the Îą sites.

With the larger quantity of receptors, the use of reversal agents may lead to a greater than expected depolarization surge at the ACh-R. The effect is unpredictable.

Sugammadex Unfortunately, no way of monitoring the depth of muscle relaxation has proven ideal. Thus, clinical judgment, and use of twitch monitoring should be applied in these patients. In the future, the newly developed drug, sugammadex, may allow for relatively safe use of the steroidal NDMR in ALS patients, by providing a quick reversal and avoidance of added respiratory weakness. Sugammadex is a selective relaxant-specific binding agent that encapsulates steroidal NDMRs and provides complete antagonism that is immediate and irrespective of the depth of blockade or time since the last dose of NDMR.20 Sugammadex interferes with the binding ability of the NDMR with the ACh-R and allows avoidance of anticholinesterase, which would be ideal for such patients with advanced ALS. The clinical development stemmed from 30 clinical trials in 2,054 patients with excellent results and has led to its widespread use throughout the European Union.21 However, due to reports of hypersensitivity/allergic reactions occurring in approximately 1% of patients, the FDA in 2008 denied the request of Schering-Plough, then manufacturer of sugammadex, to market the drug in the United States. With promising safety results from its use in many countries worldwide, it is possible that sugammadex will gain FDA approval in the future. Until sugammadex arrives in the United States, the anesthesia provider must continue to remain cautious and creative in applying muscle relaxation to patients with ALS and other neurologic disorders.

Management of the Case Presented In this case, induction of general anesthesia was accomplished using propofol, titrated to effect. Placement of an endotracheal tube without muscle relaxation proved impossible due to small mouth opening. Therefore, rocuronium 20 mg was administered to facilitate tracheal intubation without redosing. Train-of-four was checked until 4 of 4 twitches returned and a sustained tetanus could be observed at the orbicularis oculi muscle prior to

35

CONTINUING MEDICAL EDUCATION

36

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

administration of anticholinesterase agents. Neostigmine 2.5 mg (1 mg/cc) and glycopyrrolate 0.5 mg (0.2 mg/cc) were mixed and given at a rate of 1 cc per minute. Following oral suctioning, deep endotracheal suction was performed. Equipment was prepared and readily available for possible reintubation. The monitored patient was transferred to the postanesthesia care unit with face mask oxygen (6 L), sitting at 60 degrees. He made an uneventful recovery to his baseline and was discharged to the care of his daughter the following day. Subsequently, the patient’s heath progressively deteriorated; 4 months after discharge he was readmitted to the intensive care unit with pneumonia and underwent tracheostomy. He is now at home under hospice care.

Summary Although ALS is encountered with significant frequency in anesthesiology practice, anecdotal case reports recommend avoidance of NMBs. However, if skeletal relaxation is necessary, cisatracurium among other NDMRs may prove useful adjuncts. However, it is likely that a greater initial dose of NDMRs will be required due to resistance, although even minimal occupation of ACh-R by NDMRs can result in significant weakness, potentiating the possibility for postoperative respiratory complications. Sugammadex may allow safer use in the future. Unfortunately, no means of monitoring the depth of muscle relaxation

has proven ideal. Thus, clinical judgment and use of twitch monitoring should be applied.

References 1.

Logroscino G, Traynor BJ, Hardiman O, et al. Descriptive epidemiology of amyotrophic lateral sclerosis: new evidence and unsolved issues. J Neurol Neurosurg Psychiatry.

2008;79(1):6-11.

2.

Ticozzi N, Tiloca C, Morelli C, et al. Genetics of familial amyotrophic lateral sclerosis. Arch Ital Biol. 2011;149(1):65-82.

3.

Rosen DR, Siddique T, Patterson D, et al. Mutations in Cu/Zn superoxide dismutase gene are associated with familial amyotrophic lateral sclerosis. Nature. 1993;362(6415):59-62.

4.

Appel SH, Zhao W, Beers DR, Henkel JS. The microglial-motoneuron dialogue in ALS. Acta Myol. 2011;30(1):4-8.

5.

Fischer LR, Culver DG, Tennant P, et al. Amyotrophic lateral sclerosis is a distal axonopathy: evidence in mice and man.

Exp Neurol. 2004;185(2):232-240.

6.

Martyn JAJ. Basic and clinical pharmacology of the acetylcholine receptor: implication for the use of neuromuscular relaxants. Keio J Med. 1995;44(1):1-8.

7.

Martyn JAJ, Richtsfield M. Succinylcholine-induced hyperkalemia in acquired pathologic states. Anesthesiology.

2006;104(1):158-169.

8.

Martyn JAJ, White DA, Gronert GA, Jaffe RS, Ward JM. Up- and down regulation of skeletal muscle acetylcholine receptors.

Anesthesiology. 1992;76:822-843.

9.

Fisher DM. Clinical pharmacology of neuromuscular blocking agents. Am J Health Syst Pharm. 1999;56(11 suppl 1):S4-S9.

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.

Post-Test

DECEMBER 2012

10. Hines RL, Marschall KE. Stoelting’s Anesthesia and Co-Existing Disease. 5th ed. Philadelphia, PA: Churchill Livingstone; 2008.

11. Larijani GE, Gratz I, Silverberg M, Jacobi AG. Clinical pharmacology of the neuromuscular blocking agents. DICP. 1991;25(1):54-64.

12. Azar I. The response of patients with neuromuscular disorders to muscle relaxants: a review. Anesthesiology.

1984;61(2):173-187.

13. Cooperman LH. Succinylcholine induced hyperkalemia in neuromuscular disease. JAMA. 1970;213(11):1867-1871.

14. Diercks DB, Shumaik GM, Harrigan RA, Brady WJ, Chan TC. Electrocardiographic manifestations: electrolyte abnormalities. J Emerg Med. 2004;27(2):153-160.

15. Kaplan JA, Reich DL, Lake CL, Konstadt SN. Kaplan’s Cardiac Anesthesia. 5th ed. Philadelphia, PA: Saunders; 2006.

16. Ahee P, Crowe AV. The management of hyperkalaemia in the emergency department. J Accid Emerg Med. 2000;17(3):188-191.

17. Barash PG, Cullen BF, Stoelting RK, Cahalan MK, Stock MC. Clinical Anesthesia. 6th ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2009.

18. Naguib M, Flood P, McArdle JJ, Brenner HR. Advances in neurobiology of the neuromuscular junction: implications for the anesthesiologist. Anesthesiology. 2002;96(1):202-231.

19. Hara K, Sakura S, Saito Y, Maeda M, Kosaka Y. Epidural anesthesia and pulmonary function in a patient with amyotrophic lateral sclerosis. Anesth Analg. 1996;83(4):878-879.

20. Lien CA. Development and potential clinical impairment of ultra-short acting neuromuscular blocking agents. Br J Anaesth. 2011;107(suppl 1):Si60-S71.

21. Naguib M, Brull SJ. Sugammadex: a novel selective relaxant binding agent. Expert Rev Clin Pharmacol. 2009;2(1):37-53.

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 Mount Sinai School of Medicine, New York, NY.

6.

In patients experiencing denervation (such as after stroke or immobilization), which of the following effects are observed with respect to DMR and NDMR? a. Sensitivity to DMR and resistance to NDMR b. Sensitivity to DMR and NDMR c. Resistance to DMR and NDMR d. Resistance to DMR and sensitivity to NDMR

7.

Which of the following statements regarding hyperkalemia is false? a. The use of an NDMR at preinduction doses will reliably prevent a hyperkalemic response to Ach. b. Under normal circumstances, the serum potassium may rise 0.5 mEq/L after ACh administration. c. Receptor changes following denervation states may occur only hours following denervation. d. Tenting of T waves can be an early sign of hyperkalemia on EKGs.

1.

Which of the following statements regarding ALS is false? a. ALS affects approximately 1.5 to 2.5 per 100,000 people worldwide. b. People aged 40 to 60 years are most commonly affected. c. A cause can be identified in about 10% of patients. d. The prevalence of ALS among men and women is equal.

2.

Which of the following statements regarding symptoms in ALS patients is false? a. ALS affects upper motor and lower motor neurons. b. ALS can have an effect on sensory neurons. c. Ocular function is well preserved in ALS. d. Ventilation and feeding issues may occur 3 to 5 years from onset.

3.

In denervation states, the correct ACh-R conformational change is _____. a. (α,α,β,ε,σ) to (α,α,β,γ, γ σ) b. (α,α,β,ε,σ) to (α,α,α,γ, γ σ) c. (α,α,β,ε,σ) to (α,β,β,γ, γ σ) d. (α,α,β,ε,σ) to (α,α,γ, γ γ, γ σ)

8.

With regard to immature ACh-R channels, which of the following is false? a. Immature channels are found only at the neuromuscular junction. b. They have a lower channel conductance compared with adult-type channels. c. They have a 2- to 10-fold longer channel opening time compared with the adult ACh-R. d. Less agonist drug will cause more depolarization in immature ACh-R.

Which of the following statements regarding sugammadex is correct? a. It binds nonselectively to DMR. b. The effect is irrespective of the time since last NDMR dose. c. It does not work on steroidal NDMRs. d. It provides an incomplete antagonism.

9.

Which of the following treatments/mechanisms for hyperkalemia is incorrect? a. Use calcium chloride for cellular membrane stabilization. b. Use sodium bicarbonate—pH change and intracellular potassium shift. c. Use insulin—potassium binding and excretion. d. Use sodium polystyrene sulfonate—potassium binding and excretion.

4.

5.

Which of the following statements about the α7ACh-R is false? a. The precursor to Ach and succinylcholine, choline, is a full agonist at the α7ACh-R. b. The α7ACh-R has a lower affinity for NDMR. c. The α7ACh-R is present only during denervation states. d. The additional α subunits impart the resistance to NDMR.

10. With respect to the respiratory changes in ALS, which of the following choices is false? a. Respiratory complications are the leading cause of death in ALS patients. b. A nerve twitch monitor can be used reliably to assess muscle weakness in ALS patients. c. Patients with bulbar-type ALS have an increased risk for aspiration. d. ALS is associated with weakness of the tongue, pharynx, larynx, and chest wall.

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38 I AnesthesiologyNews.com

DECEMBER 2012

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

Early Surgery for Acute Cholecystitis Trims Hospital Stays

M

ost surgeons agree that patients with acute cholecystitis should have surgery during their initial hospitalization— the so-called early cholecystectomy.

But the definition of “early” has been debated. Surgeons from Duke University, in Durham, N.C., tried to clarify this issue in a paper presented at the 2012 annual meeting of the American

Association for the Surgery of Trauma (AAST).

The researchers found that postponing surgery just one day after admission resulted in a significantly longer hospital length of stay (LOS). A preoperative stay of two or more days produced longer operative times, and patients were significantly more likely to need open cholecystectomy. Patients

undergoing cholecystectomy after three or more preoperative hospital days had significantly longer postoperative and hospital stays. However, the number of preoperative days did not affect 30-dayy morbidity and mortality.

“Our group concluded that early or immediate cholecystectomy was justified, safe and more efficient than delaying the procedure,” author Mark L.

Shapiro, MD, wrote in an email.

The Duke study was based on data from the National Surgical Quality Improvement Project (NSQIP) for the years 2005 to 2010, for emergency cholecystectomy. The study included 5,268 patients, with nearly 50% of these patients undergoing cholecystectomy on the day of admission and 33% having surgery on the following day.

Two preoperative days were noted in 498 patients (9.5%), three days in 204 patients (3.9%) and four or more days in 189 patients (3.6%).

There were 1,620 high-riskk patients, defined as those with a preoperative acute medical condition, preoperative septic shock, age 65 years or older, or an American Society of Anesthesiologists score of 4 or higher. These patients had their operations significantly later than those without highriskk factors, but preoperative LOS did not affect morbidity, mortality, operative duration or the need for open surgery. For high-riskk patients, a preoperative stay of four or more days led to significantly longer postoperative and hospital lengths of stay.

The study showed that reducing the LOS by even one day would save a significant amount of money if extrapolated to all patients having surgery for acute cholecystitis.

Nathan T. Mowery, MD, assistant professor of surgery at Wake Forest Baptist Medical Center, in WinstonSalem, N.C., said the paper “supports my bias and is another nail in the coffin of delayed intervention.”

But he pointed out that the study was subject to all the shortcomings of other studies that used NSQIP data, such as missing clinical information and NSQIP’s failure to capture all relevant cases.

The authors acknowledged some limitations of their study. The time that symptoms began and the studies used to make the diagnosis of acute cholecystitis were not available. Causes of delays, such as difficulty establishing the diagnosis, could not be determined. Time of day of the admission, which could have influenced the decision about when to schedule the emergency procedure, also was unknown.

Dr. Shapiro considered the matter settled and said, “The cost to perform a randomized trial showing ‘no difference’ in timing of operation would be excessive given the number of patients that would need to be enrolled in order to adequately power such a study. Our

DECEMBER 2012

AnesthesiologyNews.com I 39

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

CONTINUED FROM PAGE 32

(RR, 4). In third pregnancies, the risk was 23.7% when both previous pregnancies were affected, compared with 3.4% among women without PPH in their first two pregnancies (RR, 7).

The authors also examined recurrence risk by PPH etiology, including uterine atony, retained placenta and lacerations, and found that a previous PPH increased the risk for PPH in subsequent pregnancy not only

analysis gives every indication that performing the operation early is safe and that it is associated with significant potential societal cost advantages.”

Regarding the management of patients with acute cholecystitis and serious medical comorbidities, Dr. Shapiro said, “Patients in whom operation within the first few days of admission is deemed too risky might be better managed with a percutaneous cholecystostomy tube.” He added that a comparison of same-dayy admission cholecystectomy versus percutaneous cholecystostomy tube placement and interval cholecystectomy would be an interesting study.

“We have tried to treat night and day as the same and post these cases whenever they present,” Dr. Moweryy said.

“That means the vast majority of the cholecystectomies we do urgently happen between 5 p.m. and 7 a.m.”

The Duke group does not have a strict treatment protocol in place for these patients, but Dr. Shapiro said that a 24-hour service for handling patients with acute cholecystitis with surgery on the day of admission should be the goal, while acknowledging the challenges in providing such a service.

“A balance must be struck between efficiency, safety and good old common sense,” he said. “For instance, how many hours has the operating room and its staff been struggling through the night? How many hours and cases have the surgeon and the anesthesiologist been toiling through?”

“I think the question of doing cholecystectomy in the first 72 hours versus later in the hospitalization has been answered,” Dr. Mowery said. “Additional prospective data are needed to know when exactly in that 72 hours it can safely be done. One advantage of the acute care surgery model is the ability to intervene very early in that 72-hour window.”

from the same etiology but from other causes as well.

“That a history of one PPH etiology confers risk of other etiologies in subsequent pregnancies is a novel finding,” Dr. Bateman told Anesthesiology News. “It suggests that there are shared pathologic features across the different PPH subtypes, which is an exciting area for future investigation.”

Sudharma Ranasinghe, MD, professor of clinical anesthesiology and chief of obstetric anesthesiology at

the University of Miami, Jackson Memorial Hospital, said the study is important because “even when PPH is not fatal, it may have a significant negative impact on a woman’s fertility, as she may need a hysterectomy.

There is an increased risk of blood transfusion, intensive care admission with prolonged hospital stay and overall increased cost. We need to know which women are at high risk.”

The study “warns us that these patients with previous history of

PPH should be delivered at hospitals with adequate facilities, such as blood banks and additional personnel,” Dr. Ranasinghe added. “We also need to train staff in monitoring of these women, including early treatment with oxytocin and an early exam of the uterus to make sure it’s contracting. Delayed initial care has been shown to increase the risk of severe PPH.” —Karen Blum

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DECEMBER 2012

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

Brain Monitoring Predicts Kidney Injury After Cardiac Surgery

K

eeping an eye on blood pressure in the brain could be the key to helping patients avoid a serious complication of cardiac surgery—kidney failure.

Cardiac surgery with cardiopulmonary bypass carries a potentially dangerous side effect: acute kidney damage and in some cases, renal failure.

Approximately 30% of patients recovering from this surgery suffer acute kidney injury (AKI) and 1% require dialysis, researchers found.

The current standard diagnostic biomarker for AKI—serum creatinine—does not show a change in concentration until day 2 or 3 of recovery, which is a lag that, if shortened, might improve the care of these patients.

So Charles Hogue Jr., MD, professor of anesthesiology and critical care medicine at Johns Hopkins University School of Medicine, in Baltimore, and his colleagues tried another approach: monitoring hemodynamics in the brain during the surgery itself. In a new study, they found that the point when cerebral blood pressure reaches its lower limit and changes cerebral blood flow from autoregulated to pressuredependent is significantly linked with a patient’s risk for developing AKI. “Blood pressure is one of the only modifiable risk factors for AKI,” said Dr. Hogue, who also is chief of the Division of Adult Anesthesia. Cerebral blood flow tends to be independent of blood pressure. It stays the same, between 50 and 150 mm Hg, depending on the individual. Outside that range, blood flow becomes pressure-dependent.

The study, presented at the Euroanaesthesia 2012 meeting (abstract 4AP1-1), included 349 patients undergoing cardiac surgery with cardiopulmonary bypass. Using near-infrared spectroscopy, the clinicians monitored the correlation between mean cerebral blood pressure and the variable cerebral oximetry index. When cerebral blood flow is autoregulated, no relationship between the metrics exists.

Dr. Hogue’s group found that as expected, about one-third (34.7%) of patients experienced AKI. The researchers found that AKI risk was associated with excursions of cerebral blood pressure below levels required for cerebral blood flow to become autoregulated. Risk also was significantly and independently associated with diabetes and with the duration and magnitude that blood pressure

was below the threshold of cerebral autoregulation.

The autoregulation limit of mean arterial pressure in healthy patients was found to be lower than that in patients with AKI after surgery. In other words, the researchers said, risk factors for kidney injury can be detected by looking at the brain. That might seem farfetched, but brain

hemodynamics have been shown to correlate with the function of other organs. Previously, for example, John Murkin, MD, professor of anesthesiology at the University of Western Ontario, in London, Canada, showed that the brain is a sentinel organ for monitoring the whole body’s status during surgery.

“You can use an organ that’s distant

INDICATIONS ULTIVA is indicated for intravenous administration:

from the kidney as a marker to predict how the organ will function after being on the heart-lungg machine,” said Gregory Fischer, MD, associate professor of anesthesiology at Mount Sinai School of Medicine, in New York City. “It’s a completely different way of looking at things; it’s much more mechanistic.”

Whether anesthesiologists will soon

IMPORTANT RISK INFORMATION

DECEMBER 2012

AnesthesiologyNews.com I 41

CL IN ICA L A N E STH E SIOL OG Y start monitoring cerebral blood pressure to keep an eye on their patients’ kidneys during surgery remains to be seen. “Basically, I love what [Dr. Hogue] is doing here,” Dr. Fischer said. “The way this research has to go now is [to] take it from the bench to the bedside.”

The approach could lead to individualized instead of global protocols because each patient has a different autoregulation threshold. “I certainly think that what he’s doing is the

On Off

future of hemodynamic monitoring,” Dr. Fischer said.

The approach is not ready for the clinic yet, but Dr. Hogue said the method is based on processing information from monitors that are FDAapproved and widely used.

“Other biomarkers may be more specific and sensitive, but they are not used clinically,” Dr. Hogue added.

“We’re still actively studying the monitoring and the potential outcomes for patients. Now we’re showing whether

it matters for patient organ outcomes.”

Meanwhile, researchers have not given up on the search for serologic biomarkers of AKI. Candidates for new markers already exist, such as urinary neutrophil gelatinase–associated lipocalin (N-GAL), interleukins such as IL-18, kidney injury molecule 1 and serum cystatin C, but none has been approved for clinical use.

“Novel biomarkers for AKI have ushered in a paradigm shift in nephrology,” wrote John G. T. Augoustides,

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ULTIVA is contraindicated for

Reference: 1.

MD, in the April issue of the Journal of Cardiothoracic and Vascular Anesthesia (2012;26:340-345). “It is likely that the management of [cardiac surgeryassociated acute kidney injury] will be affected significantly by this surge of new data from clinical trials. The biomarkers have significant promise to assist the cardiac anesthesia community in the ongoing mission to take better care of patients.”

—Trevor Stokes

42 I AnesthesiologyNews.com

DECEMBER 2012

T E C H NO L O G Y

Can You Hear Me Now? New Device Uses Sound To Monitor Residual Paralysis

Society (paper WeA08.2).

Fewer than 25% of anesthesiologists use monitors to detect residual block, Dr. Hemmerlingg said (Anesth Analg 2010;111:110-119). The practice of more subjective tactile or visual monianadian researchers are hoping The new device, which is not yet professor of anesthesia at McGill Uni- toring has left the incidence of residual that a device they have devel- commercially available, is based on the versity, in Montreal, and lead inven- paralysis unacceptably high, he said. oped to monitor neuromus- principle of phonomyography: collect- tor of the technology with the working Approximately 60% of the 40 milcular blockade will replace commonly ing low-frequencyy sounds associated name Relaxofon, presented data on lion surgeries performed annually in the used and subjective visual or tactile with stimulated muscle contractions to the device earlier this year at the 2012 United States involve the use of general monitoring techniques and ultimately calculate train-ofInternational Conference of the IEEE anesthesia. Experts estimate that some f four (TOF) ratios. help prevent residual paresis.

Thomas Hemmerling, MD, associate Engineering in Medicine and Biology degree of residual paralysis occurs in as many as 40% of patients who receive general anesthesia—or about 10 mil® lion patients. Serious respiratory events women.

ULTIVA should be used during pregnancy only if the potential benefit justifies the potential risk to ULTIVA for Injection the fetus. Administration of remifentanil to rats throughout late gestation and lactation at IV doses up to 400 (remifentanil hydrochloride) affect 0.8% of those patients, and 0.1% times the MRHD in terms of mg/m2 of body surface area, had no significant effect on the survival, For IV Use Only Rx only development, or reproductive performance of the F1 generation. Animal Toxicology: Intrathecal will require emergent reintubation in Brief Summary: The following is a brief summary only. Before prescribing, see complete ULTIVA prescribing administration of the glycine formulation without remifentanil to dogs caused agitation, pain, hind limb the postanesthesia care unit. That works information. dysfunction, and incoordination. These effects are believed to be caused by the glycine. Glycine is a CONTRAINDICATIONS Due to the presence of glycine in the formulation, ULTIVA is contraindicated for commonly used excipient in IV products and this finding has no relevance for IV administration of ULTIVA. out to roughly 100,000 cases per year of epidural or intrathecal administration. ULTIVA is also contraindicated in patients with known hypersensitivity Labor and Delivery: Respiratory depression and other opioid effects may occur in newborns whose potential harm resulting from residual to fentanyl analogs. WARNINGS AND PRECAUTIONS Continuous infusions of ULTIVA should be administered mothers are given ULTIVA shortly before delivery. The safety of ULTIVA during labor or delivery has not been only by an infusion device. IV bolus administration of ULTIVA should be used only during the maintenance demonstrated. Placental transfer studies in rats and rabbits showed that pups are exposed to remifentanil paralysis. of general anesthesia. In nonintubated patients, single doses of ULTIVA should be administered over 30 to

C

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 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 longterm (> 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 vivo 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 and rats demonstrated significant placental transfer to fetal tissue. There are no adequate and well-controlled studies in pregnant

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

Postoperative Analgesia

After Discontinuation

Adverse Event

ULTIVA (n=921)

Alfentanil/ Fentanyl (n=466)

ULTIVA (n=281)

Morphine (n=98)

ULTIVA (n=929)

Alfentanil/ Fentanyl (n=466)

Nausea Hypotension Vomiting Muscle rigidity Bradycardia Shivering Fever Dizziness Visual disturbance Headache Respiratory depression Apnea Pruritus Tachycardia Postoperative pain Hypertension Agitation Hypoxia

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 B, 06/08/2011 Manufactured for Bioniche Pharma USA LLC, Lake Forest, IL 60045 Manufactured by Hospira, Inc. Lake Forest IL 60045

Bulky, Costly, Scarce “Decades after this complication was described, 30% to 40% of patients still show some sign of residual paralysis and are at risk of postoperative pulmonary complications,” Dr. Hemmerlingg said in an interview. “One reason for the persistently high rate is that available devices are not used. Existing devices are too bulky, too expensive or are simply too difficult to find.”

Phonomyography, in contrast, is compact and “user-friendly, y” Dr. Hemmerlingg said. He estimated that the device would cost approximately $1,000 once it is commercially available, which he speculated will be within one to two years.

Glenn Murphy, MD, director of research at the NorthShore University Health System and clinical professor at the University of Chicago Pritzker School of Medicine, said that the projected cost of the device seemed “very reasonable.”

“Right now, the only one other quantitative neuromuscular blockade monitor is the TOF-Watch , and it costs approximately $1,500,” Dr. Murphyy said.

“The standard peripheral nerve stimulators range between $250 and $800, but the small additional cost for a quantitative monitor is clearly justified. The only way that clinicians can reliably detect residual neuromuscular block at the end of an anesthetic is through the use of quantitative monitoring. Significant muscle weakness may still be present when no fade is observed with standard peripheral nerve stimulators.

When quantitative monitors are used, clinicians can be assured that full neuromuscular recovery is present before the patient is extubated.”

DECEMBER 2012

AnesthesiologyNews.com I 43

TE CH N OL OG Y

Figure 2. Relaxofon user interface.

Figure 1. Microphone and peripheral nerve stimulator electrode positioning: for the corrugator supercilii muscle (left) and the adductor pollicis muscle (right).

Photos courtesy of Thomas Hemmerling, MD.

The Relaxofon has hardware and software components. The hardware component consists of a USB link, a battery and a dual-channel signal acquisition circuit for inputs from two microphones that are placed on separate muscle sites (Figure 1). Signals are recorded following electrical stimulation and then amplified and filtered to

eliminate sounds above 70 Hz, which is the highest frequency emitted by contracting muscles. The system’s software collects the signals and calculates TOF ratios, which are plotted and displayed on a computer that the device links to through a USB connection (Figure 2).

Although the accuracy of the Relaxofon has not been compared with existing monitors, Dr. Hemmerlingg pointed to previous research showing that phonomyography had “good to very good agreement” with mechanomyography, which is considered the gold standard of quantitative monitoring (Can J Anesth 2006;53:130-135). Furthermore, data that he presented at the conference

showed that it accurately and rapidly calculated TOF ratios compared with calculations made by clinicians.

Mark Nunnally, MD, associate professor in the Department of Anesthesia & Critical Care at the University of Chicago Medical Center’s Pritzker School of Medicine, echoed the importance of objective, quantitative monitoring for residual paralysis, noting that “some argue tactile or visual monitoring cannot discern between clinically significant and insignificant residual neuromuscular blockade.”

However, Dr. Nunnallyy noted that clinical data on the new device are needed to demonstrate its clinical utility.

Collecting these data may be challenging, he said.

“It is actually very hard to ‘prove’ a monitor improves outcomes in a way that is accepted by the entire clinical community, in part because the monitor is part of a more complicated process of data interpretation and intervention,” Dr. Nunnallyy told Anesthesiology News.

“Monitors also change the way we care for patients over time, leading to effects that are even more difficult to measure.”

But Dr. Hemmerlingg pointed to a 2006 article suggesting that “the absence of neuromuscular monitoring impairs detection of postoperative paralysis” (Contin Educ Anaesth Crit Care Pain 2006;6:7-12). “Hence, it follows that quantitative neuromuscular monitoring leads to better patient outcomes.”

—David Wild

44 I AnesthesiologyNews.com

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My Second-Worst Anesthetic

A

s a junior registrar, of a failed block and give I once worked at the patient a general anesthe Queen Victothetic, I, with the foolria Hospital, in East Grinish pride of inexperience, stead. This hospital had an would try to ‘supplement’ the block by giving IV awesome reputation in England, being the place where ketamine, which in subthe war surgeon Archibald anesthetic doses was a McIndoe conducted a series potent analgesic. of pioneering experiments Stavros Prineas, MBBS Using ketamine in this in plastic surgery on burned way, I could often mask an Royal Air Force pilots durincomplete nerve block— ing World War II. the patient would feel no pain, and I QVH today remains a center for would avoid having to admit my block burn surgery, but it also hosts an had failed. However, at these lower eclectic range of surgical special- doses ketamine also could be a powerties, including hand trauma. I learned ful hallucinogen. to do axillary brachial plexus blocks One weekend on call, I was prethere, although initially I seemed to sented with a short, gruff 54-year-old be very good at what I used to call bearded man, who had lacerated a my ‘East Grinstead block’; that is, one nerve and a tendon in his forearm in that completely numbed every part a metalworking accident. I performed of the arm—except the wound. This a brachial plexus block that seemed seemed to happen with frustrating to numb the arm beautifully. Brimregularity when I started training; but ming with overconfidence, I took the rather than endure the embarrassment patient into the operating room.

That night I did not sleep. I had made a complete fool of myself. I had traumatized the patient. I then failed to keep my head during a crisis and was woefully ill prepared. Why was I bothering to do

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blocks anyway? They never work. Ketamine, I decided, was a stupid drug. I vowed never to use it again.

The old operating suite at QVH was quite small, but with high ceilings and tall windows on one side, filling the rooms with natural light. An observation gallery loomed high on the opposite side. I used to imagine students and dignitaries piling into this gallery to observe Dr. McIndoe working miracles below, although there must been some incidents with these observers, as an incongruously modern perspex screen now spanned the gallery. This screen was set at an odd angle, so that viewed from the floor at certain times of the day, light from the window reflected off the perspex in a curious play of colors.

I helped the patient onto the operating table, attached the monitoring and instructed the surgical team to prep and drape. As they scrubbed the wound, the patient winced—another East Grinstead block. I received a disdainful look from the surgeon. No problem, I said, giving some ketamine.

“Does your hand hurt now, sir?”

“What hand?” the patient replied, more than a little spaced out. I cockily

waved at the surgeon to proceed.

I should have known things would not end well when the patient looked at the pulse oximeter probe on the index finger of his free hand and started to make jet-plane sounds as he waved it around. The surgical team raised a collective brow but carried on. Suddenly the patient stopped whooshing. He was staring, wild-eyed, at the perspex, his face deathly pale.

“Mum?” he murmured. Tears welled in his eyes. “MUUUUM!!” the man screamed, his arms and legs flailing.

“I’m sorry, Mum! I love you, Mum!” Surgical sterility went (almost literally) out the window as all hands struggled to hold the patient down. I lunged for the emergency thiopentone and jostled to make the syringe connect with the IV cannula in his arm, the patient all the while trying to leap off the operating table, sobbing and crying for his mother. Luckily I connected, and without thinking, emptied the entire contents of the syringe into the patient. This was way see second-worst page 46

DECEMBER 2012

AnesthesiologyNews.com I 45

AN-1212-002.pdf

CL A SSIF IE D S

DUKE CME: TRANSFORMING KNOWLEDGE

Duke University School of Medicine & The Department of Anesthesiology

Assistant Professor of Clinical Anesthesiology University of Miami – Miller School of Medicine is seeking an Assistant Professor of Clinical Anesthesiology. Duties include administration of anesthesia to patients for all surgical procedures at Jackson Memorial Hospital, University of Miami Hospital, Sylvester Comprehensive Cancer Center and Broward Health Medical Center; teaching anesthesia procedures to residents and fellows and supervising CRNAs; and attending in-service education and continuing education for practicing physician conferences. Position requires M.D. or D.O. (foreign equivalent acceptable) and a Florida Medical License. Strong preference will be given to applicants with a research background and experience in liver transplantation.

To apply, please send your CV and cover letter to Cynthia Saldarriaga csaldarriaga@med.miami.edu, attention: Dr. David Lubarsky, Professor & Chairman, Department of Anesthesiology, Perioperative Medicine and Pain Management; University of Miami Miller School of Medicine.

An equal opportunity/affirmative action employer.

AN-1212-001.pdf

PRESENTS

Sponsored by the Duke University School of Medicine.

WEDNESDAY, MARCH 6, 2013 Morning Session

SUNDAY, MARCH 3, 2013

6:15 am Breakfast / Meet with Exhibitors

Afternoon Session

7:00 am All Downhill From Here: The Life of a Ski Team Doctor - Olson

Registration / Meet with Exhibitors

7th Annual Winter Anesthesia & Critical Care Review March 3-8, 2013 Canyons Resort Park City, Utah

AGENDA

4:00 pm Billing and Documentation for Regional Anesthesia and Ultrasound - Auyong 5:00 pm LVAD’s in Non Cardiac Surgery - Shaw 6:00 pm Adjourn

MONDAY, MARCH 4, 2013 Morning Session 6:15 am Registration / Breakfast / Meet with Exhibitors 7:00 am Vascular Access - Ultrasound Every Time? - Grant 8:00 am Cerebral Aneurysm Anesthesia Update - Borel 9:00 am Adjourn Morning Session Afternoon Session 3:30 pm Afternoon Snacks / Meet with Exhibitors 4:00 pm Best Practice in Major Joint Replacement Anesthesia: Shoulder and Ankle - Benonis 4:40 pm Best Practice in Major Joint Replacement Anesthesia: Hip and Knee - Auyong 5:20 pm Panel Discussion: Anesthesia and Orthopedics Benonis, Auyoug, Grant 6:10 pm Ultrasound Workshop - Benonis, Auyong, Grant, Brudney 7:40 pm Adjourn

TUESDAY, MARCH 5, 2013 Morning Session 6:15 am Breakfast / Meet with Exhibitors 7:00 am Sepsis Update - Brudney 8:00 am The Obese Parturient - Muir 9:00 am Adjourn Morning Session Afternoon Session 3:30 pm Afternoon Snacks / Meet with Exhibitors 4:00 pm Anesthesia and the Elderly - Tung

8:00 am Massive Hemorrhage in Obstetrics - Muir 9:00 am Adjourn Morning Session Afternoon Session 3:30 pm Afternoon Snacks / Meet with Exhibitors 4:00 pm Non Rational Factors in Medical Decision Making - Tung 5:00 pm Are Starches Good for You? Pro/Con Debate - Shaw, Brudney 6:00 pm Adjourn

THURSDAY, MARCH 7, 2013 Morning Session 6:15 am Breakfast / Meet with Exhibitors 7:00 am Anesthesia for Awake Craniotomy - Borel 8:00 am Mechanical Ventilation - Tung 9:00 am Adjourn Morning Session Afternoon Session 3:30 pm Afternoon Snacks / Meet with Exhibitors 4:00 pm Out There Anesthesia: Anesthesia in the Interventional Radiology Suite - Borel 4:30 pm Pre-Op Management and the Role of a Pre-Op Screening Unit Olson 5:00 pm Tomorrow’s Anesthesia: Federal Regulations and Their Impact Benonis 5:30 pm Panel Discussion - Borel, Olson, Benonis 6:00 pm Adjourn

FRIDAY, MARCH 8, 2013 Morning Session 6:15 am Breakfast / Meet with Exhibitors 7:00 am Perioperative Cardiac Protective Strategies - Shaw 8:00 am The Impaired Anesthesia Provider - Grant 9:00 am Adjourn Meeting

4:45 pm How to Save That Airway - Muir 5:30 pm Panel Discussion: Complex Case Management - Tung, Muir 6:00 pm Airway Management Workshop Muir, Brudney, Benonis, Auyong 7:30 pm Adjourn

AN-1212-003.pdf

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46 I AnesthesiologyNews.com

DECEMBER 2012

AD LIB

SECOND-WORST

CONTINUED FROM PAGE 44

over the standard sleep dose for a man of his size.

His eyes began to roll and he fell back onto the pillow, unconscious, now not breathing and rapidly turning blue.

I tried to hand-ventilate using a bag and mask, but the man’s beard prevented a decent seal. His jaw was a little tight but I managed to get a laryngeal mask down—suffice to say it was not a textbook insertion—and was able to ventilate. Soon the patient was pink and stable.

The rest of the case proceeded uneventfully. The surgeons barely spoke to me, and when they did, it was with that perfunctory politeness typical of people who are really ticked off. At the end of the procedure, I took the patient asleep to the recovery bay so he would not wake up in the operating theater.

I left to do the next case, but when I returned to recovery the patient had already gone to the ward. I decided to go home and see him the next day.

That night I did not sleep. I had made a complete fool of myself. I had traumatized the patient. I then failed to keep my head during a crisis and was woefully ill prepared. Why was I bothering to do blocks anyway? They never work. Ketamine, I decided, was a stupid drug. I vowed never to use it again.

The following day, I returned to face my patient.

Like many hospital wards of the era, Canadian Wing was built in a Nightingale-style open plan: everyone within the line of sight of a central nurses station, and of each other as well. Predictably, my patient was at the other end of the ward, his arm in a sling. He saw me as soon as I entered, and his gaze stayed with me all the way along what seemed like the longest bloody ward I’d ever had to walk across.

As I approached, his face turned bright red.

“You’re the doctor who gave me that anesthetic,” he

Queen Victoria Hospital, in East Grinstead, England.

vvery tightly. “Today I feel wonderful. A new man. I w wanted to thank you.”

I felt quite ambivalent at this point. On one hand, I thought I should tell him he had suffered a drugiinduced hallucination triggered by light reflected off a sheet of plastic following my incompetent attempt to mask an inadequate nerve block. On the other hand, maybe he didd see his mother.

“Don’t thank me,” I said at last, sheepishly. “I’m just glad you’re OK.” “More than OK, doctor. Better than ever.”

I would like to think that, thanks to this experience, I have matured in many ways, personally and professionally. I learned that many patients carry heavy burdens in silence to which their caregivers, by and large, are oblivious. I learned that you have to be big enough to admit when something you have done is not working, particularly when you are supposed to be good at it.

I learned, as they say in the military, “Prior preparation and planning prevents piss-poor performance.” And I learned that a drug is only as good as why and how you use it (for a small, discrete set of clinical situations, ketamine remains my drug of choice). Finally, I learned that, although they often appear so, errors are not intrinsically related to outcome. Then again, it’s easy to learn lots of things when the ending is happy—something I only truly understood after my worst-ever anesthetic. But that’s another story.

said. I pulled up a chair and sat down, my apology at the ready. He gripped my arm with his free hand and quivering, he said, “Thank you!”

That was unexpected.

“When you gave me whatever you gave me, I saw my mother. She spoke to me.”

“Yes, I’m so sorry about that,” I said. “I gave you a drug called ketamine, it causes …”

“No, you don’t understand,” he interrupted.

“When I was 4, my mother and I visited my aunt not far from here. My father was a pilot—he’d died in the Battle of Britain a year before—so going to Auntie always cheered us up. We had a wonderful day there, but come sunset Mum decided we should go home. We were walking on the path leading from my aunt’s house. Mum was waving goodbye, and I was ahead of her. But I spotted a ladybird— I still remember it now—and I stopped to look at it.

My Mum’s back was turned, and she didn’t see me.

She tripped over me and hit her head on a cobblestone. She went into a coma and never woke up.”

It felt like the whole ward had gone silent.

“All my life, I’ve carried the fact that I killed my mother. You can’t know what that’s like. I don’t —Stavros Prineas, BSc(Med), MBBS, FRCA, FANZCA wish it on anyone. But when I looked up yesterday in that operating theater, I saw her, in beautiful colDr. Prineas is a specialist consultant anesthesiologist from ors. She spoke to me.”

Sydney, Australia. He runs a human factors training consultancy “What did she say?” I asked.

“She said it wasn’t my fault.” He gripped my arm and works in Australia and the United Kingdom.

Preferred Physicians Medical (PPM) formed in 1987 to exclusively insure anesthesiologists and their practices. From day one, each new policyholder also became an owner of PPM, so it’s no surprise thatt protecting our physicians’ professional reputation is at the core of evverything we do.

Our substantial database of more than 11,000 adversse anesthesia events collected over the last quarter of a century arms our physician owners with practical, anesthesia-specifi fic strategies to effectively identify and manage risk, including: On-site, anesthesia-specific fi risk management seeminars Exclusive online access to timely and useful risk management resources A subscription b i ti to t Anesthesia A th i & the th Law, L our indu i dustry-respected risk management newsletter In-house Claims Attorneys and Claims Specialistts skilled in using this data to effectively develop defense strategiess and resolve claims without indemnity payment Don’t wait another year. Take ownership of your own reputation by calling PPM today.

Add your good name to our growing list of ASA “standard of care” clinicians. Call us toll free today at 800.562.5589 and join other select anesthesiologists who have already secured ownership in their professional reputations.

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