Waking up under the knife: Potential preventive monitoring under debate
Waking up under the knife: Potential preventive monitoring under debate
Patients, anesthesiologists disagree on brain activity monitoring
Many anesthesiologists say it’s what they fear second only to a patient dying during surgery: A patient wakes up during an operation and, though feeling and hearing what is happening to him or her, is incapable of letting the surgical team know.
Called anesthesia awareness or intraoperative awareness, this experience happens in an estimated one or two out of every 1,000 surgeries, although the numbers are debated, depending on who does the estimating.
Less debatable is the effect. While some may argue that, though regrettable and to be avoided, intraoperative awareness does no permanent physical harm, most medical experts and patient advocates say it can result in lifelong sequelae ranging from flashbacks to full-blown post-traumatic stress disorder.
A point of contention that was a main topic of discussion at this year’s meeting of the American Society of Anesthesiologists (ASA) is the push by patient advocates for use of a monitor they say can help prevent anesthesia awareness, but which anesthesiologists have thus far been reluctant to adopt as standard for surgical monitoring.
It changed me forever’
Carol Weihrer, a court reporter in Reston, VA, underwent drastic surgery six years ago. A degenerative eye condition had kept her in constant pain, and removal of her right eye finally was determined to be the only course for relief.
"I woke up," she says. "I was as awake as I am right now, totally awake, for two hours out of the five-and-a-half hour operation."
A local anesthetic kept Weihrer from feeling the pain of her eye being cut out; however, she could feel pulling and tugging, could hear the conversations of the surgical team, and was frantic because paralytic agents kept her from communicating that she was awake.
"I couldn’t do anything. I thought I was going to die. I wished I could die," she says. "Finally, someone noticed that I was awake."
Though she did not feel pain from the excision of her eye, she was acutely aware of the ventilator tube in her throat, the sounds going on around her, and the intense burning sensation she felt when two additional anesthetic agents were introduced into her IV — a feeling she describes as being "roasted alive from the inside."
Studies show that half of patients who experience intraoperative awareness can hear or feel what is going on, and nearly 30% feel pain. About half develop serious psychological problems, including post-traumatic stress disorder (PTSD).
Adding to the trauma, patients have said, is the fear that no one believes them — a fear Weihrer says is well founded.
"I woke up screaming, I was awake when they cut my eye out,’ and nobody believed me," she says. When she recounted, verbatim, conversations that took place during her surgery, however, her story gained acceptance.
"I hear that time and time again — patients are told they had a dream, or that they’re crazy," says Weihrer, whose experience caused her to establish a web site and advocacy group, the Anesthesia Awareness Campaign (www.anesthesiaawareness.com). She says she’s talked with more than 2,600 people who woke up during their surgeries. For some, the experience remains akin to a bad dream. For others, the trauma has led to debilitating psychological problems, destroyed relationships, neglect of their health (out of fear of future surgery), and even suicide.
JCAHO issues sentinel event alert
In response to growing interest and concern over intraoperative awareness among patients and clinicians, in 2004 the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), the nation’s largest health care accrediting organization, issued a sentinel event alert — Sentinel Event Alert 31 — aimed at reducing anesthesia awareness.
In issuing a sentinel event alert on any health risk, JCAHO announced it will collect data, from which future guidelines or standards might be drawn. A sentinel event alert itself constitutes no new demands or requirements on health care professionals or organizations.
The commission estimates that 20,000 to 40,000 patients every year wake up during surgery in the United States. JCAHO President Dennis O’Leary, MD, said at the time the sentinel alert was issued that health care providers should take steps to avoid the psychological risks of anesthesia awareness while safeguarding patients against excessive anesthesia.
The sentinel event alert was prompted by a set of studies released in early 2004 that examined the frequency of anesthesia awareness and looked at the effectiveness of new brain activity monitors — or bispectral index monitors — in detecting and avoiding it.
The JCAHO sentinel event alert was met with mixed response by the anesthesia community. While recognizing that anesthesia awareness is an event to be avoided whenever possible — though describing it as a rare event blown out of proportion in the media — the ASA has thus far responded conservatively to suggestions that brain activity monitors be used more frequently.
In the January 2005 issue of ASA’s newsletter, now president of the ASA, Orin F. Guidry, MD, chair of anesthesiology at Ochsner Clinic and Ochsner Foundation Hospital in New Orleans, wrote that anesthesiologists "are professionals. They do not require ASA or any other entity telling them how to practice.
"Every day each of us individually does what we believe is best for our patients without the need for mandated standards," wrote Guidry.
ASA issues practice advisory on monitoring
At the ASA annual meeting in October, Guidry announced membership had voted to approve a practice advisory on intraoperative awareness and brain function monitoring, which essentially recognizes the problem of anesthesia awareness but does not recommend reliance on any additional monitoring modalities beyond the current standards.
The report calls for use of brain function monitoring on a case-by-case basis, with the decision left to the anesthesiologist based on what he or she feels is best for the patient.
Weihrer, who attended the ASA conference to promote the idea of bispectral index monitoring and to draw attention to intraoperative awareness, says the practice advisory is "a baby step" and not enough.
"This document does lip service, but has no teeth," says Weihrer. "The onus is on patients to ask about brain monitoring. It says if a patient reports experiencing awareness a report should be filed, but doesn’t say where to file it or what action will result. It says patients who experience awareness should be given psychological help, but doesn’t say by who, when it should be given, who should pay for it, or what kind of follow up should be given."
Patient advocates and anesthesiologists agree that one obstacle to tracking intraoperative awareness and its after-effects is that anesthesiologists have little contact with their patients outside the operating room. They typically meet with patients briefly before surgery, and rarely see them afterward.
The American Association of Nurse Anesthetists (AANA) was more receptive to the JCAHO sentinel alert, having published in 2002 its own advisory on intraoperative awareness. When JCAHO’s alert was issued, AANA’s immediate past president, Tom L. McKibban, said intraoperative awareness is a patient safety issue and that the sentinel alert was a positive move for patients.
Brain monitoring controversial with some
Peter S. Sebel, MD, PhD, professor of anesthesiology at Emory University in Atlanta and lead author of a study on anesthesia awareness, says the cause for reluctance among his colleagues to adopt brain monitoring during surgery is difficult to attribute.
"To a certain extent, the reservations may be politically motivated, or may be cost motivated," says Sebel. "We have prospective, randomized data that says brain function monitoring can reduce anesthesia awareness and improve outcome. That hasn’t been shown in other technologies that are accepted as standard, so I don’t know why they’re not embracing this technology."
(In the interest of disclosure, Medical Ethics Advisor points out that Sebel is a paid consultant to Aspect Medical Systems, a Newton, MA-based manufacturer of bispectral index, or BIS, monitors.)
Studies have attributed anesthesia awareness to several causes, including defective equipment, physician error, or unforeseen patient response to a drug. Awareness can also occur if a patient is intentionally given a light dose of anesthetic because a standard dose could be dangerous or fatal due to other conditions, such as traumatic injury or cardiac conditions.
Doses are calculated based on a variety of factors, including body weight, body fat, and medical history; different people metabolize anesthesia drugs at different rates, which can also affect awareness, according to Sebel.
Weihrer says that to a patient who has awakened during surgery, there is no excuse for not using brain activity monitors during general anesthesia.
"Studies show it is 82% effective in preventing awareness," she says. "It has been proven. To say it needs more testing is an unnecessary delay. It’s unethical."
The ASA has said it believes brain activity monitoring is a promising technology and should be used in some cases, but that more study is needed.
In its practice advisory, the ASA called for additional study.
Sebel says the practice advisory "goes some way toward acknowledging the issue" of awareness and brain activity monitoring, but "contains some recommendations that have been shown to be untrue in the literature."
Recommendations
In its sentinel event alert, JCAHO set forth some non-binding recommendations for preventing and managing anesthesia awareness. The first is to develop and implement an anesthesia awareness policy that addresses the following:
Education of clinical staff about anesthesia awareness and how to manage patients who have experienced awareness;
Identification of patients at proportionately higher risk for an awareness experience and discussion with such patients before surgery of the potential for anesthesia awareness;
The effective application of available anesthesia monitoring techniques, including the timely maintenance of anesthesia equipment;
Appropriate post-operative follow up of all patients who have undergone general anesthesia, including children; and
The identification, management, and, if appropriate, referral of patients who have experienced awareness.
Also, patients who have experienced awareness and are experiencing symptoms of PTSD or other mental distress should be assured access to necessary counseling or other support, JCAHO recommends.
JCAHO further recommends that doctors discuss the risk of anesthesia awareness with patients before surgery and to apologize when patients experience anesthesia awareness. The commission’s sentinel event alert did not endorse the use of brain activity monitors, but mentioned that the U.S. Food and Drug Administration has issued a favorable review of the monitors.
The ASA practice guideline, while relying on traditional methods of patient monitoring during anesthesia, does not advise against brain activity monitors.
In the report, the ASA task force recommends physicians should rely on multiple modalities that include clinical techniques (e.g., checking for clinical signs such as purposeful or reflex movement) and conventional monitoring systems (e.g., electrocardiograms, blood pressure monitors, heart rate monitors, and capnographs).
Second, the task force says that the decision to use a brain function monitor should be made on a case-by-case basis by the individual practitioner for selected patients. Selected patients could include those undergoing trauma surgery or Caesarean section who cannot tolerate a deep anesthetic.
Guidry stated at the time of the ASA meeting that there are no actual contraindications to using a brain monitor, but that concerns exist regarding the possibility of misinterpreting the information they provide, or of receiving unreliable data. He said the monitors should be considered an adjunct to traditional monitoring.
Weihrer says improving monitoring of patients under anesthesia has become "the reason I was put on earth."
"I will not rest until every operating room has a monitor, and uses those monitors for every patient," she says.
Guidry says patients should remember that "the most important monitor in the operating room is the anesthesiologist, who has 12 years of medical training and a wealth of experience to draw on when deciding what is appropriate for each individual patient."
Sources
- American Society of Anesthesiologists brochure on anesthesia awareness, available on-line at www.asahq.org/patientEducation/Awarenessbrochure.pdf.
- Peter Sebel, MD, PhD, MBA, professor of anesthesiology, Emory University School of Medicine, Atlanta, GA 30303. Phone: (404) 616-4570. E-mail: [email protected].
- The Anesthesia Awareness Campaign, Carol Weihrer, president. P.O. Box 8592, Reston, VA 20195. Phone: (703) 437-7327. Web site: www.anesthesiaawareness.com.
- Joint Commission on Accreditation of Healthcare Organizations, Dennis O’Leary, MD, president. One Renaissance Blvd., Oakbrook Terrace, IL 60181. Phone: (630) 792-5000. E-mail [email protected].
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