A terrifying failure during general anesthesia, once thought to be so rare that it did not warrant much attention, actually is common enough that risk managers should launch a specific, focused effort at reducing the problem, known as anesthesia awareness. The problem occurs when the patient is sedated and paralyzed properly during the procedure, yet he or she is awake enough to realize what is happening and to feel the surgery. Awareness during anesthesia can be extremely traumatic to the patient who, in effect, undergoes surgery while awake, with the paralytic agent making it impossible to scream.
While the problem has been known for a long time, the health care community largely dismissed concerns by saying this type of anesthesia failure happened very rarely. Many patients who reported their experience after surgery were dismissed with a reassuring pat and told it was only a nightmare.
That no longer is acceptable, says JCAHO and other professional organizations that studied the problem recently. The Joint Commission recently issued a Sentinel Event Alert on awareness during anesthesia, one of the strongest messages the accrediting body can send to providers.
And don’t think that the trial lawyers won’t notice. Now that the Joint Commission has recognized anesthesia awareness as a serious, too-common occurrence and urged you to take preventative steps, attorneys will be eager to get you in front of a jury to explain why you didn’t follow through. And you don’t want them hearing about the horror of being operated on while awake.
Joint Commission President Dennis S. O’Leary, MD, says tens of thousands of patients undergoing surgery each year experience the helplessness of being partially awake while under general anesthesia during surgery, but being unable to communicate their distress to caregivers. Better understanding among health care professionals of this frightening phenomenon could reduce the risk of these events and assure appropriate support for patients when they do occur, he says.
O’Leary says the Joint Commission issued the alert largely in response to concerns within the anesthesia community, not as the result of any increase in reported events. The first reported case of awareness came in 1842, O’Leary notes, but the problem has been seriously studied only in recent years. "Our informed knowledge about this is quite recent even though the phenomenon has been known for over a century," he says.
The Joint Commission estimates that anesthesia awareness affects an estimated 20,000 to 40,000 patients each year. While that figure represents only one to two cases in every 1,000 general anesthetics administered, the experience is traumatic for those patients who do become aware, O’Leary notes. Patients undergoing cardiac, obstetric and major trauma surgeries are at proportionately higher risk for anesthesia awareness, according to the Joint Commission’s Sentinel Event Alert.
The frequency of anesthesia awareness has been found in multiple studies to range between 0.1% and 0.2% of all patients undergoing general anesthesia, the Joint Commission reports. With general anesthesia administered to 21 million patients annually in the United States, that produces the estimate of 20,000 to 40,000 cases of anesthesia awareness each year.
Patients experiencing awareness report auditory recollections (48%), sensations of not being able to breathe (48%), and pain (28%). More than half of the patients reported mental distress following surgery, including an indeterminate number with post-traumatic stress syndrome. Some patients describe these occurrences as their "worst hospital experience," and some determine to never again undergo surgery, the Joint Commission reports.
"Anesthesia awareness is underrecognized and undertreated in health care organizations," O’Leary says. "The Joint Commission understands that anesthesia professionals must balance the psychological risks of anesthesia awareness against the physiological risks of excessive anesthesia. This alert is intended to help health care organizations address this problem in an open and constructive fashion."
The anesthesia community acknowledges that awareness is a serious problem, says Tom McKibban, CRNA, MS, the immediate past president of the American Association of Nurse Anesthetists (AANA) and a practicing certified registered nurse anesthetist. The experience is traumatic for patients, and can even have a serious affect on staff who realize afterward that the patient was suffering the procedure without their knowledge.
"We are working with the Joint Commission to reduce the incidence of these events to an acceptable number," he says. "Even though one is too many, we all realize that with the type of anesthesia given today and the critical illness we administer anesthesia to, that we will probably never be able to obliterate it entirely."
To overcome the limitations of current methods to detect anesthesia awareness, new methods are being developed that are less affected by the drugs typically used during general anesthesia. These devices measure brain activity rather than physiological responses. These electroencephalography devices (also called level-of-consciousness, sedation-level and anesthesia-depth monitors) include the Bispectral Index (BIS), spectral edge frequency, and median frequency monitors. These devices may have a role in preventing and detecting anesthesia awareness in patients with the highest risk, thereby ameliorating the impact of anesthesia awareness.
Though a body of evidence has not yet accumulated to definitely define the role of these devices in detecting and preventing anesthesia awareness, O’Leary says the Joint Commission expects additional studies on these subjects to emerge. In its review of the BIS monitor, the Food and Drug Administration determined that "use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation."
O’Leary explains that the Joint Commission is not requiring any specific monitoring technology but rather is encouraging a more comprehensive effort to prevent awareness. The professional anesthesiology associations have guidance for their members about specific technologies, including some that are now in development.
O’Leary notes that the anesthesia professional must often balance the psychological risks of anesthesia awareness against the physiological risks of excessive anesthesia for many critical medical conditions. The Joint Commission has asked the American Society of Anesthesiologists (ASA) and the AANA to address the adequacy of current monitoring practices regarding anesthesia levels, including those that involve little or no technological support.
Roger W. Litwiller, MD, ASA president, cautions that risk managers should not assume clinical wrongdoing when a patient reports awareness after surgery. Administering anesthesia is a tricky business under the best of circumstances, and the balancing act becomes far more delicate in some cases.
"An anesthetic is a continuum, and we begin by giving enough to cause a loss of consciousness, and we continue that throughout the procedure utilizing sometimes the same drugs and sometimes other drugs," he says. "They may occur during a surgical procedure a situation where the patients vital signs deteriorate, maybe because of the severity of the operation of whatever, and that would necessitate lightening the anesthetic. As we being to turn down the amount of drugs given, there is the possibility that you will have the opportunity for awareness."
Must follow up a week later
The Joint Commission’s O’Leary says patients at risk for awareness should be warned before surgery that it can occur, and that there are clinical reasons for why. He also urges careful interviewing of patients who report awareness.
"One interesting factor is that if you interview the patient within, say, 24 hours of the procedure, the recall is less than if you interview them a week later," he says. "The frequency of recall goes up by a third to a half. These patients need attention. That is one of most critical issues we are trying to raise with this alert."
But patients aren’t usually in the hospital a week later for interviews. So O’Leary says providers should institute a system for follow-up, something akin to the procedure used to check for postoperative infections. "We are extending the boundaries of potential hospital responsibility beyond the time of admission," O’Leary says. "That’s controversial, to be sure, but if you are not doing that kind of follow up at the right time you are potentially missing important information and you are not fully serving the patient."
(For the Joint Commission’s Sentinel Event Alert on anesthesia awareness, go to www.jcaho.org/about+us/news+letters/sentinel+event+alert/sea_32.htm. Or just go to www.jcaho.org and look for the link under "Accredited Organizations.")