

Study: 100 patients a day in USA wake up during surgery By Robert Davis, USA TODAY Anesthesia failure that allows a patient to wake up during surgery, paralyzed and unable to cry for help, occurs 100 times a day in the USA, a study reports Monday. The rate is similar to those documented by previous international studies, but many doctors have long questioned the prevalence. This is the first time in more than 30 years that the problem has been quantified in U.S. hospitals. These findings, and the results of two similar trials also to be released today, led the Food and Drug Administration late Friday to broaden its approval of a device it says has reduced the risk of patients waking up during surgery. The BIS monitor, which is used in one-third of U.S. hospitals, turns the brain's EEG waves into a number that can tell anesthesiologists at a glance how deeply a patient is sedated. Another study of 1,200 patients found that using the BIS monitor reduced the frequency of surgical awareness by 82%. Such study results are viewed as preliminary. "Awareness is clearly a problem," says Jeffrey Apfelbaum, professor and chairman of anesthesia and critical care medicine at the University of Chicago. "But these studies have not been vetted through the peer-reviewed process. We are all anxious to find a way to minimize the incidence of this problem, but we need to do it through sound science." The makers of the monitor, Aspect Medical Systems of Newton, Mass., financed the studies, which are being presented at the annual meeting of the American Society of Anesthesiologists in San Francisco. BIS stands for bispectral index technology. Anesthesiologists have led the medical profession in patient safety efforts. But many of them have resisted the use of BIS monitors, saying they do not need help determining whether their patients were adequately sedated. "They have their head in the sand," says the study's lead investigator, Peter Sebel, a professor of anesthesiology at Emory University School of Medicine. "They say they have never had a case in their career. I think they may have, they just don't know about it." His study of nearly 20,000 surgical patients found that for every 1,000 who receive general anesthesia, 1 to 2 people become aware of what is happening to them. Half of them feel pain. "I did not feel cutting, but I felt tremendous pulling," says Carol Weihrer, who awoke during eye-removal surgery. "It takes a lot of torque to get an eye out." Since her 45-minute ordeal in 1998, during which she felt surgical tools on her chest, listened to the music played in the surgical suite and felt like gagging because of the tube down her throat, she has become a patient advocate. "It has been described as worse than rape or kidnapping in that you can't squirm or scream," she says. "There is no way to release your fear or your frustration." She and other patient advocates say patients should ask for a BIS monitor.