Saturday, February 19, 2005
Waking in surgery gains awareness
Roanoke Valley anesthesiologists disagree on using a brain monitor.
The medical journal report highlighted patients who have waked up in surgery, some to the sting of a scalpel and the banter of busy doctors.
During a neck procedure, a patient felt bone being cut away from the neck.
A brain surgery patient heard something "being screwed into my head."
During the removal of a spinal tumor, a patient awoke on her side, with one arm suspended in the air, felt an incision and heard the doctor say, "she's moving."
It is a possibly devastating complication and happens to between 20,000 and 40,000 surgery patients a year in the United States, according to the group that sets standards for hospitals.
Doctors have debated how to prevent unintended waking in surgery, but disagree what to do about it. That disagreement extends to the Roanoke Valley, where anesthesiologists have divided into two camps about the utility of a brain monitor. According to the manufacturer, it can warn that a patient is waking up unexpectedly from the drug-induced unconsciousness known as general anesthesia so the anesthesiologist can give the patient more drugs.
Some use it.
Some don't - not out of recklessness but because these anesthesiologists aren't convinced it's needed or definitely works.
Patients can ask for monitoring for most procedures. However, it's not clear that many do.
Dr. Dan Podeschi, an anesthesiologist at Lewis-Gale Medical Center in Salem, considers the monitor essential and thinks that eventually, all anesthesiologists will agree.
"We use these monitors on almost all patients now," Podeschi said.
Dr. Roger Litwiller, an anesthesiologist at Carilion Roanoke Memorial Hospital, does not routinely use a monitor, preferring instead to rely on his interpretation of traditional measures of patient condition, such as blood pressure and oxygen in the blood.
"It's redundant," he said of brain monitoring. Litwiller spent a year as president of the American Society of Anesthesiologists and was the society's national spokesman on the issue during his term, which ran through last fall.
Medical researchers have established that patients who are supposed to be knocked out cold sometimes wake up. Three medical studies, one in 2001 and two in 2004, put the rate of occurrence at one or two out of every 1,000 patients. Patients can't always notify the medical team because they sometimes receive head-to-toe paralyzing agents to keep them still. The patient's heart, a potential indicator of distress, may be constrained by other drugs.
The patient may experience all the pain as well as the sounds and other sensations of the operation for as long as awareness lasts. Half of affected patients feel unable to breathe, while a quarter feel pain, the research suggests. Even though some patients are minimally affected, half after surgery experience mental distress, such as post-traumatic stress syndrome, according to the research.
A brain wave monitor with a list price of $9,500 has been approved by the Food and Drug Administration for preventing surgery awareness. Requiring an adhesive strip to be worn across the forehead, the bispectral index, or BIS, monitor is used daily at Carilion Roanoke Memorial Hospital and was used 3,200 times last year, Carilion spokesman Eric Earnhart said.
"We want to make sure it's available," Earnhart said, but it's up to the anesthesiologist to decide whether to use it.
Litwiller estimated that the monitor is used about a fourth of the time it can be. The hospital has received one report of surgery awareness from a patient since it began keeping track last fall, Earnhart said.
Lewis-Gale Medical Center in Salem, where Podeschi notes the brain device is used routinely, has no reports on record.
Litwiller, who at 63 has practiced for more than three decades, said he feels "a healthy skepticism" toward brain monitoring.
He asked, what if the monitor indicates a patient is waking up, but the patient looks fine and has normal vital signs? Does the anesthesiologist give the patient additional anesthetics the patient may not need and which could be detrimental?
Anesthetics slow the heart and circulation. Too much can lead to kidney failure, stroke, heart attack and death, though such complications are rare, Litwiller said.
Litwiller said he has never had a patient report surgery awareness. He said that doesn't mean it has never happened to one of his patients, only that none of them has ever reported such an experience to him or to other medical personnel who would have informed him.
As best as scientists can tell, patients who wake up during general anesthesia do so because they received a smaller dose of anesthesia for their own good. It happens more often to trauma patients, women undergoing emergency Caesarean sections and heart patients when a cardiopulmonary bypass machine is in use, Litwiller said.
In such cases, lighter anesthesia is sound medicine because the body cannot tolerate deep anesthesia, Litwiller said.
"You've got to balance depth of anesthesia against life," Litwiller said.
He denied that awareness means the anesthesiologist made an error.
"I think that's rarely the case," he said.
Just as Litwiller took office as head of the national anesthesiologists society, in 2003, the organization was thrust into a touchy debate over surgery awareness.
As the anesthesiologists gathered for their annual meeting in San Francisco, USA Today ran a story headlined, "Study: 100 patients a day in the USA wake up during surgery." The study of 19,575 patients at seven hospitals, all of whom had undergone surgery involving general anesthesia, found that 25 were awake during at least part of their procedures. The rate of surgery awareness was 0.13 percent of patients, or about one in 770, said researchers led by Dr. Pete Sebel of the Emory University School of Medicine.
"Assuming that approximately 20 million general anesthetics are administered in the United States annually, we can expect, on the basis of our data, approximately 26,000 cases of awareness to occur each year, or approximately 100 per workday," the study said.
Aspect Medical Systems, maker of the BIS monitor, paid for the study and had, just days before the conference, received its Food and Drug Administration clearance to market its device for the reduction of unintended waking.
Litwiller blamed the Newton, Mass., company for stirring up media interest in surgery awareness. He said company marketing tactics were designed to scare patients so that, if they had to have surgery, they would ask to have one of the company's monitors used, Litwiller said. The company denied the accusation and media interest only swelled.
As the conference was winding down, NBC's "Today Show" interviewed a Virginia woman who said she woke up while doctors were removing one of her eyes.
Litwiller, who during the following year was quoted in scores of newspapers and magazines, maintained that surgery awareness was an unfortunate but rare complication and anyone affected deserves compassion, medical care and, if needed, counseling. He appointed a task force of neuroscientists to study brain monitoring and its role, if any, in reducing surgery awareness.
Why hadn't the society engaged scientists sooner?
"We viewed it as a small problem," Litwiller said during a January interview. "There are a lot of unusual events or complications, I guess, that have a very rare occurrence that don't make it to headlines. Once an issue like this is out in the public, you've either got to address it or ignore it and something like this you really can't ignore. I don't think we ignored it before. I think what we thought was it hadn't risen to the level of us needing to really dig into the science of it."
In October, just as Litwiller's term was ending, the Joint Commission on Accreditation of Healthcare Organizations discussed surgery awareness in a "sentinel event alert," a special announcement for drawing attention to an emerging, specific medical risk. The commission, which sets and enforces standards for hospitals, said surgery awareness was underrecognized and undertreated. It told hospitals to reduce the risk of it happening.
One critic, Carol Weihrer, a Reston woman who was awake for her own eye surgery, faults the society of anesthesiologists for not making a formal recommendation by now.
"It has taken them how long at 100 patients a day to act on this? That's inexcusable," said Weihrer, who runs an organization called the Anesthesia Awareness Campaign. "I want it [the brain monitor] to be in every hospital."
Litwiller said it's ill-advised to rush a scientific study. The report he commissioned is due in October. If it shows brain monitoring reduces surgery awareness, Litwiller said, he would use the machine routinely. Such a finding could lead to wider or even mandatory use of monitors in the nation.
"It's a technology that I think has great promise," he said.
Aspect Medical's monitor, the only one on the market approved for preventing unintended surgery awareness, is available in 34 percent of hospitals in the United States.
Researcher Belinda Harris
contributed to this report.





