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Studies
Establish Incidence of Awareness with Recall in US and Impact
of BIS Monitoring |
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Three studies with significant
implications about the incidence and prevention of intraoperative
awareness will be presented at the American Society of Anesthesiologists
meeting in San Francisco in October. Aspect spoke with one of
the principal investigators from each of the studies: Dr.
Rolf Sandin of Kalmar Regional Hospital in Stockholm,
Sweden (Swedish Awareness Follow-up Evaluation, or SAFE
2), Dr. Kate Leslie of The Royal Melbourne
Hospital in Melbourne, Australia (Monitoring to Prevent Awareness
during Anesthesia, or The
B-Aware Trial), and Dr. Peter Sebel of
Emory University School of Medicine in Atlanta, Georgia (The
Awareness Incidence & Monitoring Study, or AIM
Study). Aspect began by asking each of the investigators
to summarize their research. |
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| Our study in Australia divided 2,503 patients at high
risk for intraoperative awareness into two groups. Half
were randomly assigned to have anesthesia guided by an
anesthesiologist using the BIS Monitor and half were assigned
to what we called “the routine care group.”
There were two reported cases of awareness in the BIS
group and 11 cases in the routine care group. BIS-guided
anesthesia reduced the risk of awareness by 82%. |
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| We looked at 5,057 cases of BIS-monitored patients
under relaxant anesthesia in Sweden to determine the incidence
of explicit recall, or awareness, during surgery and compared
the incidence of awareness with historical data on a group
of 7,811 patients. In the BIS monitored group there were
two cases of awareness, or approximately 0.04%, compared
with a historical incidence of awareness of approximately
0.2%, a reduction of 80%. Unlike Dr. Leslie’s study,
we looked at a general patient population, not just patients
at high risk for intraoperative awareness. Yet the results
were similar. In addition, our data confirmed an association
between low intraoperative BIS values and one year mortality,
as previously reported by doctors Weldon and Monk at the
University of Florida. |
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| The goal of our trial at seven geographically diverse
medical centers around the United States was to document
the incidence of awareness among 19,576 patients undergoing
general anesthesia. The result was consistent with the
0.1% to 0.2% reported incidence of awareness in other
industrialized countries: we had 25 cases of awareness,
or 0.13%, and a fairly consistent rate of between one
and two cases per thousand at each of the seven centers
involved in the study. |
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