2 Clinical Trials for Various Conditions
Awareness during anesthesia is a problem receiving increased attention by patients, clinicians, and the general public. The incidence of intraoperative awareness has been reported to be between 1-2/1000 cases, but recent data suggest that this may be an overestimate. The Bispectral Index (BIS) Monitor is an electroencephalographic method of assessing depth of anesthesia that has been shown in one study to reduce the incidence of awareness during anesthesia in the high-risk population (Myles et al, 2004). In the study of Myles et al, the number needed to treat (NNT) in order to prevent one case of awareness in the high-risk population was 138, with an associated cost of approximately US$2200. Since the NNT and the associated cost of treatment would be much higher in the general population, the efficacy of the BIS monitor in preventing awareness in all anesthetized patients needs to be clearly established. Furthermore, recent data suggest that the BIS may not be useful in the high-risk population. The investigators propose a prospective, randomized, controlled trial comparing the BIS monitor to electronic alerts based on non-electroencephalographic gauges of anesthetic depth.
This study will detect whether prior exposure to general anesthesia multiple times is associated with an increased incidence of awareness with explicit recall (AWR). This is especially important because patients who need to undergo multiple events of general anesthesia are medically some of the most vulnerable populations. The study hypothesizes that patients with significant exposure to general anesthesia have a higher incidence of AWR. This study may help clinicians and patients to better understand how to manage anesthesia care so that the safety and comfort of patients can be improved.