BIS Monitoring to Prevent Awareness during General Anesthesia

Background: Unexpected awareness is a rare but well-described complication of general anesthesia that has received increased scientific and media attention in the past few years. Transformed electroencephalogram monitors, such as the Bispectral Index monitor, have been advocated as tools to prevent unexpected recall.

Methods: The authors conducted a power analysis to estimate how many patients would be needed in an appropriately powered study to demonstrate the Bispectral Index monitor reduces awareness, as well as a cost analysis to assess the cost of using the monitor for this purpose alone.

Results: If unexpected recall is rare (1 in 20,000), it will require a large study to demonstrate that the monitor reduces awareness (200,000-800,000 patients), and the cost of using it for this purpose alone would be high ($400,000 per case prevented). If awareness is common (1 in 100), then the number of patients needed in a study to demonstrate that the monitor works becomes tractable (1,000-4,000 patients), and the cost of using the monitor for this purpose alone becomes lower ($2,000 per case prevented). Because there are reported cases of awareness despite Bispectral Index monitoring, the authors are certain that the effectiveness of the monitor is less than 100%. As the performance of the monitor decreases from 100%, the size of the study needed to demonstrate that it works increases, as does the cost of using it to prevent awareness.