Protocol for the BAG-RECALL clinical trial: a prospective, multi-center, randomized, controlled trial to determine whether a bispectral index-guided protocol is superior to an anesthesia gas-guided protocol in reducing intraoperative awareness with explicit recall in high risk surgical patients.

BMC Anesthesiology
Michael S AvidanBAG-RECALL Study Group

Abstract

Awareness with explicit recall of intra-operative events is a rare and distressing complication that may lead to severe psychological symptoms. Candidate depth of anesthesia monitors have been developed, partly with the aim of preventing this complication. Despite conflicting results from clinical trials and the lack of incisive validation, such monitors have enjoyed widespread clinical adoption, in particular the bispectral index. The American Society of Anesthesiologists has called for adequately powered and rigorously designed clinical trials to determine whether the use of such monitors decreases the incidence of awareness in various settings. The aim of this study is to determine with increased precision whether incorporating the bispectral index into a structured general anesthesia protocol decreases the incidence of awareness with explicit recall among a subset of surgical patients at increased risk for awareness and scheduled to receive an inhalation gas-based general anesthetic. BAG-RECALL is a multi-center, randomized, controlled clinical trial, in which 6,000 patients are being assigned to bispectral index-guided anesthesia (target range, 40 to 60) or end-tidal anesthetic gas-guided anesthesia (target range, 0.7 to 1...Continue Reading

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Citations

Jan 1, 2000·Colorectal Disease : the Official Journal of the Association of Coloproctology of Great Britain and Ireland· Hayman, James
Aug 19, 2011·The New England Journal of Medicine·Michael S AvidanUNKNOWN BAG-RECALL Research Group
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Methods Mentioned

BETA
GAM

Clinical Trials Mentioned

NCT00689091
NCT00281489

Software Mentioned

Excel
BAG
Metavision
Aspect Medical Systems
TrendFace Solo
RECALL

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