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

Michael S Avidan, Ben J Palanca, David Glick, Eric Jacobsohn, Alex Villafranca, Michael O'Connor, George A Mashour, BAG-RECALL Study Group, Michael S Avidan, Ben J Palanca, David Glick, Eric Jacobsohn, Alex Villafranca, Michael O'Connor, George A Mashour, BAG-RECALL Study Group

Abstract

Background: 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.

Methods/design: 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 1.3 age-adjusted minimum alveolar concentration). Postoperatively, patients are being assessed for explicit recall at two intervals (0 to 72 hours, and 30 days after extubation). The primary outcome of the trial is awareness with explicit recall. Secondary outcomes include postoperative mortality, psychological symptoms, intensive care and hospital length of stay, average anesthetic gas administration, postoperative pain and nausea and vomiting, duration of stay in the recovery area, intra-operative dreaming, and postoperative delirium.

Discussion: This trial has been designed to complement two other clinical trials: B-Unaware and MACS (ClinicalTrials.gov numbers, NCT00281489 and NCT00689091). With the large patient numbers and complementary rigorous designs, it is envisaged that pre-specified meta-analyses will address some of the outstanding controversies and questions relating to processed electroencephalography monitoring.

Trial registration: ClinicalTrials.gov Identifier: NCT00682825.

Figures

Figure 1
Figure 1
Conduct of the Trial.

References

    1. Lennmarken C, Bildfors K, Enlund G, Samuelsson P, Sandin R. Victims of awareness. Acta Anaesthesiologica Scandinavica. 2002;46(3):229–231. doi: 10.1034/j.1399-6576.2002.t01-1-460301.x.
    1. Samuelsson P, Brudin L, Sandin RH. Late psychological symptoms after awareness among consecutively included surgical patients. Anesthesiology. 2007;106(1):26–32. doi: 10.1097/00000542-200701000-00009.
    1. Sandin RH, Enlund G, Samuelsson P, Lennmarken C. Awareness during anaesthesia: a prospective case study. Lancet. 2000;355(9205):707–711. doi: 10.1016/S0140-6736(99)11010-9.
    1. Sebel PS, Bowdle TA, Ghoneim MM, Rampil IJ, Padilla RE, Gan TJ, Domino KB. The incidence of awareness during anesthesia: a multicenter United States study. Anesthesia and Analgesia. 2004;99(3):833–839. doi: 10.1213/01.ANE.0000130261.90896.6C.
    1. Kalkman CJ, Drummond JC. Monitors of depth of anesthesia, quo vadis? Anesthesiology. 2002;96(4):784–787. doi: 10.1097/00000542-200204000-00003.
    1. Ekman A, Lindholm ML, Lennmarken C, Sandin R. Reduction in the incidence of awareness using BIS monitoring. Acta Anaesthesiol Scand. 2004;48(1):20–26. doi: 10.1111/j.1399-6576.2004.00260.x.
    1. Morimoto Y, Hagihira S, Koizumi Y, Ishida K, Matsumoto M, Sakabe T. The relationship between bispectral index and electroencephalographic parameters during isoflurane anesthesia. Anesthesia and Analgesia. 2004;98(5):1336–1340. doi: 10.1213/01.ANE.0000105867.17108.B6.
    1. Practice advisory for intraoperative awareness and brain function monitoring: a report by the american society of anesthesiologists task force on intraoperative awareness. Anesthesiology. 2006;104(4):847–864. doi: 10.1097/00000542-200604000-00031.
    1. Preventing and managing the impact of anesthesia awareness. Joint Commission Perspectives. 2004;24(12):10–11.
    1. Myles PS, Leslie K, McNeil J, Forbes A, Chan MT. Bispectral index monitoring to prevent awareness during anaesthesia: the B-Aware randomised controlled trial. Lancet. 2004;363(9423):1757–1763. doi: 10.1016/S0140-6736(04)16300-9.
    1. Errando CL, Sigl JC, Robles M, Calabuig E, Garcia J, Arocas F, Higueras R, Del Rosario E, Lopez D, Peiro CM. Awareness with recall during general anaesthesia: a prospective observational evaluation of 4001 patients. British Journal of Anaesthesia. 2008;101(2):178–185. doi: 10.1093/bja/aen144.
    1. Xu L, Wu AS, Yue Y. The incidence of intra-operative awareness during general anesthesia in China: a multi-center observational study. Acta Anaesthesiologica Scandinavica. 2009;53(7):873–882. doi: 10.1111/j.1399-6576.2009.02016.x.
    1. Ghoneim MM, Block RI, Haffarnan M, Mathews MJ. Awareness during anesthesia: risk factors, causes and sequelae: a review of reported cases in the literature. Anesthesia and Analgesia. 2009;108(2):527–535. doi: 10.1213/ane.0b013e318193c634.
    1. Leslie K, Myles PS. Awareness during general anaesthesia: is it worth worrying about? The Medical journal of Australia. 2001;174(5):212–213.
    1. Avidan MS, Zhang L, Burnside BA, Finkel KJ, Searleman AC, Selvidge JA, Saager L, Turner MS, Rao S, Bottros M. Anesthesia awareness and the bispectral index. The New England Journal of Medicine. 2008;358(11):1097–1108. doi: 10.1056/NEJMoa0707361.
    1. Chortkoff BS, Gonsowski CT, Bennett HL, Levinson B, Crankshaw DP, Dutton RC, Ionescu P, Block RI, Eger EI. Subanesthetic concentrations of desflurane and propofol suppress recall of emotionally charged information. Anesthesia and Analgesia. 1995;81(4):728–736. doi: 10.1097/00000539-199510000-00013.
    1. Moher D, Schulz KF, Altman D. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. JAMA. 2001;285(15):1987–1991. doi: 10.1001/jama.285.15.1987.
    1. Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P. Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Annals of Internal Medicine. 2008;148(4):295–309.
    1. Eger EI. Age, minimum alveolar anesthetic concentration, and minimum alveolar anesthetic concentration-awake. Anesthesia and Analgesia. 2001;93(4):947–953. doi: 10.1097/00000539-200110000-00029.
    1. Nickalls RW, Mapleson WW. Age-related iso-MAC charts for isoflurane, sevoflurane and desflurane in man. British Journal of Anaesthesia. 2003;91(2):170–174. doi: 10.1093/bja/aeg132.
    1. Nussmeier NA, Moskowitz GJ, Weiskopf RB, Cohen NH, Fisher DM, Eger EI. In vitro anesthetic washin and washout via bubble oxygenators: influence of anesthetic solubility and rates of carrier gas inflow and pump blood flow. Anesthesia and Analgesia. 1988;67(10):982–987. doi: 10.1213/00000539-198810000-00015.
    1. Mashour GA, Esaki RK, Tremper KK, Glick DB, O'Connor M, Avidan MS. A Novel Classification Instrument for Intraoperative Awareness Events. Anesthesia and Analgesia. in press .

Source: PubMed

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

3
Sottoscrivi