B-Unaware Study: Comparison of BIS-guided Anesthesia With End-Tidal Volatile-Guided Anesthesia to Decrease The Incidence of Awareness During High-Risk Surgery
Sponsor study identifier
interventional
2,000
1 country
1
Study Start
August 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2006
Actual (reported)Study Completion
Not reported
Date not reportedThe overall purpose of this study is to see if a Bispectral Index (BIS) monitor, a Food and Drug Administration (FDA) approved brain monitoring device, will help to reduce the risk of patients remembering being awake during surgery. The BIS monitor may be able measure how asleep a patient is during surgery. Using the BIS monitor to guide anesthesia will be compared with using the concentration of anesthetic gas to guide anesthesia.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2005
Date type not reportedThis date has not been verified as actual or estimated.
January 20, 2006
Actual (reported)January 24, 2006
Actual (reported)October 2006
Actual (reported)The incidence of explicit recall of events during the surgical and anesthetic periods.
30 days
1 Anesthetic concentrations & BIS values in each group.
1 day
2 Implicit memory (number).
30 days
3 Dreaming.
30 days
4 One-year mortality (and "anesthetic depth").
1 year
5 Relation of assessment to BIS value.
30 days
BIS guided algorithm (BIS target 40 to 60) during anesthesia. Alarms when BIS is outside this range.
Volatile anesthetic guided algorithm. Target anesthetic concentration 0.7 to 1.3 minimum alveolar concentration during anesthesia. Alarms when anesthetic concentration not in this range.
BIS guided algorithm (BIS target 40 to 60) during anesthesia. Alarms when BIS is outside this range.
Volatile anesthetic guided algorithm. Target anesthetic concentration 0.7 to 1.3 minimum alveolar concentration during anesthesia. Alarms when anesthetic concentration not in this range.
Barnes-Jewish Hospital
St Louis, Missouri, 63110, United States
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 May 29;363(9423):1757-63. doi: 10.1016/S0140-6736(04)16300-9.
Willingham M, Ben Abdallah A, Gradwohl S, Helsten D, Lin N, Villafranca A, Jacobsohn E, Avidan M, Kaiser H. Association between intraoperative electroencephalographic suppression and postoperative mortality. Br J Anaesth. 2014 Dec;113(6):1001-8. doi: 10.1093/bja/aeu105. Epub 2014 May 22.
Michael S Avidan, MBBCh
Washington University School of Medicine
Beth Burnside
Washington University School of Medicine
2,000 participants (actual enrollment reported by the registry).
First Submitted
January 20, 2006
First Posted
January 24, 2006
Study Start
August 2005
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Avidan MS, Palanca BJ, Glick D, Jacobsohn E, Villafranca A, O'Connor M, Mashour GA; BAG-RECALL Study Group. 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 Anesthesiol. 2009 Nov 30;9:8. doi: 10.1186/1471-2253-9-8.
Avidan MS, Zhang L, Burnside BA, Finkel KJ, Searleman AC, Selvidge JA, Saager L, Turner MS, Rao S, Bottros M, Hantler C, Jacobsohn E, Evers AS. Anesthesia awareness and the bispectral index. N Engl J Med. 2008 Mar 13;358(11):1097-108. doi: 10.1056/NEJMoa0707361.
Primary Completion
October 2006
Actual (reported)Last Updated
July 23, 2012
Record last verified: 2012-07
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Source: ClinicalTrials.gov.
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