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Sponsors and Collaborators: |
Washington University School of Medicine Foundation for Anesthesia Education and Research American Society of Anesthesiologists University of Chicago University of Manitoba University of Michigan |
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Information provided by: | Washington University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00682825 |
The 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 to 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.
Condition | Intervention | Phase |
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Explicit Recall of Intra-Operative Events |
Behavioral: Bispectral index protocol Behavioral: End tidal anesthetic gas-guided |
Phase IV |
Study Type: | Interventional |
Study Design: | Active Control, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Prevention, Randomized, Safety/Efficacy Study |
Official Title: | BAG-RECALL Study: BIS or Anesthesia Gas to Reduce Explicit Recall |
Estimated Enrollment: | 6000 |
Study Start Date: | March 2008 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Bispectral index-guided protocol
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Behavioral: Bispectral index protocol
Aim to titrate anesthesia to maintain BIS between 40 and 60.
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2: Active Comparator
End-tidal anesthetic gas-guided protocol
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Behavioral: End tidal anesthetic gas-guided
Aim to maintain anesthetic gas between 0.7 and 1.3 MAC equivalents
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The incidence of anesthesia awareness (AA) is 0.1-0.2% and may result in post traumatic stress disorders. For some patients, owing to illness, medications, substance misuse or surgery, the risk approaches 1%. The B-AWARE Study by Myles et al. suggested that the bispectral index (BIS) monitor, which reportedly reflects anesthetic depth, may decrease the incidence of AA in higher risk patients by 82%. The American Society of Anesthesiologists has published a practice advisory on AA, which does not recommend the routine use of cerebral function monitors. We propose to test the hypothesis that an anesthetic protocol based on BIS decreases the incidence of AA among higher risk patients compared with an anesthetic protocol based on the end-tidal anesthetic gas (ETAG) concentration. We have completed a randomized, single-blinded prospective feasibility study (The B-Unaware Trial) which enrolled 2000 patients at higher risk for AA. Four patients (0.21%; 95% CI=0.06% to 0.57%) had definite AA, of whom two were in the BIS-guided group and two in the ETAG-guided group. Nine patients (0.46%; 95% CI=0.22% to 0.91%) had definite or possible AA, of whom six were in the BIS-guided group and three in the ETAG-guided group. The BAG RECALL study will be a multi-center, prospective, single-blinded, randomized study enrolling 6000 patients at higher risk for AA. The BAG RECALL study is adequately powered and rigorously designed to answer with a reasonable degree of scientific probability whether BIS guidance results in clinically relevant reduction in anesthesia awareness among higher risk patients undergoing general anesthesia.
At the University of Michigan, a parallel study will be conducted - Michigan Awareness Control Study, MACS (NCT00689091) - enrolling 30,000 patients to assess whether the BIS monitor decreases the likelihood of anesthesia awareness among all patients undergoing general anesthesia, regardless of their risk profile. The investigators of this study and the BAG-RECALL study have collaborated in designing these studies and are pre-specifying that common outcome measures will be examined collaboratively including data from both studies.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
MUST HAVE:
General Anesthesia with volatile anesthetic
PATIENT CHARACTERISTICS
Major Criteria (Must have any 1 of the following:)
Exclusion Criteria:
Stroke with residual neurological deficits
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Contact: Leah Karl | LKarl@dacc.uchicago.edu | |
Contact: Beth Burnside, BA | 314-747-4155 | burnsideb@wustl.edu |
United States, Illinois | |
University of Chicago | Recruiting |
Chicago, Illinois, United States | |
Contact: Leah Karl LKarl@dacc.uchicago.edu | |
Sub-Investigator: Avery Tung, MD | |
United States, Missouri | |
Washington University | Recruiting |
St Louis, Missouri, United States, 63110 | |
Contact: Michael Avidan avidanm@wustl.edu | |
Contact: Beth Burnside, BA 314-747-4155 burnsideb@anest.wustl.edu | |
Sub-Investigator: Anand Lakshminarasimhachar, MD | |
Canada, Manitoba | |
University of Manitoba | Not yet recruiting |
Winnipeg, Manitoba, Canada | |
Contact: Eric Jacobsohn EJacobsohn@exchange.hsc.mb.ca | |
Contact: Rachel Gerstein |
Principal Investigator: | Michael S Avidan, MBBCh FCA | Washington University School of Medicine |
Study Director: | David Glick, MD | University of Chicago |
Study Chair: | Eric Jacobsohn, MBChB | University of Manitoba |
Study Director: | Michael O'Connor, MD | University of Chicago |
Study Chair: | Alex S Evers, MD | Washington University School of Medicine |
Responsible Party: | Washington University ( Michael Avidan ) |
Study ID Numbers: | 07-1253 |
Study First Received: | May 16, 2008 |
Last Updated: | June 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00682825 History of Changes |
Health Authority: | United States: Institutional Review Board |
Anesthesia Awareness BIS Bispectral Recall |
Anesthetics, Inhalation Anesthetics, General Benzocaine Anesthetics |
Anesthetics, Inhalation Anesthetics, General Therapeutic Uses Physiological Effects of Drugs |
Central Nervous System Depressants Anesthetics Central Nervous System Agents Pharmacologic Actions |