Study Evaluating Ways of Preventing Patients From Being Awake During High-Risk Surgery and Anesthesia
B-Unaware Study: Comparison of BIS-guided Anesthesia With End-Tidal Volatile-Guided Anesthesia to Decrease The Incidence of Awareness During High-Risk Surgery
1 other identifier
interventional
2,000
1 country
1
Brief Summary
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
January 20, 2006
CompletedFirst Posted
Study publicly available on registry
January 24, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2006
CompletedJuly 23, 2012
July 1, 2012
1.2 years
January 20, 2006
July 20, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The incidence of explicit recall of events during the surgical and anesthetic periods.
30 days
Secondary Outcomes (7)
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
- +2 more secondary outcomes
Study Arms (2)
BIS Monitor guided algorithm
EXPERIMENTALBIS guided algorithm (BIS target 40 to 60) during anesthesia. Alarms when BIS is outside this range.
Volatile anesthetic guided algorithm
ACTIVE COMPARATORVolatile anesthetic guided algorithm. Target anesthetic concentration 0.7 to 1.3 minimum alveolar concentration during anesthesia. Alarms when anesthetic concentration not in this range.
Interventions
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.
Eligibility Criteria
You may qualify if:
- MUST HAVE:
- General Anesthesia with volatile anesthetic
- PATIENT CHARACTERISTICS
- Major Criteria (any 1 of the following:)
- Medications - anticonvulsants, abuse of opiates, benzodiazepines, cocaine
- EF\<40%
- Prior history of awareness (recall)
- History of difficult intubation or anticipated difficult intubation
- ASA IV or V status
- Aortic stenosis
- End stage lung disease
- Marginal exercise tolerance not secondary to musculoskeletal dysfunction
- Pulmonary hypertension
- Daily alcohol consumption
- Minor Criteria (any 2 of the following)
- +5 more criteria
You may not qualify if:
- Surgical procedure that prevents the use of the BIS (e.g surgery of forehead)
- Patient positioning prevents use of the BIS
- Surgery with wake-up test.
- Less than 18 years of age
- Vulnerable populations, such as those with dementia and those unable to provide informed consent.
- Stroke with residual neurological deficits
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Barnes-Jewish Hospital
St Louis, Missouri, 63110, United States
Related Publications (4)
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.
PMID: 15172773BACKGROUNDWillingham 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.
PMID: 24852500DERIVEDAvidan 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.
PMID: 19948045DERIVEDAvidan 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.
PMID: 18337600DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Michael S Avidan, MBBCh
Washington University School of Medicine
- STUDY DIRECTOR
Beth Burnside
Washington University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Institute of Quality Improvement, Research & Informatics
Study Record Dates
First Submitted
January 20, 2006
First Posted
January 24, 2006
Study Start
August 1, 2005
Primary Completion
October 1, 2006
Last Updated
July 23, 2012
Record last verified: 2012-07