Status:
COMPLETED
Study Evaluating Whether the Bispectral Index Prevents Patients at Higher Risk From Being Awake During Surgery and Anesthesia
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
Foundation for Anesthesia Education and Research
American Society of Anesthesiologists
Conditions:
Explicit Recall of Intra-Operative Events
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 remembe...
Detailed Description
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 approa...
Eligibility Criteria
Inclusion
- MUST HAVE:
- General Anesthesia with volatile anesthetic
- PATIENT CHARACTERISTICS
- Major Criteria (Must have any 1 of the following:)
- Planned open heart surgery
- 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
Exclusion
- 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
- \-
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
6000 Patients enrolled
Trial Details
Trial ID
NCT00682825
Start Date
March 1 2008
Last Update
January 4 2011
Active Locations (3)
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1
University of Chicago
Chicago, Illinois, United States
2
Washington University
St Louis, Missouri, United States, 63110
3
University of Manitoba
Winnipeg, Manitoba, Canada