Status:
COMPLETED
Study Evaluating Ways of Preventing Patients From Being Awake During High-Risk Surgery and Anesthesia
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
The Foundation for Barnes-Jewish Hospital
Conditions:
Explicit Recall of Intra-operative Events
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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
General anesthesia is a state of drug-induced unconsciousness, during which patients should neither perceive nor recall noxious stimuli. Many patients facing surgery dread the prospect of being awake,...
Eligibility Criteria
Inclusion
- 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)
- Beta blockers
- COPD
- Moderate exercise tolerance not secondary to musculoskeletal dysfunction
- Smokes ≥2 packs per day
- Morbid obesity BMI\>30 -
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 :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT00281489
Start Date
August 1 2005
Last Update
July 23 2012
Active Locations (1)
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1
Barnes-Jewish Hospital
St Louis, Missouri, United States, 63110