Study Evaluating Ways of Preventing Patients From Being Awake During High-Risk Surgery and Anesthesia
Completed · Phase 2/Phase 3
Conditions studied: Explicit Recall of Intra-operative Events
In brief
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.
Key facts
- Study ID
- NCT00281489
- Run by
- Washington University School of Medicine
- People needed
- 2000
- Starts
- 2005-08-01
- Last updated by the study team
- 2012-07-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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)
- Beta blockers
- COPD
- Moderate exercise tolerance not secondary to musculoskeletal dysfunction
- Smokes ≥2 packs per day
- Morbid obesity BMI>30 -
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
Where it is running
- Barnes-Jewish Hospital — St Louis, Missouri, United States
Full record on ClinicalTrials.gov
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