Study Evaluating Ways of Preventing Patients From Being Awake During High-Risk Surgery and Anesthesia

Phase 2

Completed

• Conditions: Explicit Recall of Intra-operative Events
• Interventions: Device: BIS Monitor guided algorithm; Behavioral: Volatile anesthetic guided algorithm

• Registration Number: NCT00281489
• Lead Sponsor: Washington University School of Medicine

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 c...

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, in pain and unable to move owing to inadequate general anesthesia. A large multi-center study in the USA showed that, despite modern anesthesia techniques, the...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2006-01-20
• Study First Submitted QC: 2006-01-20
• Study First Posted: 2006-01-24
• Primary Completion: 2006-10
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-20
• Last Update Posted: 2012-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

MUST HAVE:

General Anesthesia with volatile anesthetic

PATIENT CHARACTERISTICS

Major Criteria (any 1 of the following:)

1. Medications - anticonvulsants, abuse of opiates, benzodiazepines, cocaine
2. EF<40%
3. Prior history of awareness (recall)
4. History of difficult intubation or anticipated difficult intubation
5. ASA IV or V status
6. Aortic stenosis
7. End stage lung disease
8. Marginal exercise tolerance not secondary to musculoskeletal dysfunction
9. Pulmonary hypertension
10. Daily alcohol consumption

Minor Criteria (any 2 of the following)

1. Beta blockers
2. COPD
3. Moderate exercise tolerance not secondary to musculoskeletal dysfunction
4. Smokes ≥2 packs per day
5. Morbid obesity BMI>30 -

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Exclusion Criteria

1. Surgical procedure that prevents the use of the BIS (e.g surgery of forehead)
2. Patient positioning prevents use of the BIS
3. Surgery with wake-up test.
4. Less than 18 years of age
5. Vulnerable populations, such as those with dementia and those unable to provide informed consent.
6. Stroke with residual neurological deficits

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BIS Monitor guided algorithm	BIS Monitor guided algorithm	BIS guided algorithm (BIS target 40 to 60) during anesthesia. Alarms when BIS is outside this range.
Volatile anesthetic guided algorithm	Volatile anesthetic guided algorithm	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.

Primary Outcome Measures

Name	Time	Method
The incidence of explicit recall of events during the surgical and anesthetic periods.	30 days

Secondary Outcome Measures

Name	Time	Method
4 One-year mortality (and "anesthetic depth").	1 year
5 Relation of assessment to BIS value.	30 days
6 Relation of events (e.g. movement) to BIS & ETAG.	1 day
7 Relation of EMG to BIS.	1 day
1 Anesthetic concentrations & BIS values in each group.	1 day
2 Implicit memory (number).	30 days
3 Dreaming.	30 days

Trial Locations

Locations (1)

Barnes-Jewish Hospital; 🇺🇸 St Louis, Missouri, United States