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

NCT00281489 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 2000

Last updated 2012-07-23

No results posted yet for this study

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.

Conditions

  • Explicit Recall of Intra-operative Events

Interventions

DEVICE

BIS Monitor guided algorithm

BIS guided algorithm (BIS target 40 to 60) during anesthesia. Alarms when BIS is outside this range.

BEHAVIORAL

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.

Sponsors & Collaborators

  • The Foundation for Barnes-Jewish Hospital

    collaborator OTHER

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Michael S Avidan, MBBCh · Washington University School of Medicine

  • Beth Burnside · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2006-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00281489 on ClinicalTrials.gov