Study Evaluating Whether the Bispectral Index Prevents Patients at Higher Risk From Being Awake During Surgery and Anesthesia

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 to 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

BEHAVIORAL

Bispectral index protocol

Aim to titrate anesthesia to maintain BIS between 40 and 60.

BEHAVIORAL

End tidal anesthetic gas-guided

Aim to maintain anesthetic gas between 0.7 and 1.3 MAC equivalents

Sponsors & Collaborators

• Foundation for Anesthesia Education and Research

  collaborator OTHER

• American Society of Anesthesiologists

  collaborator OTHER

• University of Chicago

  collaborator OTHER

• University of Manitoba

  collaborator OTHER

• University of Michigan

  collaborator OTHER

• Washington University School of Medicine

  lead OTHER

Principal Investigators

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

• David Glick, MD · University of Chicago

• Eric Jacobsohn, MBChB · University of Manitoba

• Michael O'Connor, MD · University of Chicago

• Alex S Evers, MD · Washington University School of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-03-31

Primary Completion

2010-12-31

Countries

• United States
• Canada

Study Locations