Bispectral index, Entropy in Anesthesia, General - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Anesthesia, General

Intervention / Treatment

Device: Bispectral index, Entropy

Detailed Description

Several monitors are currently proposed to evaluate the depth of hypnosis. Among them, Bispectral Index (BIS) is a well known and widely used parameter derived from the patient's electroencephalograph (EEG). Spectral entropy relies on the extent of disorder in both EEG and electromyography (EMG) signals and returns 2 values: State Entropy (SE) and Response Entropy. SE is computed over the frequency range of 0.8-32 Hz and reflects the level of hypnosis while Response Entropy is computed over the frequency range of 0.8-47 Hz and reflects also EMG activity. BIS and SE are dimensionless numbers scaled from 100 to 0 for BIS and from 91 to 0 for SE.

The BIS and Entropy manufacturers claim that adequate level of anesthesia is defined by a BIS or SE value between 40 and 60. But some observations have shown that the monitors provided different information. These observations led us to carry out this prospective observational study designed to study the comparability between BIS and SE during the maintenance period of propofol-sufentanil anesthesia.

Study Type

Observational

Enrollment

84

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- - Clichy, France, 92110
    - Dept of Anesthesia and Intensive Care, Hôpital Beaujon
  - Suresnes, France, 92150
    - Dept of Anesthesiology, Hôpital Foch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

age > 18 years,
American Society of Anesthesiologists physical status 1-3,
surgery under general anesthesia using propofol, sufentanil, and a relaxant agent,
surgery lasting more than one hour,
tracheal extubation planned at end of surgery

Exclusion Criteria:

pregnant women,
allergy to propofol,
neurological or muscular disorder,
treatment with opioids or any psychoactive medication,
cardiac surgery,
thyroid disorder,
emergency surgery,
prone or lateral decubitus position (difficulty to have a correct probe position)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Time Perspectives: Prospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital Foch

Investigators

Principal Investigator: Marc Fischler, MD, Hopital Foch

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

October 24, 2006

First Submitted That Met QC Criteria