Comparison of the Bispectral Index and the Entropy of the Electroencephalogram During Total Intravenous Anesthesia - Full Text View

Sponsored by:	Hopital Foch
Information provided by:	Hopital Foch
ClinicalTrials.gov Identifier:	NCT00391963

Purpose

To compare Bispectral index and entropy during maintenance of anesthesia

Condition	Intervention
Anesthesia, General	Device: Bispectral index, Entropy

MedlinePlus related topics: Anesthesia

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective
Official Title:	Comparison of the Bispectral Index and the Entropy of the Electroencephalogram During Total Intravenous Anesthesia

Further study details as provided by Hopital Foch:

Estimated Enrollment:	84
Study Start Date:	June 2006
Study Completion Date:	April 2007

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00391963

Locations

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

Sponsors and Collaborators

Hopital Foch

Investigators

Principal Investigator:

Marc Fischler, MD

Hôpital Foch

More Information

Publications:

Schmidt GN, Bischoff P, Standl T, Hellstern A, Teuber O, Schulte Esch J. Comparative evaluation of the Datex-Ohmeda S/5 Entropy Module and the Bispectral Index monitor during propofol-remifentanil anesthesia. Anesthesiology. 2004 Dec;101(6):1283-90.

Vanluchene AL, Vereecke H, Thas O, Mortier EP, Shafer SL, Struys MM. Spectral entropy as an electroencephalographic measure of anesthetic drug effect: a comparison with bispectral index and processed midlatency auditory evoked response. Anesthesiology. 2004 Jul;101(1):34-42.

Study ID Numbers:	Foch-2
Study First Received:	October 24, 2006
Last Updated:	January 14, 2009
ClinicalTrials.gov Identifier:	NCT00391963 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:

Anesthetics

ClinicalTrials.gov processed this record on May 07, 2009