Comparison of the Bispectral Index and the Entropy of the Electroencephalogram During Total Intravenous Anesthesia

Anesthesia, General Clinical Trial

Official title:

Comparison of the Bispectral Index and the Entropy of the Electroencephalogram During Total Intravenous Anesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00391963
• Other study ID #: Foch-2
• Status: Completed
• Phase: N/A
• First received: October 24, 2006
• Last updated: January 14, 2009
• Start date: June 2006
• Est. completion date: April 2007

Study information

• Verified date: January 2009
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial Summary

To compare Bispectral index and entropy during maintenance of anesthesia

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Anesthesia, General

Intervention

Device:
• Bispectral index, Entropy

Locations

Country	Name	City	State
France	Dept of Anesthesia and Intensive Care, Hôpital Beaujon	Clichy
France	Dept of Anesthesiology, Hôpital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

References & Publications (2)

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. — View Citation

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. — View Citation