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Clinical Trials/NCT00391963
NCT00391963
Completed
Not Applicable

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

Hopital Foch2 sites in 1 country84 target enrollmentJune 2006

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anesthesia, General
Sponsor
Hopital Foch
Enrollment
84
Locations
2
Status
Completed
Last Updated
17 years ago

Overview

Brief Summary

To compare Bispectral index and entropy during maintenance of anesthesia

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.

Registry
clinicaltrials.gov
Start Date
June 2006
End Date
April 2007
Last Updated
17 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility 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)

Outcomes

Primary Outcomes

Not specified

Study Sites (2)

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