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Completed

NCT Number: NCT00391963

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

To compare Bispectral index and entropy during maintenance of anesthesia

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dept of Anesthesia and Intensive Care, Hôpital Beaujon, Clichy, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Bispectral index, Entropy

Device

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Important dates

Study start
2006
Study completion
2007
First posted
Oct 25, 2006
Registry last updated
Jan 15, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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