Comparison of the Bispectral Index and the Entropy of the Electroencephalogram During Total Intravenous Anesthesia
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|ClinicalTrials.gov Identifier: NCT00391963|
Recruitment Status : Completed
First Posted : October 25, 2006
Last Update Posted : January 15, 2009
|Condition or disease||Intervention/treatment|
|Anesthesia, General||Device: Bispectral index, Entropy|
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 participants|
|Official Title:||Comparison of the Bispectral Index and the Entropy of the Electroencephalogram During Total Intravenous Anesthesia|
|Study Start Date :||June 2006|
|Actual Study Completion Date :||April 2007|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00391963
|Dept of Anesthesia and Intensive Care, Hôpital Beaujon|
|Clichy, France, 92110|
|Dept of Anesthesiology, Hôpital Foch|
|Suresnes, France, 92150|
|Principal Investigator:||Marc Fischler, MD||Hôpital Foch|