Clinical Trials Directory

Trials / Completed

CompletedNCT00391963

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

Status
Completed
Phase
Study type
Observational
Enrollment
84 (planned)
Sponsor
Hopital Foch · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEBispectral index, Entropy

Timeline

Start date
2006-06-01
Completion
2007-04-01
First posted
2006-10-25
Last updated
2009-01-15

Locations

2 sites across 1 country: France

Source: ClinicalTrials.gov record NCT00391963. Inclusion in this directory is not an endorsement.