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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00391963
Enrollment
84
Registered
2006-10-25
Start date
2006-06-30
Completion date
2007-04-30
Last updated
2009-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, General

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.

Interventions

DEVICEBispectral index, Entropy

Sponsors

Hopital Foch
Lead SponsorOTHER

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026