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
Looking for future studies?
Notify MeKey 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
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
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.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Comparison of the Performances of the cTOFR and the mTOFR During Reversal of Deep Neuromuscular Blockade With Sugammadex
NCT06220136
Anesthesia, General, Neuromuscular Blockade
Ankara, Altındağ, Turkey (Türkiye)
View Trial DetailsComparison of Acoustic Variability Index (AVI) and Pulse Pressure Variation (PPV) for Predicting Fluid Responsiveness in Mechanically Ventilated Patients
NCT07516470
Anesthesia, General, Fluid Responsiveness Predictability
Seoul, South Korea
View Trial DetailsLMA Protector vs I-Gel in Low-Flow Anesthesia for Laparoscopic Cholecystectomy
NCT07707440
Anesthesia, General, Laparoscopic Cholecystectomy
Istanbul, Turkey (Türkiye)
View Trial DetailsInduction Agents in ECT: Effects on Seizure Duration, Quality, and Recovery
NCT07596095
Anesthesia, General, Electroconvulsive Therapy
Istanbul, Turkey (Türkiye)
View Trial Details