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Sponsored by: |
Hopital Foch |
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Information provided by: | Hopital Foch |
ClinicalTrials.gov Identifier: | NCT00391885 |
This study compares the manual administration of propofol and remifentanil and their delivery using a combined closed-loop anesthesia system, entropy of the EEG being the controler.
Condition | Intervention | Phase |
---|---|---|
Anesthesia, General |
Device: Closed-loop anesthesia system |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Target-Controlled Infusion of Propofol and Remifentanil During General Anaesthesia Guided by Entropy of the Electroencephalogram: Comparison Between Manual Perfusion and Automated Perfusion |
Estimated Enrollment: | 60 |
Study Start Date: | September 2006 |
Study Completion Date: | April 2007 |
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). A closed-loop anesthesia system can be built using BIS as the control variable, a proportional–integral–differential control algorithm, a propofol and a remifentanil target-controlled infusion systems as the control actuators Preliminary results show that this system can be used during surgery. 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. We hypothesized that SE can be used as the control variable. In preparation for a large multi-center control trial, we propose a prospective randomized study to evaluate the effectiveness of such a closed-loop anesthesia system. Two groups of patients are compared: one in which propofol and remifentanil are administered by the anesthesiologist using target-controlled infusion systems, and one in which propofol and remifentanil are administered automatically by the combined closed-loop anesthesia system. In both groups, the goal is to maintain SE between 40 and 60, the recommended range during anesthesia by the manufacturer. We expect the combined closed-loop anesthesia system group to do similar or better.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
France | |
Dept of Anesthesiology, Hôpital Foch | |
Suresnes, France, 92150 | |
Dept of Anesthesia and Intensive Care, Hôpital Beaujon | |
Clichy, France, 92110 |
Study Chair: | Marc Fischler, MD | Hôpital Foch |
Principal Investigator: | Marc Fischler, MD | Hôpital Foch |
Study ID Numbers: | Foch-4 |
Study First Received: | October 24, 2006 |
Last Updated: | April 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00391885 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Anesthetics, Intravenous Remifentanil Anesthetics, General Hypnotics and Sedatives Central Nervous System Depressants |
Anesthetics Peripheral Nervous System Agents Analgesics Propofol Analgesics, Opioid |
Anesthetics, Intravenous Remifentanil Physiological Effects of Drugs Anesthetics Central Nervous System Depressants Pharmacologic Actions Anesthetics, General |
Sensory System Agents Therapeutic Uses Hypnotics and Sedatives Analgesics Peripheral Nervous System Agents Central Nervous System Agents Analgesics, Opioid |