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Target-controlled Infusion of Propofol and Remifentanil During General Anaesthesia Guided by Entropy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00391885
Recruitment Status : Completed
First Posted : October 25, 2006
Last Update Posted : September 27, 2016
Information provided by (Responsible Party):
Hopital Foch

Brief Summary:
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 controller.

Condition or disease Intervention/treatment Phase
Anesthesia, General Device: Closed-loop anesthesia system Phase 4

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). 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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : September 2006
Actual Primary Completion Date : March 2007
Actual Study Completion Date : April 2007

Primary Outcome Measures :
  1. Global score (calculated parameter which depicts the performance of the system, i.e. its capacity to maintain BIS in the desired range)

Secondary Outcome Measures :
  1. consumption of propofol and remifentanil during the induction and the maintenance of the anaesthesia
  2. number of modifications of target of propofol and remifentanil
  3. number of episodes of hemodynamic anomalies having required a treatment
  4. intraoperative volume loading and transfusion
  5. extubation time, explicit memorisation
  6. dysfunctions of each system

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • American Society of Anesthesiologists physical status 1-3,
  • surgery under general anesthesia using relaxant agent,
  • surgery lasting more than one hour

Exclusion Criteria:

  • pregnant women,
  • indication for rapid sequence induction,
  • anticipation of difficult intubation,
  • allergy to propofol or remifentanil,
  • neurological or muscular disorder,
  • combination of general anesthesia and of regional anesthesia,
  • emergency surgery

Information from the National Library of Medicine

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 identifier (NCT number): NCT00391885

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Dept of Anesthesia and Intensive Care, Hôpital Beaujon
Clichy, France, 92110
Dept of Anesthesiology, Hôpital Foch
Suresnes, France, 92150
Sponsors and Collaborators
Hopital Foch
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Study Chair: Marc Fischler, MD Hôpital Foch
Principal Investigator: Marc Fischler, MD Hôpital Foch
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Responsible Party: Hopital Foch Identifier: NCT00391885    
Other Study ID Numbers: Foch-4
First Posted: October 25, 2006    Key Record Dates
Last Update Posted: September 27, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Central Nervous System Depressants
Physiological Effects of Drugs