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

This study has been completed.
Sponsor:
Information provided by:
Hopital Foch
ClinicalTrials.gov Identifier:
NCT00391885
First received: October 24, 2006
Last updated: April 21, 2007
Last verified: April 2007
  Purpose

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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Hopital Foch:

Primary Outcome Measures:
  • 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:
  • consumption of propofol and remifentanil during the induction and the maintenance of the anaesthesia
  • number of modifications of target of propofol and remifentanil
  • number of episodes of hemodynamic anomalies having required a treatment
  • intraoperative volume loading and transfusion
  • extubation time, explicit memorisation
  • dysfunctions of each system

Estimated Enrollment: 60
Study Start Date: September 2006
Study Completion Date: April 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00391885

Locations
France
Dept of Anesthesia and Intensive Care, Hôpital Beaujon
Clichy, France, 92110
Dept of Anesthesiology, Hôpital Foch
Suresnes, France, 92150
Sponsors and Collaborators
Hopital Foch
Investigators
Study Chair: Marc Fischler, MD Hôpital Foch
Principal Investigator: Marc Fischler, MD Hôpital Foch
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00391885     History of Changes
Other Study ID Numbers: Foch-4
Study First Received: October 24, 2006
Last Updated: April 21, 2007
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Anesthetics
Propofol
Remifentanil
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Hypnotics and Sedatives
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on April 16, 2014