Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Manual Administration of Propofol-Remifentanil Versus Dual Closed-Loop Using Bispectral Index as the Control Variable
This study has been completed.
Sponsored by: Hopital Foch
Information provided by: Hopital Foch
ClinicalTrials.gov Identifier: NCT00392158
  Purpose

To compare manual administration of propofol and remifentanil and dual closed-loop using bispectral index as the control variable during anesthesia


Condition Intervention Phase
Anesthesia, General
Device: Closed-loop anesthesia system
Phase IV

MedlinePlus related topics: Anesthesia
Drug Information available for: Propofol Remifentanil Remifentanil hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Pharmacodynamics Study
Official Title: Target-Controlled Infusion of Propofol and Remifentanil During General Anaesthesia Guided by the Index Bispectral: Comparison Between Manual Perfusion and Automated Perfusion

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: 240
Study Start Date: February 2006
Study Completion Date: April 2007
Detailed Description:

The Bispectral Index (BIS) is an electroencephalogram-derived measure of anesthetic depth. A closed-loop anesthesia system can be built using BIS as the control variable, a proportional–integral–differential control algorithm, and a propofol target-controlled infusion system as the control actuator. Recent studies have shown that such system is able to provide clinically adequate anesthesia. We hypothesized that BIS can also indicate the adequacy of analgesia and therefore built a combined closed-loop anesthesia system using BIS as the control variable, two proportional–integral–differential control algorithms, a propofol and a remifentanil target-controlled infusion systems as the control actuators. 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 BIS 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:

  • 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: NCT00392158

Locations
France
Dept of Anesthesia, Hôpital Foch
Suresnes, France, 92150
Dept of Anesthesia, CH d’Argenteuil
Argenteuil, France, 95100
Dept of Anesthesia, Clinique Saint Augustin
Bordeaux, France, 33074
Dept of Anesthesiology, CHU de Besançon
Besançon, France, 25030
Dept of Anesthesiology, Hôpital Cochin
Paris, France, 75014
Dept of Anesthesia and Intensive Care, Hôpital Beaujon
Clichy, France, 92110
Sponsors and Collaborators
Hopital Foch
Investigators
Principal Investigator: Marc Fischler, MD Hôpital Foch
  More Information

Publications:
Study ID Numbers: Foch-3
Study First Received: October 24, 2006
Last Updated: April 21, 2007
ClinicalTrials.gov Identifier: NCT00392158  
Health Authority: France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:
Remifentanil
Propofol

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

ClinicalTrials.gov processed this record on January 14, 2009