Manual Administration of Propofol-remifentanil Versus Dual Closed-loop Using Bispectral Index as the Control Variable

Phase 4

Completed

• Conditions: Anesthesia, General

• Registration Number: NCT00392158
• Lead Sponsor: Hopital Foch

Brief Summary

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

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.

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2006-10-24
• Study First Submitted QC: 2006-10-24
• Study First Posted: 2006-10-25
• Study Completion: 2007-04
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-23
• Last Update Posted: 2016-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• surgery under general anesthesia using relaxant agent,
• surgery lasting more than one hour

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (6)

Dept of Anesthesia, CH d'Argenteuil; 🇫🇷 Argenteuil, France

Dept of Anesthesia and Intensive Care, Hôpital Beaujon; 🇫🇷 Clichy, France

Dept of Anesthesiology, Hôpital Cochin; 🇫🇷 Paris, France

Dept of Anesthesia, Clinique Saint Augustin; 🇫🇷 Bordeaux, France

Dept of Anesthesiology, CHU de Besançon; 🇫🇷 Besançon, France

Dept of Anesthesia, Hôpital Foch; 🇫🇷 Suresnes, France