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

NCT ID: NCT00392158

Last Updated: 2016-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2007-04-30

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.

Conditions

Anesthesia, General

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Closed-loop anesthesia system

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hopital Foch

OTHER

Sponsor Role: lead

Principal Investigators

Marc Fischler, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Foch

Locations

Dept of Anesthesia, CH d'Argenteuil

Argenteuil, , France

Dept of Anesthesiology, CHU de Besançon

Besançon, , France

Dept of Anesthesia, Clinique Saint Augustin

Bordeaux, , France

Dept of Anesthesia and Intensive Care, Hôpital Beaujon

Clichy, , France

Dept of Anesthesiology, Hôpital Cochin

Paris, , France

Dept of Anesthesia, Hôpital Foch

Suresnes, , France

Countries

France

References

Liu N, Chazot T, Genty A, Landais A, Restoux A, McGee K, Laloe PA, Trillat B, Barvais L, Fischler M. Titration of propofol for anesthetic induction and maintenance guided by the bispectral index: closed-loop versus manual control: a prospective, randomized, multicenter study. Anesthesiology. 2006 Apr;104(4):686-95. doi: 10.1097/00000542-200604000-00012.

Reference Type: BACKGROUND

PMID: 16571963 (View on PubMed)

Liu N, Chazot T, Trillat B, Pirracchio R, Law-Koune JD, Barvais L, Fischler M. Feasibility of closed-loop titration of propofol guided by the Bispectral Index for general anaesthesia induction: a prospective randomized study. Eur J Anaesthesiol. 2006 Jun;23(6):465-9. doi: 10.1017/S0265021506000196.

Reference Type: BACKGROUND

PMID: 16672092 (View on PubMed)

Other Identifiers

Foch-3

Identifier Type: -

Identifier Source: org_study_id