Clinical trial NCT00392158: Manual Administration of Propofol-remifentanil Versus Dual Closed-loop Using Bispectral Index as the Control Variable
Official title: Target-controlled Infusion of Propofol and Remifentanil During General Anaesthesia Guided by the Index Bispectral: Comparison Between Manual Perfusion and Automated Perfusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia, General
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2006-10-25
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Global score (calculated parameter which depicts the performance of the system, i.e. its capacity to maintain BIS in the desired range)
Secondary outcomes:
measure: consumption of propofol and remifentanil during the induction and the maintenance of the anaesthesia
measure: number of modifications of target of propofol and remifentanil
measure: number of episodes of hemodynamic anomalies having required a treatment
measure: intraoperative volume loading and transfusion
measure: extubation time, explicit memorisation
measure: dysfunctions of each system
Other outcomes:
Locations:
city: Argenteuil
country: France
facility: Dept of Anesthesia, CH d'Argenteuil
city: Besançon
country: France
facility: Dept of Anesthesiology, CHU de Besançon
city: Bordeaux
country: France
facility: Dept of Anesthesia, Clinique Saint Augustin
city: Clichy
country: France
facility: Dept of Anesthesia and Intensive Care, Hôpital Beaujon
city: Paris
country: France
facility: Dept of Anesthesiology, Hôpital Cochin
city: Suresnes
country: France
facility: Dept of Anesthesia, Hôpital Foch
Study officials:
affiliation: Hôpital Foch
name: Marc Fischler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.