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

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

Detailed Description
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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.

Official Title
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Target-controlled Infusion of Propofol and Remifentanil During General Anaesthesia Guided by the Index Bispectral: Comparison Between Manual Perfusion and Automated Perfusion

Conditions
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Anesthesia, General

Intervention / Treatment
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* Device: Closed-loop anesthesia system


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Closed-loop anesthesia system|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  |