Influence of Muscle Relaxation on a Closed-loop Anesthesia System

Study Overview
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Brief Summary
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Total intra-venous anesthesia can be provided using a closed-loop system guided by the bispectral index. The purpose of this study is to determine if myorelaxation modifies its functioning.

Official Title
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Effect of Continuous Myorelaxation on the Need for Hypnotic Agent During Surgical Procedures Which do Not Require it (Multicenter, Randomized and Prospective Study)

Conditions
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Anesthesia, General

Intervention / Treatment
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* Drug: muscle relaxant
* Drug: normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients scheduled for a surgical procedure which not require a myorelaxation Exclusion Criteria: age less than 18 years, ASA III and above, pregnant woman combined general and regional anesthesia, history of prolonged myorelaxation due to a decrease in cholinesterase, patient with a known lack in cholinesterase, history of cerebral or psychiatric central, allergy to latex, propofol, remifentanil, morphine, muscle relaxant or any of the excipients, known hypersensitivity to remifentanil or to an other derivative of fentanyl, presence of a pacemaker, psychotropic or agonist-antagonist morphine treatment, planned post-operative sedation.

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Total intravenous anesthesia (propofol and remifentanil) is provided using the close-loop system. A muscle relaxant is used to facilitate tracheal intubation; its administration is continued throughout anesthesia. | Drug: muscle relaxant<br>* muscle relaxant administration throughout anesthesia<br>|
| Experimental: 2<br>Total intravenous anesthesia (propofol and remifentanil) is provided using the close-loop system. No muscle relaxant is used and a placebo is infused throughout anesthesia. | Drug: normal saline<br>* no muscle relaxant throughout anesthesia (normal saline infused as a placebo)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| propofol dose |  | one hour anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| remifentanil dose |  | one hour anesthesia | 
| number of automatic modifications of the propofol and remifentanil concentrations |  | one hour anesthesia | 
| number of patients' movements |  | one hour anesthesia | 
| number of hemodynamic abnormalities requiring treatment |  | one hour anesthesia | 
| time to wake up |  | end of anesthesia | 
| intraoperative awareness |  | postoperative day 1 or 2 | 
| performance of the closed-loop system |  | one hour anesthesia |