Influence of Esmolol on a Closed-Loop Anesthesia System

Study Overview
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Brief Summary
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Main objective is to evaluate the sparing effect of esmolol on the required doses of propofol and remifentanil

Official Title
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Closed-loop Delivery of Propofol and Remifentanil: Sparing Effect of Esmolol

Conditions
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Anesthesia

Intervention / Treatment
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* Drug: NaCl 9/00
* Drug: Esmolol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male patients scheduled for a general anesthesia Exclusion Criteria: age lower than 18 years allergy to propofol, or to soja or to peanuts, or to sufentanil, to remifentanil, or to morphine, or to a myorelaxant or to an excipient, any other history of anaphylactic reaction, hypersensibility to sufentanil, or to remifentanil, or to other derivate of fentanyl, hypersensibility to esmolol or to an excipient, history of central nervous system disease, patients receiving a psychotropic treatment or an agonist-antagonist opiate, hypovolemic patients, patients receiving a cardio-vascular treatment, patients with a pacemaker, expected bleeding more than 20% of the blood volume, simultaneous general and loco-regional anesthesia, patients suffering from asthma, COPD, trouble of the heart rhythm or conduction, cardiac insufficiency, cardiogenogenic shock, Prinzmetal syndrome, pheochromocytoma, patients with a heart rate less than 50/min and/or an arterial hypotension, neurosurgical act or any other which precludes an adequate positioning of the bispectral electrode.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>patients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and a placebo | Drug: NaCl 9/00<br>* Same volume as in the esmolol group<br>|
| Experimental: Esmolol<br>patients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and esmolol | Drug: Esmolol<br>* 1 mg/kg administrated over 10 minutes followed by an infusion of 0,2 mg/kg/hr during all the anesthetic period<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| administered doses of propofol and of remifentanil during anesthesia |  | end of anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| delay before recovery |  | at the end of anesthesia | 
| hemodynamic abnormalities requiring a treatment |  | end of anesthesia | 
| postoperative morphine requirement |  | Third post-anesthetic hour | 
| explicit memorisation |  | Second postoperative day |