Lidocaine and Closed-Loop Anesthesia System

Study Overview
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Brief Summary
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The objective is to evaluate the sparing effect of Lidocaine on doses of propofol and remifentanil.

Official Title
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Influence of Lidocaine on a Closed-Loop Anesthesia System

Conditions
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Anesthesia

Intervention / Treatment
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* Drug: Lidocaine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients ASA 1, 2 or 3 scheduled for a general anesthesia surgical procedure (abdominal surgery, urology, ENT major procedure) lasting between 1 and 3 hours Exclusion Criteria: age under 18 years simultaneous general and loco-regional anesthesia allergy to NSAID treatment with verapamil, ketamine or gabapentin patients receiving an opioid preoperatively severe hepatic insufficiency contra-indication to lidocaine contra-indication to propofol or to remifentanil history of central nervous system disease patients receiving a psychotropic treatment patients with a pace-maker

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lidocaine<br>Patients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and Lidocaine | Drug: Lidocaine<br>* bolus dose of lidocaine (1.5 mg.kg-1) followed by an infusion of lidocaine (2 mg.kg-1 h-1) until the end of anesthesia. start of the induction of anesthesia 10 minutes after the bolus dose of lidocaine<br>|
| Placebo Comparator: Placebo<br>patients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and a placebo | Drug: Placebo<br>* NaCl 9/00 (same volume as in the lidocaine group) start of the induction of anesthesia 10 minutes after the bolus dose of NaCl 9/00<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| administered dose of propofol during maintenance of anesthesia |  | day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| administered dose of propofol during induction of anesthesia |  | day 1 | 
| administered doses of remifentanil during induction and maintenance of anesthesia |  | day 1 | 
| delay (measured as minutes) between the end of propofol and remifentanil administration and the recovery from anesthesia |  | day 1 | 
| hemodynamic abnormalities requiring treatment |  | day 1 | 
| % of time with a BIS index between 40 and 60 |  | day 1 | 
| postoperative morphine requirement |  | day 1 | 
| incidence of postoperative nausea and vomiting |  | day 1 | 
| % of patients with an explicit memorisation of the intraoperative period |  | second postoperative day |