Anesthesic Propofol and Remifentanil Requirements in Obese Patients

Study Overview
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Brief Summary
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Pharmacokinetic models for anesthetic agents are questionable. The objective of the study is to compare the propofol and remifentanil doses required to maintain the bispectral index in the range 40-60 in two groups of patients: obese patients and lean patients

Official Title
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Intravenous Anesthesia in Obese Patients: Propofol and Remifentanil Requirements

Conditions
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Anesthesia, Obesity

Intervention / Treatment
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* Procedure: bariatric coelioscopic surgical procedure
* Procedure: supra-umbilical coelioscopic surgical procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Patients scheduled for a bariatric coelioscopic surgical procedure (obese patients) or for an upper abdominal laparoscopic procedure (lean patients) Exclusion Criteria: age lower than 18 years, pregnant woman, presence of a central neurological disorder or a lesion cerebral, of a severe respiratory or hepatic insufficiency, allergy to propofol, or to soja or to peanuts, or to sufentanil, or to remifentanil, or to morphine, or to a muscle myorelaxant, or to an excipient, hypersensibility to sufentanil, or to remifentanil or to another derivate of fentanyl, allergy to latex, presence of a symptomatic gastroesophageal reflux, patients receiving a psychotropic treatment or a agonist-antagonist opiate, presence of predictive signs of difficult mask ventilation of difficult intubation (else than obesity)

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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>obese patients | Procedure: bariatric coelioscopic surgical procedure<br>* total intra-venous anesthesia (propofol and remifentanil) being delivered using a close-loop system with the Bispectral Index as the single input for the controller<br>|
| Active Comparator: 2<br>lean patients | Procedure: supra-umbilical coelioscopic surgical procedure<br>* total intra-venous anesthesia (propofol and remifentanil) being delivered using a closed-loop system with the Bispectral Index as the single input for the controller<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose of propofol administered |  | intraoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| remifentanil requirement, hemodynamic profile, time to extubation, performances of the automated system of propofol and remifentanil deliver |  | intraoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Anesthesia