Anesthesia for Obese Patients: Desflurane Versus Xenon

Study Overview
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Brief Summary
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Obesity is increasing in France, resulting in an increased demand for bariatric surgery. However obesity also alters physiopathological pathways and the pharmacokinetics of anesthestic agents. The investigators objective is to compare, among morbidly obese patients, the immediate and intermediary emergence kinetics after balanced anesthesia using remifentanil associated either with desflurane (reference arm) or with xenon (experimental arm).

Official Title
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Coming Out of Anesthesia After Bariatric Surgery : Desflurane Versus Xenon

Conditions
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Obesity

Intervention / Treatment
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* Drug: Desflurane
* Drug: Xenon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists (ASA) I to III requires bariatric surgery body mass index (BMI) >= 35 kg/m2 patient speaks and writes French patient has signed consent form patient enrolled in a social security program Exclusion Criteria: patient refuses to sign consent ASA IV or more patient is pregnant or breastfeeding history of hyperthermy (or suspicion, or family history thereof) history of liver disease, icterus, unexplained fever, or eosinophilia after administration of a halogen anesthesia patient has symptomatic gastro-oesophagean reflux patient has hypersensitivity to one or more of the following substances: propofol, remifentanil, celocurine, cisatracurium, rocuronium, desflurane, xenon, paracetamol, ketoprofen, nefopam, tramadol patient has obstructive respiratory failure (chronic obstruction pneumopathy, asthma) or has heart disease with severly altered cardiac function patient has high intracranial pressure patient requires high concentrations of oxygen (fio2>40%) patient has a neuro-sensorial deficient which prevents reading, writing, or response to simple oral commands (severe deafness, language impairment...)in the absence of a prothesis patient has a psychiatric pathology, or chronically consumes alcohol or other mind-altering substance patient has had general anesthesia in the last 15 days patient under guardianship impossible to correctly communicate information to the patient absence of efficient contraception for women of childbearing age participation in another study within the last 3 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Reference - desflurane<br>The patients in this group will undergo anesthesia using remifentanil associated with desflurane. | Drug: Desflurane<br>* Patients undergo anesthesia using remifentanil associated with desflurane<br>|
| Experimental: Experimental - xenon<br>The patients in this group will undergo anesthesia using remifentanil associated with xenon | Drug: Xenon<br>* Patients undergo anesthesia using remifentanil associated with xenon<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30 min DSST ratio | (the number of correct responses to a Digit Symbol Substitution Test [DSST] 30 minutes after surgery) / (the number of correct responses to a Digit Symbol Substitution Test the night before the surgery) | 30 minutes post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 60 min DSST test | (the number of correct responses to a Digit Symbol Substitution Test 60 minutes after surgery) / (the number of correct responses to a Digit Symbol Substitution Test the night before the surgery) | 60 minutes post-op | 
| 90 min DSST test | (the number of correct responses to a Digit Symbol Substitution Test 90 minutes after surgery) / (the number of correct responses to a Digit Symbol Substitution Test the night before the surgery) | 90 min post-op | 
| Time to Aldrete score of 10 | Aldrete JA. The post-anesthesia recovery score revisited. J. Clin. Anesth. 1995. | Immediate post-op; this outcome measures the minutes of emergence (from anesthesia) time necessary to attain an Aldrete score of 10 | 
| Quality of recovery score | The score on the Quality of Recovery Scale: Myles PS, Weitkamp B, Jones K et al. Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br. J. Anaesth., 2000; 84: 11-15. | Day 1 post-op | 

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