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| Sponsor: | Centre Hospitalier Universitaire de Nīmes |
|---|---|
| Information provided by: | Centre Hospitalier Universitaire de Nīmes |
| ClinicalTrials.gov Identifier: | NCT01167803 |
Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Obesity |
Drug: Desflurane Drug: Xenon |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Coming Out of Anesthesia After Bariatric Surgery : Desflurane Versus Xenon |
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.
| Estimated Enrollment: | 140 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Reference - desflurane
The patients in this group will undergo anesthesia using remifentanil associated with desflurane.
|
Drug: Desflurane
Patients undergo anesthesia using remifentanil associated with desflurane
|
|
Experimental: Experimental - xenon
The patients in this group will undergo anesthesia using remifentanil associated with xenon
|
Drug: Xenon
Patients undergo anesthesia using remifentanil associated with xenon
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Jacques Ripart, MD PhD | 04.66.68.30.50 | jacques.ripart@chu-nimes.fr |
| Contact: Carey Suehs, PhD | 04.66.68.67.88 | carey.suehs@chu-nimes.fr |
| France | |
| CHU Hôtel Dieu D.A.R. | Recruiting |
| Clermont Ferrand, France, 63000 | |
| Sub-Investigator: Jean Etienne Bazin, MD Phd | |
| CHU de Lille - Hôpital Huriez | Recruiting |
| Lille, France, 59037 | |
| Sub-Investigator: Gilles Lebuffe, MD PhD | |
| CHU de Montpellier - Hôpital Saint Eloi | Recruiting |
| Montpellier Cedex 5, France, 34295 | |
| Sub-Investigator: Samir Jaber, MD PhD | |
| Hôpital de l'Archet | Recruiting |
| Nice, France, 06202 | |
| Sub-Investigator: Marc Raucoules, MD PhD | |
| Sub-Investigator: Bernard Goubaux, MD | |
| Centre Hospitalier Universitaire de Nîmes | Recruiting |
| Nîmes, France, 30029 | |
| Principal Investigator: Emmanuel Nouvellon, MD | |
| Sub-Investigator: Jacques Ripart, MD PhD | |
| Sub-Investigator: Philippe Cuvillon, MD | |
| CHU de Poitiers | Recruiting |
| Poitiers Cedex, France, 86021 | |
| Sub-Investigator: Bertrand Debaene, MD PhD | |
More Information
| Responsible Party: | Dr Emmanuel Nouvellon, Centre Hospitalier Universitaire de Nîmes |
| ClinicalTrials.gov Identifier: | NCT01167803 History of Changes |
| Other Study ID Numbers: | PHRC-I/2009/EN-01, 2009-017126-39 |
| Study First Received: | July 21, 2010 |
| Last Updated: | July 7, 2011 |
| Health Authority: | France: Afssaps - French Health Products Safety Agency; France: Comité de Protection des Personnes Sud Méditerranée III |
|
Bariatric surgery Anesthesia |
|
Obesity Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms Anesthetics Xenon Desflurane Remifentanil Central Nervous System Depressants Physiological Effects of Drugs |
Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anesthetics, Inhalation Anesthetics, General Analgesics, Opioid Analgesics Sensory System Agents Peripheral Nervous System Agents Hypnotics and Sedatives Anesthetics, Intravenous |