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| Sponsor: | Centre Hospitalier Universitaire de Nīmes |
|---|---|
| Information provided by (Responsible Party): | 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 4 |
| 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: | April 2013 |
| Estimated Primary Completion Date: | April 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 de Clermont Ferrand - Hôpital Estaing | Recruiting |
| Clermont Ferrand, France, 63000 | |
| Sub-Investigator: Jean Etienne Bazin, MD Phd | |
| CHRU de Lille - Hôpital Claude Huriez | Completed |
| Lille, France, 59037 | |
| CHU de Montpellier - Hôpital Saint-Eloi | Recruiting |
| Montpellier Cedex 5, France, 34295 | |
| Sub-Investigator: Samir Jaber, MD PhD | |
| CHU de Nice - Hôpitaux L'Archet 1 et 2 | Recruiting |
| Nice, France, 06202 | |
| Sub-Investigator: Marc Raucoules, MD PhD | |
| Sub-Investigator: Bernard Goubaux, MD | |
| CHU de Nîmes - Hôpital Universitaire Carémeau | 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 | |
| Principal Investigator: | Jacques Ripart, MD PhD | Centre Hospitalier Universitaire de Nîmes |
More Information
| Responsible Party: | Centre Hospitalier Universitaire de Nīmes |
| 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: | February 16, 2012 |
| Health Authority: | France: Afssaps - French Health Products Safety Agency France: Committee for the Protection of Personnes |
|
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 |