Anesthesia for Obese Patients: Desflurane Versus Xenon (XENON)
This study has been completed.
Sponsor:
Centre Hospitalier Universitaire de Nīmes
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01167803
First received: July 21, 2010
Last updated: March 29, 2013
Last verified: March 2013
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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 |
Resource links provided by NLM:
Further study details as provided by Centre Hospitalier Universitaire de Nīmes:
Primary Outcome Measures:
- 30 min DSST ratio [ Time Frame: 30 minutes post-op ] [ Designated as safety issue: No ](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)
Secondary Outcome Measures:
- 60 min DSST test [ Time Frame: 60 minutes post-op ] [ Designated as safety issue: No ](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)
- 90 min DSST test [ Time Frame: 90 min post-op ] [ Designated as safety issue: No ](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)
- Time to Aldrete score of 10 [ Time Frame: Immediate post-op; this outcome measures the minutes of emergence (from anesthesia) time necessary to attain an Aldrete score of 10 ] [ Designated as safety issue: No ]Aldrete JA. The post-anesthesia recovery score revisited. J. Clin. Anesth. 1995.
- Quality of recovery score [ Time Frame: Day 1 post-op ] [ Designated as safety issue: No ]
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.
| Enrollment: | 192 |
| Study Start Date: | October 2010 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | November 2012 (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 |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01167803
Locations
| France | |
| CHU de Clermont Ferrand - Hôpital Estaing | |
| Clermont Ferrand, France, 63000 | |
| CHRU de Lille - Hôpital Claude Huriez | |
| Lille, France, 59037 | |
| CHU de Montpellier - Hôpital Saint-Eloi | |
| Montpellier Cedex 5, France, 34295 | |
| CHU de Nice - Hôpitaux L'Archet 1 et 2 | |
| Nice, France, 06202 | |
| CHU de Nîmes - Hôpital Universitaire Carémeau | |
| Nîmes, France, 30029 | |
| CHU de Poitiers | |
| Poitiers Cedex, France, 86021 | |
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
| Principal Investigator: | Jacques Ripart, MD PhD | Centre Hospitalier Universitaire de Nîmes |
More Information
No publications provided
| 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: | March 29, 2013 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) France: Committee for the Protection of Personnes |
Keywords provided by Centre Hospitalier Universitaire de Nīmes:
|
Bariatric surgery Anesthesia |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on June 18, 2013