XENON: Anesthesia for Obese Patients: Desflurane Versus Xenon
Study Details
Study Description
Brief Summary
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 or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
|
Outcome Measures
Primary Outcome Measures
- 30 min DSST ratio [30 minutes post-op]
(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 [60 minutes post-op]
(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 [90 min post-op]
(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 [Immediate post-op; this outcome measures the minutes of emergence (from anesthesia) time necessary to attain an Aldrete score of 10]
Aldrete JA. The post-anesthesia recovery score revisited. J. Clin. Anesth. 1995.
- Quality of recovery score [Day 1 post-op]
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.
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU de Clermont Ferrand - Hôpital Estaing | Clermont Ferrand | France | 63000 | |
| 2 | CHRU de Lille - Hôpital Claude Huriez | Lille | France | 59037 | |
| 3 | CHU de Montpellier - Hôpital Saint-Eloi | Montpellier Cedex 5 | France | 34295 | |
| 4 | CHU de Nice - Hôpitaux L'Archet 1 et 2 | Nice | France | 06202 | |
| 5 | CHU de Nîmes - Hôpital Universitaire Carémeau | Nîmes | France | 30029 | |
| 6 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PHRC-I/2009/EN-01
- 2009-017126-39