Anesthesia for Obese Patients: Desflurane Versus Xenon

Phase 4

Completed

• Conditions: Obesity
• Interventions: Drug: Desflurane; Drug: Xenon

• Registration Number: NCT01167803
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-07-21
• Study First Submitted QC: 2010-07-21
• Study First Posted: 2010-07-22
• Study Start: 2010-12
• Primary Completion: 2012-11
• Study Completion: 2012-12
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-26
• Last Update Posted: 2015-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 192

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reference - desflurane	Desflurane	The patients in this group will undergo anesthesia using remifentanil associated with desflurane.
Experimental - xenon	Xenon	The patients in this group will undergo anesthesia using remifentanil associated with xenon

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)
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.
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)
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.

Trial Locations

Locations (6)

CHU de Nice - Hôpitaux L'Archet 1 et 2; 🇫🇷 Nice, France

CHU de Clermont Ferrand - Hôpital Estaing; 🇫🇷 Clermont Ferrand, France

CHRU de Lille - Hôpital Claude Huriez; 🇫🇷 Lille, France

CHU de Montpellier - Hôpital Saint-Eloi; 🇫🇷 Montpellier Cedex 5, France

CHU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes, France

CHU de Poitiers; 🇫🇷 Poitiers Cedex, France