Anesthesia for Obese Patients: Desflurane Versus Xenon (XENON)

Coming Out of Anesthesia After Bariatric Surgery : Desflurane Versus Xenon

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).

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Drug: Desflurane; Drug: Xenon

• Study Type: Interventional
• Enrollment (Actual): 192
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Clermont Ferrand, France, 63000
    • CHU de Clermont Ferrand - Hopital Estaing
  • Lille, France, 59037
    • CHRU de Lille - Hopital Claude Huriez
  • Montpellier Cedex 5, France, 34295
    • CHU de Montpellier - Hôpital Saint-Eloi
  • Nice, France, 06202
    • CHU de Nice - Hôpitaux L'Archet 1 et 2
  • Nîmes, France, 30029
    • CHU de Nimes - Hopital Universitaire Caremeau
  • Poitiers Cedex, France, 86021
    • CHU de Poitiers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30 min DSST ratio	(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)	30 minutes post-op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
60 min DSST test	(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)	60 minutes post-op
90 min DSST test	(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)	90 min post-op
Time to Aldrete score of 10	Aldrete JA. The post-anesthesia recovery score revisited. J. Clin. Anesth. 1995.	Immediate post-op; this outcome measures the minutes of emergence (from anesthesia) time necessary to attain an Aldrete score of 10
Quality of recovery score	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.	Day 1 post-op

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (ACTUAL): November 1, 2012
• Study Completion (ACTUAL): December 1, 2012

Study Registration Dates

• First Submitted: July 21, 2010
• First Submitted That Met QC Criteria: July 21, 2010
• First Posted (ESTIMATE): July 22, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): March 27, 2015
• Last Update Submitted That Met QC Criteria: March 26, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Bariatric surgery; Anesthesia
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, General; Anesthetics; Anesthetics, Inhalation; Desflurane
• Other Study ID Numbers: PHRC-I/2009/EN-01; 2009-017126-39 (EUDRACT_NUMBER)