Anesthesia for Obese Patients: Desflurane Versus Xenon

NCT ID: NCT01167803

Last Updated: 2015-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 192 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2012-12-31

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).

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Reference - desflurane

The patients in this group will undergo anesthesia using remifentanil associated with desflurane.

Group Type: ACTIVE_COMPARATOR

Desflurane

Intervention Type: DRUG

Patients undergo anesthesia using remifentanil associated with desflurane

Experimental - xenon

The patients in this group will undergo anesthesia using remifentanil associated with xenon

Group Type: EXPERIMENTAL

Xenon

Intervention Type: DRUG

Patients undergo anesthesia using remifentanil associated with xenon

Interventions

Desflurane

Patients undergo anesthesia using remifentanil associated with desflurane

Intervention Type: DRUG

Xenon

Patients undergo anesthesia using remifentanil associated with xenon

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacques Ripart, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Locations

CHU de Clermont Ferrand - Hôpital Estaing

Clermont-Ferrand, , France

CHRU de Lille - Hôpital Claude Huriez

Lille, , France

CHU de Montpellier - Hôpital Saint-Eloi

Montpellier, , France

CHU de Nice - Hôpitaux L'Archet 1 et 2

Nice, , France

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, , France

CHU de Poitiers

Poitiers, , France

Countries

France

Other Identifiers

2009-017126-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

PHRC-I/2009/EN-01

Identifier Type: -

Identifier Source: org_study_id