Anesthesia for Obese Patients: Desflurane Versus Xenon (XENON)

Centre Hospitalier Universitaire de Nīmes

Status and phase

Completed

Phase 4

Conditions

Obesity

Treatments

Drug: Desflurane

Drug: Xenon

Study type

Interventional

Funder types

Other

Identifiers

NCT01167803

PHRC-I/2009/EN-01

2009-017126-39 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment

192 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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