Clinical trial NCT01167803: Anesthesia for Obese Patients: Desflurane Versus Xenon
Official title: Coming Out of Anesthesia After Bariatric Surgery : Desflurane Versus Xenon
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obesity
Keywords: Bariatric surgery
Anesthesia
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2010-07-22
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: 30 min DSST ratio
timeFrame: 30 minutes post-op
Secondary outcomes:
measure: 60 min DSST test
timeFrame: 60 minutes post-op
measure: 90 min DSST test
timeFrame: 90 min post-op
measure: Time to Aldrete score of 10
timeFrame: Immediate post-op; this outcome measures the minutes of emergence (from anesthesia) time necessary to attain an Aldrete score of 10
measure: Quality of recovery score
timeFrame: Day 1 post-op
Other outcomes:
Locations:
city: Clermont Ferrand
country: France
facility: CHU de Clermont Ferrand - Hôpital Estaing
city: Lille
country: France
facility: CHRU de Lille - Hôpital Claude Huriez
city: Montpellier Cedex 5
country: France
facility: CHU de Montpellier - Hôpital Saint-Eloi
city: Nice
country: France
facility: CHU de Nice - Hôpitaux L'Archet 1 et 2
city: Nîmes
country: France
facility: CHU de Nîmes - Hôpital Universitaire Carémeau
city: Poitiers Cedex
country: France
facility: CHU de Poitiers
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Jacques Ripart, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: