Information obtained from ClinicalTrials.gov on September 02, 2010
Link to the current ClinicalTrials.gov record.
Anesthesia for Obese Patients: Desflurane vs Xenon
Status: Not yet recruiting
Verified by: Centre Hospitalier Universitaire de Nīmes, July 2010
Last Updated: August 5, 2010
Sponsor: Centre Hospitalier Universitaire de Nīmes
Purpose
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).
Condition: Bariatric Surgery
Study Type: Interventional
Study Design: Allocation: Randomized, Control: Active Control, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Intervention: Drug: Desflurane
Intervention: Drug: Xenon
Phase: Phase 4
Primary Outcome Measures:
Secondary Outcome Measures:
- 60 min DSST test
- 90 min DSST test
- Time to Aldrete score of 10
- Quality of recovery score
Estimated Enrollment: 140
Start Date: September 2010
Primary Completion Date: September 2013
Eligibility
Minimum Age: 18 Years
Maximium Age: 65 Years
Accepts Healthy Volunteers: No
Gender: Both
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
Location and Contacts
Contact: Jacques Ripart, MD PhD, 04.66.68.30.50, jacques.ripart@chu-nimes.fr
Contact: Carey Suehs, PhD, 04.66.68.67.88, carey.suehs@chu-nimes.fr
CHU Hôtel Dieu D.A.R.
Clermont Ferrand,
63000
France
CHU de Lille - Hôpital Huriez
Lille,
59037
France
CHU de Montpellier - Hôpital Saint Eloi
Montpellier Cedex 5,
34295
France
Hôpital de l'Archet
Nice,
06202
France
Centre Hospitalier Universitaire de Nîmes
Nîmes,
30029
France
CHU de Poitiers
Poitiers Cedex,
86021
France