Anesthesia for Obese Patients: Desflurane Versus Xenon (XENON)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01167803
First received: July 21, 2010
Last updated: March 3, 2014
Last verified: March 2014
  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 Intervention Phase
Obesity
Drug: Desflurane
Drug: Xenon
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Coming Out of Anesthesia After Bariatric Surgery : Desflurane Versus Xenon

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • 30 min DSST ratio [ Time Frame: 30 minutes post-op ] [ Designated as safety issue: No ]
    (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)


Secondary Outcome Measures:
  • 60 min DSST test [ Time Frame: 60 minutes post-op ] [ Designated as safety issue: No ]
    (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)

  • 90 min DSST test [ Time Frame: 90 min post-op ] [ Designated as safety issue: No ]
    (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)

  • Time to Aldrete score of 10 [ Time Frame: Immediate post-op; this outcome measures the minutes of emergence (from anesthesia) time necessary to attain an Aldrete score of 10 ] [ Designated as safety issue: No ]
    Aldrete JA. The post-anesthesia recovery score revisited. J. Clin. Anesth. 1995.

  • Quality of recovery score [ Time Frame: Day 1 post-op ] [ Designated as safety issue: No ]

    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.



Enrollment: 192
Study Start Date: October 2010
Study Completion Date: December 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01167803

Locations
France
CHU de Clermont Ferrand - Hôpital Estaing
Clermont Ferrand, France, 63000
CHRU de Lille - Hôpital Claude Huriez
Lille, France, 59037
CHU de Montpellier - Hôpital Saint-Eloi
Montpellier Cedex 5, France, 34295
CHU de Nice - Hôpitaux L'Archet 1 et 2
Nice, France, 06202
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, France, 30029
CHU de Poitiers
Poitiers Cedex, France, 86021
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Jacques Ripart, MD PhD Centre Hospitalier Universitaire de Nîmes
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01167803     History of Changes
Other Study ID Numbers: PHRC-I/2009/EN-01, 2009-017126-39
Study First Received: July 21, 2010
Last Updated: March 3, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes

Keywords provided by Centre Hospitalier Universitaire de Nīmes:
Bariatric surgery
Anesthesia

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Anesthetics
Xenon
Desflurane
Remifentanil
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Inhalation
Anesthetics, General
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Anesthetics, Intravenous

ClinicalTrials.gov processed this record on August 20, 2014