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Completed

NCT Number: NCT01167803

Anesthesia for Obese Patients: Desflurane Versus Xenon

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).

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHU de Clermont Ferrand - Hôpital Estaing, Clermont-Ferrand, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Desflurane

Drug

Patients undergo anesthesia using remifentanil associated with desflurane

Xenon

Drug

Patients undergo anesthesia using remifentanil associated with xenon

Primary outcomes

  1. 30 min DSST ratio

    Time frame: 30 minutes post-op

    (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 outcomes

  1. 60 min DSST test

    Time frame: 60 minutes post-op

    (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)

  2. 90 min DSST test

    Time frame: 90 min post-op

    (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)

  3. 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

    Aldrete JA. The post-anesthesia recovery score revisited. J. Clin. Anesth. 1995.

  4. Quality of recovery score

    Time frame: Day 1 post-op

    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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

Coming Out of Anesthesia After Bariatric Surgery : Desflurane Versus Xenon

Acronym: XENON

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jul 22, 2010
Registry last updated
Mar 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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