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Anesthesia for Obese Patients: Desflurane Versus Xenon

Coming Out of Anesthesia After Bariatric Surgery : Desflurane Versus Xenon

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01167803
Acronym
XENON
Enrollment
192
Registered
2010-07-22
Start date
2010-12-31
Completion date
2012-12-31
Last updated
2015-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Bariatric surgery, Anesthesia

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).

Interventions

DRUGDesflurane

Patients undergo anesthesia using remifentanil associated with desflurane

DRUGXenon

Patients undergo anesthesia using remifentanil associated with xenon

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
30 min DSST ratio30 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

MeasureTime frameDescription
60 min DSST test60 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)
90 min DSST test90 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)
Time to Aldrete score of 10Immediate post-op; this outcome measures the minutes of emergence (from anesthesia) time necessary to attain an Aldrete score of 10Aldrete JA. The post-anesthesia recovery score revisited. J. Clin. Anesth. 1995.
Quality of recovery scoreDay 1 post-opThe 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026