Anesthesia for Obese Patients: Desflurane Versus Xenon

NCT01167803 | Completed Phase 4

• 2 other identifiers: PHRC-I/2009/EN-012009-017126-39
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 6

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).

Conditions

Obesity

Keywords

Bariatric surgery; Anesthesia

Outcome Measures

Primary Outcomes (1)

• 30 min DSST ratio

  (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)

  30 minutes post-op

Secondary Outcomes (4)

• 60 min DSST test

  60 minutes post-op

• 90 min DSST test

  90 min post-op

• Time to Aldrete score of 10

  Immediate post-op; this outcome measures the minutes of emergence (from anesthesia) time necessary to attain an Aldrete score of 10

• Quality of recovery score

  Day 1 post-op

Study Arms (2)

Reference - desflurane

ACTIVE COMPARATOR

The patients in this group will undergo anesthesia using remifentanil associated with desflurane.

Drug: Desflurane

Experimental - xenon

EXPERIMENTAL

The patients in this group will undergo anesthesia using remifentanil associated with xenon

Drug: Xenon

Interventions

Desflurane DRUG

Patients undergo anesthesia using remifentanil associated with desflurane

Reference - desflurane

Xenon DRUG

Patients undergo anesthesia using remifentanil associated with xenon

Experimental - xenon

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (6)

CHU de Clermont Ferrand - Hôpital Estaing

Clermont-Ferrand, 63000, France

Location

CHRU de Lille - Hôpital Claude Huriez

Lille, 59037, France

Location

CHU de Montpellier - Hôpital Saint-Eloi

Montpellier, 34295, France

Location

CHU de Nice - Hôpitaux L'Archet 1 et 2

Nice, 06202, France

Location

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

CHU de Poitiers

Poitiers, 86021, France

Location

MeSH Terms

Conditions

Obesity

Interventions

Desflurane; Xenon

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethyl Ethers; Ethers; Organic Chemicals; Methyl Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Noble Gases; Elements; Inorganic Chemicals; Gases

Study Officials

• Jacques Ripart, MD PhD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2010
• First Posted: July 22, 2010
• Study Start: December 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: December 1, 2012
• Last Updated: March 27, 2015

Record last verified: 2015-03

Locations

FR (6)