Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2025-12-27 @ 11:32 PM
Study NCT ID:
NCT01167803
Status:
COMPLETED
Last Update Posted:
2015-03-27
First Post:
2010-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anesthesia for Obese Patients: Desflurane Versus Xenon
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077335', 'term': 'Desflurane'}, {'id': 'D014978', 'term': 'Xenon'}], 'ancestors': [{'id': 'D005019', 'term': 'Ethyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D005741', 'term': 'Noble Gases'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D005740', 'term': 'Gases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 192}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-26', 'studyFirstSubmitDate': '2010-07-21', 'studyFirstSubmitQcDate': '2010-07-21', 'lastUpdatePostDateStruct': {'date': '2015-03-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '30 min DSST ratio', 'timeFrame': '30 minutes post-op', 'description': '(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)'}], 'secondaryOutcomes': [{'measure': '60 min DSST test', 'timeFrame': '60 minutes post-op', 'description': '(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)'}, {'measure': '90 min DSST test', 'timeFrame': '90 min post-op', 'description': '(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)'}, {'measure': 'Time to Aldrete score of 10', 'timeFrame': 'Immediate post-op; this outcome measures the minutes of emergence (from anesthesia) time necessary to attain an Aldrete score of 10', 'description': 'Aldrete JA. The post-anesthesia recovery score revisited. J. Clin. Anesth. 1995.'}, {'measure': 'Quality of recovery score', 'timeFrame': 'Day 1 post-op', 'description': 'The score on the Quality of Recovery Scale:\n\nMyles 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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bariatric surgery', 'Anesthesia'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) I to III\n* requires bariatric surgery\n* body mass index (BMI) \\>= 35 kg/m2\n* patient speaks and writes French\n* patient has signed consent form\n* patient enrolled in a social security program\n\nExclusion Criteria:\n\n* patient refuses to sign consent\n* ASA IV or more\n* patient is pregnant or breastfeeding\n* history of hyperthermy (or suspicion, or family history thereof)\n* history of liver disease, icterus, unexplained fever, or eosinophilia after administration of a halogen anesthesia\n* patient has symptomatic gastro-oesophagean reflux\n* patient has hypersensitivity to one or more of the following substances: propofol, remifentanil, celocurine, cisatracurium, rocuronium, desflurane, xenon, paracetamol, ketoprofen, nefopam, tramadol\n* patient has obstructive respiratory failure (chronic obstruction pneumopathy, asthma) or has heart disease with severly altered cardiac function\n* patient has high intracranial pressure\n* patient requires high concentrations of oxygen (fio2\\>40%)\n* 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\n* patient has a psychiatric pathology, or chronically consumes alcohol or other mind-altering substance\n* patient has had general anesthesia in the last 15 days\n* patient under guardianship\n* impossible to correctly communicate information to the patient\n* absence of efficient contraception for women of childbearing age\n* participation in another study within the last 3 months'}, 'identificationModule': {'nctId': 'NCT01167803', 'acronym': 'XENON', 'briefTitle': 'Anesthesia for Obese Patients: Desflurane Versus Xenon', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Coming Out of Anesthesia After Bariatric Surgery : Desflurane Versus Xenon', 'orgStudyIdInfo': {'id': 'PHRC-I/2009/EN-01'}, 'secondaryIdInfos': [{'id': '2009-017126-39', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Reference - desflurane', 'description': 'The patients in this group will undergo anesthesia using remifentanil associated with desflurane.', 'interventionNames': ['Drug: Desflurane']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental - xenon', 'description': 'The patients in this group will undergo anesthesia using remifentanil associated with xenon', 'interventionNames': ['Drug: Xenon']}], 'interventions': [{'name': 'Desflurane', 'type': 'DRUG', 'description': 'Patients undergo anesthesia using remifentanil associated with desflurane', 'armGroupLabels': ['Reference - desflurane']}, {'name': 'Xenon', 'type': 'DRUG', 'description': 'Patients undergo anesthesia using remifentanil associated with xenon', 'armGroupLabels': ['Experimental - xenon']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63000', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU de Clermont Ferrand - Hôpital Estaing', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'CHRU de Lille - Hôpital Claude Huriez', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'CHU de Montpellier - Hôpital Saint-Eloi', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '06202', 'city': 'Nice', 'country': 'France', 'facility': "CHU de Nice - Hôpitaux L'Archet 1 et 2", 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'CHU de Nîmes - Hôpital Universitaire Carémeau', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '86021', 'city': 'Poitiers', 'country': 'France', 'facility': 'CHU de Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}], 'overallOfficials': [{'name': 'Jacques Ripart, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire de Nîmes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}