Ignite Creation Date:
2025-12-24 @ 1:49 PM
Ignite Modification Date:
2026-02-13 @ 4:35 PM
Study NCT ID:
NCT02545595
Status:
COMPLETED
Last Update Posted:
2016-10-12
First Post:
2013-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sugammadex Dosage Based on Ideal Body Weight for Profound Rocuronium-induced Neuromuscular Blockade Reversal in Morbidly Obese Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'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': 'D000077122', 'term': 'Sugammadex'}], 'ancestors': [{'id': 'D047408', 'term': 'gamma-Cyclodextrins'}, {'id': 'D003505', 'term': 'Cyclodextrins'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D003912', 'term': 'Dextrins'}, {'id': 'D013213', 'term': 'Starch'}, {'id': 'D005936', 'term': 'Glucans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL'}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'lastUpdateSubmitDate': '2016-10-10', 'studyFirstSubmitDate': '2013-03-27', 'studyFirstSubmitQcDate': '2015-09-09', 'lastUpdatePostDateStruct': {'date': '2016-10-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'determine a profound neuromuscular blockade reversal on ideal body weight', 'timeFrame': '30 minutes', 'description': 'A complete reversal failure is defined by a Train Of Four ratio \\< 0.9 within 10 min after administration of Sugammadex or if recurarization occurs within 15 min after complete reversal success'}], 'secondaryOutcomes': [{'measure': 'Compare dosages based on ideal body weight to real body weight', 'timeFrame': '30 minutes'}]}, 'conditionsModule': {'keywords': ['General anaesthesia', 'Curarization with rocuronium'], 'conditions': ['Morbid Obesity']}, 'descriptionModule': {'briefSummary': 'This randomized double blind clinical trial focuses on patients with Body Masse Index ≥ 40 kg/m2, undergoing scheduled surgery. Neuromuscular transmission monitoring at the adductor is performed using. Anaesthesia is induced with anaesthesic and maintained with curare. At the end of the procedure, patients with profound neuromuscular blockade receive either 1 mg/kg, 2 mg/kg or 4 mg/kg Sugammadex based on ideal body weight. A complete reversal failure is defined by a Train Of Four ratio \\< 0.9 within 10 min after administration of Sugammadex or if recurarization occurs within 15 min after complete reversal success.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* General anaesthesia\n* Neuromuscular blockade induce by rocuronium\n* Body Masse Indice ≥ 40 kg/m2\n* informed consent\n\nExclusion Criteria:\n\n* Contraindication to rocuronium or sugammadex\n* Pregnant women\n* Severe renal insufficiency'}, 'identificationModule': {'nctId': 'NCT02545595', 'briefTitle': 'Sugammadex Dosage Based on Ideal Body Weight for Profound Rocuronium-induced Neuromuscular Blockade Reversal in Morbidly Obese Patients', 'organization': {'class': 'OTHER', 'fullName': 'Poitiers University Hospital'}, 'orgStudyIdInfo': {'id': 'OBRITI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sugammadex 1mg/kg', 'description': 'for profound rocuronium-induced neuromuscular blockade reversal in morbidly obese patients', 'interventionNames': ['Drug: Sugammadex 1 mg/kg']}, {'type': 'EXPERIMENTAL', 'label': 'Sugammadex 2mg/kg', 'description': 'for profound rocuronium-induced neuromuscular blockade reversal in morbidly obese patients', 'interventionNames': ['Drug: Sugammadex 2 mg/kg']}, {'type': 'EXPERIMENTAL', 'label': 'Sugammadex 4mg/kg', 'description': 'for profound rocuronium-induced neuromuscular blockade reversal in morbidly obese patients', 'interventionNames': ['Drug: Sugammadex 4 mg/kg']}], 'interventions': [{'name': 'Sugammadex 1 mg/kg', 'type': 'DRUG', 'armGroupLabels': ['Sugammadex 1mg/kg']}, {'name': 'Sugammadex 2 mg/kg', 'type': 'DRUG', 'armGroupLabels': ['Sugammadex 2mg/kg']}, {'name': 'Sugammadex 4 mg/kg', 'type': 'DRUG', 'armGroupLabels': ['Sugammadex 4mg/kg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '86021', 'city': 'Poitiers', 'country': 'France', 'facility': 'CHU de Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poitiers University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}