Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 10:14 PM
Study NCT ID:
NCT01785758
Status:
COMPLETED
Last Update Posted:
2013-02-07
First Post:
2013-02-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Sugammadex in Renal Diseased Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-05', 'studyFirstSubmitDate': '2013-02-03', 'studyFirstSubmitQcDate': '2013-02-05', 'lastUpdatePostDateStruct': {'date': '2013-02-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Reoccurrence of neuromuscular blockade', 'timeFrame': '24 hours', 'description': 'Patients will be monitored for evidence of reoccurrence of neuromuscular blockade for the first two hours after administration of sugammadex and clinically reevaluated after 24 hours'}], 'primaryOutcomes': [{'measure': 'Time from administration of sugammadex to recovery of the train-of-four ratio (TOF) to 0.9', 'timeFrame': '2 hours'}], 'secondaryOutcomes': [{'measure': 'Time from administration of sugammadex to recovery of the train-of-four ratio (TOF) to 0.7 and 0.8', 'timeFrame': '2 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['complications, renal;', 'kidney, failure;', 'neuromuscular block, antagonism;', 'neuromuscular block, rocuronium;', 'safety, drug', 'sugammadex'], 'conditions': ['Kidney Failure, Chronic', 'Neuromuscular Blockade']}, 'referencesModule': {'references': [{'pmid': '18653492', 'type': 'BACKGROUND', 'citation': 'Staals LM, Snoeck MM, Driessen JJ, Flockton EA, Heeringa M, Hunter JM. Multicentre, parallel-group, comparative trial evaluating the efficacy and safety of sugammadex in patients with end-stage renal failure or normal renal function. Br J Anaesth. 2008 Oct;101(4):492-7. doi: 10.1093/bja/aen216. Epub 2008 Jul 23.'}, {'pmid': '20007792', 'type': 'BACKGROUND', 'citation': 'Staals LM, Snoeck MM, Driessen JJ, van Hamersvelt HW, Flockton EA, van den Heuvel MW, Hunter JM. Reduced clearance of rocuronium and sugammadex in patients with severe to end-stage renal failure: a pharmacokinetic study. Br J Anaesth. 2010 Jan;104(1):31-9. doi: 10.1093/bja/aep340.'}, {'pmid': '26225497', 'type': 'DERIVED', 'citation': 'de Souza CM, Tardelli MA, Tedesco H, Garcia NN, Caparros MP, Alvarez-Gomez JA, de Oliveira Junior IS. Efficacy and safety of sugammadex in the reversal of deep neuromuscular blockade induced by rocuronium in patients with end-stage renal disease: A comparative prospective clinical trial. Eur J Anaesthesiol. 2015 Oct;32(10):681-6. doi: 10.1097/EJA.0000000000000312.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether sugammadex reverses a profound neuromuscular blockade induced by rocuronium in patients with end-stage renal disease just as effectively and safely as it does in patients with normal renal function.', 'detailedDescription': 'Sugammadex antagonizes rocuronium induced neuromuscular blockade by encapsulating the molecules of this agent in the plasma and originating a complex which is highly stable, and mainly eliminated by the kidneys. In patients with end stage renal disease, this complex remains in the circulation for days. Previous studies have shown that sugammadex adequately reverses the blockade induced by rocuronium in such patients, and no evidence of recurrence was observed after a dosis of 2 mg/Kg administered to reverse a moderate level of blockade. To our knowledge, nothing has been published so far on the reversal of profound blockade by sugammadex in patients with renal failure.\n\nThe aim of our study was to evaluate the efficacy and safety of sugammadex in the reversal of profound neuromuscular block (NMB) induced by rocuronium in patients with end-stage renal failure and compare it to patients with normal renal function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age between 18 and 65 years old\n* end-stage renal disease defined by clearance of creatinine \\< 30 ml/min\n* normal renal function defined by clearance if creatinine \\> 90 ml/min\n* candidates to elective surgical procedures (control group) or kidney transplantation (renal group) under general anaesthesia\n\nExclusion Criteria:\n\n* pregnant and breastfeeding women\n* patients with known or suspected neuromuscular disorders\n* patients with hepatic disfunction\n* a history of malignant hyperthermia\n* allergy to narcotics, rocuronium or other medication used during general anaesthesia\n* patients receiving medication known to interfere with the action of rocuronium (amino glycoside antibiotics, anticonvulsants, or magnesium)'}, 'identificationModule': {'nctId': 'NCT01785758', 'briefTitle': 'Efficacy and Safety of Sugammadex in Renal Diseased Patients', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of São Paulo'}, 'officialTitle': 'Efficacy and Safety of Sugammadex (Bridion™) in the Reversal of Profound Rocuronium-induced Neuromuscular Blockade in Patients With End-stage Renal Failure: Comparison With Healthy Patients', 'orgStudyIdInfo': {'id': 'Sugamadex01'}, 'secondaryIdInfos': [{'id': 'CEP 1277/11', 'type': 'OTHER', 'domain': 'Federal University of Sao Paulo - Ethics Committee'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Renal Group', 'description': 'Sugammadex (4mg/Kg) single dose to reverse profound neuromuscular blockade', 'interventionNames': ['Drug: Sugammadex (4 mg/Kg)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Sugammadex (4mg/Kg) single dose to reverse profound neuromuscular blockade', 'interventionNames': ['Drug: Sugammadex (4 mg/Kg)']}], 'interventions': [{'name': 'Sugammadex (4 mg/Kg)', 'type': 'DRUG', 'otherNames': ['Bridion'], 'description': 'Sugammadex administered at the end of surgical procedure, once skin suture had been finished, to reverse profound neuromuscular blockade induced and maintained with rocuronium', 'armGroupLabels': ['Control group', 'Renal Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04038002', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital do Rim e Hipertensão - Fundação Oswaldo Ramos', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Camila M Souza, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University of São Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of São Paulo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital General Universitario Santa Lucía', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Camila Machado de Souza', 'investigatorAffiliation': 'Federal University of São Paulo'}}}}