Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2025-12-26 @ 5:32 PM
Study NCT ID:
NCT01972659
Status:
COMPLETED
Last Update Posted:
2014-02-25
First Post:
2013-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of Magnesium Sulphate on Sugammadex Reversal of Rocuronium Induced Blockade in Gynaecology Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D008278', 'term': 'Magnesium Sulfate'}, {'id': 'D008274', 'term': 'Magnesium'}, {'id': 'D000077122', 'term': 'Sugammadex'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D017616', 'term': 'Magnesium Compounds'}, {'id': 'D013431', 'term': 'Sulfates'}, {'id': 'D013464', 'term': 'Sulfuric Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D008673', 'term': 'Metals, Alkaline Earth'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D019565', 'term': 'Metals, Light'}, {'id': 'D008670', 'term': 'Metals'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'zehraipek48@gmail.com', 'phone': '00905325011339', 'title': 'Assistant Professor Dr Z Ipek ARSLAN AYDIN', 'organization': 'Kocaeli University Medical Faculty'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Sugammadex and Placebo', 'description': 'sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 placebo: isotonic saline (%0.9 NaCl) 50 mg/kg iv bolus plus 15 mg/kg continuous infusion until the end of surgery\n\nplacebo: Active comparator 50 mg/kg iv bolus plus 15 mg/kg continuous infusion\n\nsugammadex: 4 mg/kg iv bolus at the end of the surgery', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sugammadex and Magnesium Sulphate', 'description': 'sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 magnesium: 50 mg/kg iv bolus plus continuous infusion until the end of surgery\n\nMagnesium Sulphate: Experimental :\n\n50 mg/kg bolus plus 15 mg/kg continuous infusion\n\nsugammadex: 4 mg/kg iv bolus at the end of the surgery', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'TOF 0.9 Achieving Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sugammadex and Placebo', 'description': 'sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 placebo: isotonic saline (%0.9 NaCl) 50 mg/kg iv bolus plus 15 mg/kg continuous infusion until the end of surgery\n\nplacebo: Active comparator 50 mg/kg iv bolus plus 15 mg/kg continuous infusion\n\nsugammadex: 4 mg/kg iv bolus at the end of the surgery'}, {'id': 'OG001', 'title': 'Sugammadex and Magnesium Sulphate', 'description': 'sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 magnesium: 50 mg/kg iv bolus plus continuous infusion until the end of surgery\n\nMagnesium Sulphate: Experimental :\n\n50 mg/kg bolus plus 15 mg/kg continuous infusion\n\nsugammadex: 4 mg/kg iv bolus at the end of the surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '0.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'end of the surgery', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rocuronium Onset Time', 'timeFrame': 'during the surgery', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Rocuronium Supplementation', 'timeFrame': 'during surgery', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Postoperative Morphine Consumption', 'timeFrame': 'after 12 hour surgery', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sugammadex and Placebo', 'description': 'sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 placebo: isotonic saline (%0.9 NaCl) 50 mg/kg iv bolus plus 15 mg/kg continuous infusion until the end of surgery\n\nplacebo: Active comparator 50 mg/kg iv bolus plus 15 mg/kg continuous infusion\n\nsugammadex: 4 mg/kg iv bolus at the end of the surgery'}, {'id': 'FG001', 'title': 'Sugammadex and Magnesium Sulphate', 'description': 'sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 magnesium: 50 mg/kg iv bolus plus continuous infusion until the end of surgery\n\nMagnesium Sulphate: Experimental :\n\n50 mg/kg bolus plus 15 mg/kg continuous infusion\n\nsugammadex: 4 mg/kg iv bolus at the end of the surgery'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'problems realted to acceleromyograph', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sugammadex and Placebo', 'description': 'sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 placebo: isotonic saline (%0.9 NaCl) 50 mg/kg iv bolus plus 15 mg/kg continuous infusion until the end of surgery\n\nplacebo: Active comparator 50 mg/kg iv bolus plus 15 mg/kg continuous infusion\n\nsugammadex: 4 mg/kg iv bolus at the end of the surgery'}, {'id': 'BG001', 'title': 'Sugammadex and Magnesium Sulphate', 'description': 'sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 magnesium: 50 mg/kg iv bolus plus continuous infusion until the end of surgery\n\nMagnesium Sulphate: Experimental :\n\n50 mg/kg bolus plus 15 mg/kg continuous infusion\n\nsugammadex: 4 mg/kg iv bolus at the end of the surgery'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.3', 'spread': '10.3', 'groupId': 'BG000'}, {'value': '39.4', 'spread': '10.6', 'groupId': 'BG001'}, {'value': '40.1', 'spread': '10.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-10', 'studyFirstSubmitDate': '2013-10-11', 'resultsFirstSubmitDate': '2014-01-10', 'studyFirstSubmitQcDate': '2013-10-24', 'lastUpdatePostDateStruct': {'date': '2014-02-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-01-10', 'studyFirstPostDateStruct': {'date': '2013-10-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TOF 0.9 Achieving Time', 'timeFrame': 'end of the surgery'}], 'secondaryOutcomes': [{'measure': 'Rocuronium Onset Time', 'timeFrame': 'during the surgery'}, {'measure': 'Rocuronium Supplementation', 'timeFrame': 'during surgery'}, {'measure': 'Postoperative Morphine Consumption', 'timeFrame': 'after 12 hour surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['sugammadex', 'rocuronium', 'magnesium', 'female'], 'conditions': ['Pre-eclampsia Aggravated']}, 'descriptionModule': {'briefSummary': 'Background: The aim of this prospective study was to evaluate the effect of magnesium on the reversal of rocuronium-induced neuromuscular block by sugammadex.\n\nMethods: Eighty patients, aged 18 to 60 years, American Society of Anesthesiologists I-II, undergoing elective gynecological surgery were enrolled. Anaesthesia was induced with propofol and fentanyl and was maintained with 60% nitrous oxide and Oxygen in sevoflurane. The magnesium group received 50 milligram/kilogram (mg/kg) Magnesium intravenous (iv) as a bolus and 15 mg/kg/hour by continuous infusion until the completion of surgery. The placebo group received the equivalent volume of isotonic saline. For intubation, 0.6 mg/kg rocuronium was administered and 0.1 mg/kg was added when Train of four (TOF) counts reached 1 or more during the procedure. At the end of the surgery at a TOF count of 1, 4 mg/kg sugammadex iv was administered. Patients were observed until a TOF ratio of 0.9 was achieved. Patient-controlled analgesia with intravenous morphine was used postoperatively.', 'detailedDescription': 'Inclusion criteria:\n\n* American Society of Anesthesiologists physical status I or II\n* 18-60 years of age\n* undergoing elective gynecological surgery\n* requiring endotracheal intubation\n\nExclusion criteria:\n\n* Patients who had body mass index \\> 35\n* gastroesophageal reflux\n* a history of allergy\n* used medication known to interact with the drugs being used in this trial\n* who experienced expected or unexpected difficulty during intubation or ventilation\n* had neuromuscular disease\n* hepatic or renal insufficiency\n* pregnant\n* were American Society of Anesthesiologists III or IV\n* had a family history of malignant hyperthermia\n* detection if low or high control plasma magnesium levels'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* female patients\n* American Society of Anesthesiologists (ASA) physical status I or II\n* 18-60 years of age who were undergoing elective gynecological surgery\n* requiring endotracheal intubation were enrolled in this prospective study.\n\nExclusion Criteria:\n\n* Patients who had body mass index \\> 35\n* gastroesophageal reflux\n* a history of allergy\n* used medication known to interact with the drugs being used in this trial\n* who experienced expected or unexpected difficulty during intubation or ventilation\n* had neuromuscular disease\n* hepatic or renal insufficiency\n* were pregnant\n* had a family history of malignant hyperthermia\n* detection if low or high control plasma magnesium levels'}, 'identificationModule': {'nctId': 'NCT01972659', 'briefTitle': 'Effects of Magnesium Sulphate on Sugammadex Reversal of Rocuronium Induced Blockade in Gynaecology Patients', 'organization': {'class': 'OTHER', 'fullName': 'Kocaeli University'}, 'officialTitle': 'Effects of Magnesium Sulphate on Sugammadex Reversal of Rocuronium Induced Blockade in Gynaecology Patients', 'orgStudyIdInfo': {'id': 'KOU 2012 KAEK 144'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'sugammadex and placebo', 'description': 'sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 placebo: isotonic saline (%0.9 NaCl) 50 mg/kg iv bolus plus 15 mg/kg continuous infusion until the end of surgery', 'interventionNames': ['Drug: placebo', 'Drug: sugammadex']}, {'type': 'EXPERIMENTAL', 'label': 'sugammadex and magnesium sulphate', 'description': 'sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 magnesium: 50 mg/kg iv bolus plus continuous infusion until the end of surgery', 'interventionNames': ['Drug: Magnesium Sulphate', 'Drug: sugammadex']}], 'interventions': [{'name': 'placebo', 'type': 'DRUG', 'otherNames': ['%0.9 NaCl', 'isotonic saline'], 'description': 'Active comparator 50 mg/kg iv bolus plus 15 mg/kg continuous infusion', 'armGroupLabels': ['sugammadex and placebo']}, {'name': 'Magnesium Sulphate', 'type': 'DRUG', 'otherNames': ['magnesium'], 'description': 'Experimental :\n\n50 mg/kg bolus plus 15 mg/kg continuous infusion', 'armGroupLabels': ['sugammadex and magnesium sulphate']}, {'name': 'sugammadex', 'type': 'DRUG', 'otherNames': ['bridion'], 'description': '4 mg/kg iv bolus at the end of the surgery', 'armGroupLabels': ['sugammadex and magnesium sulphate', 'sugammadex and placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41380', 'city': 'Kocaeli', 'country': 'Turkey (Türkiye)', 'facility': 'Kocaeli University Hospital', 'geoPoint': {'lat': 39.62497, 'lon': 27.51145}}], 'overallOfficials': [{'name': 'Zehra I. ARSLAN, Asst. Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Anesthesiology and Reanimation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kocaeli University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Zehra Ipek ARSLAN', 'investigatorAffiliation': 'Kocaeli University'}}}}