Ignite Creation Date:
2025-12-25 @ 1:12 AM
Ignite Modification Date:
2026-02-25 @ 9:44 PM
Study NCT ID:
NCT02100293
Status:
COMPLETED
Last Update Posted:
2016-04-18
First Post:
2013-12-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Magnesium Sulfate on Onset and Duration of Low Dose Rocuronium
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008278', 'term': 'Magnesium Sulfate'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D017616', 'term': 'Magnesium Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D013431', 'term': 'Sulfates'}, {'id': 'D013464', 'term': 'Sulfuric Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-15', 'studyFirstSubmitDate': '2013-12-11', 'studyFirstSubmitQcDate': '2014-03-26', 'lastUpdatePostDateStruct': {'date': '2016-04-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'intubation condition', 'timeFrame': 'intubation condition during induction of anesthesia up to 10 minutes', 'description': 'We scored intubation condition on the basis of 4 items, laryngoscopy, vocal cord position, moving of limbs, and coughing.'}, {'measure': 'surgical condition', 'timeFrame': 'intraoperative surgical condition', 'description': 'to score a surgical condition according to 7 point likers scale'}, {'measure': 'postoperative sore throat', 'timeFrame': 'postoperative sore throat up to 4 hours'}], 'primaryOutcomes': [{'measure': 'onset time of rocuronium', 'timeFrame': 'from injection of rocuronium to T1 suppression more than 95% up to 10 minutes', 'description': 'from injection of rocuronium to T1 suppression more than 95% up to 10 minutes'}], 'secondaryOutcomes': [{'measure': 'maximal suppression time and duration of rocuronium', 'timeFrame': 'time from the injection of rocuronium to T1 maximal suppression time and reversal of T1 25% up to 1 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['magnesium sulfate, rocuronium'], 'conditions': ['Observation of Neuromuscular Block', 'Intubation Condition', 'Surgical Condition']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate effects of magnesium sulfate on onset and duration of low dose rocuronium, intubation condition and surgical condition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-75 yr American Society of Anesthesiologists physical status 1 or 2, BMI of 20-24.9 kg/m2 scheduled for elective laryngeal microsurgery\n\nExclusion Criteria:\n\n* severe respiratory or cardiac disease hepatic or renal function impairment neuromuscular disease on medications affecting neuromuscular function with known allergy to the drugs'}, 'identificationModule': {'nctId': 'NCT02100293', 'briefTitle': 'Effects of Magnesium Sulfate on Onset and Duration of Low Dose Rocuronium', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'orgStudyIdInfo': {'id': 'B-1307/209-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'standard dose rocuronium group', 'description': 'pretreatment of saline 100ml and rocuronium 0.6 mg/kg', 'interventionNames': ['Drug: saline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'low dose rocuronium group', 'description': 'pretreatment of saline 100ml and rocuronium 0.45 mg/kg', 'interventionNames': ['Drug: saline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'low dose rocuronium plus magnesium group', 'description': 'pretreatment of magnesium sulfate 30 mg/kg and rocuronium 0.45 mg/kg', 'interventionNames': ['Drug: magnesium sulfate 30 mg/kg']}], 'interventions': [{'name': 'magnesium sulfate 30 mg/kg', 'type': 'DRUG', 'description': 'Patients in each group received the magnesium sulfate 30 mg/kg for 2 min in 0.9% normal saline (total volume 100 ml) intravenously for 5 min before induction of anesthesia', 'armGroupLabels': ['low dose rocuronium plus magnesium group']}, {'name': 'saline', 'type': 'DRUG', 'description': 'Patients in each group received 0.9% normal saline (total volume 100 ml) alone intravenously for 5 min before induction of anesthesia', 'armGroupLabels': ['low dose rocuronium group', 'standard dose rocuronium group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '463-707', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Seoul National Univ. Bundang Hospita', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}], 'overallOfficials': [{'name': 'Sang Hwan Do', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National Univ. Bundang Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}