Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2026-03-02 @ 8:39 PM
Study NCT ID:
NCT01479751
Status:
COMPLETED
Last Update Posted:
2012-08-27
First Post:
2011-11-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Methods to Facilitate Rapid Sequence Intubation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008278', 'term': 'Magnesium Sulfate'}, {'id': 'D007649', 'term': 'Ketamine'}, {'id': 'D000077123', 'term': 'Rocuronium'}], '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': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000732', 'term': 'Androstanols'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-24', 'studyFirstSubmitDate': '2011-11-22', 'studyFirstSubmitQcDate': '2011-11-23', 'lastUpdatePostDateStruct': {'date': '2012-08-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intubation score', 'timeFrame': 'participants will be followed at the time point of intubation, an expected average of 70 sec from the start of rocuronium injection.', 'description': 'Patients are tracheally intubated, and intubation scores(poor, good,excellent)are rated.'}], 'secondaryOutcomes': [{'measure': 'Roc duration', 'timeFrame': 'participants will be followed when TOF count reaches two, an expected average of 40 min.', 'description': 'Time from the start of rocuronium injection until reappearance of two muscle twitches in TOF stimulations is measured, using ToF-Watch sx.'}, {'measure': 'Roc onset', 'timeFrame': 'participants will be followed when TOFcount =0 within an expected average of 4 min from the start of rocuronium injection.', 'description': 'Time from the start of rocuronium injection until TOF count=0 using TOF-Watch sx.'}, {'measure': 'Hemodynamic variables', 'timeFrame': 'participants will be followed at baseline, before and for 5 min after the intubation, an expected average of 8 min after the start of anesthetic induction.', 'description': 'Mean arterial pressure (MAP)and heart rate (HR) are measured at baseline, before intubation, and 1, 2, 3, 4, 5 min after intubation.'}, {'measure': 'TOF% at intubation', 'timeFrame': 'participants will be followed at the time point of intubation, an expected average of 70 sec from the start of rocuronium injection.', 'description': 'neumeric value expressed as %, displayed on the monitor of TOF watch-Sx in TOF stimulation (ex. 5% on the display means 95% suppression of T1)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Rocuronium', 'magnesium', 'priming', 'ketamine', 'intubation'], 'conditions': ['Intubating Condition']}, 'descriptionModule': {'briefSummary': 'In this study, methods which are known for facilitating rapid sequence intubation or accelerating rocuronium (Roc)onset are compared including magnesium (Mg), ketamine pretreatment, large dose rocuronium and priming.', 'detailedDescription': 'Patients are pretreated with Mg, ketamine, or priming dose Roc. Two groups do not receive pretreatment, but are given Roc 0.6 mg/kg or 0.9 mg/kg.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18 - 65 years,\n* ASA 1 - 2,\n* patients scheduled for elective surgery under general anesthesia,\n* BMI 18.5-24.9 kg/m2\n* Mallampati class I-II\n\nExclusion Criteria:\n\n* neuromuscular disorder,\n* cardiac/hepatic/renal insufficiency,\n* pregnant.\n* anticipated difficult airway\n* medications that influence neuromuscular transmission'}, 'identificationModule': {'nctId': 'NCT01479751', 'briefTitle': 'Comparison of Methods to Facilitate Rapid Sequence Intubation', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Bundang Hospital'}, 'officialTitle': 'Comparison of Mg, Ketamine, Large Dose Rocuronium, and Priming on Intubating Condition in Rapid Sequence Intubation', 'orgStudyIdInfo': {'id': 'facilitating RSI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ketamine', 'description': 'Patients receive ketamine 0.5 mg/kg 2 min before Roc injection.', 'interventionNames': ['Drug: Ketamine']}, {'type': 'EXPERIMENTAL', 'label': 'priming', 'description': 'Patients receive Roc 0.06 mg/ kg as a priming dose 3 min before injection of Roc 0.54 mg/kg.', 'interventionNames': ['Drug: rocuronium']}, {'type': 'NO_INTERVENTION', 'label': 'Roc 0.9', 'description': 'Patients receive Roc 0.9 mg/kg as an induction dose.'}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Patients receive Roc 0.6 mg/kg without any pretreatments of Mg, ketamine, or priming.'}, {'type': 'EXPERIMENTAL', 'label': 'Mg', 'description': 'Patients receive magnesium sulfate (MgSO4) 50 mg/kg over 10 min before Roc injection.', 'interventionNames': ['Drug: Magnesium Sulfate']}], 'interventions': [{'name': 'Magnesium Sulfate', 'type': 'DRUG', 'description': 'Patients receive MgSO4 50 mg/kg for 10 min before injection of Roc 0.6 mg/kg.', 'armGroupLabels': ['Mg']}, {'name': 'Ketamine', 'type': 'DRUG', 'description': 'patients receive ketamine 0.5 mg/kg 2 min before Roc injection.', 'armGroupLabels': ['ketamine']}, {'name': 'rocuronium', 'type': 'DRUG', 'description': 'Patients receive Roc 0.06 mg/ kg as a priming dose 3 min before injection of Roc 0.54 mg/kg.', 'armGroupLabels': ['priming']}]}, 'contactsLocationsModule': {'locations': [{'zip': '464-707', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Seoul National University Bundang hopital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}], 'overallOfficials': [{'name': 'Mihyun Kim, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Bundang Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'clinical professor', 'investigatorFullName': 'Kim Mihyun', 'investigatorAffiliation': 'Seoul National University Bundang Hospital'}}}}