Ignite Creation Date:
2025-12-25 @ 3:17 AM
Ignite Modification Date:
2026-03-11 @ 6:48 PM
Study NCT ID:
NCT01804205
Status:
COMPLETED
Last Update Posted:
2018-03-14
First Post:
2013-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Magnesium Sulphate and Rocuronium in Patients Over 60
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008278', 'term': 'Magnesium Sulfate'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-12', 'studyFirstSubmitDate': '2013-02-28', 'studyFirstSubmitQcDate': '2013-03-02', 'lastUpdatePostDateStruct': {'date': '2018-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-03-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total recovery time of neuromuscular block (DurTOF0.9)', 'timeFrame': 'Within the surgical procedure', 'description': 'Time from the start of injection of rocuronium until TOF ratio 0.9'}], 'secondaryOutcomes': [{'measure': 'Onset time', 'timeFrame': 'Within the surgical procedure', 'description': 'Time from the start of injection of rocuronium until 95% depression of the first twitch (T1) of the TOF'}, {'measure': 'Clinical duration (Dur25%)', 'timeFrame': 'Within the surgical procedure', 'description': 'Time from the start of injection of rocuronium until T1 of the TOF had recovered to 25% of the initial T1 value'}, {'measure': 'Recovery index (Dur25-75%)', 'timeFrame': 'Within the surgical procedure', 'description': 'Time between 25% and 75% recovery of the initial T1 value'}, {'measure': 'Recovery time (Dur25%TOF0.9)', 'timeFrame': 'Within the surgical procedure', 'description': 'Time between 25% recovery of the initial T1 value and a TOF ratio of 0.9'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['magnesium sulfate', 'rocuronium', 'neuromuscular block', 'onset time', 'elderly'], 'conditions': ['Head and Neck Cancer']}, 'referencesModule': {'references': [{'pmid': '9301400', 'type': 'BACKGROUND', 'citation': 'Kussman B, Shorten G, Uppington J, Comunale ME. Administration of magnesium sulphate before rocuronium: effects on speed of onset and duration of neuromuscular block. Br J Anaesth. 1997 Jul;79(1):122-4. doi: 10.1093/bja/79.1.122.'}, {'pmid': '19919585', 'type': 'BACKGROUND', 'citation': 'Czarnetzki C, Lysakowski C, Elia N, Tramer MR. Time course of rocuronium-induced neuromuscular block after pre-treatment with magnesium sulphate: a randomised study. Acta Anaesthesiol Scand. 2010 Mar;54(3):299-306. doi: 10.1111/j.1399-6576.2009.02160.x. Epub 2009 Nov 16.'}, {'pmid': '17635389', 'type': 'BACKGROUND', 'citation': 'Fuchs-Buder T, Claudius C, Skovgaard LT, Eriksson LI, Mirakhur RK, Viby-Mogensen J; 8th International Neuromuscular Meeting. Good clinical research practice in pharmacodynamic studies of neuromuscular blocking agents II: the Stockholm revision. Acta Anaesthesiol Scand. 2007 Aug;51(7):789-808. doi: 10.1111/j.1399-6576.2007.01352.x.'}, {'pmid': '22150409', 'type': 'BACKGROUND', 'citation': "Dubois PE, Gourdin M, Jamart J, Broka SM, Eucher P, D'Hollander A. Early and late parameters describing the offset of neuromuscular blockade are highly intercorrelated. Acta Anaesthesiol Scand. 2012 Jan;56(1):76-82. doi: 10.1111/j.1399-6576.2011.02596.x."}, {'pmid': '23635996', 'type': 'DERIVED', 'citation': 'Rotava P, Cavalcanti IL, Barrucand L, Vane LA, Vercosa N. Effects of magnesium sulphate on the pharmacodynamics of rocuronium in patients aged 60 years and older: A randomised trial. Eur J Anaesthesiol. 2013 Oct;30(10):599-604. doi: 10.1097/EJA.0b013e328361d342.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effects of MgSO4 administration on the pharmacodynamics of rocuronium in patients with 60 or more years of age.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 60 years or older\n* ASA physical status I-III\n* Scheduled for elective oncologic head and neck surgery\n\nExclusion Criteria:\n\n* Severe renal insufficiency (calculated creatinine clearance \\< 30 ml/min)\n* Pre-operatory serum magnesium values \\> 2.5 mEq/l\n* Patients receiving medications known to affect neuromuscular function (furosemide, aminoglycoside, anticonvulsivants, calcio channel blocker, litium, azatioprine, cyclofosfamide)'}, 'identificationModule': {'nctId': 'NCT01804205', 'briefTitle': 'Magnesium Sulphate and Rocuronium in Patients Over 60', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Instituto Nacional de Cancer, Brazil'}, 'officialTitle': 'Effects of Magnesium Sulphate on the Pharmacodynamics of Rocuronium in Patients 60 Years or Older: Randomised and Double-Blind Study', 'orgStudyIdInfo': {'id': 'MgRoc 60'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Magnesium sulfate group', 'description': 'In the magnesium group, patients received MgSO4 30 mg/kg in 0.9% physiological saline (total volume 100 ml) intravenously, for 10 min, and then continuous intravenous infusion of MgSO4 at a rate of 1 g/h during the surgical procedure until the maximum of 3 h.', 'interventionNames': ['Drug: Magnesium Sulfate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Controls received 100 ml of 0.9% physiological saline, for 10 min, and then continuous intravenous infusion of saline at a rate of 33 ml/h during the surgical procedure until the maximum of 3 h.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Magnesium Sulfate', 'type': 'DRUG', 'description': 'MgSO4 30 mg/kg in 0.9% physiological saline (total volume 100 ml) intravenously, for 10 min, and then continuous intravenous infusion of MgSO4 at a rate of 1 g/h during the surgical procedure until the maximum of 3 h', 'armGroupLabels': ['Magnesium sulfate group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '100 ml of 0.9% physiological saline, for 10 min, and then continuous intravenous infusion of saline at a rate of 33 ml/h during the surgical procedure until the maximum of 3 h', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20230130', 'city': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Instituto Nacional de Câncer', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}], 'overallOfficials': [{'name': 'Pedro Rotava, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto Nacional de Cancer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pedro Rotava', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Instituto Nacional de Cancer, Brazil', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Mr', 'investigatorFullName': 'Pedro Rotava', 'investigatorAffiliation': 'Instituto Nacional de Cancer, Brazil'}}}}