Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-30 @ 3:51 AM
Study NCT ID:
NCT03008850
Status:
COMPLETED
Last Update Posted:
2017-01-05
First Post:
2016-12-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Shivering Prevention During Cesarean Section by Intrathecal Injection of Magnesium Sulfate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-03', 'studyFirstSubmitDate': '2016-12-27', 'studyFirstSubmitQcDate': '2016-12-30', 'lastUpdatePostDateStruct': {'date': '2017-01-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-01-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Shivering Score', 'timeFrame': '2 hours', 'description': 'shivering will be recorded in the recovery room for 2 hours'}], 'secondaryOutcomes': [{'measure': 'Visual Analogue Pain Score', 'timeFrame': '2 hours', 'description': 'analgesics will be given if visual analogue score ≥ 4'}, {'measure': 'Complications', 'timeFrame': '2 hours', 'description': 'percentage of patients with any complications will be recorded'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Shivering', 'Intrathecal', 'Magnesium Sulfate'], 'conditions': ['Cesarean Section; Shivering']}, 'descriptionModule': {'briefSummary': 'Shivering is a common post-anesthetic complication occurring in up to 65% of patients undergoing spinal or epidural anesthesia. Shivering may interfere with electrocardiogram, blood pressure and oxygen saturation monitoring. In addition, shivering increases oxygen consumption, carbon dioxide production and metabolic rate by up to 400%. Thus, it may result in problems in patients with low cardiac and pulmonary reserves. Preventing shivering could therefore result in better postoperative outcomes or reduce the incidence of post-surgical complications.', 'detailedDescription': 'Magnesium sulfate (MgSO4) has anti-shivering effects. Moreover, it has potential neuroprotective effects and may enhance neuroprotection against the effects of hypothermia. Intrathecal MgSO4 administration provides effective perioperative analgesia and can prolong the period of anesthesia and sensory blockade without any additional side-effects. However, most of the research on the role of MgSO4 in the prevention of shivering has focused on intravenous infusion of this drug. Few clinical trials have examined the effect of adding intrathecal MgSO4 to anesthetic agents such as bupivacaine to suppress anesthesia-related shivering in patients. Similar to infusion studies, we hypothesized that the addition of intrathecal injection of MgSO4 to bupivacaine would improve perioperative shivering in female patients undergoing elective caesarean section. Few previous studies evaluated neuroaxial anti-shivering effects of intrathecal magnesium and none evaluated the anti-shivering effect of intrathecal MgSO4. Therefore, we elected to use the lowest dosage (25 mg MgSO4) that was formerly utilized for investigation of analgesic effects.\n\nMagnesium sulphate is an intracellular cation with various physiologic functions such as enzyme activation, nerve signal conduction, protein synthesis and vasomotor tonicity regulation. Magnesium sulphate has been used in various clinical situations including preeclampsia, tocolysis, arrhythmias, myocardial ischemia, bronchial asthma and postoperative shivering.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18 to 35years.\n2. Undergo elective cesarean section under spinal anesthesia.\n3. ASA physical status I-II.\n4. Singleton pregnancy.\n5. At least 38 weeks gestation.\n\nExclusion Criteria:\n\n1. Women with history of cardiac, liver or kidney diseases.\n2. Women with allergy to amide local anesthetics or medication included in the study.\n3. Women with any neurological problem.\n4. Any contraindication of regional anesthesia.\n5. Failed or insatisfactory spinal block.\n6. Preoperative temperature more than 38⁰ C.'}, 'identificationModule': {'nctId': 'NCT03008850', 'briefTitle': 'Shivering Prevention During Cesarean Section by Intrathecal Injection of Magnesium Sulfate', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Shivering Prevention During Cesarean Section by Intrathecal Injection of Magnesium Sulfate', 'orgStudyIdInfo': {'id': 'Shivering, MgSO4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group M', 'description': '2 ml (10 mg) of 0.5% heavy bupivacaine plus 0.5 ml (25 mg) MgSO4 will be injected intrathecally', 'interventionNames': ['Drug: MgSo4']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group P', 'description': '2 ml (10 mg) of 0.5% heavy bupivacaine plus 0.5 ml normal saline will be injected intrathecally', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'MgSo4', 'type': 'DRUG', 'description': 'Patients will be randomly allocated to one of two groups:\n\nGroup (M): 2 ml (10 mg) of 0.5% heavy bupivacaine plus 0.5 ml (25 mg) MgSO4 will be injected intrathecally.\n\nGroup(P): 2 ml (10 mg) of 0.5% heavy bupivacaine plus 0.5 ml normal saline will be injected intrathecally.', 'armGroupLabels': ['Group M']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Patients will be randomly allocated to one of two groups:\n\nGroup (M): 2 ml (10 mg) of 0.5% heavy bupivacaine plus 0.5 ml (25 mg) MgSO4 will be injected intrathecally.\n\nGroup(P): 2 ml (10 mg) of 0.5% heavy bupivacaine plus 0.5 ml normal saline will be injected intrathecally.', 'armGroupLabels': ['Group P']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71515', 'city': 'Asyut', 'state': 'Asyut Governorate', 'country': 'Egypt', 'facility': 'Assiut university hospital', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'overallOfficials': [{'name': 'Zain E. Hassan, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Assiut University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Anesthesia and Intensive Care', 'investigatorFullName': 'MOHAMED F. MOSTAFA', 'investigatorAffiliation': 'Assiut University'}}}}