Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:16 PM
Study NCT ID:
NCT03439358
Status:
SUSPENDED
Last Update Posted:
2021-02-26
First Post:
2018-02-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Magnesium for Shivering in Epidural Lidocaine Deliveries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008278', 'term': 'Magnesium Sulfate'}, {'id': 'D000077330', 'term': 'Saline Solution'}], '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': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'whyStopped': 'Could not recruit patients', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2018-06-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-23', 'studyFirstSubmitDate': '2018-02-07', 'studyFirstSubmitQcDate': '2018-02-13', 'lastUpdatePostDateStruct': {'date': '2021-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of intraoperative shivering', 'timeFrame': 'Through completion of cesarean surgical procedure (maximum 2 hours)', 'description': 'Incidence measured as shivering present or absent'}, {'measure': 'Severity of intraoperative shivering', 'timeFrame': 'Through completion of cesarean surgical procedure (maximum 2 hours)', 'description': 'Severity measured subjectively by anesthesiologist and patient'}], 'secondaryOutcomes': [{'measure': 'Incidence of hypothermia', 'timeFrame': 'Through study completion (maximum 2.5 hours)', 'description': 'Number of patients whose tympanic membrane temperature decreases below 36 degrees Celsius.'}, {'measure': 'Incidence of hypotension', 'timeFrame': 'Through study completion (maximum 2.5 hours)', 'description': 'Number of patients who experience a greater than or equal to 20% reduction in systolic blood pressure.'}, {'measure': 'Total vasopressor(s) dose', 'timeFrame': 'Through study completion (maximum 2.5 hours)'}, {'measure': 'Total utertonic(s) dose', 'timeFrame': 'Through completion of cesarean surgical procedure (maximum 2 hours)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Epidural top-up', 'Shivering', 'Magnesium'], 'conditions': ['Anesthesia']}, 'descriptionModule': {'briefSummary': 'Magnesium has been shown to decrease the shivering experienced from neuraxial anesthesia. This study aims to investigate whether magnesium decreases the shivering experienced in parturients undergoing labor epidural anesthesia for Cesarean delivery.', 'detailedDescription': "Women who have epidurals in place and go on to require a Cesarean delivery typically have their epidurals 'topped-up' with a fast onset local anesthetic to ensure the lower body is fully numb for surgery. This is called an epidural 'top-up'. However, a side effect of epidural top-ups is shivering, which is uncomfortable for the mother and interferes with patient monitoring. Magnesium administration has been shown to decrease shivering in the non-pregnant population. Therefore, in this study the investigators aim to determine if magnesium given prior to an epidural top-up decreases the incidence and severity of shivering in the pregnant population."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Gestational age of ≥37 weeks\n2. Women who are ≥ 19 years old\n3. Women undergoing Cesarean delivery under lidocaine top-up via a preexisting epidural catheter inserted for labor analgesia\n4. American Society of Anesthesiologist (ASA) Physical Status class 1 or 2\n\nExclusion Criteria:\n\n1. Emergency Cesarean delivery with limited time for informed consent\n2. Women who have received MgSO4 prior to study enrollment\n3. Indication for alternative mode of anesthesia for Cesarean delivery (e.g., general anesthesia)\n4. Medical conditions or medications that could lead to tremor or shivering. (e.g., movement disorder, untreated thyroid disease) or mask tremor or shivering (e.g., beta-blocker, benzodiazepine, anticonvulsants)\n5. Active shivering at time of recruitment\n6. Inability to read and understand English for the purpose of informed consent\n7. Contraindications to receiving MgSO4 (hypersensitivity reactions, respiratory rate \\<16breaths/min, absent reflexes, urine output \\<100 mL during the previous 4 hours, renal failure, or hypocalcemia)\n8. History of previous postpartum hemorrhage'}, 'identificationModule': {'nctId': 'NCT03439358', 'acronym': 'Mag-SHIELD', 'briefTitle': 'Magnesium for Shivering in Epidural Lidocaine Deliveries', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'Intravenous Magnesium Sulfate for the Prevention of Intraoperative Shivering in Parturients Undergoing Cesarean Delivery Under Lidocaine Top-up Via a Pre-existing Epidural Catheter Inserted for Labor Analgesia - A Randomized Double-blind, Placebo-controlled Trial', 'orgStudyIdInfo': {'id': 'H17-02408'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Magnesium sulfate', 'description': 'Magnesium sulfate (MgSO4) infusion will be commenced prior to epidural top-up.', 'interventionNames': ['Drug: Magnesium Sulfate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Normal saline', 'description': 'Normal saline infusion will be commenced prior to epidural top-up.', 'interventionNames': ['Other: Normal Saline']}], 'interventions': [{'name': 'Magnesium Sulfate', 'type': 'DRUG', 'description': 'Bolus infusion: 100mL normal saline with 4g MgSO4 over 30 minutes Maintenance infusion: 25mL normal saline per hour with 1g MgSO4', 'armGroupLabels': ['Magnesium sulfate']}, {'name': 'Normal Saline', 'type': 'OTHER', 'description': 'Bolus infusion: 100mL normal saline over 30 minutes Maintenance infusion: 25mL normal saline per hour', 'armGroupLabels': ['Normal saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V6H 3N1', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': "BC Women's Hospital", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'Anton Chau, MD MMSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia'}, {'name': 'Anna West, BA MBBS', 'role': 'STUDY_CHAIR', 'affiliation': 'University of British Columbia'}, {'name': 'Vit Gunka, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of British Columbia'}, {'name': 'Jonathan Collins, BA BM BCh MA', 'role': 'STUDY_CHAIR', 'affiliation': 'University of British Columbia'}, {'name': 'Monica Brunner, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of British Columbia'}, {'name': 'Arianne Albert, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Provincial Health Services Authority British Columbia'}, {'name': 'James D Taylor, BSc', 'role': 'STUDY_CHAIR', 'affiliation': 'Provincial Health Services Authority British Columbia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor', 'investigatorFullName': 'Anthony Chau', 'investigatorAffiliation': 'University of British Columbia'}}}}