Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-31 @ 12:16 AM
Study NCT ID:
NCT07377903
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-04
First Post:
2026-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post Operative Shivering Following Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D008278', 'term': 'Magnesium Sulfate'}, {'id': 'D017294', 'term': 'Ondansetron'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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': 'D002227', 'term': 'Carbazoles'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-01', 'studyFirstSubmitDate': '2026-01-22', 'studyFirstSubmitQcDate': '2026-01-22', 'lastUpdatePostDateStruct': {'date': '2026-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to cessation of shivering after drug administration.', 'timeFrame': '6 hours', 'description': 'Grade 0: No shivering.\n\n* Grade 1: Piloerection or peripheral vasoconstriction but no visible shivering. 4\n* Grade 2: Muscular activity in only one muscle group.\n* Grade 3: Muscular activity in more than one muscle group.\n* Grade 4: Whole-body shivering.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Shivering, Spinal Anesthesia']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare the efficacy of magnesium sulphate, ondansetron, and dexmedetomidine in managing post-spinal anesthesia shivering. The primary aim is the time to cessation of shivering after drug administration, while secondary aim include hemodynamic parameters (heart rate, blood pressure, SpO₂ ) and the recurrence of shivering', 'detailedDescription': 'This is a randomized double blinded study including patients undergoing surgery under spinal anesthesia. Patients will be randomly allocated into three groups to receive magnesium sulphate, ondansetron, or dexmedetomidine for the treatment of post-spinal anesthesia shivering. The time to cessation of shivering, hemodynamic parameters, and recurrence of shivering will be recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age from 18 to 45 years.\n* Both sexes.\n* American Society of Anesthesiologists physical status I, II\n* Scheduled for elective lower abdominal or lower limb surgeries under spinal anesthesia\n\nExclusion Criteria:\n\n* Patients with known allergy to study drugs.\n* Patients with baseline body temperature outside the normal range (36-37.5°C).\n* History of thermoregulatory disorders, thyroid dysfunction, or neurological diseases.\n* Patients receive sedatives, antipsychotics, or antidepressants.\n* Patients require intraoperative conversion to general anesthesia.'}, 'identificationModule': {'nctId': 'NCT07377903', 'briefTitle': 'Post Operative Shivering Following Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Pharmacological Management of Post Operative Shivering Following Anesthesia', 'orgStudyIdInfo': {'id': 'Soh_med__25_12_10MS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mg sulphate group', 'description': '50 mg/kg magnesium sulphate diluted in 100 mL of normal saline.', 'interventionNames': ['Drug: Mg (magnesium sulfate)']}, {'type': 'EXPERIMENTAL', 'label': 'dexmedetomidine group', 'interventionNames': ['Drug: Dexmedetomidin']}, {'type': 'EXPERIMENTAL', 'label': 'ondansetron group', 'interventionNames': ['Drug: Ondansetron 8 mg']}], 'interventions': [{'name': 'Dexmedetomidin', 'type': 'DRUG', 'description': '•Group D (Dexmedetomidine Group): 0.5 µg/kg dexmedetomidine diluted in 100 mL of normal saline.', 'armGroupLabels': ['dexmedetomidine group']}, {'name': 'Mg (magnesium sulfate)', 'type': 'DRUG', 'description': '50 mg/kg magnesium sulphate diluted in 100 mL of normal saline.', 'armGroupLabels': ['Mg sulphate group']}, {'name': 'Ondansetron 8 mg', 'type': 'DRUG', 'description': '8 mg ondansetron diluted in 100 mL of normal saline.', 'armGroupLabels': ['ondansetron group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Aya Mohammed Aboelwafa, Resident of anesthesia', 'role': 'CONTACT', 'email': 'aya_muhammad_post@med.sohag.edu.eg', 'phone': '01095848062', 'phoneExt': '01002181828'}, {'name': 'Ahmed Elsaied Abd Elrahman, Professor', 'role': 'CONTACT', 'email': 'elsaiedsoon@gmail.com', 'phone': '01118011611', 'phoneExt': '01095848062'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'A decision regarding sharing individual participant data has not yet been made. This will depend on future agreements, ethical approvals, and data governance policies.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident of anesthesia and surgical intensive care unit and pain management', 'investigatorFullName': 'Aya Muhammad Aboelwafa', 'investigatorAffiliation': 'Sohag University'}}}}