Ignite Creation Date:
2025-12-24 @ 1:57 PM
Ignite Modification Date:
2025-12-30 @ 11:54 AM
Study NCT ID:
NCT06134895
Status:
UNKNOWN
Last Update Posted:
2023-11-18
First Post:
2023-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tramadol and Tramadol Plus Ketamine for Shivering Prevention After Spinal Anesthesia in Lower Segment Caeserian Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014147', 'term': 'Tramadol'}, {'id': 'D007649', 'term': 'Ketamine'}], 'ancestors': [{'id': 'D003511', 'term': 'Cyclohexanols'}, {'id': 'D000441', 'term': 'Hexanols'}, {'id': 'D005233', 'term': 'Fatty Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004123', 'term': 'Dimethylamines'}, {'id': 'D008744', 'term': 'Methylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 190}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-11-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-15', 'studyFirstSubmitDate': '2023-09-11', 'studyFirstSubmitQcDate': '2023-11-15', 'lastUpdatePostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of shivering', 'timeFrame': 'Patients will be monitored from 15-45 mins from the administration of the prophylactic drug', 'description': 'Muscular activity in one or more than one muscle group or involving the whole body will be labelled as shivering'}, {'measure': 'Severity of Shivering', 'timeFrame': 'Patients will be monitored from 15-45 mins from the administration of the prophylactic drug', 'description': 'Shivering will be graded as per the following criteria:\n\n0= no shivering.\n\n1. piloerection or peripheral vasoconstriction but no visible shivering.\n2. muscular activity (visible muscular twitching) in only one muscle group;\n3. muscular (visible muscular twitching) activity in more than one muscle group but not generalized.\n4. shivering involving the whole body'}], 'secondaryOutcomes': [{'measure': 'Time to shivering', 'timeFrame': '15 mins from the administration of the prophylactic drug', 'description': 'The time to shiver will be defined as the duration from the initiation of the intervention until the onset of observable shivering.'}, {'measure': 'Complications', 'timeFrame': 'Patients will be monitored from 15-45 mins from the administration of the prophylactic drug', 'description': 'Complications such as hypotension, nausea and vomiting, bradycardia, or hallucinations will be noted'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Shivering', 'Anesthesia, Spinal', 'Caesarean'], 'conditions': ['Shivering']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to compare the efficacy of prophylactic use of intravenous tramadol versus tramadol plus ketamine for prevention of shivering under spinal anaesthesia in lower segment caeserian section.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 to 40 years\n* American Society of Anesthesiologist physical status I and II\n* Pregnant female for lower segment caeserian section\n\nExclusion Criteria:\n\n* Patients with Hypertension\n* Patients with hypo- or hyperthyroidism\n* Known case of Cardiopulmonary disease, pre-eclampsia and eclampsia\n* An initial body temperature 38.00C or, 36.0oC assessed by thermometer'}, 'identificationModule': {'nctId': 'NCT06134895', 'briefTitle': 'Tramadol and Tramadol Plus Ketamine for Shivering Prevention After Spinal Anesthesia in Lower Segment Caeserian Section', 'organization': {'class': 'OTHER', 'fullName': 'Ziauddin University'}, 'officialTitle': 'Randomised Double Blind Comparison of Prophylactic Tramadol and Tramadol Plus Ketamine for Prevention of Shivering After Spinal Anesthesia in Lower Segment Caeserian Section', 'orgStudyIdInfo': {'id': '7240623MAANE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tramadol with Ketamine', 'description': 'Tramadol 0.25mg/Kg with Ketamine 0.25 mg/Kg', 'interventionNames': ['Drug: Tramadol with Ketamine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tramadol', 'description': 'Tramadol 0.5mg/kg', 'interventionNames': ['Drug: Tramadol']}], 'interventions': [{'name': 'Tramadol with Ketamine', 'type': 'DRUG', 'description': 'Tramadol with Ketamine is being provided randomly using prospective, double-blind', 'armGroupLabels': ['Tramadol with Ketamine']}, {'name': 'Tramadol', 'type': 'DRUG', 'description': 'Tramadol alone is being provided randomly using prospective, double-blind', 'armGroupLabels': ['Tramadol']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Karachi', 'state': 'Sindh', 'status': 'RECRUITING', 'country': 'Pakistan', 'contacts': [{'name': 'Muhammad Arif', 'role': 'CONTACT', 'email': 'muhammad.aarif@zu.edu.pk', 'phone': '+92 331 3455112'}], 'facility': 'Muhammad Arif', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}], 'centralContacts': [{'name': 'Muhammad Arif', 'role': 'CONTACT', 'email': 'muhammad.aarif@zu.edu.pk', 'phone': '+92 331 3455112'}], 'overallOfficials': [{'name': 'Muhammad Arif', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ziauddin University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ziauddin University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr Muhammad Arif', 'investigatorAffiliation': 'Ziauddin University'}}}}