Ignite Creation Date:
2025-12-26 @ 5:20 PM
Ignite Modification Date:
2026-02-06 @ 4:33 AM
Study NCT ID:
NCT06513806
Status:
COMPLETED
Last Update Posted:
2025-10-02
First Post:
2024-03-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Granisetron Versus Pethidine in Treatment of Post Spinal Shivering in Cesarean Sections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017829', 'term': 'Granisetron'}, {'id': 'D008614', 'term': 'Meperidine'}], 'ancestors': [{'id': 'D053961', 'term': 'Azabicyclo Compounds'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007191', 'term': 'Indazoles'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D019086', 'term': 'Bridged Bicyclo Compounds, Heterocyclic'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D007540', 'term': 'Isonipecotic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D010880', 'term': 'Piperidines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 330}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-09-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-29', 'studyFirstSubmitDate': '2024-03-22', 'studyFirstSubmitQcDate': '2024-07-18', 'lastUpdatePostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'treating post spinal shivering', 'timeFrame': 'perioperatively/periprocedurally', 'description': 'If shivering occurs the degree of Shivering will be classified as:\n\n* 0: No shivering\n* 1: Mild fasciculations of face or neck and ECG disturbances in the absence of voluntary activity of the arms\n* 2: Visible tremor involving more than one muscle group\n* 3: Gross muscular activity involving the entire body\n\nassessment of tested drugs in treating post spinal shivering in patients who undergone cesarean delivery and have been treated with either granisetron or pethidine'}], 'secondaryOutcomes': [{'measure': 'pain assessment', 'timeFrame': '12 hours postoperative', 'description': 'pain scores by VAS (visual analogue scale) which is from 0-10 , 0 no Pain and 10 worst pain'}, {'measure': 'nausea, vomiting', 'timeFrame': '12 hours postoperative', 'description': 'incidence of postoperative complications: nausea, vomiting'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anesthesia; Adverse Effect, Spinal and Epidural']}, 'descriptionModule': {'briefSummary': 'Granisetron Versus Pethidine in Treatment of Post Spinal Shivering in Cesarean Sections', 'detailedDescription': 'Shivering is known to be a frequent complication, reported in 40 to 70% of patients undergoing surgery under regional anaesthesia. Shivering is a potentially serious complication, resulting in increased metabolic rate; increased oxygen consumption (up to 100-600%) along with raised carbon dioxide (CO2) production; ventilation and cardiac output; adverse postoperative outcomes.Post cesarean section spinal shivering is frequent. It causes involuntary muscular contractions and pain. Shivering, or muscular contractions, may be moderate or severe and persist for varying lengths. Anesthesia and body temperature fluctuations may produce post-spinal shivering. Properly managing post-spinal shivering improves patient outcomes and satisfaction.\n\nGranisetron and pethidine treat post-spinal shivering. Granisetron blocks acetylcholine, a neurotransmitter that contracts muscles. Pethidine inhibits norepinephrine. Both drugs reduce post spinal shivering. However, the efficacy of granisetron and pethidine in treating post-cesarean spinal shivering has not been adequately explored.\n\nPatients will undergo spinal anesthesia via the administration of 2.5ml of Bupivacaine 0.5% intrathecally using a 25-gauge spinal needle. The patients will be continuously monitored for any episodes of shivering, nausea, and vomiting. Vital data of the patients will also be closely monitored including oxygen saturation, pulse rate, blood pressure, respiratory rate and temperature at 10 minutes intervals throughout the operation and the stay in the recovery room. (PACU time around 30 minutes)\n\nIf shivering occurs the degree of Shivering will be classified as:\n\n* 0: No shivering\n* 1: Mild fasciculations of face or neck and ECG disturbances in the absence of voluntary activity of the arms\n* 2: Visible tremor involving more than one muscle group\n* 3: Gross muscular activity involving the entire body'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* elective for caesarian section presence of post-spinal shivering, defined as involuntary muscle contractions occurring within operative and early recovery period after cesarean delivery.\n* Age 18 - 45\n\nExclusion Criteria\n\n* Inability to provide informed consent.\n* Previous allergies or sensitivities to granisetron or pethidine.\n* Current use of medications that may interact with granisetron or pethidine.\n* Presence of other conditions that may contraindicate the use of granisetron or pethidine, such as known liver or kidney disease.\n* Patients who are too short (\\<140 cm) or too tall (\\>190 cm)'}, 'identificationModule': {'nctId': 'NCT06513806', 'briefTitle': 'Granisetron Versus Pethidine in Treatment of Post Spinal Shivering in Cesarean Sections', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Granisetron Versus Pethidine in Treatment of Post Spinal Shivering in Cesarean Sections', 'orgStudyIdInfo': {'id': 'FMASU MS84/2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'granisetron group', 'description': 'will receive granisetron 3 mg iv bolus', 'interventionNames': ['Drug: Granisetron 1 Mg/mL Intravenous Solution']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'pethidine group', 'description': 'will receive pethidine 25 mg iv bolus', 'interventionNames': ['Drug: Pethidin']}], 'interventions': [{'name': 'Granisetron 1 Mg/mL Intravenous Solution', 'type': 'DRUG', 'description': 'will receive granisetron 3 mg iv bolus', 'armGroupLabels': ['granisetron group']}, {'name': 'Pethidin', 'type': 'DRUG', 'description': 'will receive pethidine 25 mg iv bolus', 'armGroupLabels': ['pethidine group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Ayman M Kamaly, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Ain Shams University'}, {'name': 'David S Said, Msc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ain Shams University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associated professor', 'investigatorFullName': 'Khaled Abdou', 'investigatorAffiliation': 'Ain Shams University'}}}}