Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2025-12-26 @ 12:43 AM
Study NCT ID:
NCT06762860
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-01-09
First Post:
2024-12-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intravenous Granisetron Vs Dexmedetomidine on Postspinal in the Cesarean Section.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D017829', 'term': 'Granisetron'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D053961', 'term': 'Azabicyclo Compounds'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007191', 'term': 'Indazoles'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Group C: Patients in this group will receive 10 ml normal saline (0.9%) over 10minutes immediately after clamping of the cord (control group).\n\nGroup D: Patients in this group will receive (0.3 ug/kg) intravenous Dexmedetomidine added to normal saline to get 10 ml of colorless solution and injected over 10 minutes after clamping of the cord.\n\nGroup G: Patients in this group will receive 3 mg intravenous Granisetron added to normal saline to get 10 ml of colorless solution and injected over 10 minutes immediately after clamping of the cord.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 99}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2025-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-07', 'studyFirstSubmitDate': '2024-12-03', 'studyFirstSubmitQcDate': '2025-01-05', 'lastUpdatePostDateStruct': {'date': '2025-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence and severity of post spinal shivering.', 'timeFrame': 'every 10 minutes intraoperatively and every 15 minutes postoperatively for 4 hours', 'description': '-The Shivering will be graded on a scale Tsai and Chu \\[Tsai et al .,2001\\] : Grade 0= No shivering. Grade 1=Piloerection or peripheral vasoconstriction but no visible shivering. Grade 2=Muscular activity in only one muscle group. Grade 3=Muscular activity in more than one muscle group but not generalized. Grade 4=Shivering involving the whole body.'}], 'secondaryOutcomes': [{'measure': 'change in the basal axillary temperature.', 'timeFrame': 'preoperatively, immediately after spinal block and at 5 ,15 ,30 ,45 minutes and at the end of surgery, then every 15 minutes for 4 hour postoperatively', 'description': 'Changes in basal axillary temperature (Celsius (°C) scale) of the patient after administration of tested drugs.'}, {'measure': 'change in the basal mean arterial blood pressure', 'timeFrame': 'preoperatively, immediately after spinal block and at 5 ,15 ,30 ,45 minutes and at the end of surgery, then every 15 minutes for 4 hour postoperatively.', 'description': 'Changes in the basal non-invasive mean arterial blood pressure( millimetres mercury (mmHg)) of the patient after administration of tested drugs.'}, {'measure': 'Change in the basal heart rate', 'timeFrame': 'preoperatively, immediately after spinal block and at 5 ,15 ,30 ,45 minutes and at the end of surgery, then every 15 minutes for 4 hour postoperatively.', 'description': 'Change in the heart rate of the patient after administration of tested drugs (beat per minute)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['shivering after spinal anesthesia in cesarean section'], 'conditions': ['Postspinal Shivering']}, 'descriptionModule': {'briefSummary': 'The Aim of this study is to investigate and compare the efficacy of intravenous Dexmedetomidine (0.3 ug/kg) versus intravenous Granisetron (3 mg) in the prevention of shivering in parturient undergoing cesarean section under spinal anesthesia.', 'detailedDescription': 'Study groups:\n\nRandomization will be done according to computer guided table with sealed closed envelopes prepared by the supervisor, All study drugs will be prepared by the supervisor. Each group will be 25 patients.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients scheduled for cesarean section under spinal anesthesia.\n* age : (20-45) years old.\n* American Society of Anesthesia (ASA) physical status I, II.\n\nExclusion Criteria:\n\n* Patient refusal.\n* Contraindication to spinal anesthesia.\n* BMI \\> 35 kg/m².\n* Impaired renal, hepatic and cardiac function.\n* Thyroid disease.\n* Body temperature \\>38 °C or \\< 36.5 °C.'}, 'identificationModule': {'nctId': 'NCT06762860', 'briefTitle': 'Intravenous Granisetron Vs Dexmedetomidine on Postspinal in the Cesarean Section.', 'organization': {'class': 'OTHER', 'fullName': 'Minia University'}, 'officialTitle': 'The Effect of Intravenous Granisetron Versus Intravenous Dexmedetomidine on Shivering Following Spinal Anesthesia in the Cesarean Section. a Randomized Controlled Comparative Trial .', 'orgStudyIdInfo': {'id': 'postspinal shivering'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dexmedetomidine Group', 'description': 'Patients in this group will receive (0.3 ug/kg) intravenous dexmedetomidine added to normal saline to get 10 ml of colorless solution and injected over 10 minutes after clamping of the cord.', 'interventionNames': ['Drug: Dexmedetomidine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Granisetron Group', 'description': 'Patients in this group will receive 3mg intravenous Granisetron added to normal saline to get 10 ml of colorless solution and injected over 10 minutes immediately after clamping of the cord.', 'interventionNames': ['Drug: Granisetron']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'description': 'Patients in this group will receive 10 ml normal saline 0.9% over 10 minutes immediately after clamping of the cord (placebo control group).', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'description': 'label sticker', 'armGroupLabels': ['Dexmedetomidine Group']}, {'name': 'Granisetron', 'type': 'DRUG', 'description': 'label sticker', 'armGroupLabels': ['Granisetron Group']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'label sticker', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Minya', 'country': 'Egypt', 'facility': 'Minya University Faculty of Medicine', 'geoPoint': {'lat': 28.09193, 'lon': 30.75813}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer at faculty of medicine -Minia University , Menna.Mamdouh@mu.edu.eg', 'investigatorFullName': 'Mennatallah Mamdouh', 'investigatorAffiliation': 'Minia University'}}}}