Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2026-01-04 @ 1:30 PM
Study NCT ID:
NCT06431568
Status:
COMPLETED
Last Update Posted:
2024-05-28
First Post:
2024-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ondansetron Prior Spinal Anaesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-22', 'studyFirstSubmitDate': '2024-05-22', 'studyFirstSubmitQcDate': '2024-05-22', 'lastUpdatePostDateStruct': {'date': '2024-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood Pressure', 'timeFrame': 'one hour', 'description': 'incidence of hypotension after spinal anaesthesia in the patients who received Ondansetron'}], 'secondaryOutcomes': [{'measure': 'Heart rate', 'timeFrame': 'One hour', 'description': 'Incidence of bradycardia after ondansetron'}, {'measure': 'Vasopressor', 'timeFrame': 'One hour', 'description': 'Incidence of use of ephedrine or phenylpherine'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Spinal anesthesia, Cesarean section, Ondansetron'], 'conditions': ['Cesarean Section']}, 'referencesModule': {'references': [{'pmid': '30881108', 'type': 'RESULT', 'citation': 'Hofhuizen C, Lemson J, Snoeck M, Scheffer GJ. Spinal anesthesia-induced hypotension is caused by a decrease in stroke volume in elderly patients. Local Reg Anesth. 2019 Mar 4;12:19-26. doi: 10.2147/LRA.S193925. eCollection 2019.'}]}, 'descriptionModule': {'briefSummary': 'Since Ondansetron is commonly used during cesarean deliveries to treat nausea and vomiting, this study will observe the correlation between ondansetron administration and effect on hemodynamics in order to confirm that the use of Ondansetron can reduce incidence of hypotension and bradycardia associated with spinal in cesarean section, and to identify the optimal timing and dose for administration.', 'detailedDescription': 'Hypothesis:\n\nAdministration of ondansetron prior to spinal anesthesia can attenuate hypotension and bradycardia.\n\nAim:\n\nSince Ondansetron is commonly used during cesarean deliveries to treat nausea and vomiting, this study will observe the correlation between ondansetron administration and effect on hemodynamics in order to confirm that the use of Ondansetron can reduce incidence of hypotension and bradycardia associated with spinal in cesarean section, and to identify the optimal timing and dose for administration.\n\nObjectives:\n\n* Primary outcome: incidence of hypotension after spinal anaesthesia in the patients who received Ondansetron and those who did not\n* Secondary outcome : use of vasopressors , bradycardia , timing of administration of Ondansetron wether it is more or less than five minutes prior to the administration of anesthesia.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant patients undergoing elective caesarean section with no co-morbidities before or during pregnancy period, e.g. HTN, DM, PET or Eclampsia, will be recruited. Attempt will be made to include all eligible participants', 'genderDescription': 'Pregnant patients undergoing elective cesarean section with no co-morbidities before or during pregnancy period', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant patients undergoing elective caesarean section\n\nExclusion Criteria:\n\n* Preeclampsia\n* Eclampsia\n* Hypertension\n* Diabetes'}, 'identificationModule': {'nctId': 'NCT06431568', 'acronym': 'Ondansetron', 'briefTitle': 'Ondansetron Prior Spinal Anaesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Effect of Prophylactic IV Ondansetron Prior Spinal Anaesthesia in Caesarean Section on Bradycardia and Hypotension (Observational Study)', 'orgStudyIdInfo': {'id': 'IRB0000871252'}, 'secondaryIdInfos': [{'id': 'Kuwait MOH', 'type': 'OTHER', 'domain': 'Maternity Hospital'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Intravenous Ondansetron for patients undergoing Cesarean section under spinal Anesthesia', 'description': 'Pregnant patients undergoing elective caesarean section with no co-morbidities will receive intravenous ondansetron'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'country': 'Egypt', 'facility': 'Assiut university faculty of medicine', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'overallOfficials': [{'name': 'Abdelrady S Ibrahim, .M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assiut University Faculty Of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kuwait Institute for Medical Specialization', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Anesthesia and ICU', 'investigatorFullName': 'Abdelrady S Ibrahim, MD', 'investigatorAffiliation': 'Assiut University'}}}}