Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-01-01 @ 5:40 PM
Study NCT ID:
NCT06930456
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-04-16
First Post:
2025-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between Intravenous Hydrocortisone and Ondansetron in Prevention of Post Spinal Anesthesia Hypotension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D006854', 'term': 'Hydrocortisone'}, {'id': 'D017294', 'term': 'Ondansetron'}], 'ancestors': [{'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D015062', 'term': '11-Hydroxycorticosteroids'}, {'id': 'D006889', 'term': 'Hydroxycorticosteroids'}, {'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D015065', 'term': '17-Hydroxycorticosteroids'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic 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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-09', 'studyFirstSubmitDate': '2025-04-09', 'studyFirstSubmitQcDate': '2025-04-09', 'lastUpdatePostDateStruct': {'date': '2025-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'hypotension', 'timeFrame': '5 minutes after subarachnoid injection and every 5 minutes for 30 minutes-duration', 'description': 'The percentage of patients experiencing hypotension (a 20% decrease of the basal mean arterial blood pressure or systolic blood pressure less than 90 mmHg) at any point in the first thirty-minute period following spinal anesthetic induction'}], 'secondaryOutcomes': [{'measure': 'bradycardia', 'timeFrame': '5 minutes after subarachnoid injection and every 5 minutes for 30 minutes-duration', 'description': 'The percentage of patients experiencing bradycardia (HR less than 50 beat/min) at any point in the first thirty-minute period following spinal anesthesia.'}, {'measure': 'requirement of atropine or ephedrine', 'timeFrame': '5 minutes after subarachnoid injection and every 5 minutes for 30 minutes-duration', 'description': 'The proportion of those who require atropine or ephedrine for management of bradycardia or hypotension'}, {'measure': 'Doses of administered atropine and ephedrine', 'timeFrame': '5 minutes after subarachnoid injection and every 5 minutes for 30 minutes-duration', 'description': 'Doses of administered atropine and ephedrine'}, {'measure': 'nausea and vomiting', 'timeFrame': 'after subarachnoid injection till the end of operation', 'description': 'Incidence of post spinal nausea and vomiting till the end of operation'}, {'measure': 'shivering', 'timeFrame': 'after subarachnoid injection till the end of operation', 'description': 'Incidence of post spinal shivering till the end of operation'}, {'measure': 'blood pressure and heart rate variations', 'timeFrame': '5 minutes after subarachnoid injection and every 5 minutes for 30 minutes-duration', 'description': 'Variations in blood pressure and Heart Rate (HR).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post Spinal Anaesthesia Hypotension']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess and contrast the effectiveness of intravenous ondansetron and intravenous hydrocortisone in avoiding spinal anesthesia-induced hypotension.', 'detailedDescription': 'According to the medication investigated in this study, patients will be divided into three equal groups (40 each). Patients will receive one of the following 15 minutes before spinal anesthesia:\n\n1. Hydrocortisone 100 mg (H group)\n2. Ondansetron 8 mg (O group)\n3. An identical volume of sterile distilled water (Control group) (C group).\n\nSpinal anesthesia will be performed under complete aseptic conditions with the patient seated, a 25-gauge Quincke spinal needle is used to administer 3.5 ml of a 0.5% hyperbaric bupivacaine together with 25 micrograms of fentanyl at the L3-L4 or L4-L5 level.\n\nPatients will lie supine with slight head elevation after the intrathecal injection is finished. Intravenous Infusion of 500 ml normal saline over the initial post spinal 30 minutes. Sensory level and motor block will be verified. Heart rate (HR), systolic (SBP), diastolic (DBP) and mean blood pressure (MBP) will be measured every 5 min for 30 min during which the patient remains in the supine position with no application of torniquet.\n\nIf the MAP drops by 20% below baseline or the systolic blood pressure falls below 90 mmHg, hypotension is recorded and will be treated with intravenous incremental doses of 5 mg ephedrine.\n\nIf the heart rate drops below 50 beats per minute, bradycardia is recorded, and atropine 0.5 mg will be administered intravenously. If ephedrine or atropine were used, only data from before their administration would be analyzed. The doses of ephedrine and atropine needed will be recorded.\n\nNausea, vomiting and shivering will be recorded when occur till the end of operation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ASA I and II (physical status according to American Society of Anesthesiologists).\n2. Patients aged 21 years or more.\n3. Either sex.\n4. Abdominal and lower limb operations.\n\nExclusion Criteria:\n\n1. Patient refusal.\n2. hemodynamic instability\n3. Hematological diseases, bleeding or coagulation abnormality.\n4. Local skin infection and sepsis at site of spinal anesthesia\n5. neuromuscular diseases (as myopathies, myasthenia gravies…)\n6. Preexisting neurological deficit or psychiatric diseases.\n7. Known intolerance to the study drugs.\n8. patients already receiving any of the study drugs.\n9. diabetic patient.'}, 'identificationModule': {'nctId': 'NCT06930456', 'briefTitle': 'Comparison Between Intravenous Hydrocortisone and Ondansetron in Prevention of Post Spinal Anesthesia Hypotension', 'organization': {'class': 'OTHER', 'fullName': 'Port Said University hospital'}, 'officialTitle': 'Intravenous Hydrocortisone Versus Ondansetron in Prevention of Post Spinal Anesthesia Hypotension in Elective Surgeries', 'orgStudyIdInfo': {'id': 'MED(3/12/2023)/(121)ANE921_002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Hydrocortisone (H) group', 'description': 'As in intervention description', 'interventionNames': ['Drug: hydrocortisone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ondansetron (O) group', 'description': 'As in intervention description', 'interventionNames': ['Drug: ondansetron']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control (C) group', 'description': 'As in intervention description', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'hydrocortisone', 'type': 'DRUG', 'description': 'A deidentified syringe (10 mL) containing 100 mg hydrocortisone will be given 15 minutes prior subarachnoid blockade. Spinal anesthesia will be performed with a 25-gauge Quincke spinal needle to administer 3.5 ml of a 0.5% hyperbaric bupivacaine plus 25 micrograms of fentanyl at the L3-L4 or L4-L5 level. Then, Patient will lie supine with slight head elevation. Intravenous Infusion of 500 ml normal saline over the initial post spinal 30 minutes. Sensory level and motor block will be verified. Heart rate (HR), systolic (SBP), diastolic (DBP) and mean blood pressure (MBP) will be measured every 5 min for 6 readings during which the patient remains in the supine position with no application of torniquet.', 'armGroupLabels': ['Hydrocortisone (H) group']}, {'name': 'ondansetron', 'type': 'DRUG', 'description': 'A deidentified syringe (10 mL) containing 8 mg ondansetron will be given 15 minutes prior subarachnoid blockade. Spinal anesthesia will be performed with a 25-gauge Quincke spinal needle to administer 3.5 ml of a 0.5% hyperbaric bupivacaine plus 25 micrograms of fentanyl at the L3-L4 or L4-L5 level. Then, Patient will lie supine with slight head elevation. Intravenous Infusion of 500 ml normal saline over the initial post spinal 30 minutes. Sensory level and motor block will be verified. Heart rate (HR), systolic (SBP), diastolic (DBP) and mean blood pressure (MBP) will be measured every 5 min for 6 readings during which the patient remains in the supine position with no application of torniquet.', 'armGroupLabels': ['Ondansetron (O) group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'A deidentified syringe (10 mL) containing sterile distilled water for intravenous injection will be given 15 minutes prior subarachnoid blockade. Spinal anesthesia will be performed with a 25-gauge Quincke spinal needle to administer 3.5 ml of a 0.5% hyperbaric bupivacaine plus 25 micrograms of fentanyl at the L3-L4 or L4-L5 level. Then, Patient will lie supine with slight head elevation. Intravenous Infusion of 500 ml normal saline over the initial post spinal 30 minutes. Sensory level and motor block will be verified. Heart rate (HR), systolic (SBP), diastolic (DBP) and mean blood pressure (MBP) will be measured every 5 min for 6 readings during which the patient remains in the supine position with no application of torniquet.', 'armGroupLabels': ['control (C) group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Port Said', 'state': 'Port Said Governorate', 'country': 'Egypt', 'facility': 'Port Said Hospital', 'geoPoint': {'lat': 31.26531, 'lon': 32.3019}}], 'overallOfficials': [{'name': 'Magdy Ali Omera, prof. of Anesthesia and ICU', 'role': 'STUDY_CHAIR', 'affiliation': 'Port Said University, Faculty of Medicine, Department of Anesthesia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nada kamel Elgamal', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer of Anesthesia and ICU', 'investigatorFullName': 'Nada kamel Elgamal', 'investigatorAffiliation': 'Port Said University hospital'}}}}