Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2026-02-22 @ 7:24 AM
Study NCT ID:
NCT03624166
Status:
COMPLETED
Last Update Posted:
2020-05-19
First Post:
2018-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Sub-anesthetic Dose of Ketamine on Post Spinal Hypotension in Caesarean Delivery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007649', 'term': 'Ketamine'}, {'id': 'D018681', 'term': 'Anesthetics, General'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000777', 'term': 'Anesthetics'}, {'id': 'D002492', 'term': 'Central Nervous System Depressants'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D002491', 'term': 'Central Nervous System Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-18', 'studyFirstSubmitDate': '2018-08-07', 'studyFirstSubmitQcDate': '2018-08-08', 'lastUpdatePostDateStruct': {'date': '2020-05-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of hypotension', 'timeFrame': '5 hours', 'description': 'after spinal anesthesia sub- anesthetic dose of ketamine will be given and blood pressure will be recorded every 2 minutes till delivery , every 5 minutes till end of surgery'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anesthesia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect of sub anesthetic dose of ketamine on vasopressor (Ephedrine) requirement to prevent maternal hypotension after spinal anesthesia in caesarean section.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Physical status American Society of Anesthesiologist(ASA) I or II. Full term pregnancy\n\nExclusion Criteria:\n\n* ,Pre-eclampsia.\n* Chronic hypertension.\n* Cardiovascular troubles.\n* any contraindications to spinal anesthesia as back infection , coaguolopathy , patient refusal'}, 'identificationModule': {'nctId': 'NCT03624166', 'briefTitle': 'Impact of Sub-anesthetic Dose of Ketamine on Post Spinal Hypotension in Caesarean Delivery', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Impact of Sub-anesthetic Dose of Ketamine on Post Spinal Hypotension in Caesarean Delivery :Prospective , Randomized Double- Blinded Study', 'orgStudyIdInfo': {'id': 'FAMUS R 38/ 2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ketamine', 'description': 'sub- anesthetic dose of ketamine 0.5 mg/kg will be given in 3 ml volume', 'interventionNames': ['Drug: Ketamine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'isotonic saline', 'description': 'isotonic saline 3 ml volume will be given', 'interventionNames': ['Drug: isotonic saline']}], 'interventions': [{'name': 'Ketamine', 'type': 'DRUG', 'otherNames': ['general anesthetic'], 'description': 'patients will receive sub- anesthetic dose of ketamine 0.5 mg/kg in 3 ml of isotonic saline after spinal anesthesia', 'armGroupLabels': ['Ketamine']}, {'name': 'isotonic saline', 'type': 'DRUG', 'description': 'patients will receive 3 ml of isotonic saline after spinal anesthesia', 'armGroupLabels': ['isotonic saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11591', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain Shams University hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Amin Mohammed Alansary Amin Ahmed Helwa', 'investigatorAffiliation': 'Ain Shams University'}}}}