Ignite Creation Date:
2025-12-26 @ 12:14 PM
Ignite Modification Date:
2025-12-31 @ 3:55 PM
Study NCT ID:
NCT06498700
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-08-19
First Post:
2024-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intraoperative Subanesthetic Ketamine Versus Dexmedetomidine Infusion for Prevention of Post-traumatic Stress Disorder After Traumatic Brain Surgeries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007649', 'term': 'Ketamine'}, {'id': 'D020927', 'term': 'Dexmedetomidine'}], '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': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-03-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-15', 'studyFirstSubmitDate': '2024-07-07', 'studyFirstSubmitQcDate': '2024-07-07', 'lastUpdatePostDateStruct': {'date': '2024-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '(PTSD)', 'timeFrame': '6 months', 'description': 'To measure the change in PTSD symptom severity using the PTSD Checklist'}], 'secondaryOutcomes': [{'measure': 'VAS', 'timeFrame': '(24 hours, 48 hours, and 1 month)', 'description': 'postoperative pain'}, {'measure': 'postoperative delirium', 'timeFrame': 'twice daily for 3 days', 'description': 'using the confusion assessment method criteria'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ketamine, Dexmedetomidine ,Post-traumatic Stress Disorder , traumatic Brain surgeries'], 'conditions': ['Subanesthetic Ketamine Dexmedetomidin']}, 'descriptionModule': {'briefSummary': 'Prevention of Post-traumatic Stress Disorder after traumatic Brain surgeries by using either subanesthetic ketamine or dexmedetomidine infusion.', 'detailedDescription': 'after being informed about the study and potential risks. All patients giving written consent will be randomized by double blind manner into two equal groups (K group and D group). Using computer generated randomization table; each group consists of 26 patients: K group (n=26): Patient will receive with 0.5 mg/kg/h ketamine infusion. D group (n=26): Patient will receive 0.1 ug/kg/h dexmedetomidine infusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAged 18-60 years old.Body mass index of less than or equal 35.American Society of I and II.Duration of surgery not more than 3 hours.\n\nExclusion Criteria:\n\nKnown hypersensitivity to dexmedetomidine or ketamine. Hemorrhagic shock decompensation.History of alcohol or drug abuse.History of neurologic or psychiatric diseases Advanced renal ,liver or cardiovascular disorders.'}, 'identificationModule': {'nctId': 'NCT06498700', 'briefTitle': 'Intraoperative Subanesthetic Ketamine Versus Dexmedetomidine Infusion for Prevention of Post-traumatic Stress Disorder After Traumatic Brain Surgeries', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Zagazig University'}, 'officialTitle': 'Intraoperative Subanesthetic Ketamine Versus Dexmedetomidine Infusion for Prevention of Post-traumatic Stress Disorder After Traumatic Brain Surgeries: A Randomized Trial', 'orgStudyIdInfo': {'id': '440'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ketamine(K)', 'description': '0.5 mg/kg/h ketamine infusion', 'interventionNames': ['Drug: ketamine']}, {'type': 'EXPERIMENTAL', 'label': 'dexmedetomidine(D)', 'description': '0.1 ug/kg/h dexmedetomidine infusion', 'interventionNames': ['Drug: dexmedetomidine']}], 'interventions': [{'name': 'ketamine', 'type': 'DRUG', 'description': '0.5 mg/kg/h ketamine infusion', 'armGroupLabels': ['Ketamine(K)']}, {'name': 'dexmedetomidine', 'type': 'DRUG', 'description': '0.1 ug/kg/h dexmedetomidine infusion', 'armGroupLabels': ['dexmedetomidine(D)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44519', 'city': 'Zagazig', 'state': 'Sharqia Province', 'country': 'Egypt', 'facility': 'Faculty of Medicine,Zagazig University', 'geoPoint': {'lat': 30.58768, 'lon': 31.502}}], 'overallOfficials': [{'name': 'marwa M Medhat', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zagazig University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zagazig University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor of anesthesia and surgical intensive care (Principal Investigator)', 'investigatorFullName': 'Marwa Mohamed Medhat', 'investigatorAffiliation': 'Zagazig University'}}}}