Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-25 @ 8:18 PM
Study NCT ID:
NCT06237569
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-01
First Post:
2024-01-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dose Low Dose Ketamine in Casesarian
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D019052', 'term': 'Depression, Postpartum'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D011644', 'term': 'Puerperal Disorders'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008874', 'term': 'Midazolam'}], 'ancestors': [{'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-24', 'studyFirstSubmitDate': '2024-01-12', 'studyFirstSubmitQcDate': '2024-01-24', 'lastUpdatePostDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postpartum depression', 'timeFrame': '4 weeks', 'description': 'Reducing postpartum depression with low-dose ketamine'}, {'measure': 'intraoperative complications', 'timeFrame': '1 day', 'description': 'Reducing postpartum depression by reducing ketamine-related intraoperative complications'}, {'measure': 'postoperative pain', 'timeFrame': '1 day', 'description': 'Reducing postoperative pain with low dose ketamine'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['midazolam with low dose ketamine', 'low dose ketamine', 'postoperatıve analgesıc need', 'postpartum depression'], 'conditions': ['Postoperative Pain', 'Postpartum Depression']}, 'descriptionModule': {'briefSummary': 'The results of ketamine, ketamine and midazolom and placebo can be copied after birth in cesareans subjected to spinal anesthesia.', 'detailedDescription': 'Postpartum depression will be evaluated by dividing the patients into 3 groups: group 1 as ketamine, group 2 as ketamine and midasom, and group 3 as placebo group.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing cesarean section under spinal anesthesia', 'genderDescription': 'being a patient undergoing cesarean section', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAmerican Society of Anesthesiologists 2-.3 18 -45years old Patients planned to be born by cesarean section The patient requests a cesarean section with spinal anesthesia\n\nExclusionCriteria:\n\nPathological obstetric complications\n\nHypertension\n\nContraindication for ketamine Contraindication for spinal'}, 'identificationModule': {'nctId': 'NCT06237569', 'briefTitle': 'Dose Low Dose Ketamine in Casesarian', 'organization': {'class': 'OTHER', 'fullName': 'Inonu University'}, 'officialTitle': 'Effects of Low Dose ketamıne on Postpartum Depression During Caesarean Sections', 'orgStudyIdInfo': {'id': 'inonu Caesarean'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Grup 1 -Ketamine Group', 'description': 'Ketamine Group (GROUP 1) 0.5 mg/kg IV single dose bolus diluted to 5 ml with 0.9% saline', 'interventionNames': ['Drug: Application of ketamine and midazolam or ketamine alone to patients undergoing cesarean section under spinal anesthesia']}, {'label': 'Group 2-ketamine + midazolam', 'description': 'Midazolam 0.0125 mg/kg is given followed by a single IV bolus dose of 0.5 mg/kg diluted to 5 ml with 0.9% saline.', 'interventionNames': ['Drug: Application of ketamine and midazolam or ketamine alone to patients undergoing cesarean section under spinal anesthesia']}, {'label': 'Group 3-placebo', 'description': 'Group 3-placebo ;A single dose of IV 5 ml physiological saline will be given.', 'interventionNames': ['Drug: Application of ketamine and midazolam or ketamine alone to patients undergoing cesarean section under spinal anesthesia']}], 'interventions': [{'name': 'Application of ketamine and midazolam or ketamine alone to patients undergoing cesarean section under spinal anesthesia', 'type': 'DRUG', 'description': 'A single dose of 0.5 mg/kg IV diluted to 5 ml with 0.9% saline was planned to be administered simultaneously to the Ketamine Group (GROUP 1), ketamine and midazolam within 5 minutes after the newborn umbilical cord was clamped (Group 2). After midazolam 0.03 mg/kg is given, a single dose IV bolus of 0.5 mg/kg diluted to 5 ml with 0.9% saline will be administered.\n\nPatients experience dizziness, hallucinations, nausea, headache, vomiting, diplopia and blurred vision, the time until the first analgesic request; Depression parameters will be evaluated with the Edinburgh Postpartum Depression Scale (EPDS) in all patients before cesarean section and at the 1st, 2nd and 4th weeks after birth.', 'armGroupLabels': ['Group 2-ketamine + midazolam', 'Group 3-placebo', 'Grup 1 -Ketamine Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44050', 'city': 'Malatya', 'country': 'Turkey (Türkiye)', 'facility': 'Inonu universitesi', 'geoPoint': {'lat': 38.35018, 'lon': 38.31667}}], 'centralContacts': [{'name': 'DUYGU DEMIROZ, dr', 'role': 'CONTACT', 'email': 'drduygudemiroz@hotmail.com', 'phone': '+905319504421'}, {'name': 'OSMAN TOPLU, dr', 'role': 'CONTACT', 'email': 'osman.toplu@inonu.edu.tr', 'phone': '905321137771'}], 'overallOfficials': [{'name': 'DUYGU DEMIROZ', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Inonu University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inonu University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'DUYGU DEMİROZ', 'investigatorAffiliation': 'Inonu University'}}}}