Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 3:50 AM
Study NCT ID:
NCT07411794
Status:
RECRUITING
Last Update Posted:
2026-02-17
First Post:
2026-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dexmedetomidine vs Midazolam in Coronary Artery By-pass Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071257', 'term': 'Emergence Delirium'}], 'ancestors': [{'id': 'D003693', 'term': 'Delirium'}, {'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-06-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-09', 'studyFirstSubmitDate': '2026-02-09', 'studyFirstSubmitQcDate': '2026-02-09', 'lastUpdatePostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Delirium', 'timeFrame': 'Postoperative 24 hours', 'description': 'Presence of delirium according to the CAM-ICU assessment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['postoperative delirium', 'dexmedetomidine', 'midazolam', 'coronary artery by pass'], 'conditions': ['Postoperative Delirium']}, 'descriptionModule': {'briefSummary': 'The aim is to compare the incidence of postoperative delirium following coronary artery bypass grafting (CABG) between patients receiving dexmedetomidine and those receiving midazolam infusions.', 'detailedDescription': 'Patients will be allocated into two groups. Those receiving intraoperative dexmedetomidine infusion will constitute Group D (n = 30), while those receiving intraoperative midazolam infusion will constitute Group M (n = 30). Demographic data, including age, sex, and body mass index, will be recorded.\n\nIntraoperative heart rate, mean arterial pressure, SpO₂, bispectral index (BIS), and cerebral oxygenation values will be documented at predetermined intervals. Changes in pCO₂ levels will also be recorded. Surgical duration, cardiopulmonary bypass time, recovery time, length of intensive care unit stay, and the presence of delirium as assessed by the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) will be documented.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients scheduled for elective coronary artery bypass graft surgery.\n\nExclusion Criteria:\n\n* Patients with renal disorders,\n* Patients with hepatic disorders,\n* Patients with neuropsychiatric disorders,\n* Patients whom informed consent could not be obtained\n* Patients who declined to participate in the study.'}, 'identificationModule': {'nctId': 'NCT07411794', 'briefTitle': 'Dexmedetomidine vs Midazolam in Coronary Artery By-pass Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Cumhuriyet University'}, 'officialTitle': 'A Comparative Evaluation of Dexmedetomidine and Midazolam ınfusions With Respect to Postoperative Delirium in Patients Undergoing Coronary Artery Bypass Grafting', 'orgStudyIdInfo': {'id': '2025-06/15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dexmedetomidine', 'description': 'Following the induction of standard general anaesthesia, dexmedetomidine will be administered as a continuous intravenous infusion at a dose of 0.3-0.7 µg/kg/h.', 'interventionNames': ['Drug: Intravenous Dexmedetomidine infusion + Standard Anesthesia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Midazolam', 'description': 'Following the induction of standard general anaesthesia, midazolam will be administered as a continuous intravenous infusion at a dose of 0.03-0.06 mg/kg/h.', 'interventionNames': ['Drug: intravenous midazolam infusion + Standard anesthesia']}], 'interventions': [{'name': 'Intravenous Dexmedetomidine infusion + Standard Anesthesia', 'type': 'DRUG', 'description': 'Following the induction of standard general anaesthesia, dexmedetomidine will be administered as a continuous intravenous infusion at a dose of 0.3-0.7 µg/kg/h.', 'armGroupLabels': ['Dexmedetomidine']}, {'name': 'intravenous midazolam infusion + Standard anesthesia', 'type': 'DRUG', 'description': 'Following the induction of standard general anaesthesia, midazolam will be administered as a continuous intravenous infusion at a dose of 0.03-0.06 mg/kg/h.', 'armGroupLabels': ['Midazolam']}]}, 'contactsLocationsModule': {'locations': [{'zip': '58140', 'city': 'Sivas', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Oğuz Gündoğdu', 'role': 'CONTACT', 'email': 'droguzgundogdu@gmail.com', 'phone': '05545945469'}], 'facility': 'Sivas Cumhuriyet University', 'geoPoint': {'lat': 39.74833, 'lon': 37.01611}}], 'centralContacts': [{'name': 'Oğuz Gündoğdu', 'role': 'CONTACT', 'email': 'droguzgundogdu@gmail.com', 'phone': '+905545945469'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cumhuriyet University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Oguz Gundogdu', 'investigatorAffiliation': 'Cumhuriyet University'}}}}