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Clinical trial

Dexmedetomidinine in the Prevention of Postoperative Delirium in the Intensive Care Unit After Cardiac Surgery

ID
Name
612-1/1
Description
This is a prospective, randomized, single blinded, controlled clinical trial designed to compare the clinical effects of sedation with dexmedetomidine versus propofol in patients undergoing cardiac surgery.
Trial arms
Trial start
2022-03-01
Estimated PCD
2024-04-01
Trial end
2024-12-01
Status
Recruiting
Phase
Early phase I
Treatment
Dexmedetomidine
Upon arrival to the intensive care unit after open heart surgery, the patients will be sedated with continuous dexmedetomidine infusion in doses 0.2-0.7 mcg/kg/h.
Arms:
Dexmedetomidine
Propofol
Upon arrival to the intensive care unit after open heart surgery, the patients will be sedated with continuous propofol infusion in doses 1-2 mg/kg/h.
Arms:
Propofol
Size
200
Primary endpoint
Occurrence of postoperative delirium
5 days
Eligibility criteria
Inclusion Criteria: * patients undergoing open heart surgery with the use of cardiopulmonary bypass (including coronary artery bypass grafting, valve repair/replacement, and combined) * left ventricular ejection fraction (LVEF) \>40%. Exclusion Criteria: * preoperative atrial fibrillation * previous history of interventionally treated arrhythmias * second and third degree atrioventricular block * bradycardia with heart rate ≤50/min * pacemaker * renal or hepatic insufficiency * emergency procedures * history of serious mental illness, delirium, and severe dementia
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 200, 'type': 'ESTIMATED'}}
Updated at
2023-05-09

1 organization

2 products

1 indication

Organization
University of Novi Sad
Product
Dexmedetomidine
Indication
Delirium
Product
Propofol