Dexmedetomidinine in the Prevention of Postoperative Delirium in the Intensive Care Unit After Cardiac Surgery
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- University of Novi Sad
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Occurrence of postoperative delirium
Study Overview
Brief Summary
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.
Detailed Description
The study will include adult patients of both sexes scheduled for elective cardiac surgery with the use of cardiopulmonary bypass (including coronary artery bypass grafting, valve repair/replacement, and combined).
The patients included in the study will be randomized in 1:1 ratio using computer generated numbers into two groups. The first group of patients, upon arrival to the intensive care unit will be sedated with continuous dexmedetomidine infusion in doses 0.2-0.7 mcg/kg/h. Dexmedetomidine infusion will be discontinued before weaning from mechanical ventilation and extubation. The second group of patients, upon arrival to the intensive care unit will be sedated with continuous propofol infusion in doses 1-2 mg/kg/h. Propofol infusion will also be discontinued before weaning from mechanical ventilation and extubation.
Sedation level will be assessed using Richmond Agitation and Sedation Scale (RASS) every two hours. Postoperative analgesia will be managed according to protocol (opioid analgesics, non-steroid anti-inflammatory drugs, paracetamol), with pain level assessment using visual analog scale (0 - no pain; 10 - unbearable pain).
The following data will be registered: age, sex, body mass index (BMI), hemoglobin, heart rate, and LVEF. Among the postoperative parameters, the following will registered: duration of mechanical ventilation (in hours), extubation time, ICU and hospital length of stay (in days), postoperative hemoglobin, blood product transfusion rates, occurrence of atrial fibrillation and assessment of delirium. Assessment of delirium will be performed using the confusion assessment method for intensive care unit (CAM-ICU) every 12 hours during five postoperative days.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Dexmedetomidine
Evaluate the effects of dexmedetomidine for sedation of patients in the intensive care unit after open heart surgery
Intervention: Dexmedetomidine (Drug)
Propofol
Compare the clinical outcomes of the experimental group with the standard of care, i.e. sedation with propofol
Intervention: Propofol (Drug)
Outcomes
Primary Outcomes
Occurrence of postoperative delirium
Time Frame: 5 days
Assessment of delirium will be performed using the confusion assessment method for intensive care unit (CAM-ICU) at any time in the first five days after surgery
Secondary Outcomes
- Hospital length of stay(30 days)
- ICU length of stay(30 days)
- MV duration(30 days)
Investigators
Mihaela Preveden
Research Assistant
University of Novi Sad