Dexmedetomidinine in the Prevention of Postoperative Delirium in the Intensive Care Unit After Cardiac Surgery
NCT ID: NCT05849597
Last Updated: 2024-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
200 participants
INTERVENTIONAL
2022-03-01
2025-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Dexmedetomidine
Evaluate the effects of dexmedetomidine for sedation of patients in the intensive care unit after open heart surgery
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.
Propofol
Compare the clinical outcomes of the experimental group with the standard of care, i.e. sedation with propofol
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* left ventricular ejection fraction (LVEF) \>40%.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University of Novi Sad
OTHER
Responsible Party
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Mihaela Preveden
Research Assistant
Principal Investigators
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Mihaela Preveden, MD
Role: PRINCIPAL_INVESTIGATOR
Institute of Cardiovascular Diseases of Vojvodina
Locations
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Institute of Cardiovascular Diseases of Vojvodina
Kamenitz, , Serbia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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612-1/1
Identifier Type: -
Identifier Source: org_study_id