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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Novi Sad

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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%.

Disqualifiers

preoperative atrial fibrillation

previous history of interventionally treated arrhythmias

second and third degree atrioventricular block

bradycardia with heart rate ≤50/min

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dexmedetomidine

    Drug

    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

    Drug

    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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: DexmedetomidineExperimental treatment 1 intervention
Group B: PropofolActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Occurrence of postoperative delirium

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

Time frame
5 days

Secondary outcomes

1

MV duration

Duration of mechanical ventilation

Time frame
30 days
2

ICU length of stay

Total duration of stay in the intensive care unit

Time frame
30 days
3

Hospital length of stay

Total duration of stay in hospital

Time frame
30 days

Other outcomes

Sponsors and contacts

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