RecruitingPhase 3NCT05849597

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


Sponsor

University of Novi Sad

Enrollment

200 participants

Start Date

Mar 1, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria2

  • 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 Criteria8

  • 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

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Interventions

DRUGDexmedetomidine

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.

DRUGPropofol

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.


Locations(1)

Institute of Cardiovascular Diseases of Vojvodina

Kamenitz, Serbia

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NCT05849597


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