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NCT Number: NCT05849597

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Institute of Cardiovascular Diseases of Vojvodina

Kamenitz, 21204, Serbia

Location status: Recruiting

Location contact

Mihaela Preveden, MD

CONTACT

[email protected]

+381214805702

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. MV duration

    Time frame: 30 days

    Duration of mechanical ventilation

  2. ICU length of stay

    Time frame: 30 days

    Total duration of stay in the intensive care unit

  3. Hospital length of stay

    Time frame: 30 days

    Total duration of stay in hospital

Study contacts

Contact information is provided by the study sponsor or research team.

Mihaela Preveden, MD

CONTACT

[email protected]

+381214805702

Sponsors and collaborators

Lead sponsor

University of Novi Sad

Other

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
May 9, 2023
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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