Dexmedetomidinine in the Prevention of Postoperative Delirium in

Status Recruiting

Clinical Trial 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05849597
Study type	Interventional
Source	University of Novi Sad
Contact	Mihaela Preveden, MD
Phone	+381214805702
Email	mihaela.detki@gmail.com
Status	Recruiting
Phase	Phase 3
Start date	March 1, 2022
Completion date	December 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms