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NCT05849597 Clinical Trial

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

Intensive Care Unit Delirium Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05849597
Other study ID # 612-1/1
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date March 1, 2022
Est. completion date December 2024

Study information
Verified date May 2023
Source University of Novi Sad
Contact Mihaela Preveden, MD
Phone +381214805702
Email mihaela.detki@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date December 2024
Est. primary completion date April 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 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.

Locations
Country Name City State
Serbia Institute of Cardiovascular Diseases of Vojvodina Sremska Kamenica

Sponsors (1)
Lead Sponsor Collaborator
University of Novi Sad

Country where clinical trial is conducted

Serbia, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 5 days
Secondary MV duration Duration of mechanical ventilation 30 days
Secondary ICU length of stay Total duration of stay in the intensive care unit 30 days
Secondary Hospital length of stay Total duration of stay in hospital 30 days
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