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
• Status: Recruiting
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Delirium
• Intensive Care Unit Delirium

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