Using dexmedetomidine to prevent delirium after heart surgery
Official title: Dexmedetomidinine in the Prevention of Postoperative Delirium in the Intensive Care Unit After Cardiac Surgery
Run by University of Novi Sad · NCT05849597 · Data updated 2026-11-12
This study is testing if using a medication called dexmedetomidine instead of propofol can help prevent confusion and improve recovery in adults after heart surgery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | University of Novi Sad Academic / other |
| Locations | 1 site (Kamenitz) |
| Status | Recruiting |
| Started | March 1, 2022 |
| Main results expected | February 2025 |
| Study ends | June 2025 |
| Registry record updated | December 4, 2024 |
| Trial ID | NCT05849597 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults undergoing elective open heart surgery with a left ventricular ejection fraction greater than 40%.
✕Probably not a fit
Patients with preoperative atrial fibrillation, serious mental illness, or those requiring emergency procedures may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial is a prospective, randomized, single-blinded, controlled study comparing the effects of sedation with dexmedetomidine versus propofol in patients undergoing elective cardiac surgery. Adult patients scheduled for procedures involving cardiopulmonary bypass will be randomly assigned to receive either dexmedetomidine or propofol upon arrival in the intensive care unit. The sedation levels will be monitored using the Richmond Agitation and Sedation Scale, and various postoperative parameters will be recorded to assess outcomes related to delirium and recovery.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of postoperative delirium in cardiac surgery patients, improving recovery and overall outcomes.
How similar studies have gone: Other studies have shown promising results with dexmedetomidine in reducing postoperative delirium, suggesting this approach may be effective.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Institute of Cardiovascular Diseases of Vojvodina
Kamenitz, Serbia Recruiting
Study contacts
- Principal investigator: Mihaela Preveden, MD — Institute of Cardiovascular Diseases of Vojvodina
- Study coordinator: Mihaela Preveden, MD
- Email: mihaela.detki@gmail.com
- Phone: +381214805702
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.