Using dexmedetomidine to prevent delirium after heart surgery
Dexmedetomidinine in the Prevention of Postoperative Delirium in the Intensive Care Unit After Cardiac Surgery
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 |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Novi Sad Academic / other |
| Locations | 1 site (Kamenitz) |
| Trial ID | NCT05849597 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults undergoing elective open heart surgery with a left ventricular ejection fraction greater than 40%.
Not a fit: Patients with preoperative atrial fibrillation, serious mental illness, or those requiring emergency procedures may not benefit from this study.
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 performed: Other studies have shown promising results with dexmedetomidine in reducing postoperative delirium, suggesting this approach may be effective.
Eligibility criteria
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 this trial is running
Kamenitz
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.