NCT05849597 Dexmedetomidinine in the Prevention of Postoperative Delirium in the Intensive Care Unit After Cardiac Surgery
| NCT ID | NCT05849597 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of Novi Sad |
| Condition | Intensive Care Unit Delirium |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2022-03-01 |
| Primary Completion | 2025-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 200 participants in total. It began in 2022-03-01 with a primary completion date of 2025-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Mihaela Preveden, MD
PRINCIPAL INVESTIGATOR
Institute of Cardiovascular Diseases of Vojvodina
Frequently Asked Questions
Who can join the NCT05849597 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Intensive Care Unit Delirium. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05849597 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 200 participants.
Is NCT05849597 currently recruiting?
Yes, NCT05849597 is actively recruiting participants. Contact the research team at mihaela.detki@gmail.com for enrollment information.
Where is the NCT05849597 trial being conducted?
This trial is being conducted at Kamenitz, Serbia.
Who is sponsoring the NCT05849597 clinical trial?
NCT05849597 is sponsored by University of Novi Sad. The principal investigator is Mihaela Preveden, MD at Institute of Cardiovascular Diseases of Vojvodina. The trial plans to enroll 200 participants.