Dexmedetomidine in Reducing Postoperative Delirium in Cardiac Surgery Patients (NCT06619912) | Clinical Trial Compass
RecruitingPhase 3
Dexmedetomidine in Reducing Postoperative Delirium in Cardiac Surgery Patients
China686 participantsStarted 2025-03-03
Plain-language summary
Delirium is a common consequence of cardiac surgery and associates with poor outcomes. Multiple causes can trigger delirium occurence, and it has been hypothesised that sleep disturbances can be one of them. Dexmedetomidine may be effective in reducing delirium. The aim of this study was to demonstrate preoperative dexmedetomidine nasal spray in cardiac surgery patients can reduce postoperative delirium by improving preoperative sleep.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Aged 18 years or older.
. Cardiac surgery with cardiopulmonary bypass.
. Ability to provide consent.
Exclusion criteria
. Preoperative schizophrenia, epilepsy, Parkinson's disease, myasthenia gravis, history of neurosurgery, or Mini-mental State Examination(MMSE) score: illiteracy\<17, primary school level\<20, high school level \<24.
. Patients with sick sinus syndrome, severe sinus bradycardia (heart rate\<50 beats/minute), grade II or above atrioventricular block, and no pacemaker implanted.
. Unable to communicate due to coma, severe dementia, or language barriers prior to surgery.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 3 trial testing dexmedetomidine specifically to reduce delirium after cardiac surgery, can you explain how likely I am to develop postoperative delirium based on my situation, and whether this drug has already shown enough promise in earlier studies to be worth discussing for my care?
2The trial also looks at preoperative sleep disorders as a related condition — should I be evaluated for sleep problems before my surgery, and could that affect whether this trial might be relevant to my case?
3What are the known risks or side effects of dexmedetomidine that I should weigh against the potential benefit of reducing delirium after cardiac surgery?
4Are there already standard-of-care approaches to preventing postoperative delirium after cardiac surgery that I should consider first, or alongside this trial?
5How would participating in this trial affect my overall care plan — for example, would it change how I'm monitored, sedated, or managed during my recovery in the ICU?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.