NCT06619912 Dexmedetomidine in Reducing Postoperative Delirium in Cardiac Surgery Patients
| NCT ID | NCT06619912 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Xijing Hospital |
| Condition | Postoperative Delirium |
| Study Type | INTERVENTIONAL |
| Enrollment | 686 participants |
| Start Date | 2025-03-03 |
| Primary Completion | 2026-10-31 |
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 686 participants in total. It began in 2025-03-03 with a primary completion date of 2026-10-31.
⚠ 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
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.
Eligibility Criteria
Inclusion Criteria: 1. Aged 18 years or older. 2. Cardiac surgery with cardiopulmonary bypass. 3. Ability to provide consent. Exclusion Criteria: 1. 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. 2. Patients with sick sinus syndrome, severe sinus bradycardia (heart rate\<50 beats/minute), grade II or above atrioventricular block, and no pacemaker implanted. 3. Unable to communicate due to coma, severe dementia, or language barriers prior to surgery. 4. Patients with severe liver dysfunction (Child Pugh C grade), renal dysfunction (preoperative dialysis), ASA grade V or expected survival ≤ 24 hours. 5. Heart transplant surgery 6. Surgery for congenital heart disease. 7. Deep hypothermic circulatory arrest surgery. 8. Already enrolled in other study patients. 9. Refuse to participate.
Contact & Investigator
Chong Lei, M.D., phd
PRINCIPAL INVESTIGATOR
Xijing Hospital
Frequently Asked Questions
Who can join the NCT06619912 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Postoperative 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 NCT06619912 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 686 participants.
Is NCT06619912 currently recruiting?
Yes, NCT06619912 is actively recruiting participants. Contact the research team at crystalleichong@126.com for enrollment information.
Where is the NCT06619912 trial being conducted?
This trial is being conducted at Xi'an, China.
Who is sponsoring the NCT06619912 clinical trial?
NCT06619912 is sponsored by Xijing Hospital. The principal investigator is Chong Lei, M.D., phd at Xijing Hospital. The trial plans to enroll 686 participants.