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RecruitingPhase 3NCT06619912

Dexmedetomidine in Reducing Postoperative Delirium in Cardiac Surgery Patients

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Trial Parameters

ConditionPostoperative Delirium
SponsorXijing Hospital
Study TypeINTERVENTIONAL
PhasePhase 3
Enrollment686
SexALL
Min Age18 Years
Max AgeN/A
Start Date2025-03-03
Completion2026-10-31
Interventions
Dexmedetomidine nasal spray

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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.

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