RecruitingPhase 3NCT06619912

Dexmedetomidine in Reducing Postoperative Delirium in Cardiac Surgery Patients

Dexmedetomidine in Reducing Postoperative Delirium in Cardiac Surgery Patients：a Single-center, Double- Blind, Controlled Trial

Sponsor

Xijing Hospital

Enrollment

686 participants

Start Date

Mar 3, 2025

Study Type

INTERVENTIONAL

Conditions

Postoperative Delirium Preoperative Sleep Disorder

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

Min Age: 18 Years

Inclusion Criteria3

Aged 18 years or older.
Cardiac surgery with cardiopulmonary bypass.
Ability to provide consent.

Exclusion Criteria9

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.
Patients with severe liver dysfunction (Child Pugh C grade), renal dysfunction (preoperative dialysis), ASA grade V or expected survival ≤ 24 hours.
Heart transplant surgery
Surgery for congenital heart disease.
Deep hypothermic circulatory arrest surgery.
Already enrolled in other study patients.
Refuse to participate.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGDexmedetomidine nasal spray

Participants will be randomised to receive either dexmedetomidine or saline nasal spray (1.5ug/kg, ideal body weight) at the night before surgery and 30 minutes before induction.