Dexmedetomidine in Reducing Postoperative Delirium in Cardiac Surgery Patients
Key facts
- Who runs it
- Xijing Hospital
- Where
- China1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- Phase
- Phase 3
- People taking part
- 686 people enrolled
- Started
- 3 Mar 2025
- Ended
- 8 Sept 2026
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Dexmedetomidine nasal spray
- Record updated
- 13 November 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- Aged 18 years or older
- Cardiac surgery with cardiopulmonary bypass
- Ability to provide consent
Who cannot take part
- Unable to communicate due to coma, severe dementia, or language barriers prior to surgery
- Deep hypothermic circulatory arrest surgery
- 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
- Heart transplant surgery
- Surgery for congenital heart disease
- Patients with severe liver dysfunction (Child Pugh C grade), renal dysfunction (preoperative dialysis), ASA grade V or expected survival ≤ 24 hours
- Already enrolled in other study patients
- Refuse to participate
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Dexmedetomidine groupTreatment being tested
The Dexmedetomidine group will receive dexmedetomidine nasal spray （1.5ug/kg, ideal body weight) at the night before surgery and 15 minutes before induction.
Treatment: Dexmedetomidine nasal spray
- Control groupNo study treatment, for comparison
In the control group, the treatment is sodium chloride 0.9% nasal spray. Follows the same rules as in the experimental group.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Dexmedetomidine in Reducing Postoperative Delirium in Cardiac Surgery Patients：a Single-center, Double- Blind, Controlled Trial
- Record updated
- 13 November 2026