Using dexmedetomidine nasal spray to reduce postoperative delirium in cardiac surgery patients
Dexmedetomidine in Reducing Postoperative Delirium in Cardiac Surgery Patients：a Single-center, Double- Blind, Controlled Trial
This study is testing if a nasal spray called dexmedetomidine can help prevent confusion after heart surgery by improving sleep before the operation.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 686 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Xijing Hospital Academic / other |
| Locations | 1 site (Xi'an, Shaanxi) |
| Trial ID | NCT06619912 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of dexmedetomidine nasal spray in reducing postoperative delirium (POD) among patients undergoing cardiac surgery. The study hypothesizes that improving preoperative sleep quality with dexmedetomidine can lead to a decrease in the incidence of POD, which is a common and serious complication following such surgeries. The trial will involve adult patients who are scheduled for cardiac surgery with cardiopulmonary bypass and will assess the outcomes related to cognitive function and hospital stay length. The research aims to clarify the role of sleep disturbances in the development of POD and the potential neuroprotective effects of dexmedetomidine.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 years or older who are scheduled for cardiac surgery involving cardiopulmonary bypass.
Not a fit: Patients with severe neurological disorders, significant cardiac issues, or those who cannot communicate effectively prior to surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of postoperative delirium, leading to better recovery outcomes for cardiac surgery patients.
How similar studies have performed: While there have been mixed results in previous studies regarding the use of dexmedetomidine for preventing postoperative delirium, this trial aims to address the inconsistencies by focusing on preoperative sleep quality.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Xi'an, Shaanxi
- Xijing Hospital — Xi'an, Shaanxi, China (Recruiting)
Study contacts
- Principal investigator: Chong Lei, M.D., phd — Xijing Hospital
- Study coordinator: Chong Lei, M.D., phd
- Email: crystalleichong@126.com
- Phone: 86-18629011362
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.