Improving sleep quality in older patients undergoing knee or hip replacement surgery
Effect of Mini-dose Dexmedetomidine-Esketamine Infusion on Sleep Quality in Older Patients Undergoing Knee or Hip Replacement Surgery: A Multicenter Randomized Controlled Trial
This study tests if a combination of two medications can help older patients sleep better before they have knee or hip replacement surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 154 (estimated) |
| Ages | 65 Years to 90 Years |
| Sex | All |
| Sponsor | Peking University First Hospital Academic / other |
| Locations | 2 sites (Beijing, Beijing Municipality and 1 other locations) |
| Trial ID | NCT05950646 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of a mini-dose infusion of dexmedetomidine and esketamine on sleep quality in older patients scheduled for knee or hip replacement surgery. The study aims to address the prevalent sleep disturbances in this population, which can lead to worse surgical outcomes. By utilizing dexmedetomidine's sedative properties and esketamine's sleep-promoting effects, the trial seeks to enhance perioperative sleep quality. Participants will receive either the drug combination or normal saline as a control during the night before surgery.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 65 to 89 years who are scheduled for unilateral knee or hip arthroplasty.
Not a fit: Patients with a history of certain neurological disorders, severe sleep apnea, or those currently on specific sleep medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve sleep quality and postoperative recovery in older patients undergoing major surgeries.
How similar studies have performed: Previous studies have shown promising results with similar approaches using dexmedetomidine and esketamine for improving sleep quality, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥65 years and \<90 years; * Scheduled to undergo unilateral knee or hip arthroplasty. Exclusion Criteria: * Refuse to participate; * Hypnotic therapy for sleep disorders within 3 months; * Preoperative history of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis; * Diagnosed as obstructive sleep apnea, or at high risk of moderate to severe obstructive sleep apnea according to the Stop-Bang questionnaire; * Inability to communicate in the preoperative period because of coma, profound dementia, or language barrier; * Sick sinus syndrome, severe sinus bradycardia (heart rate \<50 beats/min), or atrioventricular block above grade II without pacemaker implanted; * Severe hepatic dysfunction (Child-Pugh class C), renal dysfunction (required preoperative dialysis), or expected survival ≤24 hours; * Receiving treatment with dexmedetomidine, clonidine, or esketamine; * Allergy to dexmedetomidine or esketamine.
Where this trial is running
Beijing, Beijing Municipality and 1 other locations
- Beijing Hospital — Beijing, Beijing Municipality, China (Recruiting)
- Peking University First Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Dong-Xin Wang, MD,PhD — Peking University First Hospital
- Study coordinator: Dong-Xin Wang, MD,PhD
- Email: wangdongxin@hotmail.com
- Phone: 86 10 83572784
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.