Mini-dose dexmedetomidine and esketamine for better sleep after surgery in OSA patients
Mini-dose Dexmedetomidine-Esketamine Supplemented Analgesia for Postoperative Sleep Promotion in Patients at High-risk of Obstructive Sleep Apnea: A Randomized Trial
This study is testing if a mix of mini-dose dexmedetomidine and esketamine can help improve sleep and reduce pain after surgery for people at risk of obstructive sleep apnea.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Peking University First Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06566482 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of a combination of mini-dose dexmedetomidine and esketamine on postoperative sleep quality in patients at high risk for obstructive sleep apnea (OSA). The study aims to determine if this combination can improve analgesia and reduce sleep disturbances that often occur after surgery. Patients aged 18 to 80 with a diagnosis of OSA or moderate-to-high risk of OSA will be enrolled and monitored for sleep quality and pain management post-surgery. The trial compares the effects of the drug combination against a placebo in a controlled setting.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with a preoperative diagnosis of obstructive sleep apnea or those assessed to be at moderate-to-high risk of OSA.
Not a fit: Patients with central sleep apnea syndrome or those with a history of certain neurological disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance postoperative sleep quality and reduce complications in patients with obstructive sleep apnea.
How similar studies have performed: Previous studies have shown promising results with similar combinations of dexmedetomidine and esketamine, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: 1. Aged ≥18 years but ≤80 years; 2. Preoperative diagnosis of OSA, or judged to be at moderate-to-high risk of OSA according to the STOP-Bang Questionnaire; 3. Scheduled to undergo thoracoscopic or laparoscopic surgery under general anesthesia, with an expected surgical duration of ≥1 hours, and required patient-controlled intravenous analgesia (PCIA) after surgery. Exclusion criteria: 1. Diagnosed as central sleep apnea syndrome; 2. Previous history of schizophrenia, epilepsy, Parkinson disease, or myasthenia gravis. 3. History of schizophrenia, or having antipsychotic drugs (including antidepressants or anxiolytics); 4. Inability to communicate in the preoperative period because of coma, profound dementia, or deafness; 5. History of drug or alcohol dependence, or sedative or hypnotic therapy within 1 month before surgery; 6. Contraindications to ketamine (such as hyperthyroidism, pheochromocytoma, or glaucoma); 7. Sick sinus syndrome, severe sinus bradycardia (\<50 beats per minute), or second-degree or above atrioventricular block without pacemaker; 8. Contraindications to high-flow nasal cannula therapy (such as mediastinal emphysema, shock or hypotension, cerebrospinal fluid leakage, nasosinusitis, otitis media, or deviation of nasal septum); 9. Severe hepatic dysfunction (Child-Pugh class C), severe renal dysfunction (requirement of renal replacement therapy), severe heart dysfunction (preoperative New York Heart Association functional classification ≥3 or left ventricular ejection fraction \<30%), or ASA classification IV or above; 10. Expected intensive care unit (ICU) admission with tracheal intubation after surgery; 11. Other conditions that are considered unsuitable for study participation.
Where this trial is running
Beijing, Beijing Municipality
- Peking University First Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Dong-Xin Wang, M.D. — Peking University First Hospital
- Study coordinator: Xin-Quan Liang, M.D.
- Email: liangxinquan09@163.com
- Phone: +86 152 1084 6532
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.