NCT06566482 Mini-dose Dexmedetomidine-Esketamine Supplemented Analgesia in Patients at High-risk of OSA
| NCT ID | NCT06566482 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Peking University First Hospital |
| Condition | Obstructive Sleep Apnea |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-09-11 |
| Primary Completion | 2025-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 100 participants in total. It began in 2024-09-11 with a primary completion date of 2025-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Patients with obstructive sleep apnea (OSA) are at increased risk of developing sleep disturbances after surgery. Dexmedetomidine is a highly selective α2-adrenergic agonist with sedative, analgesic, and anxiolytic effects. Ketamine is a noncompetitive N-methyl-d-aspartate (NMDA) receptor antagonist. Esketamine is the S-enantiomer of racemic ketamine and twice as potent as racemic ketamine for analgesia. A recent trial showed that mini-dose esketamine-dexmedetomidine in combination with opioids improved analgesia and subjective sleep quality after scoliosis correction surgery. This trial is designed to test the hypothesis that mini-dose dexmedetomidine-esketamine supplemented analgesia may improve postoperative sleep quality in patients at high-risk of OSA.
Eligibility 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.
Contact & Investigator
Dong-Xin Wang, M.D.
PRINCIPAL INVESTIGATOR
Peking University First Hospital
Frequently Asked Questions
Who can join the NCT06566482 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Obstructive Sleep Apnea. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06566482 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06566482 currently recruiting?
Yes, NCT06566482 is actively recruiting participants. Contact the research team at liangxinquan09@163.com for enrollment information.
Where is the NCT06566482 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06566482 clinical trial?
NCT06566482 is sponsored by Peking University First Hospital. The principal investigator is Dong-Xin Wang, M.D. at Peking University First Hospital. The trial plans to enroll 100 participants.