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Recruiting Phase 4 NCT06566482

Mini-dose Dexmedetomidine-Esketamine Supplemented Analgesia in Patients at High-risk of OSA

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Trial Parameters

Condition Obstructive Sleep Apnea
Sponsor Peking University First Hospital
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 100
Sex ALL
Min Age 18 Years
Max Age 80 Years
Start Date 2024-09-11
Completion 2025-09
Interventions
Dexmedetomidine-esketamine combinationPlacebo

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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 (\<5

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