Mini-dose Dexmedetomidine-Esketamine Supplemented Analgesia in Patients at High-risk of OSA
Eligible age
18–80 yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
No
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About this study
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.
Sponsor: Peking University First Hospital
You may qualify if…
- ✓ 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.
You may not qualify if…
- ✕ 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);
Source: ClinicalTrials.gov · NCT06566482 · last updated 2024-09-25