Actively Recruiting
Mini-dose Dexmedetomidine-Esketamine Supplemented Analgesia in Patients at High-risk of OSA
Led by Peking University First Hospital · Updated on 2024-09-25
100
Participants Needed
1
Research Sites
63 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Mini-dose Dexmedetomidine-Esketamine Supplemented Analgesia in Patients at High-risk of OSA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years but not older than 80 years
- Diagnosed with obstructive sleep apnea or at moderate-to-high risk based on the STOP-Bang Questionnaire
- Scheduled for thoracoscopic or laparoscopic surgery under general anesthesia lasting at least 1 hour
- Requires patient-controlled intravenous analgesia after surgery
You will not qualify if you...
- Diagnosed with central sleep apnea syndrome
- History of schizophrenia, epilepsy, Parkinson disease, or myasthenia gravis
- Taking antipsychotic medications including antidepressants or anxiolytics
- Unable to communicate before surgery due to coma, severe dementia, or deafness
- History of drug or alcohol dependence or sedative/hypnotic therapy within 1 month before surgery
- Contraindications to ketamine such as hyperthyroidism, pheochromocytoma, or glaucoma
- Sick sinus syndrome, severe sinus bradycardia (<50 bpm), or second-degree or higher atrioventricular block without pacemaker
- Contraindications to high-flow nasal cannula therapy such as mediastinal emphysema, shock, cerebrospinal fluid leakage, nasosinusitis, otitis media, or nasal septum deviation
- Severe liver, kidney, or heart dysfunction or ASA classification IV or above
- Expected ICU admission with tracheal intubation after surgery
- Other conditions deemed unsuitable for study participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
Actively Recruiting
Research Team
X
Xin-Quan Liang, M.D.
CONTACT
D
Dong-Xin Wang, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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