Status:
RECRUITING
Mini-dose Dexmedetomidine-Esketamine Supplemented Analgesia in Patients at High-risk of OSA
Lead Sponsor:
Peking University First Hospital
Conditions:
Obstructive Sleep Apnea
Surgery
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
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, ...
Detailed Description
Obstructive sleep apnea (OSA) is characterized by repetitive narrowing or obstruction of the upper airway during sleep, resulting in recurrent hypoxemia and hypercapnia and disordered sleep. During th...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Aged ≥18 years but ≤80 years;
- Preoperative diagnosis of OSA, or judged to be at moderate-to-high risk of OSA according to the STOP-Bang Questionnaire;
- 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:
- Diagnosed as central sleep apnea syndrome;
- Previous history of schizophrenia, epilepsy, Parkinson disease, or myasthenia gravis.
- History of schizophrenia, or having antipsychotic drugs (including antidepressants or anxiolytics);
- Inability to communicate in the preoperative period because of coma, profound dementia, or deafness;
- History of drug or alcohol dependence, or sedative or hypnotic therapy within 1 month before surgery;
- Contraindications to ketamine (such as hyperthyroidism, pheochromocytoma, or glaucoma);
- Sick sinus syndrome, severe sinus bradycardia (\<50 beats per minute), or second-degree or above atrioventricular block without pacemaker;
- 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);
- 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;
- Expected intensive care unit (ICU) admission with tracheal intubation after surgery;
- Other conditions that are considered unsuitable for study participation.
Exclusion
Key Trial Info
Start Date :
September 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06566482
Start Date
September 11 2024
End Date
December 1 2025
Last Update
September 25 2024
Active Locations (1)
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1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034