Can a Mini-Dose drug combo rescue Post-Surgery sleep for sleep apnea patients?
NCT ID NCT06566482
First seen Sep 04, 2026 · Last updated Sep 04, 2026
Summary
This trial tests whether adding mini-doses of dexmedetomidine and esketamine to standard pain relief can improve sleep quality after surgery in people at high risk of obstructive sleep apnea. Participants receive either the drug combo or a placebo through a patient-controlled pain pump for up to 48 hours after surgery. Researchers measure sleep quality using a questionnaire and monitor sleep structure overnight with a polysomnograph. The goal is to see if this approach can reduce the sleep disturbances that often occur after surgery in this group.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A combination of dexmedetomidine and esketamine added to standard patient-controlled pain relief after surgery
- What this could lead to
- If it works, this approach could offer a simple way to improve sleep quality after surgery for people with or at risk of obstructive sleep apnea, potentially aiding recovery.
- What could go wrong
- This is a single trial with 100 participants, so results may not apply broadly. The drugs can cause side effects like low blood pressure or sedation, and the benefit over standard care is not yet proven.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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100 people
The number who actually took part.
- Started
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Sep 2024
- Finished
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Aug 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Real-world evaluation of the clinical performance and safety of apneal dx for the screening and aid in the diagnosis of obstructive sleep apnea-hypopnea syndrome in adults: a post-market clinical follow-up study
- An equity focused intervention to improve utilization of guideline concordant extended venous thromboembolism prophylaxis after major cancer surgery
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