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New treatment option for Obstructive Sleep Apnea
Official title Mini-dose Dexmedetomidine-Esketamine Supplemented Analgesia in Patients at High-risk of OSA
ClinicalTrials.gov ID: NCT06566482
What this study is testing
What is Dexmedetomidine-esketamine combination?
Dexmedetomidine-esketamine combination is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for obstructive sleep apnea.
Also referred to as Dexmedetomidine-esketamine group.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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...
You likely can't join if
- 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);
See the full eligibility 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.
- 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...
- Expected intensive care unit (ICU) admission with tracheal intubation after surgery;
- Other conditions that are considered unsuitable for study participation.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.