Mini-dose Dexmedetomidine-Esketamine Supplemented Analgesia in Patients at High-risk of OSA

Q: Who can participate in NCT06566482?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

Q: How do I contact the trial site for NCT06566482?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Q: Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Q: Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

Mini-dose Dexmedetomidine-Esketamine Supplemented Analgesia for Postoperative Sleep Promotion in Patients at High-risk of Obstructive Sleep Apnea: A Randomized Trial

Mini-dose Dexmedetomidine-Esketamine Supplemented Analgesia in Patients at High-risk of OSA (NCT06566482) is a Phase 4 interventional studying Obstructive Sleep Apnea and Surgery, sponsored by Peking University First Hospital. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 100 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Obstructive Sleep Apnea subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 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. Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DRUG

Dexmedetomidine-esketamine combination

Patient-controlled analgesia is established with dexmedetomidine (1 μg/ml), esketamine (1 mg/ml), and sufentanil (1 μg/ml) in a total volume of 100 ml. The pump is programmed to deliver 2-ml boluses at 6 to 8-minute lockout intervals with a background infusion rate at 1 ml/h. Patient-controlled analgesia is provided for at least 24 hours but no more than 48 hours after surgery.

DRUG

Placebo

Patient-controlled analgesia is established with sufentanil (1 μg/ml) in a total volume of 100 ml. The pump is programmed to deliver 2-ml boluses at 6 to 8-minute lockout intervals with a background infusion rate at 1 ml/h. Patient-controlled analgesia is provided for at least 24 hours but no more than 48 hours after surgery.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Peking University First Hospital

Beijing, Beijing Municipality, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06566482), the sponsor (Peking University First Hospital), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06566482 clinical trial studying?

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 de… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06566482?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06566482?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06566482. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06566482. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.