Obstructive Sleep ApneaPhase 4NCT06566482

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

A Phase 4 study testing Dexmedetomidine-esketamine combination in people with Obstructive Sleep Apnea and Surgery, run by Peking University First Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Obstructive Sleep Apnea, Surgery, Dexmedetomidine
What is being tested?: Dexmedetomidine-esketamine combination
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 100 participants
Where: 1 siteChina
Study dates: 11 Sep 2024to 30 Aug 2025
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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);

Show all 11Show fewer

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.

Trial locations and contacts

1 site in 1 country.

China1 site

Peking University First Hospital
Beijing, Beijing Municipality, 100034

Other trials in China

About this study

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

Read the 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 the postoperative period, the residual effects of anesthetics, sedatives, analgesics, and muscle relaxants suppress the activation of airway muscles; surgical stress, pain, and environmental interference further deteriorate sleep quality. All these factors aggravate the pathophysiological changes in OSA patients and may lead to worse perioperative outcomes, including increased respiratory and cardiac events, intensive care unit (ICU) admission and delirium, as well as prolonged length of hospital stay.

Opioids are commonly used for postoperative analgesia. Patients with OSA have significantly increased sensitivity to the side effects of opioids, such as central respiratory depression (reduced central respiratory drive) and peripheral respiratory depression (airway collapse). Opioids themselves can also cause sleep disturbances, as manifested by sleep fragmentation, decreased rapid-eye-movement sleep, and frequent nightmares. On the other hand, sleep deprivations can also lead to increased pain sensitivity and thus opioid consumption. Therefore, it is important to explore better postoperative analgesia to improve postoperative sleep quality of patients at high-risk of OSA.

Dexmedetomidine is a highly selective α2-adrenergic agonist with sedative, analgesic, and anxiolytic effects. It produces sedation by activating the endogenous sleep-promoting pathway and produces a state resembling nonrapid eye movement sleep. Ketamine is a noncompetitive N-methyl-d-aspartate (NMDA) receptor antagonist. When given in sub-anaesthetic doses, ketamine produces analgesic and anti-hyperalgesic effects and is recommended as a component of multimodal analgesia. Esketamine is the S-enantiomer of racemic ketamine and approximately 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 sleep quality in patients at high-risk of OSA after thoracic or abdominal surgery.

Conditions: Obstructive Sleep Apnea, Surgery, Dexmedetomidine, Esketamine, Postoperative Sleep Quality
Being tested: Dexmedetomidine-esketamine combination, Placebo
Keywords: Obstructive Sleep Apnea, Surgery, Dexmedetomidine, Esketamine, Postoperative sleep quality
Medical subject headings: Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dexmedetomidine-esketamine combinationDrug
Also called Dexmedetomidine-esketamine group
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.
PlaceboDrug
Also called Placebo group
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.

Study groups in NCT06566482
Study group	Role	What they receive
Dexmedetomidine-esketamine combination	Experimental	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. Receives: Drug: Dexmedetomidine-esketamine combination
Placebo	Placebo comparator	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. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Subjective sleep quality during the first night after surgery.
Subjective sleep quality is assessed with the Richards-Campbell Sleep Questionnaire (RCSQ). The RCSQ is a self-reported measure of subjective sleep quality with 5 items, including sleep depth, sleep latency, awakening, return to sleep, and overall sleep quality; the score of each item ranges from 0 to 100, with a higher score indicating better sleep.
Measured: During the first night after surgery.

Secondary outcomes (5)

Sleep structure parameters during the first night after surgery.
Sleep structure is monitored with a polysomnograph from 9:00 pm on the night of surgery to 6:00 am the next morning. Sleep stages and respiratory events are scored according to the American Academy of Sleep Medicine (AASM) manual by qualified sleep physicians.
Measured: During the first night after surgery
Cumulative subjective sleep quality score after surgery
Subjective sleep quality is assessed with the Richards-Campbell Sleep Questionnaire (RCSQ). The RCSQ is a self-reported measure of subjective sleep quality with 5 items, including sleep depth, sleep latency, awakening, return to sleep, and overall sleep quality; the score of each item ranges from 0 to 100, with a higher score indicating better sleep.
Measured: During the first three nights after surgery.
Proportion of patients with poor sleep quality after surgery.
Subjective sleep quality is assessed with the Richards-Campbell Sleep Questionnaire (RCSQ). Poor sleep quality is defined as overall RCSQ<50 on any night after surgery.
Measured: During the first three nights after surgery.
Area under curve of pain intensity score within 3 days after surgery.
Pain intensity is assessed twice daily (8-10 am and 18-20 pm) with the numeric rating scale (NRS), an 11-point scale where 0=no pain and 10=the worst pain.
Measured: Up to 3 days after surgery.
Subjective sleep quality at 30 days after surgery.
Subjective sleep quality is assessed with the Pittsburgh Sleep Quality Index (PSQI; score ranges from 0 to 21, with higher score indicating worse sleep quality).
Measured: At 30 days after surgery.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Sep 202430 Aug 2025

First posted22 Aug 2024
Study start11 Sep 2024
Primary completion28 Jul 2025
Study completion30 Aug 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (31)Papers the sponsor has linked to this study.
Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
More trials run by Peking University First HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06566482
Sponsor's protocol ID: 2024-234
Status last verified: Sep 2026
First submitted: 20 Aug 2024
Last updated: 4 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Gottlieb DJ, Punjabi NM. Diagnosis and Management of Obstructive Sleep Apnea: A Review. JAMA. 2020 Apr 14;323(14):1389-1400. doi: 10.1001/jama.2020.3514.
PubMed 32286648
Benjafield AV, Ayas NT, Eastwood PR, Heinzer R, Ip MSM, Morrell MJ, Nunez CM, Patel SR, Penzel T, Pepin JL, Peppard PE, Sinha S, Tufik S, Valentine K, Malhotra A. Estimation of the global prevalence and burden of obstructive sleep apnoea: a literature-based analysis. Lancet Respir Med. 2019 Aug;7(8):687-698. doi: 10.1016/S2213-2600(19)30198-5. Epub 2019 Jul 9.
PubMed 31300334
Young T, Evans L, Finn L, Palta M. Estimation of the clinically diagnosed proportion of sleep apnea syndrome in middle-aged men and women. Sleep. 1997 Sep;20(9):705-6. doi: 10.1093/sleep/20.9.705.
PubMed 9406321
Kapur VK, Auckley DH, Chowdhuri S, Kuhlmann DC, Mehra R, Ramar K, Harrod CG. Clinical Practice Guideline for Diagnostic Testing for Adult Obstructive Sleep Apnea: An American Academy of Sleep Medicine Clinical Practice Guideline. J Clin Sleep Med. 2017 Mar 15;13(3):479-504. doi: 10.5664/jcsm.6506.
PubMed 28162150
Brown KA. Intermittent hypoxia and the practice of anesthesia. Anesthesiology. 2009 Apr;110(4):922-7. doi: 10.1097/ALN.0b013e31819c480a.
PubMed 19293703
Chung F, Liao P, Yegneswaran B, Shapiro CM, Kang W. Postoperative changes in sleep-disordered breathing and sleep architecture in patients with obstructive sleep apnea. Anesthesiology. 2014 Feb;120(2):287-98. doi: 10.1097/ALN.0000000000000040.
PubMed 24158049
Hai F, Porhomayon J, Vermont L, Frydrych L, Jaoude P, El-Solh AA. Postoperative complications in patients with obstructive sleep apnea: a meta-analysis. J Clin Anesth. 2014 Dec;26(8):591-600. doi: 10.1016/j.jclinane.2014.05.010. Epub 2014 Oct 16.
PubMed 25439403
Sun X, Yu J, Luo J, Xu S, Yang N, Wang Y. Meta-analysis of the association between obstructive sleep apnea and postoperative complications. Sleep Med. 2022 Mar;91:1-11. doi: 10.1016/j.sleep.2021.11.019. Epub 2022 Feb 11.
PubMed 35231774
Lam KK, Kunder S, Wong J, Doufas AG, Chung F. Obstructive sleep apnea, pain, and opioids: is the riddle solved? Curr Opin Anaesthesiol. 2016 Feb;29(1):134-40. doi: 10.1097/ACO.0000000000000265.
PubMed 26545144
Robertson JA, Purple RJ, Cole P, Zaiwalla Z, Wulff K, Pattinson KT. Sleep disturbance in patients taking opioid medication for chronic back pain. Anaesthesia. 2016 Nov;71(11):1296-1307. doi: 10.1111/anae.13601. Epub 2016 Aug 22.
PubMed 27545291
Finan PH, Goodin BR, Smith MT. The association of sleep and pain: an update and a path forward. J Pain. 2013 Dec;14(12):1539-52. doi: 10.1016/j.jpain.2013.08.007.
PubMed 24290442
Mo Y, Zimmermann AE. Role of dexmedetomidine for the prevention and treatment of delirium in intensive care unit patients. Ann Pharmacother. 2013 Jun;47(6):869-76. doi: 10.1345/aph.1AR708.
PubMed 23719785
Nelson LE, Lu J, Guo T, Saper CB, Franks NP, Maze M. The alpha2-adrenoceptor agonist dexmedetomidine converges on an endogenous sleep-promoting pathway to exert its sedative effects. Anesthesiology. 2003 Feb;98(2):428-36. doi: 10.1097/00000542-200302000-00024.
PubMed 12552203
Wu Y, Ma R, Zhou Q, Lau HY, Wang Y, Li J, Wen W. Dexmedetomidine-induced polysomnography as a diagnostic method in obstructive sleep apnea: a reliable alternative method? Sleep Med. 2021 Mar;79:145-151. doi: 10.1016/j.sleep.2021.01.005. Epub 2021 Jan 5.
PubMed 33524840
Guldenmund P, Vanhaudenhuyse A, Sanders RD, Sleigh J, Bruno MA, Demertzi A, Bahri MA, Jaquet O, Sanfilippo J, Baquero K, Boly M, Brichant JF, Laureys S, Bonhomme V. Brain functional connectivity differentiates dexmedetomidine from propofol and natural sleep. Br J Anaesth. 2017 Oct 1;119(4):674-684. doi: 10.1093/bja/aex257.
PubMed 29121293

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea

All Obstructive Sleep Apnea trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Mini-dose Dexmedetomidine-Esketamine Supplemented Analgesia for Postoperative Sleep Promotion in Patients at High-risk of Obstructive Sleep Apnea: A Randomized Trial
ClinicalTrials.gov ID: NCT06566482
Acronym / sponsor ID: 2024-234
Conditions: Obstructive Sleep Apnea, Surgery, Dexmedetomidine, Esketamine, Postoperative Sleep Quality
Keywords: Obstructive Sleep Apnea, Surgery, Dexmedetomidine, Esketamine, Postoperative sleep quality
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Peking University First HospitalUniversity, hospital or other
Study start: 11 Sep 2024 (actual)
Primary completion: 28 Jul 2025 (actual)
Study completion: 30 Aug 2025 (actual)
First posted: 22 Aug 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Dexmedetomidine-esketamine combination	Experimental	Drug: Dexmedetomidine-esketamine combinationPatient-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.
Placebo	Placebo comparator	Drug: PlaceboPatient-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.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (11 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Dexmedetomidine-esketamine combinationAlso: Dexmedetomidine-esketamine groupPatient-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	Dexmedetomidine-esketamine combination
PlaceboAlso: Placebo groupPatient-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.	Drug	Placebo

Primary outcome

Subjective sleep quality during the first night after surgery.
Time frame: During the first night after surgery.
Subjective sleep quality is assessed with the Richards-Campbell Sleep Questionnaire (RCSQ). The RCSQ is a self-reported measure of subjective sleep quality with 5 items, including sleep depth, sleep latency, awakening, return to sleep, and overall sleep quality; the score of each item ranges from 0 to 100, with a higher score indicating better sleep.

5 secondary outcomes

Sleep structure parameters during the first night after surgery.
Time frame: During the first night after surgery
Cumulative subjective sleep quality score after surgery
Time frame: During the first three nights after surgery.
Proportion of patients with poor sleep quality after surgery.
Time frame: During the first three nights after surgery.
Area under curve of pain intensity score within 3 days after surgery.
Time frame: Up to 3 days after surgery.
Subjective sleep quality at 30 days after surgery.
Time frame: At 30 days after surgery.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
Background: PubMed 32286648Gottlieb DJ, Punjabi NM. Diagnosis and Management of Obstructive Sleep Apnea: A Review. JAMA. 2020 Apr 14;323(14):1389-1400. doi: 10.1001/jama.2020.3514.
Background: PubMed 31300334Benjafield AV, Ayas NT, Eastwood PR, Heinzer R, Ip MSM, Morrell MJ, Nunez CM, Patel SR, Penzel T, Pepin JL, Peppard PE, Sinha S, Tufik S, Valentine K, Malhotra A. Estimation of the global prevalence and burden of obstructive sleep apnoea: a literature-based analysis. Lancet Respir Med. 2019 Aug;7(8):687-698. doi: 10.1016/S2213-2600(19)30198-5. Epub 2019 Jul 9.
Background: PubMed 9406321Young T, Evans L, Finn L, Palta M. Estimation of the clinically diagnosed proportion of sleep apnea syndrome in middle-aged men and women. Sleep. 1997 Sep;20(9):705-6. doi: 10.1093/sleep/20.9.705.
Background: PubMed 28162150Kapur VK, Auckley DH, Chowdhuri S, Kuhlmann DC, Mehra R, Ramar K, Harrod CG. Clinical Practice Guideline for Diagnostic Testing for Adult Obstructive Sleep Apnea: An American Academy of Sleep Medicine Clinical Practice Guideline. J Clin Sleep Med. 2017 Mar 15;13(3):479-504. doi: 10.5664/jcsm.6506.
Background: PubMed 19293703Brown KA. Intermittent hypoxia and the practice of anesthesia. Anesthesiology. 2009 Apr;110(4):922-7. doi: 10.1097/ALN.0b013e31819c480a.
Background: PubMed 24158049Chung F, Liao P, Yegneswaran B, Shapiro CM, Kang W. Postoperative changes in sleep-disordered breathing and sleep architecture in patients with obstructive sleep apnea. Anesthesiology. 2014 Feb;120(2):287-98. doi: 10.1097/ALN.0000000000000040.
Background: PubMed 25439403Hai F, Porhomayon J, Vermont L, Frydrych L, Jaoude P, El-Solh AA. Postoperative complications in patients with obstructive sleep apnea: a meta-analysis. J Clin Anesth. 2014 Dec;26(8):591-600. doi: 10.1016/j.jclinane.2014.05.010. Epub 2014 Oct 16.
Background: PubMed 35231774Sun X, Yu J, Luo J, Xu S, Yang N, Wang Y. Meta-analysis of the association between obstructive sleep apnea and postoperative complications. Sleep Med. 2022 Mar;91:1-11. doi: 10.1016/j.sleep.2021.11.019. Epub 2022 Feb 11.
Background: PubMed 26545144Lam KK, Kunder S, Wong J, Doufas AG, Chung F. Obstructive sleep apnea, pain, and opioids: is the riddle solved? Curr Opin Anaesthesiol. 2016 Feb;29(1):134-40. doi: 10.1097/ACO.0000000000000265.
Background: PubMed 27545291Robertson JA, Purple RJ, Cole P, Zaiwalla Z, Wulff K, Pattinson KT. Sleep disturbance in patients taking opioid medication for chronic back pain. Anaesthesia. 2016 Nov;71(11):1296-1307. doi: 10.1111/anae.13601. Epub 2016 Aug 22.
Background: PubMed 24290442Finan PH, Goodin BR, Smith MT. The association of sleep and pain: an update and a path forward. J Pain. 2013 Dec;14(12):1539-52. doi: 10.1016/j.jpain.2013.08.007.
Background: PubMed 23719785Mo Y, Zimmermann AE. Role of dexmedetomidine for the prevention and treatment of delirium in intensive care unit patients. Ann Pharmacother. 2013 Jun;47(6):869-76. doi: 10.1345/aph.1AR708.
Individual participant dataSharing planned: No

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Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dong-Xin Wang, M.D. principal investigator

Peking University First Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dexmedetomidine-esketamine combination in people with Obstructive Sleep Apnea and Surgery, run by Peking University First Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subjective sleep quality during the first night after surgery. (time frame: During the first night after surgery.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06566482, which also lists 31 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.