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CompletedPhase 4

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

Key facts

Who runs it
Peking University First Hospital
Where
China1 site in 1 countryChoose a country to see its sites
Trial code
Status
Completed
Phase
Phase 4
People taking part
100 people enrolled
Started
11 Sept 2024
Ended
30 Aug 2025
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Dexmedetomidine-esketamine combination
  • Placebo
Record updated
4 September 2026

Who can take part

Age
18 years to 80 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • 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 take part

  • Previous history of schizophrenia, epilepsy, Parkinson disease, or myasthenia gravis
  • History of drug or alcohol dependence, or sedative or hypnotic therapy within 1 month before surgery
  • 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)
  • Expected intensive care unit (ICU) admission with tracheal intubation after surgery
  • Diagnosed as central sleep apnea syndrome
  • 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
  • Sick sinus syndrome, severe sinus bradycardia (<50 beats per minute), or second-degree or above atrioventricular block without pacemaker
  • Other conditions that are considered unsuitable for study participation
  • 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
  • Contraindications to ketamine (such as hyperthyroidism, pheochromocytoma, or glaucoma)

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Dexmedetomidine-esketamine combinationTreatment being tested

    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.

  • PlaceboPlacebo, for comparison

    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.

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Mini-dose Dexmedetomidine-Esketamine Supplemented Analgesia for Postoperative Sleep Promotion in Patients at High-risk of Obstructive Sleep Apnea: A Randomized Trial
Record updated
4 September 2026