Combining dexmedetomidine and esketamine to improve sleep after major surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial investigates the effects of a dexmedetomidine-esketamine combination on postoperative sleep disturbances in adults undergoing major noncardiac surgery. The study aims to determine if this combination, used during general anesthesia and for postoperative pain management, can enhance sleep quality and reduce the incidence of sleep disturbances. Previous research indicated that this combination improved analgesia and subjective sleep quality in patients after scoliosis surgery, prompting further exploration in a broader surgical context. The trial will compare the effects of the combination against a placebo.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Aged ≥18 years.
2. Scheduled for major noncardiac surgery (≥60 minutes) under general anesthesia with an expected end of surgery no later than 18:00 pm.
3. Required patient-controlled intravenous analgesia after surgery.

Exclusion Criteria:

1. Emergency surgery, transurethral surgery, organ transplantation.
2. Pregnant or lactating women.
3. Patients who need hypnotics for sleep disturbance or antidepressants for depression prior to surgery.
4. History of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis.
5. Inability to communicate due to coma, severe dementia, or speech disorders, endured hypoxic encephalopathy or traumatic brain injury, or after neurosurgery.
6. Comorbid with hyperthyroidism and pheochromocytoma.
7. Preoperative left ventricular ejection fraction \<30%, sick sinus syndrome, severe sinus bradycardia (heart rate \<50 beats/min), atrioventricular block of degree II or higher without pacemaker implantation, or systolic blood pressure below 90 mmHg despite use of vasopressors.
8. Diagnosed as sleep apnea, or judged to be at high risk of moderate-to-severe sleep apnea as assessed by STOP-Bang.
9. Severe hepatic dysfunction (Child-Pugh class C), severe renal dysfunction (on dialysis), or ASA classification ≥IV.
10. Hypersensitive to dexmedetomidine and/or esketamine.
11. Other conditions that are deemed unsuitable for study participation.

Where it's running

• Peking University First Hospital
  Beijing, China Recruiting

Study contacts

• Study coordinator: Mo Li, MD, PhD
• Email: 2361011139@pku.edu.cn
• Phone: +86 19801260665

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Using dexmedetomidine and esketamine for sedation in young children before surgery

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• Using Dexmedetomidine and Esketamine to Reduce Bladder Discomfort from Catheters

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  Recruiting at 2 sites Phase 4 Peking University First Hospital · Beijing, Beijing Municipality and 1 other locations · NCT06399185

• Esketamine dose levels combined with dexmedetomidine to reduce pain after scoliosis correction

  This study will test whether different doses of esketamine given with dexmedetomidine and opioids can reduce immediate postoperative pain and lower the chance of chronic postsurgical pain in adults having scoliosis correction.

  Recruiting Phase 4 Peking University First Hospital · Beijing, Beijing Municipality · NCT06087510

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.