Combining dexmedetomidine and esketamine to improve sleep after major surgery
Effect of Dexmedetomidine-esketamine Combination on Sleep Disturbances After Major Noncardiac Surgery: a Single-center, Randomised, Double-blind, Placebo-controlled Trial
This study is testing whether a mix of two medications, dexmedetomidine and esketamine, can help adults sleep better after major surgery compared to a placebo.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 476 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Peking University First Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06859892 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older scheduled for major noncardiac surgery requiring general anesthesia and postoperative intravenous analgesia.
Not a fit: Patients undergoing emergency surgeries, those with specific psychiatric or neurological conditions, or those requiring preoperative hypnotics or antidepressants may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve sleep quality and recovery outcomes for patients after major surgery.
How similar studies have performed: Previous studies have shown success with similar combinations in improving postoperative outcomes, indicating potential for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Beijing
- Peking University First Hospital — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Mo Li, MD, PhD
- Email: 2361011139@pku.edu.cn
- Phone: +86 19801260665
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.