NCT06859892 Dexmedetomidine-Esketamine Combination and Sleep Disturbances After Major Noncardiac Surgery
| NCT ID | NCT06859892 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Peking University First Hospital |
| Condition | Adults |
| Study Type | INTERVENTIONAL |
| Enrollment | 476 participants |
| Start Date | 2025-03-18 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 476 participants in total. It began in 2025-03-18 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Sleep disturbances are common early after major surgery, and are associated with delayed recovery. A previous study showed that dexmedetomidine-esketamine combination as a supplement to patient-controlled intravenous analgesia improved postoperative analgesia and subjective sleep quality in patients after scoliosis correction surgery. The purpose of this trial is to test the hypothesis that dexmedetomidine-esketamine combination used as a supplement during general anesthesia and postoperative intravenous analgesia may reduce sleep disturbances in adult after major noncardiac surgery.
Eligibility 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.
Contact & Investigator
Dong-Xin Wang
STUDY CHAIR
Dong-Xin Wang, MD, PhD, Peking University First Hospital
Frequently Asked Questions
Who can join the NCT06859892 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Adults. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06859892 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06859892 currently recruiting?
Yes, NCT06859892 is actively recruiting participants. Contact the research team at 2361011139@pku.edu.cn for enrollment information.
Where is the NCT06859892 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06859892 clinical trial?
NCT06859892 is sponsored by Peking University First Hospital. The principal investigator is Dong-Xin Wang at Dong-Xin Wang, MD, PhD, Peking University First Hospital. The trial plans to enroll 476 participants.