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Effect of dexmedetomidine-esketamine combined sedation and analgesia on postoperative sleep disturbances in patients undergoing major non-cardiac surgery: a single-center, randomised, double-blind, placebo-controlled trial

Effect of dexmedetomidine-esketamine combined sedation and analgesia on postoperative sleep disturbances in patients undergoing major non-cardiac surgery: a single-center, randomised, double-blind, placebo-controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500098867
Enrollment
Unknown
Registered
2025-03-14
Start date
2025-03-20
Completion date
Unknown
Last updated
2025-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative sleep disturbances

Interventions

Dexmedetomidine-esketamine group:Dexmedetomidine hydrochloride injection, esketamine hydrochloride injection
Placebo group:0.9% sodium chloride injection

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years; 2. Non-cardiac surgery under general anesthesia with an estimated duration of =60 minutes and an end time of no later than 18:00; 3. A patient-controlled intravenous analgesic pump is required postoperatively;

Exclusion criteria

Exclusion criteria: 1. Emergency surgery, transurethral surgery, organ transplants; 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, myasthenia gravis; 5. Inability to communicate due to coma, severe dementia, or speech disorders, hypoxic encephalopathy, craniocerebral injury, or postoperative neurosurgery; 6. Combined history of hyperthyroidism and pheochromocytoma; 7. Preoperative LVEF <30%, sick sinus node 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 the use of antihypertensive drugs prior to enrollment; 8. Patients with a diagnosis of sleep apnea (diagnosis of sleep apnea, or high-risk patients with 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. Hypersensitivity to dexmedetomidine and/or esketamine; 11. Other circumstances that the researcher felt were not appropriate for inclusion in the study;

Design outcomes

Primary

MeasureTime frame
Incidence of sleep disturbances within 3 days after surgery;

Secondary

MeasureTime frame
Pittsburgh Sleep Quality Index (PSQI) score on the 30th postoperative day;Richards-Campbell Sleepiness Questionaire (RCSQ) scores on the morning of postoperative days 1, 2, and 3;The Quality of Recovery-15 (QoR-15) score at 24 hours postoperatively.;NRS score at rest and during activity within the first 3 postoperative days;Hospital Anxiety and Depression Scale score on postoperative day 3;

Countries

China

Contacts

Public ContactMo Li

Peking University First Hospital

limo535029277@163.com+86 10 83575085

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026