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Effect of perioperative subanesthetic esketamine infusion on postoperative sleep quality in patients after total joint arthroplasty: a randomized controlled trial

Effect of perioperative subanesthetic esketamine infusion on postoperative sleep quality in patients after total joint arthroplasty: a randomized controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500099848
Enrollment
Unknown
Registered
2025-03-31
Start date
2025-04-01
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

People with arthritis of the knee or hip are more likely to suffer from sleep disorders

Interventions

Esketamine group (E group):The subanesthetic dose of esketamine was administered intraoperatively, and the combined microdose of esketamine was administered postoperatively for
saline group (S group):Intraoperative infusion of the same dose of normal saline, postoperative use of conventional analgesic pump 48h

Sponsors

Peking University Shenzhen Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age: 18-65 years old; 2. Total joint replacement surgery was performed with intraspinal anesthesia. 3. ASA Grade I - III; 4. The operation should be completed before 20:00 on the same day;

Exclusion criteria

Exclusion criteria: 1. Refuse to participate in the study; 2. BMI > 30kg/m^2; 3. Patients at high risk of sleep apnea syndrome before surgery (STOP-Bang score >=3 points); 4. a history of drug abuse; 5. severe cardiac insufficiency, severe liver and kidney insufficiency; 6. Patients with elevated blood pressure or cranial pressure, patients with intraocular hypertension or penetrating eye injury, patients with poorly controlled or untreated hypertension (resting systolic and/or diastolic blood pressure >=180 and/or \110mmHg); 7. Untreated or undertreated patients with hyperthyroidism; 8. Allergic or contraindicated to esketamine; 9. preoperative diagnosis of mental illness, cognitive dysfunction, or inability to communicate; 10. Unable to use the intravenous controlled analgesia pump; 11. Patients with contraindications to intraspinal anesthesia.

Design outcomes

Primary

MeasureTime frame
Richards Campbell sleep questionnaire (RCSQ) score on the first night after surgery;;

Secondary

MeasureTime frame
Richards Campbell sleep questionnaire (RCSQ) score on the second night after surgery;;Total sleep duration on the first and second nights after surgery?Sleep efficiency((Sleep duration recorded by the bracelet/total sleep duration reported by the patient ×100););Sedation score 1-2 days after surgery (using Richmond agitation and sedation (RASS) score);NRS pain intensity was recorded during exercise and resting within 2 days after surgery (0: no pain; 1-3: mild pain; 4-6: moderate pain; 7-10: severe pain), twice daily (8-10am and 6-8pm) and postoper;Postoperative hospital stay (changed to postoperative hospital stay to the time interval between the date of operation and discharge);Anxiety and depression scores 1-2 days after surgery (using hospital Anxiety and Depression Scale HADS score);Pittsburgh Sleep Score (PSQI) 30 days after surgery;

Countries

China

Contacts

Public ContactLi Yanze

Peking University Shenzhen Hospital

1361718065@qq.com+86 13692272323

Outcome results

None listed

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