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Effect of postoperative self-controlled analgesia of esketamine on postoperative sleep disturbance in elderly patients with joint replacement

Effect of postoperative self-controlled analgesia of esketamine on postoperative sleep disturbance in elderly patients with joint replacement

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400085319
Enrollment
Unknown
Registered
2024-06-05
Start date
2024-06-10
Completion date
Unknown
Last updated
2024-07-08

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

Conditions

sleep disturbance

Interventions

experimental group:Postoperative analgesic formula in the experimental group (S group): sufentanil 2ug/kg + esketamine 0.72mg/kg + tropisetron 6mg
control group:Postoperative analgesic formula in the control group (C group): sufentanil 2ug/kg + tropisetron 6mg

Sponsors

Affiliated Hospital of Xuzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 65-80 years undergoing hip replacement or knee arthroplasty; 2. ASA Grade was II-III.

Exclusion criteria

Exclusion criteria: 1. History of dementia or cognitive impairment as assessed by the Mini-Mental State Rating Scale (MMSE); 2. Has a history of severe liver (Child-Pugh grade C) or renal (requiring renal replacement therapy) disease; 3. Patients with poorly controlled or untreated hypertension (SBP more than 180 mmHg and DBP more than 100 mmHg in the resting state); 4. BMI=28kg/?; 5. Patients with ischemic heart disease and congestive heart failure; 6. History of glaucoma or hyperthyroidism; 7. Known allergy to any of the study drugs; 8. Mental illness; 9. Increased intracranial pressure; 10. Opioid dependence; 11. Patient has substance abuse that affects perception and pain assessment; 12. Long-term and severe sleep disturbance before surgery.

Design outcomes

Primary

MeasureTime frame
Incidence of postoperative sleep disturbances;

Secondary

MeasureTime frame
Incidence of postoperative sleep disturbances;Cognitive function;The number of effective compressions of the postoperative analgesic pump;Anxiety score;Depression scores;(QoR-15) recovery quality scale score;

Countries

China

Contacts

Public ContactMing Yan

Affiliated Hospital of Xuzhou Medical University

yiy3001@163.com+86 180 5226 8329

Outcome results

None listed

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