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The Effect of Esketamine on Postoperative Sleep Disorders in Elderly Patients Undergoing Total Knee Arthroplasty

The Effect of Esketamine on Postoperative Sleep Disorders in Elderly Patients Undergoing Total Knee Arthroplasty

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500112981
Enrollment
Unknown
Registered
2025-11-21
Start date
2025-07-01
Completion date
Unknown
Last updated
2025-11-24

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

Conditions

Postoperative sleep disturbance

Interventions

Control group:Sufentanil 2µg/kg
Experimental group:Esketamine 2mg/kg

Sponsors

The First Affiliated Hospital of Dalian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Patients undergoing elective unilateral total knee arthroplasty; 2. Aged >= 65 years, regardless of gender; 3. BMI 18 - 25 kg/?; 4. Patients with American Society of Anesthesiologists (ASA) physical status ? - ?; 5. Signed informed consent form.

Exclusion criteria

Exclusion criteria: 1. Presence of preoperative sleep disorders (Pittsburgh Sleep Quality Index (PSQI) score > 7 points); 2. Severe dysfunction of vital organs, complicated with ischemic heart disease or adrenal cortical insufficiency; 3. Severe neurological diseases (Parkinson's disease, Alzheimer's disease, schizophrenia, epilepsy) and long-term use of opioids, sedatives, antidepressants or anxiolytics; 4. Untreated or poorly controlled hypertension, hyperthyroidism; increased intracranial pressure, glaucoma; 5. Allergic to esketamine; 6. Difficulty in communication and inability to cooperate with the assessors.

Design outcomes

Primary

MeasureTime frame
Sleep Quality on the Night After Surgery;

Secondary

MeasureTime frame
Surgical Data;Somnolence;Postoperative Recovery;Long-term Recovery;Analgesia;Incidence of Adverse Reactions;Perioperative Hemodynamics;Postoperative Pain;

Countries

China

Contacts

Public ContactWen Chao

The First Affiliated Hospital of Dalian Medical University

doctwen@163.com+86 180 9887 6177

Outcome results

None listed

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