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Sex Differences in the Efficacy of Esketamine for Improving Sleep Quality after Total Knee Arthroplasty

Sex Differences in the Efficacy of Esketamine for Improving Sleep Quality after Total Knee Arthroplasty

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500113183
Enrollment
Unknown
Registered
2025-11-25
Start date
2025-11-28
Completion date
Unknown
Last updated
2025-12-01

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

Conditions

Sleep quality

Interventions

Observation group (Intravenous esketamine):None

Sponsors

The Third Affiliated Hospital of Guangzhou University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients scheduled for elective, first-time, unilateral total knee replacement surgery; 2. Patients aged 18 to 75 years; 3. American Society of Anesthesiologists (ASA) classification levels I-III: (ASA Level I: Patients without systemic diseases except localized lesions; 1.ASA Level II: Patients with mild, well-controlled systemic diseases without significant functional limitations; 2.ASA Level III: Patients with at least one poorly controlled or end-organ-damaging systemic disease causing substantial functional limitations); 4. Patients with clear consciousness, adequate cognitive and communication abilities to understand study content and cooperate with relevant scale assessments (e.g., VAS, PSQI, HADS) and information collection; 5. Patients have provided full informed consent and voluntarily signed a written informed consent form.

Exclusion criteria

Exclusion criteria: 1. The patient or their legal representative refuses to participate in this study; 2. History of severe neurological disorders (e.g., dementia, Parkinson's disease, epilepsy, severe post-stroke functional impairment), psychiatric disorders (e.g., schizophrenia, bipolar disorder), or confirmed substance/alcohol abuse; 3. Known hypersensitivity to esketamine or any of its excipient components, or contraindications (e.g., uncontrolled hypertension, severe heart failure, increased intracranial pressure, glaucoma, acute schizophrenia); 4. Long-term preoperative use (over 4 weeks) of medications affecting central nervous system, sleep, anxiety, or depression (e.g., benzodiazepines, antidepressants, antipsychotics) that cannot be discontinued during the study; 5. Patients scheduled for surgery after 3:00 PM to avoid significant circadian rhythm disruption from late surgical completion; 6. Refusal to use postoperative analgesia pump; 7. Concurrent severe systemic diseases (e.g., severe hepatic/renal insufficiency, uncontrolled coagulation disorders, immune system diseases) deemed unsuitable by investigators for participation.

Design outcomes

Primary

MeasureTime frame
Sleep quality;

Secondary

MeasureTime frame
Postoperative emotional indicators;Postoperative pain index;

Countries

China

Contacts

Public ContactZhang Xiaoyu

The Third Affiliated Hospital of Guangzhou University of Chinese Medicine

1445191972@qq.com+86 20 2229 2881

Outcome results

None listed

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