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Effect of perioperative application of esketamine on chronic pain after total knee arthroplasty in elderly patients with preoperative sleep disorders: a single-center, prospective, single-arm intervention study

Effect of perioperative application of esketamine on chronic pain after total knee arthroplasty in elderly patients with preoperative sleep disorders: a single-center, prospective, single-arm intervention study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500099408
Enrollment
Unknown
Registered
2025-03-24
Start date
2025-04-01
Completion date
Unknown
Last updated
2025-03-31

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

Conditions

Chronic postsurgical pain

Interventions

Intervention group:The drug (esketamine 0.2 mg/kg diluted to 10 ml in saline) was injected intravenously before the induction of general anesthesia, followed by the usual anesthesia induction protocol

Sponsors

Nanjing Drum Tower Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age>= 65 years old, gender is not limited 2. American Society of Anesthesiologists (ASA) Class I- III; 3. Patients with an admission diagnosis of osteoarthritis; 4. Patients undergoing elective unilateral primary total knee arthroplasty; 5. Preoperative Pittsburgh Sleep Quality Index (PSQI) score > 7; 6. Electronic medical record system entrants; 7. Subjects agreed to participate in this study and signed an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with severe hypertension (resting systolic/diastolic blood pressure over 180/100 mmHg), intracranial occupations, or intracranial hypertension; 2. Patients with recent brain injury, cerebral infarction, or cerebral hemorrhage; those with severe organ dysfunction; patients with glaucoma or hyperthyroidism; patients with a previous history of angina pectoris, myocardial infarction, or heart failure; and patients with coagulation disorders; 3. Patients with a previous history of chronic pain; 4. Combined history of peripheral neuropathy and psychosis; 5. Patients with cognitive dysfunction; 6. Those with severe hearing or speech impairments who are unable to cooperate with the evaluation; 7. Those taking oral central nervous system-acting medications that interfere with perioperative pain assessment; 8. Those who are allergic to known test drugs; 9. Missing case information entered into the electronic case system; 10. Those who were uncooperative and unable to communicate; 11. Those with a history of previous knee surgery or recovery from anesthesia for an unusual procedure; 12. Recent participation in other clinical trials.

Design outcomes

Primary

MeasureTime frame
Pain score at rest at 90 days postoperatively;Pain scores during activity at 90 days postoperatively;Incidence of chronic postsurgical pain at 90 days postoperatively;

Secondary

MeasureTime frame
Pittsburgh sleep quality index (PSQI);Vital signs monitoring: systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), heart rate (HR), pulse oximetry (SpO2), bispectral index (BIS), pulse pressure variability (PPV);Routine examinations and test results during the perioperative period;Blood gas values;Richards—CampbeIl sleep Questionnaire ;Types and doses of intraoperative and postoperative analgesic drugs;Test drug-related adverse reactions within 1 day postoperatively;Incidence, pain scores, and nature of acute pain in resting and active subjects 1 to 3 days after surgery;Post-operative down time;Postoperative drainage tube removal time;Postoperative complications during hospitalization;Clavien-Dindo grading;Intraoperative hypotension, hypertension, number and dose of vasoactive drugs used during operation;New cardiac and cerebrovascular complications during hospitalization;postoperative hospital stay;90 days after surgery pain, nature of pain, type and dose of rescue analgesic drugs used;

Countries

China

Contacts

Public ContactMa Zhengliang

Nanjing Drum Tower Hospital

13611586781@163.com+86 136 1158 6781

Outcome results

None listed

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