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Antidepressant effects of esketamine in elderly depressed patients undergoing knee/hip replacement surgery: a multicenter randomized, double-blind, placebo-controlled study

Antidepressant effects of esketamine in elderly depressed patients undergoing knee/hip replacement surgery: a multicenter randomized, double-blind placebo-controlled study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076603
Enrollment
Unknown
Registered
2023-10-12
Start date
2023-10-20
Completion date
Unknown
Last updated
2024-04-08

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

Conditions

Depression

Interventions

Intervention group:During surgery, esketamine (0.4 mg/kg, 0.8ml/kg of solution) will be infused intravenously for 40 minutes. The postoperative intravenous analgesic formula is sufentanil 100 ug with
Control group:During surgery, placebo (0.8ml/kg normal saline) will be infused intravenously for 40 minutes. The formula of postoperative intravenous analgesia is sufentanil 125 ug, with a total volum

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Aged 60-85 years; 2. Undergo elective knee or hip replacement surgery; 3. ASA (American Society of Anesthesiologists) I-III; 4. Preoperative depressive status (GDS-15 score >= 6 points); 5. Agree to participate in the study.

Exclusion criteria

Exclusion criteria: 1. Refused to participate in the study; 2. Emergency surgery of joint replacement due to fracture or other reasons; 3. Have been diagnosed with depression and receive antidepressant therapy, or have taken antidepressant medication within 1 month; 4. Preoperative obstructive sleep apnea; 5. Unable to communicate before operation due to coma, severe dementia, speech disorder or severe hearing disorder; 6. Patients with severe hypertension, sinus tachycardia, acute coronary syndrome and severe intracranial hypertension before surgery; 7. Patients with severe liver dysfunction (Child-Pugh C grade), abnormal renal function (preoperative dialysis) or expected survival <= 24 hours; 8. Preoperative symptoms of schizophrenia, bipolar disorder, epilepsy, myasthenia gravis; 9. Have been treated with ketamine/esketamine; 10. Allergic to ketamine/Esketamine; 11. Refuse to use postoperative patient-controlled analgesia; 12. Participating in other interventional clinical studies.

Design outcomes

Primary

MeasureTime frame
Incidence of depression within 7 days after surgery;

Secondary

MeasureTime frame
Depression severity within 7 days after surgery;Opioid consumption within 7 days after surgery;Pain severity within 5 days after surgery;

Countries

China

Contacts

Public ContactYawei Li

Peking University First Hospital

liyaweibmu@hotmail.com+86 138 1048 1891

Outcome results

None listed

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