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Effect of Esketamine on depression and perioperative neuropsychiatric disorders in patients with malignant tumors

Effect of Esketamine on depression and perioperative neuropsychiatric disorders in patients with malignant tumors

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300069249
Enrollment
Unknown
Registered
2023-03-10
Start date
2021-02-01
Completion date
Unknown
Last updated
2023-05-29

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

Conditions

Perioperative neurocognitive dysfunction

Interventions

group E :After anesthesia induction, group E was given 0.5mg/kg Esketamine (esketamine diluted to 10mg/ml) and 100ml postoperative analgesic pump, and the analgesic formula was Esketamine 2mg/kg(Esket
group C :After anesthesia induction, group C was given 0.05ml/kg normal saline and 100ml postoperative analgesic pump. The analgesic formula was Sufentanil 2.5µg/kg+ flurbiprofen ester 2mg/kg+ toranis

Sponsors

Affiliated Tumor Hospital of Guangxi Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. From February 1, 2021 to August 31, 2022, patients aged over 60 years with malignant tumors were selected for surgery in Guangxi Medical University Cancer Hospital (gynecological tumors, gastrointestinal tumors, thoracic surgery, urological surgery), no gender limit; 2. ASA ? -?, BMI 18-25kg/m^2; 3. Years of education >=6 years; 4. Pathological report diagnosed cancer; 5. Expected operation time >=2 hours and postoperative hospital stay > 7 days.

Exclusion criteria

Exclusion criteria: 1. Preoperative history of neurological, muscular and endocrine system diseases, psychiatric system diseases (Alzheimer's disease, Parkinson's disease or dementia); 2. History of major cardiovascular and respiratory diseases, severe damage to liver function (Child-Pugh Grade C) and kidney function (preoperative dialysis required); 3. Cerebrovascular disease can not be successfully completed before the operation of mental function test; 4. Preoperative HGB < 90 g/L; 5. Intracranial space occupation or intracranial hypertension, glaucoma, hyperthyroidism; 6. Patients unwilling to accept analgesia after surgery or unable to understand numerical pain scales or operate patient-controlled analgesia (PCA) pumps; 7. Serious heart or lung disease; 8. Esketamine allergy, organic disease caused by depression, mania history; 9. Pregnant, planning to become pregnant, breastfeeding; 10. Significant hearing and visual impairment (including color blindness and color weakness) could not complete the subjects; 11. Cancer brain metastasis; 12. Patients with severe arrhythmia who are fitted with pacemakers; 13. Known allergies to propofol, remifentanil, or hydroxyethyl starch; 14. Patients with TICS m score less than 27.

Design outcomes

Primary

MeasureTime frame
Incidence of postoperative delirium;Neuropsychological testing;The occurrence of postoperative depression;

Secondary

MeasureTime frame
Scores on telephone interview for cognitive status-modified;Numeric rating scale score;PCA press times;Intraoperative anesthetic dosage;Use of vasoactive drugs;Intraoperative fluid entry and exit volume;Duration of operation and anesthesia;Postoperative adverse reaction;All-cause mortality, readmission rate and secondary operation rate 30 days after surgery;Rate of tumor recurrence and metastasis within 3 months after surgery;Postoperative recovery quality;

Countries

China

Contacts

Public ContactHuang Cuifang; Pan Linghui

Affiliated Cancer Hospital of Guangxi Medical University

plinghui@hotmail.com+86 15994345824; +86 13807808637

Outcome results

None listed

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