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Effects of s-ketamine on postoperative sleep quality of tumor patients undergoing surgery: A prospective randomised study

Effects of s-ketamine on postoperative sleep quality of tumor patients undergoing surgery: A prospective randomised study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200055180
Enrollment
Unknown
Registered
2022-01-02
Start date
2022-01-03
Completion date
Unknown
Last updated
2023-01-16

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

Conditions

postoperative sleep disturbance

Interventions

Experimental group:Sufentanil 2 µg/kg + ketochromate tromethamine 90 mg + S-ketamine 50 mg + tropisetron 30 mg + 0.9 % sodium chloride solution, volume 120 ml
Control group:Sufentanil 2 µg/kg + ketochromate tromethamine 90 mg + tropisetron 30 mg + 0.9 % sodium chloride solution, volume 120 ml

Sponsors

Peking University Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged >=18 years and <65 years; 2. BMI between 18-30 kg/m^2; 3. ASA classification II-III; 4. No serious liver, kidney, heart, brain, lung and other important organ diseases before surgery; 5. Patients who are expected to be hospitalized for 4 days or more. 6. The operation can be completed before 20pm.

Exclusion criteria

Exclusion criteria: 1. Refuse to participate in this research; 2. Patients with tumor recurrence; 3. Combined with primary malignant tumors in other parts, and received multiple operations during a single surgical operation; 4. Patients receiving long-term psychotropic drug therapy, hormone therapy and long-term use of opioids or non-steroidal anti-inflammatory analgesics; 5. Preoperative diagnosis of schizophrenia, dementia, Alzheimer's disease, delirium, unable to communicate due to language barriers or end-stage diseases; 6. Long-term use of sleeping pills, history of obstructive sleep apnea syndrome, poorly controlled or untreated hypertension (arterial hypertension, resting systolic/diastolic blood pressure exceeds 180/100 mmHg); 7. Severe heart block and (or) severe ventricular insufficiency, severe liver dysfunction (Child-Pugh class C); 8. Severe renal dysfunction (those who received renal replacement therapy before surgery); 9. Patients who are allergic to S-ketamine or sufentanil active ingredients or excipients; 10. Other researchers think that it is not suitable for inclusion (specific reasons should be indicated).

Design outcomes

Primary

MeasureTime frame
postoperative sleep quality;serum cytokines;

Secondary

MeasureTime frame
time to first postoperative exhaust;dosage of analgesics within 72 hours after the operation;visual analogue scale;adverse reaction;

Countries

China

Contacts

Public ContactTan Hongyu

Peking University Cancer Hospital

maggitan@yeah.net+86 13520299625

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 9, 2026