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Effect of intraoperative esketamine on postoperative sleep quality in menopausal women with lung cancer

Effect of intraoperative esketamine on postoperative sleep quality in menopausal women with lung cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600124130
Enrollment
Unknown
Registered
2026-05-07
Start date
2026-05-07
Completion date
Unknown
Last updated
2026-05-11

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

Conditions

Lung cancer

Interventions

Experimental group:Intravenous esketamine infusion at 0.3 mg/kg/h during surgery. One vial of esketamine hydrochloride injection (50mg) is diluted with 0.9% normal saline to 50mL (concentration 1mg/mL
Control group:Intravenous infusion of an equal volume of 0.9% normal saline (50mL) during surgery. The infusion starts after tracheal intubation and stops at the end of surgery.

Sponsors

Tangdu Hospital, Air Force Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
45 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Patients scheduled for thoracoscopic lung cancer radical surgery under general anesthesia; 2. Age 45-60 years (menopausal women); 3. BMI 18-30 kg/m^2; 4. ASA physical status I-III; 5. Primary lung tumor without preoperative radiotherapy or chemotherapy; 6. Normal cognitive function; 7. Willing to sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Refuse to participate in this study; 2. Communication disorders or inability to cooperate (e.g., language impairment, mental illness, epilepsy, Parkinson's disease); 3. Confirmed or suspected history of alcohol, analgesic or other drug abuse or addiction; 4. Allergy to esketamine; 5. Preoperative blood pressure >=180/110 mmHg; 6. Unstable angina or myocardial infarction within 3 months, or NYHA cardiac function grade =3; 7. Severe liver or kidney dysfunction; 8. Diabetic patients with diabetic complications; 9. COPD GOLD grade III-IV, pulmonary fibrosis, uncontrolled asthma; 10. History of lung surgery or conversion to thoracotomy; 11. Poor postoperative analgesia; 12. Patients with sleep disorders such as obstructive sleep apnea or restless legs syndrome; 13. Participation in other clinical trials within 3 months; 14. Other conditions deemed unsuitable for participation by the attending physician or investigator.

Design outcomes

Primary

MeasureTime frame
Incidence of postoperative sleep disturbance on day 1;

Secondary

MeasureTime frame
Postoperative subjective sleep quality;Severity of postoperative insomnia;Postoperative anxiety and depression status;Postoperative pain score;Postoperative quality of recovery;Postoperative hospital stay;Incidence of postoperative adverse reactions;Total nocturnal sleep duration;Sleep efficiency;Daytime sleep duration;Nighttime awakening frequency;Deep sleep proportion;Light sleep proportion;REM sleep proportion;Pittsburgh Sleep Quality Index (PSQI);Estradiol (E2);Progesterone (P);Cortisol;

Countries

China

Contacts

Public ContactLi Sun

Tangdu Hospital of the Fourth Military Medical University

sunliincmu@163.com+86 29 8471 7761

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 16, 2026