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The Effect of Perioperative Esketamine on Postoperative Depression in Patients Undergoing Gynecological Tumor Surgery: randomised clinical trial

The Effect of Perioperative Esketamine on Postoperative Depression in Patients Undergoing Gynecological Tumor Surgery: randomised clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108606
Enrollment
Unknown
Registered
2025-09-02
Start date
2025-09-02
Completion date
Unknown
Last updated
2025-09-08

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

Conditions

Postoperative Depression in Patients Undergoing Gynecological Tumor Surgery

Interventions

Control Group (Group A) :Group A: Following anesthesia induction, an infusion of an equivalent volume of normal saline was initiated at the start of surgery. Postoperatively, patients received a sufen
Esketamine Group 1 (Group B):Group B: Following anesthesia induction, an infusion of esketamine 0.2 mg/kg was initiated at the start of surgery. Postoperatively, patients received a sufentanil-esketam
Esketamine Group 2 (Group C):Group C:Following anesthesia induction, an infusion of esketamine 0.5 mg/kg was initiated at the start of surgery. Postoperatively, patients received a sufentanil-esketami

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age >=18 years, ASA physical status classification I-III ; 2. Scheduled to undergo gynecological tumor surgery ; 3.Ethically approved, voluntarily signed informed consent, and able to complete scale assessments.

Exclusion criteria

Exclusion criteria: 1.Any contraindications to ketamine or esketamine, such as refractory hypertension, severe cardiovascular disease, or hyperthyroidism. 2.Patients with severe systemic diseases, including significant cardiac, hepatic, or renal dysfunction. 3.Patients with preexisting neuropsychiatric disorders (e.g., mania, schizophrenia) or cognitive impairment. 4. Confirmed or suspected history of substance abuse or chronic use of narcotic sedatives/analgesics. 5. Relative contraindications to general anesthesia, such as known difficult airway or susceptibility to malignant hyperthermia. 6. Concurrent participation in another clinical trial. 7. Patients planned for postoperative ICU admission. 8. Patients deemed ineligible by the attending surgeon, anesthesiologist, or clinical investigator (or their designee).

Design outcomes

Primary

MeasureTime frame
Positive Rate of Depressive Symptoms;

Secondary

MeasureTime frame
Numerical Rating Scale Score for Pain;sleep quality ;Hamilton Anxiety Rating Scale (HAMA);Quality of Recovery ;

Countries

China

Contacts

Public ContactXiangdong Chen

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

xiangdongchen2013@163.com+86 150 7109 6621

Outcome results

None listed

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