Esketamine for Prevention of Depression After Cytoreductive Surgery in Ovarian Cancer

NCT06624878 | Completed DMC

• 1 other identifier: IRB-2024-885 (IIT)
• Study Type: interventional
• Target: 568
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if intraoperative administration of esketamine would prevent or mitigate postoperative depressive symptoms after cytoreductive surgery in ovarian cancer. The main questions it aims to answer are:

• Whether a single low dose of esketamine administered would reduce the postoperative depressive symptoms three days after cytoreductive surgery in ovarian cancer?
• Whether a single low dose of esketamine administered would relief the postoperative sleep disturbance, postoperative recovery? Researchers will compare the esketamine to a placebo (normal saline) to see if the esketamine works to reduce the postoperative depressive symptoms. Participants will:
• Receive either 0.2 mg/kg esketamine or placebo infused intravenously after induction of general anesthesia.
• The preoperative Patient Health Questionnaire 9 (PHQ-9) scale was used to verify the symptoms suggestive of depression.

Conditions

Ovarian Cancer; Cytoreductive Surgery; Depressive Symptom

Outcome Measures

Primary Outcomes (1)

• the incidence of postoperative depressive symptoms after cytoreductive surgery in ovarian cancer

  The postoperative depressive symptoms are assessed using the preoperative Patient Health Questionnaire 9 (PHQ-9) scale. The range of this scale is 0-27, and a standard threshold score of 10 or higher indicates symptoms of depression.

  on postoperative day 3

Secondary Outcomes (25)

• the incidence of depressive symptoms in ovarian cancer

  Baseline (before surgery), on postoperative day 30

• the incidence of sleep disturbance in ovarian cancer

  Baseline (before surgery), on postoperative day 3 and on postoperative day 30

• the incidence of anxiety in ovarian cancer

  Baseline (before surgery)

• the postoperative recovery of ovarian cancer

  Baseline (before surgery), on postoperative day 3

• postoperative pain score at rest and coughing pain

  at 1, 24, 48, 72 hours after surgery

Study Arms (2)

the esketamine group

EXPERIMENTAL

Drug: esketamine

the placebo group

PLACEBO COMPARATOR

Drug: placebo

Interventions

placebo DRUG

a placebo (an equivalent volume of normal saline) infused intravenously after induction of general anesthesia.

the placebo group

esketamine DRUG

0.2 mg/kg esketamine infused intravenously after induction of general anesthesia.

the esketamine group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• undergoing cytoreductive surgery for ovarian cancer under general anesthesia
• ASA physical status I-III
• Ages 18-80 years

You may not qualify if:

• Patients taking anti-psychotic medications
• Contraindications to esketamine
• Language barrier
• Inability to provide consent

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang cancer hospital

Hangzhou, Zhejiang, 310022, China

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Depression

Interventions

Esketamine

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: October 3, 2024
• Study Start: October 8, 2024
• Primary Completion: January 14, 2026
• Study Completion: February 14, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: starting about 6 months after publication

Locations

CN (1)