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NCT Number: NCT06624878

Esketamine for Prevention of Depression After Cytoreductive Surgery in Ovarian Cancer

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.

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Behavior Behavioral Symptoms Cytoreductive Surgery Depression Depressive Symptom Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Zhejiang cancer hospital

Hangzhou, Zhejiang, 310022, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Esketamine

Drug

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

Placebo

Drug

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

Primary outcomes

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

    Time frame: on postoperative day 3

    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.

Secondary outcomes

  1. the incidence of depressive symptoms in ovarian cancer

    Time frame: Baseline (before surgery), on postoperative day 30

    The PHQ-9 was also used to assess the depressive symptoms.The range of this scale is 0-27, and a standard threshold score of 10 or higher indicates symptoms of depression.

  2. the incidence of sleep disturbance in ovarian cancer

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

    The sleep disturbance are assessed using the Athens Insomnia Scale (AIS). The range of this scale is 0-24, and a standard threshold score of 7 or higher indicates sleep disturbance.

  3. the incidence of anxiety in ovarian cancer

    Time frame: Baseline (before surgery)

    The anxiety symptom is assessed using the Generalized Anxiety Disorder-7 (GAD-7). The range of this scale is 0-21, and a standard threshold score of 10 or higher indicates anxiety.

  4. the postoperative recovery of ovarian cancer

    Time frame: Baseline (before surgery), on postoperative day 3

    The postoperative recovery is assessed using the quality of recovery-15 questionnaire (QoR-15) .The QoR-15 has 15 questions. Each question is rated on a 10-point scale, ranging from 0 (none of the time or poor) to 10 (all of the time or excellent). The maximum score (best recovery) is 150.

  5. postoperative pain score at rest and coughing pain

    Time frame: at 1, 24, 48, 72 hours after surgery

    The postoperative pain at rest and during coughing are assessed by NRS score with a range of 0 to 10 (0=no pain, 10=the worst possible pain).

  6. the lengh of postoperative ICU admission

    Time frame: through study completion, an average of 1-5 days

  7. the time to initiation of postoperative chemotherapy

    Time frame: through study completion, an average of 5-20 days

  8. the postoperative complications of ovarian cancer

    Time frame: within 30 days after surgery

    The complications are assessed using the Claviene-Dindo score.

  9. the time to walk after surgery

    Time frame: through study completion, an average of 2-5 days

  10. the time to return of bowel function

    Time frame: through study completion, an average of 5-10 days

  11. the time to readiness for discharge

    Time frame: through study completion, an average of 7-15 days

  12. morphine requirements after surgery

    Time frame: at 24 hours after surgery

  13. morphine requirements after surgery

    Time frame: at 48 hours after surgery

  14. the residual disease after cytoreductive surgery

    Time frame: on postoperative day 1

    The residual disease is assessed using the propotion of optimal debulking.

  15. the incidence of nausea and vomiting

    Time frame: during 72 hours after surgery

  16. the incidence of postoperative hypotension

    Time frame: during 72 hours after surgery

  17. the incidence of pruritus

    Time frame: during 72 hours after surgery

  18. the incidence of drowsiness

    Time frame: during 72 hours after surgery

  19. the incidence of respiratory depression

    Time frame: during 72 hours after surgery

  20. the incidence of nystagmus

    Time frame: during 72 hours after surgery

  21. the incidence of diplopia

    Time frame: during 72 hours after surgery

  22. the incidence of hypertonia

    Time frame: during 72 hours after surgery

  23. the incidence of daymare

    Time frame: during 72 hours after surgery

  24. the incedence of neuropsychiatric symptoms

    Time frame: during 72 hours after surgery

    The neuropsychiatric symptoms are assessed using BPRS-4. The range of this scale is 0-28, and a standard threshold score of 5 or higher indicates symptoms of neuropsychiatric symptoms.

  25. the incidence of dissociative states

    Time frame: during 72 hours after surgery

    The dissociative states are assessed using the CADSS-6. The range of this scale is 0-24, and a standard threshold score of 3 or higher indicates symptoms of dissociative states.

Sponsors and collaborators

Lead sponsor

Zhejiang Cancer Hospital

Other

Registry information

Official study title

Intraoperative Esketamine for Prevention of Depressive Symptoms After Cytoreductive Surgery in Ovarian Cancer: a Controlled, Randomized Clinical Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 3, 2024
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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