Clinical TrialDepressive DisordersEsketaminePlaceboRecruiting

Effect of Esketamine on Postoperative Depression, Gut Microbiota, Bispectral Index Data of Depression Patients Undergoing Breast Cancer Operation (ESPOD-BI)

This prospective, randomized, double-blinded, parallel-group trial (n≈72) compares intraoperative esketamine 0.2 mg/kg versus saline adjunct to general anaesthesia to assess postoperative depression, gut microbiota, and bispectral index in female breast cancer patients.

Target Enrollment
72 participants
Study Type
Phase IV interventional
Design
Randomized, quadruple Blind

Detailed Description

Prospective, randomized (1:1), parallel-group, quadruple‑masked clinical trial evaluating esketamine 0.2 mg/kg versus saline as an adjunct to general anaesthesia in female patients undergoing elective breast cancer surgery to assess postoperative depressive symptoms, gut microbiota changes, and bispectral index measures.

Primary outcomes include postoperative depression scores; secondary assessments include gut microbiota composition and intraoperative bispectral index data. Participants must be pre‑menopausal adults with MADRS ≥22 and ASA I–II.

Study Arms & Interventions

Esketamine

experimental

Esketamine 0.2 mg/kg as adjunct to general anaesthesia during breast cancer operation.

Interventions

  • Esketamine0.2 mg/kg
    via IV• single dose

    Adjunct to general anaesthesia during operation.

Saline

inactive

Normal saline adjunct to general anaesthesia (placebo comparator).

Interventions

  • Placebo
    via IV• single dose

    Normal saline placebo.

Participants

Ages
18 – 65
Sexes
female

Inclusion Criteria

  • Inclusion Criteria:
  • At least 18 years and pre-menopausal;
  • Scheduled to undergo elective breast cancer operation;
  • American Society of Anaesthesiologists (ASA) risk classification I-II;
  • Montgomery‑Åsberg Depression Rating Scale (MADRS) score ≥22.

Exclusion Criteria

  • Exclusion Criteria:
  • Cognitive difficulties;
  • Partial or complete gastrectomy;
  • Previous oesophageal surgery;
  • Inability to conform to the study's requirements;
  • Ongoing participation or participation in another study <1 month ago.

Study Details

  • Status
    Recruiting
  • Phase
    Phase IV
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment72 participants
  • Timeline
    Start: 2021-10-08
    End: 2023-12-30
  • Compounds
    EsketaminePlacebo
  • Topic
    Depressive Disorders

Locations

the First Hospital of China Medical University — Shenyang, Liaoning, China

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