Clinical TrialDepressive DisordersEsketaminePlaceboCompleted

Effect of Low-dose Esketamine on Postoperative Depression in Patients With Breast Cancer

Randomised, double-blind, parallel study (n=90) testing a single IV low dose esketamine 0.25 mg/kg versus saline to prevent postoperative depression and reduce pain in women undergoing radical mastectomy.

Target Enrollment
90 participants
Study Type
Phase NA interventional
Design
Randomized, double Blind

Detailed Description

This parallel, double-blind randomised trial evaluates whether a single intravenous low dose of esketamine (0.25 mg/kg) given after anaesthesia induction reduces postoperative depressive symptoms and pain in women undergoing modified radical mastectomy.

Outcomes include Hamilton Depression Scale at baseline, day 2, day 5, day 30 and day 90; serum leptin at baseline, day 2 and day 5; acute and longer-term pain scores (VAS at multiple timepoints) and analgesic consumption; safety via vital signs, recovery duration and adverse events.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Study Arms & Interventions

Esketamine 0.25 mg/kg

experimental

Single IV esketamine 0.25 mg/kg given after induction of anaesthesia; vitals monitored.

Interventions

  • Esketamine0.25 mg/kg
    via IV• single dose

    Slow IV after induction; monitor BP and HR.

Normal saline

inactive

Placebo comparator: normal saline administered after induction.

Interventions

  • Placebo0.5 ml/kg
    via IV• single dose

    Normal saline matching volume (per protocol).

Participants

Ages
18 – 65
Sexes
female

Inclusion Criteria

  • Female patients scheduled for unilateral modified radical mastectomy; years of education ≥5 years; American Society of Anesthesiologists I–II; surgery within 1 week of breast cancer diagnosis with no preoperative radiotherapy or chemotherapy; married with children and mainly cared for by immediate family after surgery.

Exclusion Criteria

  • Antidepressant treatment within the last 2 months; prior personality disorder, intellectual disability, brain injury or brain disease, schizophrenia, mania or other major psychiatric disorders; preoperative hyperthyroidism or hypothyroidism; severe cardiovascular disease, diabetes, severe anaemia, or significant heart, lung, liver, or kidney dysfunction; immune system disease or use of drugs with major immune effects; pregnancy or lactation.

Study Details

  • Status
    Completed
  • Phase
    Phase NA
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment90 participants
  • Timeline
    Start: 2021-02-10
    End: 2022-05-10
  • Compounds
    EsketaminePlacebo
  • Topic
    Depressive Disorders

Locations

Affiliated hospital of yangzhou university — Yangzhou, Jiangsu, China

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