Clinical TrialPostpartum DepressionEsketaminePlaceboCompleted

Esketamine on Postpartum Depression in Cesarean Section Women

Randomised, quadruple-blind, parallel study (n=336) testing prophylactic IV esketamine (0.25 mg/kg) after cord clamp plus esketamine-supplemented PCIA versus saline to prevent postpartum depression after elective cesarean section.

Target Enrollment
336 participants
Study Type
Phase NA interventional
Design
Randomized, quadruple Blind

Detailed Description

This randomised, quadruple-blind, parallel trial evaluates whether a single IV bolus of esketamine (0.25 mg/kg) given 15 minutes after umbilical cord amputation, together with an esketamine-containing PCIA (80 mg esketamine + sufentanil 100 µg), reduces incidence of postpartum depression compared with saline and standard PCIA.

Primary outcome is incidence of PPD assessed by EPDS at 7, 30, 60 and 90 days (EPDS ≥10). Safety and tolerability are monitored intraoperatively and during postpartum follow-up.

Study Arms & Interventions

Esketamine

experimental

IV esketamine 0.25 mg/kg after cord clamp plus esketamine-sufentanil PCIA regimen

Interventions

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

    0.25 mg/kg IV 15 min after cord amputation; PCIA contains sufentanil 100 µg + esketamine 80 mg diluted to 100 ml (background 2 ml/h, bolus 2 ml, lock 8 min)

Placebo

inactive

Normal saline 10 ml IV after cord clamp; standard PCIA without esketamine

Interventions

  • Placebo
    via IV• single dose

    10 ml normal saline IV 15 minutes after umbilical cord amputation; PCIA regimen without esketamine

Participants

Ages
18 – 40
Sexes
female

Inclusion Criteria

  • Inclusion Criteria:
  • Elective cesarean section;
  • 18-40 years;
  • Primipara;
  • Singleton pregnancy;
  • Signed informed consent.

Exclusion Criteria

  • Exclusion Criteria:
  • ASA grade III and above;
  • Intracranial hypertension;
  • Hypertension;
  • Severe heart disease;
  • Untreated or insufficiently treated hyperthyroidism;
  • Liver or kidney dysfunction;
  • Preeclampsia or eclampsia;
  • Mental disorder or intellectual disability;
  • Drug abuse or alcoholism;
  • Contraindication to intraspinal anesthesia;
  • Preoperative EPDS score ≥ 10;
  • Participation in other clinical studies.

Study Details

  • Status
    Completed
  • Phase
    Phase NA
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment336 participants
  • Timeline
    Start: 2021-05-01
    End: 2023-12-31
  • Compounds
    EsketaminePlacebo
  • Topic
    Postpartum Depression

Locations

Tongji Hospital — Wuhan, Hubei, China

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