Clinical TrialPostpartum DepressionPlaceboEsketamineEsketamineEsketamineEsketamineUnknown status

Effects of Esketamine on Postpartum Depression

Randomised, phase IV trial (n=500) comparing four esketamine concentrations added to postoperative PCIA versus no esketamine for postpartum depression and analgesia after cesarean section.

Target Enrollment
500 participants
Study Type
Phase IV interventional
Design
Randomized, double Blind

Detailed Description

Randomised, sequential interventional study enrolling 500 women undergoing cesarean section; participants randomised to control or one of four esketamine dose groups delivered via PCIA.

Primary aims are to evaluate postoperative psychological status (PPD measures) and analgesic efficacy to determine optimal esketamine dosing for combined antidepressant and analgesic effects.

PCIA formula: total 100 mL; background infusion 2 mL/h; PCA bolus 1 mL; lockout 20 min; duration 48 h. Outcomes analysed with ANOVA, t tests and repeated-measures where appropriate (SPSS26.0).

Study Protocol

Preparation

sessions

Dosing

1 sessions
2880 min each

Integration

sessions

Study Arms & Interventions

Control (no esketamine)

inactive

Postoperative PCIA with sufentanil and flurbiprofen; no esketamine added.

Interventions

  • Placebo
    via IV• continuous infusion

    PCIA: Sufentanil 1 µg/kg + Flurbiprofen Axetil 200 mg; total volume 100 mL; background 2 mL/h; PCA bolus 1 mL; lockout 20 min; duration 48 h.

Esketamine 0.2 mg/kg

experimental

PCIA containing esketamine 0.2 mg/kg plus sufentanil and flurbiprofen.

Interventions

  • Esketamine0.2 mg/kg
    via IV• continuous infusion

    Added to PCIA (see pump: total 100 mL; background 2 mL/h; PCA 1 mL; lockout 20 min; duration 48 h).

Esketamine 0.4 mg/kg

experimental

PCIA containing esketamine 0.4 mg/kg plus sufentanil and flurbiprofen.

Interventions

  • Esketamine0.4 mg/kg
    via IV• continuous infusion

    Added to PCIA as per group formula; duration 48 h.

Esketamine 0.6 mg/kg

experimental

PCIA containing esketamine 0.6 mg/kg plus sufentanil and flurbiprofen.

Interventions

  • Esketamine0.6 mg/kg
    via IV• continuous infusion

    Added to PCIA; duration 48 h.

Esketamine 0.8 mg/kg

experimental

PCIA containing esketamine 0.8 mg/kg plus sufentanil and flurbiprofen.

Interventions

  • Esketamine0.8 mg/kg
    via IV• continuous infusion

    Added to PCIA; duration 48 h.

Participants

Ages
25 – 35
Sexes
female

Inclusion Criteria

  • Inclusion Criteria:
  • 1. All participating patients signed an informed consent form;
  • 2. Age 25-35 years old;
  • 3. BMI≤35kg/m2;
  • 4. ASA classification I or II;
  • 5. Ultrasound showed a single pregnancy in the uterus, fetal, placental maturity grade Ⅱ+.

Exclusion Criteria

  • Exclusion Criteria:
  • 1. Unable or unwilling to sign the consent form, or unable to follow the research procedures;
  • 2. History of thyroid disease;
  • 3. A history of local anesthetic allergy;
  • 4. A history of addiction or abuse to opioids and ketamine;
  • 5. Preoperative mental illness; severe eclampsia;
  • 6. Abnormal ECG, hypertension and severe cardiac medical history;
  • 7. Other contraindications to the use of esketamine.

Study Details

Locations

China

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