Clinical TrialParallelPeripartumEsketaminePlaceboNot yet recruiting

Effect of a single low-dose dose of esketamine on postpartum depression and quality of recovery in women undergoing cesarean section: a prospective, randomised controlled study

This randomised, parallel-group trial (n=136) is evaluating whether a single low-dose infusion of esketamine after caesarean section can reduce postpartum depressive symptoms and improve recovery in women in China. Participants are allocated to receive intravenous esketamine 0.2 mg/kg over 40 minutes after surgery or an intravenous physiological saline infusion for the same duration as the comparator. The study is interventional and involves adult women aged 18 to 60 years undergoing caesarean delivery. The primary outcome is the Edinburgh Postnatal Depression Scale (EPDS) score, assessed on postpartum day 2 and postpartum day 7. Secondary outcomes include the Obstetric Quality of Recovery-10 (ObsQoR-10) score at 24 and 48 hours postpartum, resting and exercise pain scores measured using a visual analogue scale at 24 hours postpartum, and postpartum length of hospital stay. No phase is specified. The trial is being conducted in China and is sponsored by Dongguan Maternal and Child Health Hospital.

Target Enrollment
68 participants
Study Type
Phase NA interventional
Design
Randomized, single Blind

Detailed Description

Main research objectives

Evaluation of the effect of single low-dose ketamine on postpartum depression score in cesarean section women after delivery

Secondary research objectives

Evaluation of the effect of single low-dose ketamine on postpartum recovery quality in cesarean section women

Study Arms & Interventions

Esketamine group

experimental

Single low-dose esketamine (0.2 mg/kg) intravenously infused for 40 minutes immediately after fetal delivery, combined with patient-controlled intravenous analgesia (PCIA).

Interventions

  • Esketamine0.2 mg/kg
    via IVsingle dose1 doses total

    Infused over 40 minutes immediately after fetal delivery and umbilical cord ligation; combined with PCIA for pain relief maintenance.

Control group

placebo

Equal volume of normal saline intravenously infused for 40 minutes immediately after fetal delivery, combined with patient-controlled intravenous analgesia (PCIA).

Interventions

  • Placebo
    via IVsingle dose1 doses total

    Normal saline infused over 40 minutes; combined with PCIA for pain relief maintenance.

Study Details

  • Status
    Not yet recruiting
  • Phase
    Phase NA
  • Type
    interventional
  • Design
    Randomizedsingle Blind
  • Target Enrollment68 participants
  • Timeline
    Start: 2024-09-01
    End: 2025-03-31
  • Compounds
  • Topic

Locations

China

Related Publications