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.
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
Single low-dose esketamine (0.2 mg/kg) intravenously infused for 40 minutes immediately after fetal delivery, combined with patient-controlled intravenous analgesia (PCIA).
Infused over 40 minutes immediately after fetal delivery and umbilical cord ligation; combined with PCIA for pain relief maintenance.
Equal volume of normal saline intravenously infused for 40 minutes immediately after fetal delivery, combined with patient-controlled intravenous analgesia (PCIA).
Normal saline infused over 40 minutes; combined with PCIA for pain relief maintenance.