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.
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).
Postoperative PCIA with sufentanil and flurbiprofen; no esketamine added.
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.
PCIA containing esketamine 0.2 mg/kg plus sufentanil and flurbiprofen.
Added to PCIA (see pump: total 100 mL; background 2 mL/h; PCA 1 mL; lockout 20 min; duration 48 h).
PCIA containing esketamine 0.4 mg/kg plus sufentanil and flurbiprofen.
Added to PCIA as per group formula; duration 48 h.
PCIA containing esketamine 0.6 mg/kg plus sufentanil and flurbiprofen.
Added to PCIA; duration 48 h.
PCIA containing esketamine 0.8 mg/kg plus sufentanil and flurbiprofen.
Added to PCIA; duration 48 h.