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.
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.
IV esketamine 0.25 mg/kg after cord clamp plus esketamine-sufentanil PCIA regimen
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)
Normal saline 10 ml IV after cord clamp; standard PCIA without esketamine
10 ml normal saline IV 15 minutes after umbilical cord amputation; PCIA regimen without esketamine