Phase I interventional study (n=50) comparing ketamine pharmacokinetics and pharmacodynamics in postpartum cesarean patients versus healthy controls using a 12-hour infusion (0.18 mg/kg/hr x1 h loading then 0.05 mg/kg/hr x11 h maintenance).
This study characterises ketamine pharmacokinetics and pharmacodynamics in postpartum women after cesarean delivery and compares kinetics to non-pregnant female and male controls receiving the same 12-hour infusion.
Primary objective is to define ketamine PK in the post‑delivery physiologic state; secondary objectives include comparison with reproductive age matched controls and assessment of sex differences in metabolism.
Peripartum participants receive a loading infusion for 1 hour followed by an 11‑hour maintenance infusion beginning after cord clamping; blood sampling will define PK parameters and PD measures.
Cesarean delivery population receiving a 12-hour ketamine infusion after cord clamping (loading then maintenance).
Loading infusion 0.18 mg/kg/hr for 1 hour starting after cord clamping.
Maintenance infusion 0.05 mg/kg/hr for 11 hours following loading dose.
Non-pregnant female and male healthy controls receiving identical 12-hour ketamine infusion.
Loading infusion 0.18 mg/kg/hr for 1 hour.
Maintenance infusion 0.05 mg/kg/hr for 11 hours.