Randomised, double-blind, parallel study (n=90) testing a single IV low dose esketamine 0.25 mg/kg versus saline to prevent postoperative depression and reduce pain in women undergoing radical mastectomy.
This parallel, double-blind randomised trial evaluates whether a single intravenous low dose of esketamine (0.25 mg/kg) given after anaesthesia induction reduces postoperative depressive symptoms and pain in women undergoing modified radical mastectomy.
Outcomes include Hamilton Depression Scale at baseline, day 2, day 5, day 30 and day 90; serum leptin at baseline, day 2 and day 5; acute and longer-term pain scores (VAS at multiple timepoints) and analgesic consumption; safety via vital signs, recovery duration and adverse events.
Single IV esketamine 0.25 mg/kg given after induction of anaesthesia; vitals monitored.
Slow IV after induction; monitor BP and HR.
Placebo comparator: normal saline administered after induction.
Normal saline matching volume (per protocol).