Randomised, double-arm (esketamine vs saline) parallel trial (n=435 actual) testing a single intra-operative IV esketamine infusion 0.2 mg/kg over 40 minutes to treat perioperative depressive symptoms in adults undergoing major surgery.
This parallel, randomised, quadruple-masked trial evaluates the efficacy and safety of a single intra-operative intravenous esketamine infusion (0.2 mg/kg over 40 minutes) administered during wound closure for moderate to severe perioperative depressive symptoms in adults undergoing major elective surgery.
Secondary outcomes include anxiety, postoperative pain and broader psychiatric and safety assessments. Actual enrolled count of 435 is reported on the registry.
Single intra-operative IV esketamine infusion during wound closure (0.2 mg/kg over 40 minutes).
Infused over 40 minutes during suturing/incision closure.
Equivalent volume normal saline IV infusion during wound closure.
Normal saline, equivalent volume and infusion duration.