Effect of Low-dose Esketamine on Delirium in High-risk Elderly Patients Undergoing Elective Surgery (ELEMENT)
Double-blind, placebo-controlled randomised trial (n=1670) testing low-dose intraoperative and postoperative esketamine versus placebo to prevent postoperative delirium in high-risk elderly patients undergoing major non-cardiac surgery.
Details
Postoperative delirium is a common, acute neurocognitive disorder among older surgical patients and is associated with worse short- and long-term outcomes; this multicentre trial tests whether intraoperative and postoperative low-dose esketamine reduces delirium incidence in high‑risk elderly patients undergoing major non‑cardiac surgery.
Esketamine has anti‑inflammatory and neuroprotective effects; the trial administers a 0.2 mg/kg loading dose after induction with 0.1 mg/kg/h maintenance until 40 minutes before surgery end, plus postoperative PCIA containing esketamine and sufentanil, compared with matched saline infusion and sufentanil‑only PCIA; outcomes include delirium incidence and cognitive and safety measures.