Effect of Low-dose EsketaMine on dElirium in High-risk Elderly Patients uNdergoing elecTive Surgery (ELEMENT)

This double-blind, placebo-controlled trial (n=1670) will assess the effect of low-dose esketamine on postoperative delirium in elderly high-risk patients undergoing major non-cardiac surgery. Participants will receive either esketamine (14mg/70kg loading dose, followed by 7mg/70kg/h infusion) or a placebo during surgery, with esketamine included in postoperative patient-controlled analgesia.

Delirium, a temporary state of confusion that can occur after surgery, is particularly common in older adults and is linked to worse long-term health outcomes. While esketamine, a variant of ketamine, has anti-inflammatory and neuroprotective effects, previous studies on its ability to prevent postoperative delirium have been inconclusive. This large-scale, multicentre trial, conducted by Nanfang Hospital, Southern Medical University, aims to clarify whether esketamine can reduce delirium incidence and improve recovery. The study will measure delirium occurrence, pain levels, opioid use, cognitive function, and overall recovery within 30 days after surgery.

Trial Details

Delirium is an acutely occurred neurocognitive disorder characterized by fluctuating symptoms of inattention, altered consciousness and cognitive dysfunction. Delirium is reported to occur in 4% to 65% of postoperative patients depending on the population, and is especially common in older patients. Postoperative delirium is disturbing to patients and their families, and it is a strong predictor of both early and long-term worse outcomes including increased non-delirium complications, increased perioperative mortality, shortened overall survival, declined cognitive function, and lowered quality of life. Although ketamine/esketamine has anti-inflammatory and neuroprotective effects, evidence on its efficacy in reducing postoperative delirium remains inconsistent and inconclusive. Existing studies are limited by heterogeneity, small sample sizes, single-center designs, and a focus on specific type of surgery. Research on elderly high-risk patients is lacking, and most studies administer the drug intraoperatively, with limited exploration of postoperative use. The optimal dosing and timing for POD prevention are unclear. This study aims to carry out a multicenter, single-blind, placebo-controlled, large-sample randomized controlled trial assessing the effect of low-dose esketamine, given intraoperatively and postoperatively, on delirium in elderly high-risk patients undergoing major non-cardiac surgery.

Trial Number NCT06817239

Data attribution

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