Effect of Perioperative Low-dose EsketaMine on dElirium in High-risk Elderly Patients uNdergoing elecTive Major Non-cardiac Surgery: a Multi-center Randomized Trial (ELEMENT Trial)

NCT06817239 NA RECRUITING

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.

Details

Lead sponsor	Nanfang Hospital, Southern Medical University
Phase	NA
Status	RECRUITING
Enrolment	1670
Start date	2025-02-12
Completion	2027-07

Conditions

• Delirium in Old Age
• Delirium, Postoperative
• Anesthesia
• Cognitive Dysfunction
• Pain, Postoperative
• Esketamine
• Non-cardiac Surgery

Interventions

• Esketamine
• Normal saline

Primary outcomes

• The incidence of delirium within 5 days after surgery — Up to 5 days after surgery
  Delirium is assessed twice daily (8-10 am and 6-8 pm) with The Confusion Assessment Method (CAM) for non-intubated patients or The confusion assessment method for the Intensive Care Unit (CAM-ICU) for intubated patients.
• Quality of recovery on postoperative day 1 (Sub-study) — On postoperative day 1
  Quality of recovery is assessed once daily (6-8 pm) with 15-item Quality of Recovery Scale (QoR-15).

Countries

China