Low-dose Esketamine to Prevent Delirium in High-risk Elderly Patients Having Major Non-cardiac Surgery A Multicenter Randomized Trial

What this Trial Is About

Delirium is a sudden brain disorder that causes confusion, attention problems, and changes in consciousness, especially common in older patients after surgery. It can lead to serious consequences like more complications, higher risk of death, poorer thinking skills, and lower quality of life. This trial studies the effect of low-dose esketamine, a drug with anti-inflammatory and brain-protecting effects, on preventing delirium in older high-risk patients undergoing major non-heart-related surgery. Participants will be randomly assigned to receive either esketamine or a placebo during surgery and after surgery. Esketamine is given first as a 0.2 mgkg dose over 10 minutes after anesthesia starts, then continuously at a lower dose until shortly before surgery ends. After surgery, pain control is managed with patient-controlled intravenous analgesia PCIA using a mix of esketamine and sufentanil in the esketamine group or sufentanil alone in the placebo group. The study is conducted across multiple centers, with a single-blind design. Participants will be monitored for delirium symptoms for up to five days after surgery, along with recovery quality, pain levels, opioid use, cognitive function, and complications up to 30 days post-surgery. Various assessments and questionnaires will be used to track outcomes. Safety and side effects will also be closely observed throughout the study. The total participation period lasts about one month after surgery.

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