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

Launched by NANFANG HOSPITAL, SOUTHERN MEDICAL UNIVERSITY · Feb 4, 2025

Keywords

ClinConnect Summary

The ELEMENT trial is studying the effects of a low dose of esketamine, a medication that may help reduce the risk of delirium in older patients undergoing major non-cardiac surgery. Delirium is a sudden change in mental function that can cause confusion and difficulty focusing, and it is especially common in older adults after surgery. This study aims to see if giving esketamine during and after surgery can help prevent this condition, which can lead to serious complications and affect recovery.

To participate in this trial, you need to be between 65 and 90 years old, scheduled for major non-heart surgery, and have at least one risk factor for delirium, like a history of stroke or chronic health issues. If eligible, participants will receive either esketamine or a placebo (a non-active substance) during their surgery and afterward. The trial is currently recruiting participants, and it aims to gather more information on how effective esketamine can be in preventing delirium, which could greatly improve the recovery experience for older patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥65 years and \<90 years;
• • Scheduled to undergo major non-cardiac surgery.
• • Fulfill at least one of risk factors as follows: history of stroke; history of delirium; hypertension; congestive heart failure; coronary artery disease; atrial fibrillation; peripheral artery disease; chronic obstructive pulmonary disease; obstructive sleep apnea; diabetes; chronic kidney disease; anemia; malnutrition; hypoalbuminemia; chronic pain; anxiety and depression; poor sleep quality; smoke; alcoholism.
• • Scheduled to receive patient-controlled intravenous analgesia (PCIA).
• Exclusion Criteria:
• • Refuse to participate;
• • Preoperative history of epilepsy, myasthenia gravis, Parkinson's disease, intracranial hypertension, delirium, schizophrenia, or other psychiatric diseases;
• • Inability to communicate in the preoperative period because of coma, profound dementia, or language barrier;
• • Preoperative uncontrolled severe hypertension (baseline SBP\>180 mmHg or DBP\>110 mmHg);
• • Preoperative history of hyperthyroidism and pheochromocytoma;
• • Acute cardiovascular event occurring within 30 days before surgery;
• • Severe hepatic dysfunction (Child-Pugh class C), renal dysfunction (required preoperative dialysis), or expected survival ≤24 hours;
• • Scheduled to undergo organ transplantation, vascular surgery, neurosurgery;
• • Receiving treatment with ketamine or esketamine;
• • Contradiction to ketamine or esketamine;
• • Other situations where the investigator or physician considers the patient ineligible for the study.