Low-dose Esketamine for preventing delirium in elderly patients undergoing surgery

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)

This study is testing if low-dose Esketamine can help prevent confusion after surgery in older adults aged 65 to 90.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1670 (estimated)
• Ages: 65 Years to 90 Years
• Sex: All
• Sponsor: Nanfang Hospital, Southern Medical University (Academic / other)
• Locations: 6 sites (Fuzhou, Fujian and 5 other locations)
• Trial ID: NCT06817239 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of low-dose Esketamine on preventing postoperative delirium in elderly patients aged 65 to 90 who are scheduled for major non-cardiac surgery. Delirium is a common and serious complication in older adults after surgery, leading to various negative outcomes. The study aims to assess whether Esketamine, known for its anti-inflammatory and neuroprotective properties, can reduce the incidence of delirium compared to a placebo. Eligible participants will receive either Esketamine or normal saline during their surgery, and their cognitive function will be monitored postoperatively.

Who should consider this trial

Good fit: Ideal candidates are elderly patients aged 65 to 90 with specific risk factors for delirium who are scheduled for major non-cardiac surgery.

Not a fit: Patients with a history of certain neurological or psychiatric disorders, or those unable to communicate preoperatively, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the incidence of postoperative delirium, improving recovery and quality of life for elderly patients.

How similar studies have performed: Previous studies have shown mixed results regarding the efficacy of ketamine in reducing postoperative delirium, indicating that this approach is still being explored.

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.

Where this trial is running

Fuzhou, Fujian and 5 other locations

• Fujian Provincial Hospital — Fuzhou, Fujian, China (Recruiting)
• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Not_yet_recruiting)
• Nanfang Hospital, Southern Medical University — Guangzhou, Guangdong, China (Recruiting)
• The First Affiliated Hospital of JiNan University — Guangzhou, Guangdong, China (Active_not_recruiting)
• The Eighth Affliated Hospital of Southern Medical Universily — Guangzhou, Guangdong, China (Recruiting)
• Ganzhou People's Hospital — Ganzhou, Jiangxi, China (Active_not_recruiting)

Study contacts

• Principal investigator: Ke-Xuan Liu, MD — Nanfang Hospital, Southern Medical University
• Study coordinator: Ke-Xuan Liu, MD

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