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

RecruitingNAAges 65 Years - 90 YearsAllNanfang Hospital, Southern Medical University
NCT06817239 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 spec

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📋 Eligibility rules (as published)
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.
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What it tests

  • Esketamine
  • Normal saline
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Where

6 sites
Fujian Provincial Hospital
Fuzhou, China
Sun Yat-sen University Cancer Center
Guangzhou, China
Nanfang Hospital, Southern Medical University
Guangzhou, China
The First Affiliated Hospital of JiNan University
Guangzhou, China
The Eighth Affliated Hospital of Southern Medical Universily
Guangzhou, China
Ganzhou People's Hospital
Ganzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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