NCT06817239 Effect of Low-dose EsketaMine on dElirium in High-risk Elderly Patients uNdergoing elecTive Surgery (ELEMENT)
| NCT ID | NCT06817239 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nanfang Hospital, Southern Medical University |
| Condition | Delirium in Old Age |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,670 participants |
| Start Date | 2025-02-12 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,670 participants in total. It began in 2025-02-12 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Ke-Xuan Liu, MD
PRINCIPAL INVESTIGATOR
Nanfang Hospital, Southern Medical University
Frequently Asked Questions
Who can join the NCT06817239 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, up to 90 Years, studying Delirium in Old Age. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06817239 currently recruiting?
Yes, NCT06817239 is actively recruiting participants. Contact the research team at liukexuan705@163.com for enrollment information.
Where is the NCT06817239 trial being conducted?
This trial is being conducted at Fuzhou, China, Guangzhou, China, Guangzhou, China, Guangzhou, China and 2 additional locations.
Who is sponsoring the NCT06817239 clinical trial?
NCT06817239 is sponsored by Nanfang Hospital, Southern Medical University. The principal investigator is Ke-Xuan Liu, MD at Nanfang Hospital, Southern Medical University. The trial plans to enroll 1,670 participants.