Actively Recruiting
Effect of Low-dose EsketaMine on dElirium in High-risk Elderly Patients uNdergoing elecTive Surgery (ELEMENT)
Led by Nanfang Hospital, Southern Medical University · Updated on 2025-04-27
1670
Participants Needed
6
Research Sites
124 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effect of Low-dose EsketaMine on dElirium in High-risk Elderly Patients uNdergoing elecTive Surgery (ELEMENT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 65 years or older and less than 90 years
- Scheduled to undergo major non-cardiac surgery
- Have at least one risk factor such as history of stroke, 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, depression, poor sleep quality, smoking, or alcoholism
- Scheduled to receive patient-controlled intravenous analgesia (PCIA)
You will not qualify if you...
- Refusal to participate
- History of epilepsy, myasthenia gravis, Parkinson's disease, intracranial hypertension, delirium, schizophrenia, or other psychiatric diseases before surgery
- Unable to communicate before surgery due to coma, severe dementia, or language barriers
- Uncontrolled severe hypertension before surgery (systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg)
- History of hyperthyroidism or pheochromocytoma before surgery
- Acute cardiovascular event within 30 days before surgery
- Severe liver dysfunction (Child-Pugh class C), kidney dysfunction requiring dialysis, or expected survival less than 24 hours
- Scheduled for organ transplantation, vascular surgery, or neurosurgery
- Currently receiving treatment with ketamine or esketamine
- Allergy or contraindication to ketamine or esketamine
- Any other condition judged by the investigator or physician as not suitable for the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Fujian Provincial Hospital
Fuzhou, Fujian, China, 350001
Actively Recruiting
2
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Not Yet Recruiting
3
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China, 510515
Actively Recruiting
4
The First Affiliated Hospital of JiNan University
Guangzhou, Guangdong, China, 510632
Active, Not Recruiting
5
The Eighth Affliated Hospital of Southern Medical Universily
Guangzhou, Guangdong, China, 528399
Actively Recruiting
6
Ganzhou People's Hospital
Ganzhou, Jiangxi, China, 341001
Active, Not Recruiting
Research Team
K
Ke-Xuan Liu, MD
CONTACT
S
Shuang-Jie Cao, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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