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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Fujian Provincial Hospital
  Fuzhou, Fujian, China Recruiting
• Nanfang Hospital, Southern Medical University
  Guangzhou, Guangdong, China Recruiting
• The Eighth Affliated Hospital of Southern Medical Universily
  Guangzhou, Guangdong, China Recruiting
• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Not yet recruiting
• The First Affiliated Hospital of JiNan University
  Guangzhou, Guangdong, China Active not 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
• Email: liukexuan705@163.com
• Phone: +86 13710684096

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.