Actively Recruiting

Phase Not Applicable
Age: 65Years - 90Years
All Genders
ID06817239

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)

Led by Nanfang Hospital, Southern Medical University · Updated on 2025-04-27

1670

Participants Needed

6

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Delirium is a sudden brain disorder that causes confusion, attention problems, and changes in consciousness, especially common in older patients after surgery. It can lead to serious consequences like more complications, higher risk of death, poorer thinking skills, and lower quality of life. This trial studies the effect of low-dose esketamine, a drug with anti-inflammatory and brain-protecting effects, on preventing delirium in older high-risk patients undergoing major non-heart-related surgery. Participants will be randomly assigned to receive either esketamine or a placebo during surgery and after surgery. Esketamine is given first as a 0.2 mg/kg dose over 10 minutes after anesthesia starts, then continuously at a lower dose until shortly before surgery ends. After surgery, pain control is managed with patient-controlled intravenous analgesia (PCIA) using a mix of esketamine and sufentanil in the esketamine group or sufentanil alone in the placebo group. The study is conducted across multiple centers, with a single-blind design. Participants will be monitored for delirium symptoms for up to five days after surgery, along with recovery quality, pain levels, opioid use, cognitive function, and complications up to 30 days post-surgery. Various assessments and questionnaires will be used to track outcomes. Safety and side effects will also be closely observed throughout the study. The total participation period lasts about one month after surgery.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 65Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 65 years or older but less than 90 years
  • Scheduled for major non-cardiac surgery
  • Have at least one risk factor such as history of stroke, delirium, hypertension, heart failure, coronary artery disease, atrial fibrillation, peripheral artery disease, chronic obstructive pulmonary disease, obstructive sleep apnea, diabetes, chronic kidney disease, anemia, malnutrition, low albumin, chronic pain, anxiety, depression, poor sleep quality, smoking, or alcoholism
  • Planned to receive patient-controlled intravenous analgesia (PCIA)
Not Eligible

You will not qualify if you...

  • Refuse to participate
  • History before surgery of epilepsy, myasthenia gravis, Parkinson's disease, high brain pressure, delirium, schizophrenia, or other psychiatric disorders
  • Unable to communicate before surgery due to coma, severe dementia, or language barriers
  • Uncontrolled severe high blood pressure before surgery (systolic >180 mmHg or diastolic >110 mmHg)
  • History of hyperthyroidism or pheochromocytoma before surgery
  • Acute heart event within 30 days before surgery
  • Severe liver failure (Child-Pugh class C), need for dialysis, or expected survival less than 24 hours
  • Scheduled for organ transplant, vascular, or brain surgery
  • Currently treated with ketamine or esketamine
  • Allergic or contraindicated to ketamine or esketamine
  • Other reasons the doctor considers the patient unsuitable for the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Duration of surgery and up to 3 days postoperatively

Participants receive a loading dose and maintenance infusion of esketamine or placebo during surgery, followed by postoperative analgesia with patient-controlled intravenous analgesia (PCIA).

Surgery day and daily visits for up to 3 days after surgery

Follow-up

Duration - Up to 30 days after surgery

Participants are monitored for delirium and other recovery outcomes up to 30 days after surgery.

Visits on postoperative days 1, 3, and 30

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

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Research Team

K

Ke-Xuan Liu, MD

S

Shuang-Jie Cao, MD

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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Published Research Related To This Trial

Low-dose ketamine inhibits neuronal apoptosis and neuroinflammation in PC12 cells via α7nAChR mediated TLR4/MAPK/NF-κB signaling pathway.

Jinghua Zhao, Ruxin Zhang, Wei Wang...

https://pubmed.ncbi.nlm.nih.gov/36842233

Prophylactic Effects of Sub-anesthesia Ketamine on Cognitive Decline, Neuroinflammation, and Oxidative Stress in Elderly Mice.

Minmin Chen, Yinqiu Han, Bin Que...

https://pubmed.ncbi.nlm.nih.gov/36474365