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New treatment option for Delirium in Old Age
Official title Effect of Low-dose EsketaMine on dElirium in High-risk Elderly Patients uNdergoing elecTive Surgery (ELEMENT)
ClinicalTrials.gov ID: NCT06817239
What this study is testing
What is Esketamine?
Esketamine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for delirium in old age.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 to 90
You may be able to join if
- 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...
- Scheduled to receive patient-controlled intravenous analgesia (PCIA).
You likely can't join if
- Refuse to participate;
- Preoperative history of epilepsy, myasthenia gravis, Parkinson's disease, intracranial hypertension, delirium, schizophrenia, or other psychiatric...
- 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;
See the full eligibility 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...
- Scheduled to receive patient-controlled intravenous analgesia (PCIA).
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Fuzhou, Fujian, China
- Guangzhou, Guangdong, China
- Ganzhou, Jiangxi, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fuzhou, Fujian, China; Guangzhou, Guangdong, China; Ganzhou, Jiangxi, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.