Huperzine A Injection to reduce postoperative delirium in elderly patients after non-cardiac surgery
A Multi-center, Randomized, Double-blinded, Placebo-controlled Study of Huperzine A Injection in Reducing Postoperative Delirium in Elderly Patients Undergoing Non-cardiac Surgery
This study is testing if an injection of Huperzine A can help older patients, aged 75 and up, avoid confusion and delirium after non-heart surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 75 Years and up |
| Sex | All |
| Sponsor | Second Affiliated Hospital of Wenzhou Medical University Academic / other |
| Locations | 1 site (Wenzhou, Zhejiang) |
| Trial ID | NCT05242419 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of Huperzine A Injection on elderly patients aged 75 and older who are undergoing non-cardiac surgery. The primary focus is to observe whether this intervention can effectively reduce the incidence of postoperative delirium, a common complication in this age group. Patients will receive either Huperzine A or a sodium chloride injection as a control, and their outcomes will be monitored following surgery. The study aims to provide insights into the potential benefits of Huperzine A in improving postoperative recovery for elderly patients.
Who should consider this trial
Good fit: Ideal candidates for this study are elderly patients aged 75 and older who are scheduled for non-cardiac surgery requiring general anesthesia.
Not a fit: Patients with impaired renal or liver function, a history of delirium, or those on psychoactive medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the occurrence of postoperative delirium, leading to better recovery outcomes for elderly patients.
How similar studies have performed: While there is limited data on Huperzine A specifically for this purpose, similar studies targeting postoperative delirium in elderly patients have shown promising results with various interventions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ≥ 75 years old. * Comply with the indication of non-cardiac surgery under general anesthesia. * Anesthesia grade of American Society of Anesthesiologist (ASA) as III\~IV grade. * The estimated operation time ≥ 2 hours. * Voluntarily sign the informed consent form. Exclusion Criteria: * Patients with impaired renal function (Cr is 1.5 times higher than the upper limit of the normal value of the central laboratory) or abnormal liver function (Alanine aminotransferase(ALT) and Aspartate aminotransferase(AST) are 2 times higher than the upper limit of the normal value of the central laboratory). * Patients who are positive for infectious diseases. * Patients accompanied with central nervous system injury. * Patients with previous history of delirium and epilepsy, long-term use of psychoactive drugs or preoperative assessment of delirium. * Patients who involved diseases with drug taboos, bronchial asthma, mechanical intestinal obstruction and urinary tract obstruction, or serious systemic diseases, especially circulatory diseases: such as myocardial infarction, heart failure, angina pectoris, history of sinus bradycardia. * Patients who are known to be allergic to narcotic drugs or Huperzine A Injection, or must use drugs that are not compatible with Huperzine An Injection. * patients who participated in other clinical trials within 3 months before this study, for any reason, who could not tolerate the test or cooperate with the examination, or who has any aphasia, audio-visual dysfunction, etc. * the investigators think that the patients is not suitable to participate in this study.
Where this trial is running
Wenzhou, Zhejiang
- The 2nd Second Affiliated Hospital of WMU Phase I Clinical Trial Unit /Center Of Bioequivalence Study — Wenzhou, Zhejiang, China (Recruiting)
Study contacts
- Principal investigator: Ting Li, MD. PhD — Second Affiliated Hospital of Wenzhou Medical University
- Study coordinator: Ting Li, MD. PhD
- Email: liting1021@aliyun.com
- Phone: 13587876896
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.