Actively Recruiting
A Multi-center, Randomized, Double-blinded, Placebo-controlled Study of Huperzine A Injection in Reducing Postoperative Delirium in Elderly Patients Undergoing Non-cardiac Surgery
Led by Second Affiliated Hospital of Wenzhou Medical University · Updated on 2025-04-02
40
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
S
Second Affiliated Hospital of Wenzhou Medical University
Lead Sponsor
A
Affiliated Wenling Hospital of Wenzhou Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the effects of Huperzine A Injection on reducing postoperative delirium in elderly patients aged 75 and older who are undergoing non-cardiac surgery. This randomized, double-blinded, placebo-controlled trial aims to observe how this treatment may influence the occurrence of delirium after surgery in this older population. Participants will be randomly assigned to receive either Huperzine A Injection or a placebo of 0.9% Sodium Chloride Injection during their non-cardiac surgical procedure. The study includes patients with an anesthesia grade of III to IV and an estimated operation time of at least 2 hours. The treatments will be administered under controlled conditions to carefully assess their effects on postoperative delirium. During the study, participants will be monitored for delirium incidence within 7 days after surgery, with additional evaluations at 24, 48, and 72 hours post-operation. Researchers will also assess the type, severity, and duration of delirium, length of hospital stay, economic costs, complications, mortality rates, and cognitive function using the Mini-mental State Examination and EuroQol scale. Follow-up assessments will continue up to 2 months after surgery, with some evaluations occurring around 30 days after discharge.
CONDITIONS
Brief Title
A Study of Huperzine A Injection in Reducing Postoperative Delirium in Elderly Patients Undergoing Non-cardiac Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 75 years old or older
- Scheduled for non-cardiac surgery under general anesthesia
- Anesthesia risk classified as American Society of Anesthesiologist (ASA) grade III to IV
- Estimated surgery time of 2 hours or longer
- Willing to voluntarily sign the informed consent form
You will not qualify if you...
- Impaired kidney function with creatinine 1.5 times above normal laboratory limits
- Abnormal liver function with ALT or AST levels 2 times above normal laboratory limits
- Positive for infectious diseases
- Central nervous system injury
- History of delirium, epilepsy, long-term use of psychoactive drugs, or preoperative delirium
- Diseases with drug contraindications including bronchial asthma, mechanical intestinal obstruction, urinary tract obstruction, or serious systemic diseases such as myocardial infarction, heart failure, angina, or sinus bradycardia
- Known allergy to narcotic drugs or Huperzine A Injection
- Use of incompatible drugs with Huperzine A Injection
- Participation in other clinical trials within 3 months before this study
- Unable to tolerate tests or cooperate with examinations
- Presence of aphasia, audio-visual dysfunction, or other communication disorders
- Judged by investigators as unsuitable for participation
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From surgery day to hospital discharge, around 7 to 14 days
Participants receive either Huperzine A Injection or placebo (0.9% Sodium Chloride Injection) around the time of non-cardiac surgery under general anesthesia.
Assessments at screening, 24, 48, and 72 hours after operation
Duration - Up to 2 months after surgery
Participants are monitored for delirium incidence, cognitive function, quality of life, complications, and mortality after hospital discharge.
Visits around 30 days after discharge
Trial Site Locations
Total: 1 location
1
The 2nd Second Affiliated Hospital of WMU Phase I Clinical Trial Unit /Center Of Bioequivalence Study
Wenzhou, Zhejiang, China, 325000
Actively Recruiting
Research Team
T
Ting Li, MD. PhD
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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