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HIPAA Compliant
ISO 27001 Certified

Actively Recruiting

Phase Not Applicable
Age: 75Years +
All Genders
ID05242419

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

Age: 75Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Research Team

T

Ting Li, MD. PhD

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