RecruitingNot ApplicableNCT05242419

A Study of Huperzine A Injection in Reducing Postoperative Delirium in Elderly Patients Undergoing 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


Sponsor

Second Affiliated Hospital of Wenzhou Medical University

Enrollment

40 participants

Start Date

Jun 10, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

To observe and study the clinical effect of Huperzine A Injection on reducing postoperative delirium in elderly patients undergoing non-cardiac surgery


Eligibility

Min Age: 75 Years

Inclusion Criteria5

  • ≥ 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 Criteria8

  • 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.

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Interventions

DRUGSodium Chloride Injection

0.9% Sodium Chloride Injection

DRUGHuperzine A Injection

Huperzine A Injection


Locations(1)

The 2nd Second Affiliated Hospital of WMU Phase I Clinical Trial Unit /Center Of Bioequivalence Study

Wenzhou, Zhejiang, China

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NCT05242419


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