Status:

RECRUITING

A Study of Huperzine A Injection in Reducing Postoperative Delirium in Elderly Patients Undergoing Non-cardiac Surgery

Lead Sponsor:

Second Affiliated Hospital of Wenzhou Medical University

Collaborating Sponsors:

Affiliated Wenling Hospital of Wenzhou Medical University

Conditions:

Injection

Non-cardiac Surgery

Eligibility:

All Genders

75+ years

Phase:

NA

Brief Summary

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

Eligibility Criteria

Inclusion

  • ≥ 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

  • 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.

Key Trial Info

Start Date :

June 10 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 30 2025

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT05242419

Start Date

June 10 2022

End Date

December 30 2025

Last Update

April 2 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

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

Wenzhou, Zhejiang, China, 325000