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NCT Number: NCT05242419

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

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

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Key information

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Wenzhou, Zhejiang, 325000, China

Location status: Recruiting

Location contact

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

sodium chloride injection

Drug

0.9% Sodium Chloride Injection

Huperzine A injection

Drug

Huperzine A Injection

Primary outcomes

  1. Incidence of delirium within 7 days after operation

    Time frame: 7 days after operation

    Delirium will be evaluated by The 3-dimensional Confusion Assessment Method(3D-CAM) and delirium rating scale-revised-98(DRS-R-98) scale form.

Secondary outcomes

  1. type of delirium

    Time frame: evaluated at screening, 24 hours, 48 hours, 72 hours after operation

    diagnosed by delirium rating scale-revised-98(DRS-R-98) scale form

  2. severity of delirium

    Time frame: evaluated at screening, 24 hours, 48 hours, 72 hours after operation

    diagnosed by delirium rating scale-revised-98(DRS-R-98) scale form

  3. duration of delirium

    Time frame: evaluated at screening, 24 hours, 48 hours, 72 hours after operation

    diagnosed by delirium rating scale-revised-98(DRS-R-98) scale form

  4. length of hospital stay

    Time frame: from the day of operation to the day of discharge, around 7 to 14 days

    total number of days of hospital stay

  5. Economic indicators (total hospitalization cost, anesthesia cost, operation cost).

    Time frame: through study completion, up to 2 months

    costs at hospital

  6. Occurrence of complications

    Time frame: through study completion, up to 2 months

    pulmonary infection, myocardial infarction, renal failure, gastrointestinal bleeding, etc.

  7. Incidence of Mortality

    Time frame: the day of hospital discharge, and the day of follow-up, around 30 days after discharge

    rate of Mortality during the hospital stay and follow-up within 30 days after discharge

  8. the total score of Mini-mental State Examination scale

    Time frame: evaluated at screening, 72 hours after operation, and the day of follow-up, around 30 days after discharge

    Mini-mental State Examination scale

  9. the score of EuroQol (EQ-5D) scale

    Time frame: 96 hours after operation, the day of hospital discharge, and the day of follow-up, around 30 days after discharge

    EQ-5D scale

Study contacts

Contact information is provided by the study sponsor or research team.

Ting Li, MD. PhD

CONTACT

[email protected]

13587876896

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Wenzhou Medical University

Other

Collaborators

  • Affiliated Wenling Hospital of Wenzhou Medical University

Registry information

Official study title

A Multi-center, Randomized, Double-blinded, Placebo-controlled Study of Huperzine A Injection in Reducing Postoperative Delirium in Elderly Patients Undergoing Non-cardiac Surgery

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Feb 16, 2022
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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