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

NCT05242419 | Recruiting DMC

• 1 other identifier: SSJJZ-WW-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Injection; Non-cardiac Surgery; Delirium in Old Age; Post Operative Delirium

Keywords

Huperzine A Injection; postoperative delirium; Non-cardiac Surgery; Elderly Patients

Outcome Measures

Primary Outcomes (1)

• Incidence of delirium within 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.

  7 days after operation

Secondary Outcomes (9)

• type of delirium

  evaluated at screening, 24 hours, 48 hours, 72 hours after operation

• severity of delirium

  evaluated at screening, 24 hours, 48 hours, 72 hours after operation

• duration of delirium

  evaluated at screening, 24 hours, 48 hours, 72 hours after operation

• length of hospital stay

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

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

  through study completion, up to 2 months

Study Arms (2)

Treatment group

EXPERIMENTAL

Huperzine A Injection

Drug: Huperzine A Injection

Control group

PLACEBO COMPARATOR

0.9% Sodium Chloride Injection

Drug: Sodium Chloride Injection

Interventions

Sodium Chloride Injection DRUG

0.9% Sodium Chloride Injection

Control group

Huperzine A Injection DRUG

Huperzine A Injection

Treatment group

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• ≥ 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead
• Affiliated Wenling Hospital of Wenzhou Medical University: collaborator

Study Sites (1)

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

Wenzhou, Zhejiang, 325000, China

RECRUITING

MeSH Terms

Conditions

Emergence Delirium

Interventions

Sodium Chloride; huperzine A

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Ting Li, MD. PhD

  Second Affiliated Hospital of Wenzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ting Li, MD. PhD

CONTACT

13587876896; liting1021@aliyun.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 9, 2022
• First Posted: February 16, 2022
• Study Start: June 10, 2022
• Primary Completion: November 30, 2025
• Study Completion: December 30, 2025
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)