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

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

Study Overview

• Status: Recruiting
• Conditions: Injection; Delirium in Old Age; Post Operative Delirium; Non-cardiac Surgery
• Intervention / Treatment: Drug: Huperzine A Injection; Drug: Sodium Chloride Injection

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ting Li, MD. PhD; Phone Number: 13587876896; Email: liting1021@aliyun.com

Study Locations

• China
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325000
      • Recruiting
      • The 2nd Second Affiliated Hospital of WMU Phase I Clinical Trial Unit /Center Of Bioequivalence Study
      • Contact: TING LI; Phone Number: 057785676822; Email: feclinicalresearch@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control group; 0.9% Sodium Chloride Injection	Drug: Sodium Chloride Injection; 0.9% Sodium Chloride Injection
Experimental: Treatment group; Huperzine A Injection	Drug: Huperzine A Injection; Huperzine A Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
type of delirium	diagnosed by delirium rating scale-revised-98(DRS-R-98) scale form	evaluated at screening, 24 hours, 48 hours, 72 hours after operation
severity of delirium	diagnosed by delirium rating scale-revised-98(DRS-R-98) scale form	evaluated at screening, 24 hours, 48 hours, 72 hours after operation
duration of delirium	diagnosed by delirium rating scale-revised-98(DRS-R-98) scale form	evaluated at screening, 24 hours, 48 hours, 72 hours after operation
length of hospital stay	total number of days 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).	costs at hospital	through study completion, up to 2 months
Occurrence of complications	pulmonary infection, myocardial infarction, renal failure, gastrointestinal bleeding, etc.	through study completion, up to 2 months
Incidence of Mortality	rate of Mortality during the hospital stay and follow-up within 30 days after discharge	the day of hospital discharge, and the day of follow-up, around 30 days after discharge
the total score of Mini-mental State Examination scale	Mini-mental State Examination scale	evaluated at screening, 72 hours after operation, and the day of follow-up, around 30 days after discharge
the score of EuroQol (EQ-5D) scale	EQ-5D scale	96 hours after operation, the day of hospital discharge, and the day of follow-up, around 30 days after discharge

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Wenzhou Medical University
• Collaborators: Affiliated Wenling Hospital of Wenzhou Medical University
• Investigators: Principal Investigator: Ting Li, MD. PhD, Second Affiliated Hospital of Wenzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2022
• Primary Completion (Estimated): November 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: January 9, 2022
• First Submitted That Met QC Criteria: February 6, 2022
• First Posted (Actual): February 16, 2022

Study Record Updates

• Last Update Posted (Actual): April 2, 2025
• Last Update Submitted That Met QC Criteria: March 27, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: postoperative delirium; Elderly Patients; Non-cardiac Surgery; Huperzine A Injection
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Emergence Delirium; Delirium; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Neurotransmitter Agents; Protective Agents; Neuroprotective Agents; Cholinergic Agents; Cholinesterase Inhibitors; Huperzine A
• Other Study ID Numbers: SSJJZ-WW-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No