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

Not Applicable

Recruiting

• Conditions: Injection; Non-cardiac Surgery; Delirium in Old Age; Post Operative Delirium
• Interventions: Drug: Sodium Chloride Injection; Drug: Huperzine A Injection

• Registration Number: NCT05242419
• Lead Sponsor: Second Affiliated Hospital of Wenzhou Medical University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-09
• Study First Submitted QC: 2022-02-06
• Study First Posted: 2022-02-16
• Study Start: 2022-06-10
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-27
• Last Update Posted: 2025-04-02
• Primary Completion: 2025-11-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Sodium Chloride Injection	0.9% Sodium Chloride Injection
Treatment group	Huperzine A Injection	Huperzine A Injection

Primary Outcome Measures

Name	Time	Method
Incidence of delirium within 7 days after operation	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 Outcome Measures

Name	Time	Method
type of delirium	evaluated at screening, 24 hours, 48 hours, 72 hours after operation	diagnosed by delirium rating scale-revised-98(DRS-R-98) scale form
severity of delirium	evaluated at screening, 24 hours, 48 hours, 72 hours after operation	diagnosed by delirium rating scale-revised-98(DRS-R-98) scale form
duration of delirium	evaluated at screening, 24 hours, 48 hours, 72 hours after operation	diagnosed by delirium rating scale-revised-98(DRS-R-98) scale form
length of hospital stay	from the day of operation to the day of discharge, around 7 to 14 days	total number of days of hospital stay
Economic indicators (total hospitalization cost, anesthesia cost, operation cost).	through study completion, up to 2 months	costs at hospital
Occurrence of complications	through study completion, up to 2 months	pulmonary infection, myocardial infarction, renal failure, gastrointestinal bleeding, etc.
the total score of Mini-mental State Examination scale	evaluated at screening, 72 hours after operation, and the day of follow-up, around 30 days after discharge	Mini-mental State Examination scale
the score of EuroQol (EQ-5D) scale	96 hours after operation, the day of hospital discharge, and the day of follow-up, around 30 days after discharge	EQ-5D scale
Incidence of Mortality	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

Trial Locations

Locations (1)

The 2nd Second Affiliated Hospital of WMU Phase I Clinical Trial Unit /Center Of Bioequivalence Study; 🇨🇳 Wenzhou, Zhejiang, China