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

Delirium in Old Age Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05242419
• Other study ID #: SSJJZ-WW-01
• Status: Recruiting
• Phase: N/A
• Start date: June 10, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: May 2023
• Source: Second Affiliated Hospital of Wenzhou Medical University
• Contact: Ting Li, MD. PhD
• Phone: 13587876896
• Email: liting1021[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Sodium Chloride Injection
0.9% Sodium Chloride Injection
• Huperzine A Injection
Huperzine A Injection

Locations

Country	Name	City	State
China	The 2nd Second Affiliated Hospital of WMU Phase I Clinical Trial Unit /Center Of Bioequivalence Study	Wenzhou	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Wenzhou Medical University	The First People's Hospital of Wenling

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Economic indicators (total hospitalization cost, anesthesia cost, operation cost).	costs at hospital	through study completion, up to 2 months
Secondary	Occurrence of complications	pulmonary infection, myocardial infarction, renal failure, gastrointestinal bleeding, etc.	through study completion, up to 2 months
Secondary	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
Secondary	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
Secondary	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