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

Primary Purpose

Injection, Non-cardiac Surgery, Delirium in Old Age

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Sodium Chloride Injection
Huperzine A Injection
Sponsored by
Second Affiliated Hospital of Wenzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Injection focused on measuring Huperzine A Injection, postoperative delirium, Non-cardiac Surgery, Elderly Patients

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment group

Control group

Arm Description

Huperzine A Injection

0.9% Sodium Chloride Injection

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

type of delirium
diagnosed by delirium rating scale-revised-98(DRS-R-98) scale form
severity of delirium
diagnosed by delirium rating scale-revised-98(DRS-R-98) scale form
duration of delirium
diagnosed by delirium rating scale-revised-98(DRS-R-98) scale form
length of hospital stay
total number of days of hospital stay
Economic indicators (total hospitalization cost, anesthesia cost, operation cost).
costs at hospital
Occurrence of complications
pulmonary infection, myocardial infarction, renal failure, gastrointestinal bleeding, etc.
Incidence of Mortality
rate of Mortality during the hospital stay and follow-up within 30 days after discharge
the total score of Mini-mental State Examination scale
Mini-mental State Examination scale
the score of EuroQol (EQ-5D) scale
EQ-5D scale

Full Information

First Posted
January 9, 2022
Last Updated
May 9, 2023
Sponsor
Second Affiliated Hospital of Wenzhou Medical University
Collaborators
The First People's Hospital of Wenling
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1. Study Identification

Unique Protocol Identification Number
NCT05242419
Brief Title
A Study of Huperzine A Injection in Reducing Postoperative Delirium in Elderly Patients Undergoing Non-cardiac Surgery
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 10, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Second Affiliated Hospital of Wenzhou Medical University
Collaborators
The First People's Hospital of Wenling

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Injection, Non-cardiac Surgery, Delirium in Old Age, Post Operative Delirium
Keywords
Huperzine A Injection, postoperative delirium, Non-cardiac Surgery, Elderly Patients

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
Huperzine A Injection
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
0.9% Sodium Chloride Injection
Intervention Type
Drug
Intervention Name(s)
Sodium Chloride Injection
Intervention Description
0.9% Sodium Chloride Injection
Intervention Type
Drug
Intervention Name(s)
Huperzine A Injection
Intervention Description
Huperzine A Injection
Primary Outcome Measure Information:
Title
Incidence of delirium within 7 days after operation
Description
Delirium will be evaluated by The 3-dimensional Confusion Assessment Method(3D-CAM) and delirium rating scale-revised-98(DRS-R-98) scale form.
Time Frame
7 days after operation
Secondary Outcome Measure Information:
Title
type of delirium
Description
diagnosed by delirium rating scale-revised-98(DRS-R-98) scale form
Time Frame
evaluated at screening, 24 hours, 48 hours, 72 hours after operation
Title
severity of delirium
Description
diagnosed by delirium rating scale-revised-98(DRS-R-98) scale form
Time Frame
evaluated at screening, 24 hours, 48 hours, 72 hours after operation
Title
duration of delirium
Description
diagnosed by delirium rating scale-revised-98(DRS-R-98) scale form
Time Frame
evaluated at screening, 24 hours, 48 hours, 72 hours after operation
Title
length of hospital stay
Description
total number of days of hospital stay
Time Frame
from the day of operation to the day of discharge, around 7 to 14 days
Title
Economic indicators (total hospitalization cost, anesthesia cost, operation cost).
Description
costs at hospital
Time Frame
through study completion, up to 2 months
Title
Occurrence of complications
Description
pulmonary infection, myocardial infarction, renal failure, gastrointestinal bleeding, etc.
Time Frame
through study completion, up to 2 months
Title
Incidence of Mortality
Description
rate of Mortality during the hospital stay and follow-up within 30 days after discharge
Time Frame
the day of hospital discharge, and the day of follow-up, around 30 days after discharge
Title
the total score of Mini-mental State Examination scale
Description
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
Title
the score of EuroQol (EQ-5D) scale
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ting Li, MD. PhD
Phone
13587876896
Email
liting1021@aliyun.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ting Li, MD. PhD
Organizational Affiliation
Second Affiliated Hospital of Wenzhou Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The 2nd Second Affiliated Hospital of WMU Phase I Clinical Trial Unit /Center Of Bioequivalence Study
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
TING LI
Phone
057785676822
Email
feclinicalresearch@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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