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

Sponsor

Second Affiliated Hospital of Wenzhou Medical University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05242419

Collaborator

(none)

Enrollment

Arms

16.3

Anticipated Duration (Months)

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Injection Non-cardiac Surgery Delirium in Old Age Post Operative Delirium	Drug: Sodium Chloride Injection Drug: Huperzine A Injection	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Official Title:

A Single-center, Randomized, Double-blinded, Placebo-controlled Study of Huperzine A Injection in Reducing Postoperative Delirium in Elderly Patients Undergoing Non-cardiac Surgery

Anticipated Study Start Date :

Feb 20, 2022

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Treatment group

Huperzine A Injection

Drug: Huperzine A Injection

Huperzine A Injection

Placebo Comparator: Control group

0.9% Sodium Chloride Injection

Drug: Sodium Chloride Injection

0.9% Sodium Chloride Injection

Outcome Measures

Primary Outcome Measures

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

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.
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

75 Years and Older

Sexes Eligible for Study:

All

Accepts 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.