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

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

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

Conditions
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Injection, Non-cardiac Surgery, Delirium in Old Age, Post Operative Delirium

Intervention / Treatment
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* Drug: Sodium Chloride Injection
* Drug: Huperzine A Injection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>Huperzine A Injection | Drug: Huperzine A Injection<br>* Huperzine A Injection<br>|
| Placebo Comparator: Control group<br>0.9% Sodium Chloride Injection | Drug: Sodium Chloride Injection<br>* 0.9% Sodium Chloride Injection<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Huperzine A Injection, postoperative delirium, Non-cardiac Surgery, Elderly Patients