Clinical trial NCT05242419: 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
Overall status: RECRUITING
Phase: NA
Conditions: Injection
Non-cardiac Surgery
Delirium in Old Age
Post Operative Delirium
Keywords: Huperzine A Injection
postoperative delirium
Non-cardiac Surgery
Elderly Patients
Lead sponsor: Second Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
Collaborators: name: Affiliated Wenling Hospital of Wenzhou Medical University
First posted: 2022-02-16
Enrollment: 40
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


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.

Primary outcomes:
measure: Incidence of delirium within 7 days after operation
timeFrame: 7 days after operation
Secondary outcomes:
measure: type of delirium
timeFrame: evaluated at screening, 24 hours, 48 hours, 72 hours after operation
measure: severity of delirium
timeFrame: evaluated at screening, 24 hours, 48 hours, 72 hours after operation
measure: duration of delirium
timeFrame: evaluated at screening, 24 hours, 48 hours, 72 hours after operation
measure: length of hospital stay
timeFrame: from the day of operation to the day of discharge, around 7 to 14 days
measure: Economic indicators (total hospitalization cost, anesthesia cost, operation cost).
timeFrame: through study completion, up to 2 months
measure: Occurrence of complications
timeFrame: through study completion, up to 2 months
measure: Incidence of Mortality
timeFrame: the day of hospital discharge, and the day of follow-up, around 30 days after discharge
measure: the total score of Mini-mental State Examination scale
timeFrame: evaluated at screening, 72 hours after operation, and the day of follow-up, around 30 days after discharge
measure: the score of EuroQol (EQ-5D) scale
timeFrame: 96 hours after operation, the day of hospital discharge, and the day of follow-up, around 30 days after discharge
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: The 2nd Second Affiliated Hospital of WMU Phase I Clinical Trial Unit /Center Of Bioequivalence Study
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital of Wenzhou Medical University
name: Ting Li, MD. PhD
role: PRINCIPAL_INVESTIGATOR
References: