To observe and study the clinical effect of Huperzine A Injection on reducing postoperative delirium in elderly patients undergoing non-cardiac surgery
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
40
0.9% Sodium Chloride Injection
Huperzine A Injection
The 2nd Second Affiliated Hospital of WMU Phase I Clinical Trial Unit /Center Of Bioequivalence Study
Wenzhou, Zhejiang, China
RECRUITINGIncidence 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.
Time frame: 7 days after operation
type of delirium
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
severity of delirium
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
duration of delirium
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
length of hospital stay
total number of days of hospital stay
Time frame: 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
Time frame: through study completion, up to 2 months
Occurrence of complications
pulmonary infection, myocardial infarction, renal failure, gastrointestinal bleeding, etc.
Time frame: through study completion, up to 2 months
Incidence of Mortality
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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
the total score of Mini-mental State Examination scale
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
the score of EuroQol (EQ-5D) scale
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