Injection, Non-cardiac Surgery, Delirium in Old Age, Post Operative Delirium
Conditions
Keywords
Huperzine A Injection, postoperative delirium, Non-cardiac Surgery, Elderly Patients
Brief summary
To observe and study the clinical effect of Huperzine A Injection on reducing postoperative delirium in elderly patients undergoing non-cardiac surgery
Interventions
0.9% Sodium Chloride Injection
Huperzine A Injection
Sponsors
Affiliated Wenling Hospital of Wenzhou Medical University
Second Affiliated Hospital of Wenzhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Occurrence of complications | through study completion, up to 2 months | pulmonary infection, myocardial infarction, renal failure, gastrointestinal bleeding, etc. |
Countries
China
Contacts
Primary ContactTing Li, MD. PhD
Outcome results
None listed