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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age75+
SponsorSecond Affiliated Hospital of Wenzhou Medical University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥ 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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sodium Chloride Injection

    Drug

    0.9% Sodium Chloride Injection

  • Huperzine A Injection

    Drug

    Huperzine A Injection

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Treatment groupExperimental treatment 1 intervention
Group B: Control groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
7 days after operation

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Second Affiliated Hospital of Wenzhou Medical University

Lead sponsor

Affiliated Wenling Hospital of Wenzhou Medical University

Collaborator