According to the 3D-CAM scale, evaluate the incidence of Postoperative Delirium within 5 days after surgery in elderly patients receiving taVNS.The results are expected to provide evidence of the safety and efficacy of perioperative prophylactic use of taVNS in the clinical application of improving postoperative brain health in elderly patients, as well as theoretical and practical basis for subsequent studies or clinical applications.
This study aims to conduct a prospective, randomized controlled clinical trial on the preventive use of taVNS to improve the incidence of Postoperative Delirium(POD) in elderly patients undergoing anesthesia surgery. The intervention group will receive "standard-stimulation parameters" of taVNS（25HZ，250μs）, while the control group will receive "low-stimulation parameters" of taVNS(1HZ,250μs). The main outcome measure of the study was the incidence of POD within 5 days after surgery. Secondary outcome measures include incidence of new mild and severe postoperative neurocognitive impairment during hospitalization and 90 days, all-cause mortality rate at 90 days, incidence of related adverse events, and length of stay.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
1,776
transauricular auricular vagus nerve stimulation
Beijing Tiantan Hospital, Capital Medical University
Beijing, China
RECRUITINGIncidence of POD at discharge or within 5 days postoperatively
POD assessment was performed using the 3D-CAM scale estimate. Assessed 2 times daily until postoperative day 5 or hospital discharge
Time frame: At discharge or within 5 days postoperatively
Incidence of delayed cognitive recovery during hospitalization
The MMSE/MoCA scale were used for evaluation
Time frame: Day 1 before surgery, day 5 after surgery, day 90 after surgery
Incidence of neurocognitive dysfunction at 90 days postoperatively
assessed by AMTS scale
Time frame: on the 90 days
Degree of decline in activities of daily living at 90 days postoperatively
use the IADL score
Time frame: on the 90 days
All-cause mortality
Time frame: on the 90 days
Incidence of unplanned ICU or HDU admissions
Time frame: on the 90 days
Proportion of patients requiring higher levels of care postdischarge, specifically long-term care.
Time frame: on the 90 days
Length of hospital stay
Time frame: on the 90 days
Delirium severity
Delirium severity was assessed via the 3D-CAM-S scale. 3D-CAM-S scale: The total score is 7, with 0 being normal, 1 being mild delirium, 2 being moderate delirium, and 3-7 being severe delirium
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Time frame: At discharge or within 5 days postoperatively