To investigate the efficacy and safety of perioperative Transauricular vagal nerve stimulation in improving Postoperative Delirium in elderly patients undergoing elective surgery Lay the groundwork for a Phase III study.
This study aims to conduct a prospective, randomized controlled clinical trial on the preventive use of Transauricular vagal nerve stimulation(taVNS) to improve the incidence of Postoperative Delirium(POD) in elderly patients undergoing anesthesia surgery. The intervention group will receive taVNS, while the control group will only wear a taVNS stimulator without current stimulation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
150
Transauricular vagal nerve stimulation，Intervention group25Hz，Control group1Hz
Beijing Tiantan Hospital, Capital Medical University
Beijing, China
RECRUITINGTaVNS tolerance
The proportion of subjects who completed all the expected interventions
Time frame: 1-5 days after surgery
Incidence of adverse events
Myocardial infarction, cardiac arrest, pulmonary embolism, infection, etc
Time frame: At discharge，an average of 2 weeks
Incidence 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 cognitive decline
The MMSE scale and MoCA scale was used for evaluation
Time frame: Day 1 before surgery, day 5 after surgery, day 90 after surgery
All-cause mortality
Time frame: on the 90 days
Postoperative pain
VAS score
Time frame: 1-5 days after surgery
Time of anesthesia recovery
Time frame: Within 2 hours after the end of the surgery
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