Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06421077
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-05-10
Brief Title:
Transauricular Vagus Nerve Stimulation Improves Postoperative Delirium in Elderly Patients
Sponsor:
Beijing Tiantan Hospital
Organization:
Beijing Tiantan Hospital
Study Overview
Official Title:
Transauricular Vagus Nerve StimulationtaVNSImproves Postoperative Delirium in Elderly Patients a Randomized Controlled Study
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Vnstar
Brief Summary:
According to the 3D-CAM scale evaluate the incidence of Postoperative Delirium within 5 days after surgery in elderly patients receiving Transauricular vagal nerve stimulationThe 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
Detailed Description:
This study aims to conduct a prospective randomized controlled clinical trial on the preventive use of Transauricular vagal nerve stimulation to improve the incidence of Postoperative Delirium 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 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None