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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06421077
Other study ID # VNS20240510
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 21, 2024
Est. completion date December 31, 2025

Study information

Verified date May 2024
Source Beijing Tiantan Hospital
Contact Ruquan Han, MD
Phone 8610-59976660
Email ruquan.han@ccmu.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 stimulation.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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1438
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - Age=65 years - Expected operation time= 2 hours - Postoperative hospital stay= 4 days - Sign the informed consent form Exclusion Criteria: - Neurosurgery or cardiac surgery - Emergency surgery within 6 hours of admission - End-stage disease with an expected survival of < 3 months - Preoperative intention cognitive impairment - Severe sinus bradycardia, AVB of degree II and above, pacemaker placement

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Transauricular Vagal Nerve Stimulation
Transauricular vagal nerve stimulation

Locations

Country Name City State
China Beijing Tiantan Hospital, Capital Medical University Beijing

Sponsors (1)

Lead Sponsor Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 At discharge or within 5 days postoperatively
Secondary Incidence of cognitive decline The MMSE scale and MoCA scale was used for evaluation Day 1 before surgery, day 5 after surgery, day 90 after surgery
Secondary All-cause mortality on the 90 days
Secondary Incidence of unplanned ICU or HDU admissions on the 90 days
Secondary Length of hospital stay on the 90 days
Secondary Time of anesthesia recovery Within 2 hours after the end of the surgery
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