Transauricular Vagal Nerve Stimulation Improves Postoperative Delirium in Elderly Patients

Vagus Nerve Stimulation Clinical Trial

— Vnstar-IIa  

Official title:

Safety and Feasibility of Transauricular Vagus Nerve Stimulation in Improving Postoperative Delirium in Elderly Patients: a Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06421090
• Other study ID #: VNS20240510IIa
• Status: Recruiting
• Phase: N/A
• 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
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• 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

Related Conditions & MeSH terms

• Delirium
• Emergence Delirium
• Vagus Nerve Stimulation

Intervention

Device:
• Transauricular Vagal Nerve Stimulation
Transauricular vagal nerve stimulation,Intervention group25Hz,Control group1Hz

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	TaVNS tolerance	The proportion of subjects who completed all the expected interventions	1-5 days after surgery
Primary	Incidence of adverse events	Myocardial infarction, cardiac arrest, pulmonary embolism, infection, etc	At discharge,an average of 2 weeks
Secondary	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	Postoperative pain	VAS score	1-5 days after surgery
Secondary	Time of anesthesia recovery		Within 2 hours after the end of the surgery