Transauricular Vagal Nerve Stimulation Improves Postoperative Delirium in Elderly Patients

Not Applicable

Recruiting

• Conditions: Vagus Nerve Stimulation
• Interventions: Device: Transauricular Vagal Nerve Stimulation

• Registration Number: NCT06421090
• Lead Sponsor: Beijing Tiantan Hospital

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-10
• Study First Submitted QC: 2024-05-15
• Study First Posted: 2024-05-20
• Study Start: 2024-05-21
• Last Update Submitted: 2024-06-30
• Last Update Posted: 2024-07-03
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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 severe cognitive dysfunction affected perioperative cognitive function assessment
• Severe sinus bradycardia, AVB of degree II and above, pacemaker placement

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transauricular Vagal Nerve Stimulation	Transauricular Vagal Nerve Stimulation	-
Transauricular Vagal Nerve sham Stimulation	Transauricular Vagal Nerve Stimulation	-

Primary Outcome Measures

Name	Time	Method
TaVNS tolerance	1-5 days after surgery	The proportion of subjects who completed all the expected interventions
Incidence of adverse events	At discharge，an average of 2 weeks	Myocardial infarction, cardiac arrest, pulmonary embolism, infection, etc

Secondary Outcome Measures

Name	Time	Method
Incidence of POD at discharge or within 5 days postoperatively	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.
All-cause mortality	on the 90 days
Postoperative pain	1-5 days after surgery	VAS score
Incidence of cognitive decline	Day 1 before surgery, day 5 after surgery, day 90 after surgery	The MMSE scale and MoCA scale was used for evaluation
Time of anesthesia recovery	Within 2 hours after the end of the surgery

Trial Locations

Locations (1)

Beijing Tiantan Hospital, Capital Medical University; 🇨🇳 Beijing, China