Transauricular Vagal Nerve Stimulation Improves Postoperative Delirium in Elderly Patients (Vnstar-IIa)

Capital Medical University

Status: Enrolling

Conditions: Vagus Nerve Stimulation

Treatments: Device: Transauricular Vagal Nerve Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06421090

VNS20240510IIa

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

150 participants in 2 patient groups

Transauricular Vagal Nerve Stimulation

Active Comparator group

Treatment:

Device: Transauricular Vagal Nerve Stimulation

Transauricular Vagal Nerve sham Stimulation

Sham Comparator group

Treatment:

Device: Transauricular Vagal Nerve Stimulation