Transcutaneous Auricular Vagus Nerve Stimulation Prevents Postoperative Delirium in Elderly Patients (Vnstar)

Capital Medical University

Status: Enrolling

Conditions: Vagus Nerve Stimulation

Treatments: Device: transauricular auricular vagus nerve stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06421077

VNS20240510

Details and patient eligibility

About

According to the 3D-CAM scale, evaluate the incidence of Postoperative Delirium within 5 days after surgery in elderly patients receiving taVNS.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.

Full description

This study aims to conduct a prospective, randomized controlled clinical trial on the preventive use of taVNS to improve the incidence of Postoperative Delirium(POD) in elderly patients undergoing anesthesia surgery. The intervention group will receive "standard-stimulation parameters" of taVNS（25HZ，250μs）, while the control group will receive "low-stimulation parameters" of taVNS(1HZ,250μs). 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.

Enrollment: 1,776 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

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1,776 participants in 2 patient groups

taVNS with "standard-stimulation parameters"

Active Comparator group

Description:

with a current stimulation frequency of 25 Hz and a pulse width of 250 μs

Treatment:

Device: transauricular auricular vagus nerve stimulation

taVNS with "low-stimulation parameters"

Sham Comparator group

Description:

with a current stimulation frequency of 1 Hz and a pulse width of 250 μs.

Treatment:

Device: transauricular auricular vagus nerve stimulation