Transcutaneous Auricular Vagus Nerve Stimulation Prevents Postoperative Delirium in Elderly Patients

NCT ID: NCT06421077

Last Updated: 2025-04-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1776 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-20
• Study Completion Date: 2025-12-31

Brief Summary

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.

Detailed 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.

Conditions

Vagus Nerve Stimulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

taVNS with "standard-stimulation parameters"

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

Group Type: ACTIVE_COMPARATOR

transauricular auricular vagus nerve stimulation

Intervention Type: DEVICE

transauricular auricular vagus nerve stimulation

taVNS with "low-stimulation parameters"

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

Group Type: SHAM_COMPARATOR

transauricular auricular vagus nerve stimulation

Intervention Type: DEVICE

transauricular auricular vagus nerve stimulation

Interventions

transauricular auricular vagus nerve stimulation

transauricular auricular vagus nerve stimulation

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tiantan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ruquan Han

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beijing Tiantan Hospital, Capital Medical University

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Ruquan Han, MD

Role: CONTACT

ruquan.han@ccmu.edu.cn

8610-59976660

Facility Contacts

Ruquan Han, M.D., Ph.D

Role: primary

ruquan.han@gmail.com

8610-59976660

References

Wu Y, Hou X, Wang T, Wang X, Zhang K, Liang F, Jian M, Wang B, Liu H, Wang A, Han R. Transcutaneous auricular vagus nerve stimulation prevents postoperative delirium in elderly patients (VNSTAR): protocol for a multicentre, randomised controlled trial. BMJ Open. 2025 May 30;15(5):e099736. doi: 10.1136/bmjopen-2025-099736.

Reference Type: DERIVED

PMID: 40447430 (View on PubMed)

Other Identifiers

VNS20240510

Identifier Type: -

Identifier Source: org_study_id