Transcutaneous Auricular Vagus Nerve Stimulation Prevents Postoperative Delirium in Elderly Patients

NCT06421077 | Recruiting DMC

• 1 other identifier: VNS20240510
• Study Type: interventional
• Target: 1,776
• Locations: 1 country
• Sites: 1

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.

Conditions

Vagus Nerve Stimulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Incidence of delayed cognitive recovery during hospitalization

  Day 1 before surgery, day 5 after surgery, day 90 after surgery

• Incidence of neurocognitive dysfunction at 90 days postoperatively

  on the 90 days

• Degree of decline in activities of daily living at 90 days postoperatively

  on the 90 days

• All-cause mortality

  on the 90 days

• Incidence of unplanned ICU or HDU admissions

  on the 90 days

Study Arms (2)

taVNS with "standard-stimulation parameters"

ACTIVE COMPARATOR

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

Device: transauricular auricular vagus nerve stimulation

taVNS with "low-stimulation parameters"

SHAM COMPARATOR

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

Device: transauricular auricular vagus nerve stimulation

Interventions

transauricular auricular vagus nerve stimulation DEVICE

transauricular auricular vagus nerve stimulation

taVNS with "low-stimulation parameters"; taVNS with "standard-stimulation parameters"

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age≥65 years
• Expected operation time≥ 2 hours
• Postoperative hospital stay≥ 4 days
• Sign the informed consent form

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, 100070, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 40447430 DERIVED

Central Study Contacts

Ruquan Han, MD

CONTACT

8610-59976660; ruquan.han@ccmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: May 10, 2024
• First Posted: May 20, 2024
• Study Start: June 20, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 25, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)