Transcutaneous Auricular Vagus Nerve Stimulation Prevents Postoperative Delirium in Elderly Patients

Official title

Transcutaneous Auricular Vagus Nerve Stimulation （taVNS）Prevents Postoperative Delirium in Elderly Patients: a Randomized Controlled Study

Overview

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.

Interventions

• Device transauricular auricular vagus nerve stimulation
  transauricular auricular vagus nerve stimulation

Primary outcome measures

• Incidence of POD at discharge or within 5 days postoperatively [Time frame: At discharge or within 5 days postoperatively]

Secondary outcome measures (8)

• Incidence of delayed cognitive recovery during hospitalization [Time frame: Day 1 before surgery, day 5 after surgery, day 90 after surgery]
• Incidence of neurocognitive dysfunction at 90 days postoperatively [Time frame: on the 90 days]
• Degree of decline in activities of daily living at 90 days postoperatively [Time frame: on the 90 days]
• All-cause mortality [Time frame: on the 90 days]
• Incidence of unplanned ICU or HDU admissions [Time frame: on the 90 days]
• Proportion of patients requiring higher levels of care postdischarge, specifically long-term care. [Time frame: on the 90 days]
• Length of hospital stay [Time frame: on the 90 days]
• Delirium severity [Time frame: At discharge or within 5 days postoperatively]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Prevention

Study locations

China · 1 center

• Beijing Tiantan Hospital, Capital Medical University — Beijing

Publications

• 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

Identifiers

NCT: NCT06421077 · VNS20240510

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗