Transcutaneous Auricular Vagus Nerve Stimulation Prevents Postoperative Delirium in Elderly Patients

Not Applicable

Recruiting

• Conditions: Vagus Nerve Stimulation
• Interventions: Device: Transauricular Vagal Nerve Stimulation

• Registration Number: NCT06421077
• Lead Sponsor: Beijing Tiantan Hospital

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.

Study Timeline

• Study First Submitted: 2024-05-10
• Study First Submitted QC: 2024-05-15
• Study First Posted: 2024-05-20
• Study Start: 2024-06-20
• Status Verified: 2025-01
• Last Update Submitted: 2025-04-21
• Last Update Posted: 2025-04-25
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1776

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transauricular Vagal Nerve Stimulation	Transauricular Vagal Nerve Stimulation	-
Transauricular Vagal Nerve sham Stimulation	Transauricular Vagal Nerve Stimulation	-

Primary Outcome Measures

Name	Time	Method
Incidence of POD at discharge or within 5 days postoperatively	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

Secondary Outcome Measures

Name	Time	Method
Incidence of delayed cognitive recovery during hospitalization	Day 1 before surgery, day 5 after surgery, day 90 after surgery	The MMSE/MoCA scale were used for evaluation
Incidence of neurocognitive dysfunction at 90 days postoperatively	on the 90 days	assessed by AMTS scale
Degree of decline in activities of daily living at 90 days postoperatively	on the 90 days	use the IADL score
All-cause mortality	on the 90 days
Incidence of unplanned ICU or HDU admissions	on the 90 days
Proportion of patients requiring higher levels of care postdischarge, specifically long-term care.	on the 90 days
Length of hospital stay	on the 90 days
Delirium severity	At discharge or within 5 days postoperatively	Delirium severity was assessed via the 3D-CAM-S scale. 3D-CAM-S scale: The total score is 7, with 0 being normal, 1 being mild delirium, 2 being moderate delirium, and 3-7 being severe delirium

Trial Locations

Locations (1)

Beijing Tiantan Hospital, Capital Medical University; 🇨🇳 Beijing, China