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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Vagus Nerve Stimulation
• Intervention / Treatment: Device: transauricular auricular vagus nerve stimulation

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 Type: Interventional
• Enrollment (Estimated): 1776
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ruquan Han, MD; Phone Number: 8610-59976660; Email: ruquan.han@ccmu.edu.cn

Study Locations

• China
  • Beijing, China, 100070
    • Recruiting
    • Beijing Tiantan Hospital, Capital Medical University
    • Contact: Ruquan Han, M.D., Ph.D; Phone Number: 8610-59976660; Email: ruquan.han@gmail.com
    • Contact: Ruquan Han, M.D., Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: taVNS with "standard-stimulation parameters"; with a current stimulation frequency of 25 Hz and a pulse width of 250 μs	Device: transauricular auricular vagus nerve stimulation; transauricular auricular vagus nerve stimulation
Sham Comparator: taVNS with "low-stimulation parameters"; with a current stimulation frequency of 1 Hz and a pulse width of 250 μs.	Device: transauricular auricular vagus nerve stimulation; transauricular auricular vagus nerve stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality		on the 90 days
Incidence of unplanned ICU or HDU admissions		on the 90 days
Length of hospital stay		on the 90 days
Incidence of delayed cognitive recovery during hospitalization	The MMSE/MoCA scale were used for evaluation	Day 1 before surgery, day 5 after surgery, day 90 after surgery
Incidence of neurocognitive dysfunction at 90 days postoperatively	assessed by AMTS scale	on the 90 days
Degree of decline in activities of daily living at 90 days postoperatively	use the IADL score	on the 90 days
Proportion of patients requiring higher levels of care postdischarge, specifically long-term care.		on the 90 days
Delirium severity	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	At discharge or within 5 days postoperatively

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: May 10, 2024
• First Submitted That Met QC Criteria: May 15, 2024
• First Posted (Actual): May 20, 2024

Study Record Updates

• Last Update Posted (Actual): April 25, 2025
• Last Update Submitted That Met QC Criteria: April 21, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Emergence Delirium; Delirium
• Other Study ID Numbers: VNS20240510

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No