Transauricular Vagus Nerve Stimulation Improves Postoperative Delirium in Elderly Patients (Vnstar)

Transauricular Vagus Nerve Stimulation（taVNS）Improves 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 Transauricular vagal nerve stimulation.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 Vagal Nerve Stimulation

Detailed Description

This study aims to conduct a prospective, randomized controlled clinical trial on the preventive use of Transauricular vagal nerve stimulation to improve the incidence of Postoperative Delirium in elderly patients undergoing anesthesia surgery. The intervention group will receive taVNS, while the control group will only wear a taVNS stimulator without current stimulation. 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): 1438
• 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
    • Principal Investigator: 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 intention cognitive impairment
• 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: Transauricular Vagal Nerve Stimulation	Device: Transauricular Vagal Nerve Stimulation; Transauricular vagal nerve stimulation
Sham Comparator: Transauricular Vagal Nerve sham Stimulation	Device: Transauricular Vagal Nerve Stimulation; Transauricular vagal 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
Incidence of cognitive decline	The MMSE scale and MoCA scale was used for evaluation	Day 1 before surgery, day 5 after surgery, day 90 after surgery
All-cause mortality		on the 90 days
Time of anesthesia recovery		Within 2 hours after the end of the surgery
Incidence of unplanned ICU or HDU admissions		on the 90 days
Length of hospital stay		on the 90 days

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 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): May 28, 2024
• Last Update Submitted That Met QC Criteria: May 24, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No