Transauricular Vagal Nerve Stimulation Improves Postoperative Delirium in Elderly Patients (Vnstar-IIa)

Safety and Feasibility of Transauricular Vagus Nerve Stimulation in Improving Postoperative Delirium in Elderly Patients: a Randomized Controlled Study

To investigate the efficacy and safety of perioperative Transauricular vagal nerve stimulation in improving Postoperative Delirium in elderly patients undergoing elective surgery Lay the groundwork for a Phase III study.

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(taVNS) to improve the incidence of Postoperative Delirium(POD) 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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• 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 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: Transauricular Vagal Nerve Stimulation	Device: Transauricular Vagal Nerve Stimulation; Transauricular vagal nerve stimulation，Intervention group25Hz，Control group1Hz
Sham Comparator: Transauricular Vagal Nerve sham Stimulation	Device: Transauricular Vagal Nerve Stimulation; Transauricular vagal nerve stimulation，Intervention group25Hz，Control group1Hz

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TaVNS tolerance	The proportion of subjects who completed all the expected interventions	1-5 days after surgery
Incidence of adverse events	Myocardial infarction, cardiac arrest, pulmonary embolism, infection, etc	At discharge，an average of 2 weeks

Secondary 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
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
Postoperative pain	VAS score	1-5 days after surgery
Time of anesthesia recovery		Within 2 hours after the end of the surgery

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2024
• Primary Completion (Estimated): December 31, 2024
• 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): July 3, 2024
• Last Update Submitted That Met QC Criteria: June 30, 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: VNS20240510IIa

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