Transauricular Vagal Nerve Stimulation Improves Postoperative Delirium in Elderly Patients

NCT ID: NCT06421090

Last Updated: 2024-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-21

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Vagus Nerve Stimulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Transauricular Vagal Nerve Stimulation

Group Type ACTIVE_COMPARATOR

Transauricular Vagal Nerve Stimulation

Intervention Type DEVICE

Transauricular vagal nerve stimulation,Intervention group25Hz,Control group1Hz

Transauricular Vagal Nerve sham Stimulation

Group Type SHAM_COMPARATOR

Transauricular Vagal Nerve Stimulation

Intervention Type DEVICE

Transauricular vagal nerve stimulation,Intervention group25Hz,Control group1Hz

Interventions

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Transauricular Vagal Nerve Stimulation

Transauricular vagal nerve stimulation,Intervention group25Hz,Control group1Hz

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Tiantan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ruquan Han

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beijing Tiantan Hospital, Capital Medical University

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ruquan Han, MD

Role: CONTACT

8610-59976660

Facility Contacts

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Ruquan Han, M.D., Ph.D

Role: primary

8610-59976660

Other Identifiers

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VNS20240510IIa

Identifier Type: -

Identifier Source: org_study_id

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