## Protocol Section
### Identification Module
**NCT ID:** NCT06421090

**Acronym:** Vnstar-IIa

**Brief Title:** Transauricular Vagal Nerve Stimulation Improves Postoperative Delirium in Elderly Patients

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

#### Organization Study ID Info
**ID:** VNS20240510IIa
#### Organization
**Class:** OTHER
**Full Name:** Beijing Tiantan Hospital
### Status Module
#### Completion Date
**Date:** 2025-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-24

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-21

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Beijing Tiantan Hospital

#### Responsible Party

**Investigator Affiliation:** Beijing Tiantan Hospital

**Investigator Full Name:** Ruquan Han

**Investigator Title:** professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** 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:** 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 Module

**Conditions:**

- Vagus Nerve Stimulation

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 150

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Device: Transauricular Vagal Nerve Stimulation

**Label:** Transauricular Vagal Nerve Stimulation

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Intervention Names:**

- Device: Transauricular Vagal Nerve Stimulation

**Label:** Transauricular Vagal Nerve sham Stimulation

**Type:** SHAM_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Transauricular Vagal Nerve Stimulation

- Transauricular Vagal Nerve sham Stimulation

**Description:** Transauricular vagal nerve stimulation，Intervention group25Hz，Control group1Hz

**Name:** Transauricular Vagal Nerve Stimulation

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** The proportion of subjects who completed all the expected interventions

**Measure:** TaVNS tolerance

**Time Frame:** 1-5 days after surgery

**Description:** Myocardial infarction, cardiac arrest, pulmonary embolism, infection, etc

**Measure:** Incidence of adverse events

**Time Frame:** At discharge，an average of 2 weeks

#### Secondary Outcomes

**Description:** POD assessment was performed using the 3D-CAM scale estimate. Assessed 2 times daily until postoperative day 5 or hospital discharge.

**Measure:** Incidence of POD at discharge or within 5 days postoperatively

**Time Frame:** At discharge or within 5 days postoperatively

**Description:** The MMSE scale and MoCA scale was used for evaluation

**Measure:** Incidence of cognitive decline

**Time Frame:** Day 1 before surgery, day 5 after surgery, day 90 after surgery

**Measure:** All-cause mortality

**Time Frame:** on the 90 days

**Description:** VAS score

**Measure:** Postoperative pain

**Time Frame:** 1-5 days after surgery

**Measure:** Time of anesthesia recovery

**Time Frame:** Within 2 hours after the end of the surgery

### Eligibility Module

**Eligibility Criteria:** 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

**Minimum Age:** 65 Years

**Sex:** ALL

**Standard Ages:**

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** ruquan.han@ccmu.edu.cn

**Name:** Ruquan Han, MD

**Phone:** 8610-59976660

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Beijing

**Contacts:**

***Contact 1:***

- **Email:** ruquan.han@gmail.com

- **Name:** Ruquan Han, M.D., Ph.D

- **Phone:** 8610-59976660

- **Role:** CONTACT

***Contact 2:***

- **Name:** Ruquan Han, M.D., Ph.D

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** China

**Facility:** Beijing Tiantan Hospital, Capital Medical University

**Status:** RECRUITING

**Zip:** 100070

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000003221

- Term: Confusion

- ID: D000019954

- Term: Neurobehavioral Manifestations

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000019965

- Term: Neurocognitive Disorders

- ID: D000001523

- Term: Mental Disorders

- ID: D000011183

- Term: Postoperative Complications

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M6894

- Name: Delirium

- Relevance: HIGH

- As Found: Delirium

- ID: M772

- Name: Emergence Delirium

- Relevance: HIGH

- As Found: Postoperative Delirium

- ID: M6446

- Name: Confusion

- Relevance: LOW

- As Found: Unknown

- ID: M21826

- Name: Neurobehavioral Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M21836

- Name: Neurocognitive Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14065

- Name: Postoperative Complications

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003693

- Term: Delirium

- ID: D000071257

- Term: Emergence Delirium

### Misc Info Module

- Version Holder: 2024-05-31
