## Protocol Section
### Identification Module
**NCT ID:** NCT06421077

**Acronym:** Vnstar

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

**Official Title:** Transauricular Vagus Nerve Stimulation（taVNS）Improves Postoperative Delirium in Elderly Patients: a Randomized Controlled Study

#### Organization Study ID Info
**ID:** VNS20240510
#### 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:** 2025-12-31

**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:** 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.

**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.

### 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:** 1438

**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

**Name:** Transauricular Vagal Nerve Stimulation

**Type:** DEVICE

### Outcomes Module

#### Primary 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

#### Secondary Outcomes

**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

**Measure:** Incidence of unplanned ICU or HDU admissions

**Time Frame:** on the 90 days

**Measure:** Length of hospital stay

**Time Frame:** on the 90 days

**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

## 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
