Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Delirium and Negative Emotions in Patients Undergoing Cardiac Surgery

NCT07476742 | Not Yet Recruiting

• 1 other identifier: PLAGH-RCT-taVNS-Cardiac
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

A multicenter, randomized, double-blind, sham-controlled trial to investigate the effects of intraoperative transcutaneous auricular vagus nerve stimulation (taVNS) on the incidence of postoperative delirium and negative emotional states (anxiety, depression) in patients undergoing elective cardiac surgery.

Conditions

Postoperative Delirium (POD); Postoperative; Anxiety; Depression; Cardiac Surgical Procedures

Keywords

Transcutaneous Vagus Nerve Stimulation; Cardiac Surgery; Postoperative Delirium; Depression; Anxiety; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Incidence of Postoperative Delirium

  Postoperative delirium will be assessed using the 3-Minute Diagnostic Interview for CAM (3D-CAM) for general ward patients and the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) for ICU patients, from postoperative day 1 to day 7. Diagnosis requires the presence of acute onset/fluctuating course and inattention, plus either disorganized thinking or altered level of consciousness.

  Within 7 days after surgery

Secondary Outcomes (11)

• Incidence and Severity of Postoperative Depression

  Preoperative day, Postoperative day 1, 2, 3, 7, and 30

• Incidence and Severity of Postoperative Anxiety

  Preoperative day, Postoperative day 1, 2, 3, 7, and 30

• Incidence and Severity of Postoperative Depression

  Preoperative day, Postoperative day 1, 2, 3, 7, and 30

• Incidence and Severity of Postoperative Anxiety (HADS-A)

  Preoperative day, Postoperative day 1, 2, 3, 7, and 30

• Postoperative Agitation Score

  At the time of extubation (within 24 hours post-surgery)

Other Outcomes (12)

• Postoperative Quality of Life

  Postoperative day 7 and 30

• Postoperative Complications

  From surgery completion to hospital discharge or up to 30 days postoperatively

• Length of Hospital Stay

  The duration is calculated from the date of admission (Day 0) until the date of discharge. The assessment period was censored at 100 days, meaning if patients were not discharged by then, they were considered censored at that point.

Study Arms (2)

Active taVNS Group

EXPERIMENTAL

Patients receiving active transcutaneous auricular vagus nerve stimulation during surgery.

Device: Active taVNS

Sham taVNS Group

SHAM COMPARATOR

Patients receiving sham (placebo) stimulation with an identical device during surgery.

Device: Sham taVNS Group

Interventions

Active taVNS DEVICE

Stimulation parameters: Amplitude 20 (mA), Frequency 20Hz, Pulse width 200μs, asymmetric biphasic square wave. The current is gradually increased from 10mA to a level slightly below the individual's "prickling" sensation threshold (20-60mA). Stimulation is applied to the left auricular concha for 30 minutes after anesthesia induction and for another 30 minutes after cardiopulmonary bypass weaning.

Active taVNS Group

Sham taVNS Group DEVICE

The sham device is identical in appearance, weight, indicator lights, and operation sounds to the active device but delivers no effective electrical current. It is applied to the left auricular concha at the same time points as the active group (30 minutes after induction and 30 minutes after CPB weaning).

Sham taVNS Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 to 85 years. Scheduled for elective cardiac surgery (e.g., CABG, valve replacement/repair). NYHA cardiac function class I-III. Willing and able to provide informed consent. Expected surgery duration ≥ 2 hours.

You may not qualify if:

• Preoperative MMSE score \< 24; severe communication barriers. History of diagnosed delirium, dementia, Parkinson's disease, schizophrenia, bipolar disorder, major depressive disorder, or long-term use of psychotropic drugs.
• Skin lesions, infection, or deformity of bilateral ears; history of ear surgery or nerve injury; allergy to electrode materials.
• Severe arrhythmia; implanted electronic devices (e.g., pacemaker, ICD). Participation in another interventional trial within 3 months. Other conditions deemed unsuitable by investigators.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead
• The Sixth Medical Center of Chinese PLA General Hospital: collaborator

Study Sites (1)

First Medical Center of Chinese PLA General Hospital, Beijing, China.

Beijing, China

Location

MeSH Terms

Conditions

Emergence Delirium; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director (Cheif expert of National key research and development program of China 2018YFC2001900)

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 17, 2026
• Study Start: February 28, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: March 17, 2026

Record last verified: 2026-03

Locations

CN (1)