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

N/ANot Yet RecruitingNCT07476742

Chinese PLA General Hospital270 enrolled

Overview

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.

Cardiac surgery is associated with a high risk of postoperative neurocognitive disorders, including delirium and negative emotional states such as anxiety and depression, which significantly impact patient recovery and long-term outcomes. This study aims to evaluate whether intraoperative taVNS, a non-invasive neuromodulation technique, can reduce the incidence and severity of these complications. Patients will be randomized to receive either active taVNS or sham stimulation during surgery. Outcomes including delirium, anxiety, depression, pain, sleep quality, recovery quality, and relevant biomarkers will be assessed postoperatively.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

270

Conditions

Postoperative Delirium (POD)Postoperative Anxiety

Interventions

Active taVNSDEVICE

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.

Sham taVNS GroupDEVICE

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).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Outcomes

Primary Outcomes

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.

Time frame: Within 7 days after surgery

Secondary Outcomes

Incidence and Severity of Postoperative Depression

Postoperative Anxiety Incidence and Severity: HADS-D (Hospital Anxiety and Depression Scale - Anxiety Subscale) Score.Higher score indicates greater depression severity. A score ≥ 8 is considered clinically significant for depression (per standard cutoff).

Time frame: Preoperative day, Postoperative day 1, 2, 3, 7, and 30

Incidence and Severity of Postoperative Anxiety

Postoperative Anxiety Incidence and Severity: HADS-A (Hospital Anxiety and Depression Scale - Anxiety Subscale) Score. Higher score indicates greater anxiety severity. A score ≥ 8 is considered clinically significant for anxiety (per standard cutoff).

Time frame: Preoperative day, Postoperative day 1, 2, 3, 7, and 30

Incidence and Severity of Postoperative Depression

Assessed using Hamilton Depression Rating Scale (HAMD-17). Scores above standard cut-offs indicate depressive states.

Time frame: Preoperative day, Postoperative day 1, 2, 3, 7, and 30

Incidence and Severity of Postoperative Anxiety (HADS-A)

Assessed using the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A) at specified time points. Scores above standard cut-offs indicate anxiety states.

Time frame: Preoperative day, Postoperative day 1, 2, 3, 7, and 30

Postoperative Agitation Score

Assessed using the Riker Sedation-Agitation Scale (SAS) at the time of extubation.

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

Postoperative Nausea and Vomiting (PONV)

Assessed using a Visual Analogue Scale (VAS, 0-10) within 3 days after extubation.

Time frame: Within 3 days after extubation

Postoperative Pain Score

Assessed using the Numerical Rating Scale (NRS, 0-10).

Time frame: Postoperative day 1, 2, 3, 7, and 30

Postoperative Sleep Quality

Assessed using the Insomnia Severity Index (ISI, score 0-28).

Time frame: Postoperative day 1, 2, 3, 7, and 30

Postoperative Recovery Quality

Assessed using the Quality of Recovery-15 or QoR-40 scale.

Time frame: Postoperative day 7 and 30

Incidence and Severity of Postoperative Anxiety (GAD-7)

Assessed using the Generalized Anxiety Disorder-7 (GAD-7) at specified time points. Scores above standard cut-offs indicate anxiety states.

Time frame: Preoperative day, Postoperative day 1, 2, 3, 7, and 30

Incidence and Severity of Postoperative Anxiety (SAS)

Assessed using the Self-Rating Anxiety Scale (SAS) at specified time points. Scores above standard cut-offs indicate anxiety states.

Time frame: Preoperative day, Postoperative day 1, 2, 3, 7, and 30

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes