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| Name | Class |
|---|---|
| Navy General Hospital, Beijing | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active taVNS Group | Experimental | Patients receiving active transcutaneous auricular vagus nerve stimulation during surgery. |
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| Sham taVNS Group | Sham Comparator | Patients receiving sham (placebo) stimulation with an identical device during surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Preoperative day, Postoperative day 1, 2, 3, 7, and 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Quality of Life | Assessed using the EQ-5D-5L scale. | Postoperative day 7 and 30 |
| Postoperative Complications | Incidence of complications such as respiratory failure, stroke, acute kidney injury, etc. |
Inclusion Criteria:
Exclusion Criteria:
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Medical Center of Chinese PLA General Hospital, Beijing, China. | Beijing | China |
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| 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). |
|
| 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). | 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. | 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. | 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. | 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. | Within 3 days after extubation |
| Postoperative Pain Score | Assessed using the Numerical Rating Scale (NRS, 0-10). | Postoperative day 1, 2, 3, 7, and 30 |
| Postoperative Sleep Quality | Assessed using the Insomnia Severity Index (ISI, score 0-28). | Postoperative day 1, 2, 3, 7, and 30 |
| Postoperative Recovery Quality | Assessed using the Quality of Recovery-15 or QoR-40 scale. | 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. | 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. | Preoperative day, Postoperative day 1, 2, 3, 7, and 30 |
| From surgery completion to hospital discharge or up to 30 days postoperatively |
| Length of Hospital Stay | 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. |
| CRP | Perioperative Serum Biomarker: C-Reactive Protein (CRP) Levels | Preoperative day, end of surgery, postoperative day 1 |
| Arterial Blood Pressure | Perioperative Arterial Blood Pressure | Perioperative period |
| Perioperative Electroencephalogram (EEG) Data | Including Ai (0-100), EMG index, BSR, SEF95, α/β/γ band power. | Intraoperative period |
| Adverse Events Related to taVNS | Including skin reactions, dizziness, nausea, etc. | From stimulation start to postoperative day 3 |
| IL-6 | Interleukin-6 (IL-6) Levels | Preoperative day, end of surgery, postoperative day 1 |
| S100β | S100β Protein Levels | Preoperative day, end of surgery, postoperative day 1 |
| BDNF | Brain-Derived Neurotrophic Factor (BDNF) Levels | Preoperative day, end of surgery, postoperative day 1 |
| IL-10 | Interleukin-10 (IL-10) Levels | Preoperative day, end of surgery, postoperative day 1 |
| Heart Rate | Perioperative Heart Rate | Perioperative period |
| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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