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.
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.
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.
Parallel
Active taVNS
DeviceStimulation 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 Group
DeviceThe 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 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.
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).
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).
Incidence and Severity of Postoperative Depression
Assessed using Hamilton Depression Rating Scale (HAMD-17). Scores above standard cut-offs indicate depressive states.
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.
Postoperative Quality of Life
Assessed using the EQ-5D-5L scale.
Postoperative Complications
Incidence of complications such as respiratory failure, stroke, acute kidney injury, etc.
Length of Hospital Stay
Length of Hospital Stay
CRP
Perioperative Serum Biomarker: C-Reactive Protein (CRP) Levels
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Chinese PLA General Hospital
Lead sponsor
Navy General Hospital, Beijing
Collaborator
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