Postoperative Delirium (POD), Postoperative, Anxiety, Depression, Cardiac Surgical Procedures
Conditions
Keywords
Transcutaneous Vagus Nerve Stimulation, Cardiac Surgery, Postoperative Delirium, Depression, Anxiety, Randomized Controlled Trial
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.
Detailed description
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.
Interventions
DEVICEActive taVNS
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.
DEVICESham taVNS Group
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).
Sponsors
Chinese PLA General Hospital
The Sixth Medical Center of Chinese PLA General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Postoperative Delirium | Within 7 days after surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and Severity of Postoperative Depression | Preoperative day, Postoperative day 1, 2, 3, 7, and 30 | 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 | Preoperative day, Postoperative day 1, 2, 3, 7, and 30 | 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 Anxiety (HADS-A) | Preoperative day, Postoperative day 1, 2, 3, 7, and 30 | 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 Agitation Score | At the time of extubation (within 24 hours post-surgery) | Assessed using the Riker Sedation-Agitation Scale (SAS) at the time of extubation. |
| Postoperative Nausea and Vomiting (PONV) | Within 3 days after extubation | Assessed using a Visual Analogue Scale (VAS, 0-10) within 3 days after extubation. |
| Postoperative Pain Score | Postoperative day 1, 2, 3, 7, and 30 | Assessed using the Numerical Rating Scale (NRS, 0-10). |
| Postoperative Sleep Quality | Postoperative day 1, 2, 3, 7, and 30 | Assessed using the Insomnia Severity Index (ISI, score 0-28). |
| Postoperative Recovery Quality | Postoperative day 7 and 30 | Assessed using the Quality of Recovery-15 or QoR-40 scale. |
| Incidence and Severity of Postoperative Anxiety (GAD-7) | Preoperative day, Postoperative day 1, 2, 3, 7, and 30 | Assessed using the Generalized Anxiety Disorder-7 (GAD-7) at specified time points. Scores above standard cut-offs indicate anxiety states. |
| Incidence and Severity of Postoperative Anxiety (SAS) | Preoperative day, Postoperative day 1, 2, 3, 7, and 30 | Assessed using the Self-Rating Anxiety Scale (SAS) at specified time points. Scores above standard cut-offs indicate anxiety states. |
Countries
China
Outcome results
None listed