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Not yet recruiting NCT07476742

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

No phase Interventional Postoperative Delirium (POD) Postoperative Anxiety Depression

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Active taVNS, Sham taVNS Group.
Who it may be relevant to
Registry conditions: Postoperative Delirium (POD), Postoperative, Anxiety, Depression. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Effect of Intraoperative Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Delirium and Negative Emotional States in Patients Undergoing Cardiac Surgery: A Multicenter, Randomized, Double-Blind, Sham-Controlled Trial

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.

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

  • Device Active 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.
  • Device Sham 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).

Primary outcome measures

  • Incidence of Postoperative Delirium [Time frame: Within 7 days after surgery]
Secondary outcome measures (11)
  • Incidence and Severity of Postoperative Depression [Time frame: Preoperative day, Postoperative day 1, 2, 3, 7, and 30]
  • Incidence and Severity of Postoperative Anxiety [Time frame: Preoperative day, Postoperative day 1, 2, 3, 7, and 30]
  • Incidence and Severity of Postoperative Depression [Time frame: Preoperative day, Postoperative day 1, 2, 3, 7, and 30]
  • Incidence and Severity of Postoperative Anxiety (HADS-A) [Time frame: Preoperative day, Postoperative day 1, 2, 3, 7, and 30]
  • Postoperative Agitation Score [Time frame: At the time of extubation (within 24 hours post-surgery)]
  • Postoperative Nausea and Vomiting (PONV) [Time frame: Within 3 days after extubation]
  • Postoperative Pain Score [Time frame: Postoperative day 1, 2, 3, 7, and 30]
  • Postoperative Sleep Quality [Time frame: Postoperative day 1, 2, 3, 7, and 30]
  • Postoperative Recovery Quality [Time frame: Postoperative day 7 and 30]
  • Incidence and Severity of Postoperative Anxiety (GAD-7) [Time frame: Preoperative day, Postoperative day 1, 2, 3, 7, and 30]
  • Incidence and Severity of Postoperative Anxiety (SAS) [Time frame: Preoperative day, Postoperative day 1, 2, 3, 7, and 30]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • First Medical Center of Chinese PLA General Hospital, Beijing, China. — Beijing

Identifiers

NCT: NCT07476742 · PLAGH-RCT-taVNS-Cardiac

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗