Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Quality of Recovery After Major Noncardiac Surgery: A Randomized Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 320
- Locations
- 1
- Primary Endpoint
- Quality of recovery scores at 24 hours after surgery
Study Overview
Brief Summary
Transcutaneous auricular vagus nerve stimulation (taVNS) is a novel non-invasive neuromodulation technique. Existing evidence suggested that taVNS improves pain management, sleep quality, inflammatory responses, and gastrointestinal recovery after surgery. This study is designed to test the hypothesis that perioperative use of taVNS may improve quality of recovery in patients after major noncardiac surgery.
Detailed Description
The evolution of quality improvement initiatives, such as Enhanced Recovery After Surgery (ERAS) protocols, has shifted perioperative management paradigms toward prioritizing patient-centered subjective experiences such as quality of recovery over traditional outcomes such as mortality, morbidity, or physiological parameter recovery. Poor quality of recovery after surgery not only diminishes patient satisfaction but also correlates with increased 30-day postoperative complications, prolonged hospital stays, and elevated medical expenses.
The vagus nerve is a major component of the parasympathetic nervous system and is a critical relay for neuro-metabolic signals between the abdominal viscera and the brain. The ear is the only area where the vagus nerve is distributed on the body surface, and the auricular branch of the vagus nerve can project to nerve centers such as nucleus of solitary tract in the brainstem and the nucleus coeruleus in the midbrain.
Transcutaneous auricular vagus nerve stimulation (taVNS) can stimulate the auricular branch of the vagus nerve through surface electrodes located in the cymba conchae, and thus activate the vagus nerve circuit, regulate the activity of the brainstem, thalamus, and other brain regions, and regulate the related peripheral organs. Available evidences showed that taVNS reduces inflammatory response to surgery through cholinergic anti-inflammatory pathways, improves analgesia by reducing inflammation and activating serotonin and endorphins analgesic pathways, and promotes gastrointestinal function by regulating peristalsis and secretion of the digestive system; it was also found effective in improving sleep quality and relieving anxiolytic and depressive symptoms. The use of taVNS is relative safe; the incidence of adverse event is low and mainly included transient earache, headache, and local tingling, with no causal association to serious adverse events.
The investigators hypothesize that the application of taVNS in patients undergoing major noncardiac surgery may improve early postoperative quality of recovery.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Aged ≥18 years but <85 years.
- •Scheduled for elective or limited-time noncardiac surgery with expected duration ≥2 hours.
Exclusion Criteria
- •Lesions or infections of the auricle skin.
- •Recent or long-term use of cholinergic or anticholinergic medications.
- •Neurosurgery.
- •Expected mechanical ventilation with intubation for ≥1 day after surgery.
- •Diagnosed schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis before surgery.
- •Preoperative left ventricular ejection fraction (LVEF) <30%, or those with sick sinus syndrome, sinus bradycardia (heart rate <50 beats per minute), atrioventricular block of grade II or above, or implanted pacemaker.
- •Inability to communicate due to coma, severe dementia, or language barrier before surgery, or unable to cooperate with intervention.
- •American Society of Anesthesiologists physical status grade >IV, or estimated survival <24 hours.
Arms & Interventions
Transcutaneous auricular vagus nerve stimulation group
Transcutaneous auricular vagus nerve stimulation
Intervention: Transcutaneous auricular vagus nerve stimulation (Device)
Sham stimulation group
Sham stimulation
Intervention: Sham stimulation (Device)
Outcomes
Primary Outcomes
Quality of recovery scores at 24 hours after surgery
Time Frame: At 24 hours after surgery
Quality of recovery is assessed using the 15-item Quality of Recovery (QoR-15) Scale. The QoR-15 is a valid, reliable, responsive, and simple-to-use measure that can be applied across a broad range of surgical settings. The scale contains 15 questions that measure five dimensions of patient's health, including: physical comfort, emotional state, physical independence, psychological support, and pain, with scores ranging from 0 (the poorest quality of recovery) to 150 (the best quality of recovery).
Secondary Outcomes
- Quality of recovery scores at 48 and 72 hours after surgery(At 48 and 72 hours after surgery)
- Pain intensity both at rest and with movement after surgery(Up to 3 days after surgery.)
- Subjective sleep quality after surgery(Up to 3 days after surgery.)
- Opioid consumption within 3 days after surgery(Up to 3 days after surgery.)
- Pain intensity and opioid consumption (PIOC) index within 3 days after surgery.(Up to 3 days after surgery.)
Investigators
Dong-Xin Wang
Professor and Chairman, Department of Anesthesiology
Peking University First Hospital