Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
Location status: Recruiting
NCT Number: NCT06957912
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.
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Request Info18 year–85 year
All sexes
Interventional
Not applicable
Beijing, Beijing Municipality, 100034, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Transcutaneous auricular vagus nerve stimulation is performed using earphone-shaped stimulators (tVNS501, Ruishenan Medical Device, Inc. JiangSu, China) on the left tragus areas of the outer ear for a total of 30 min. Using parameters we have identified through systematic review, electrical stimulation (pulse width: 200-300 μs; frequency: 25 Hz; duty cycles: 50%) is initiated at 200% perceptual threshold (PT) which means the minimum amount of electricity required to perceive electrical stimulation on the skin described as a pricking or tingling sensation. All conscious patients will be told they may or may not feel any sensation from the stimulation.
The stimulation will be performed between 15:00 and 17:00 on the first day before surgery, at least 30 minutes before the start of surgery and between 08:00 and 10:00 on the first to third day after surgery.
Other names: taVNS
Sham stimulation is performed using earphone-shaped stimulators (tVNS501, Ruishenan Medical Device, Inc. JiangSu, China) on the left tragus areas of the outer ear for a total of 30 min. Using parameters we have identified through systematic review, electrical stimulation (pulse width: 200-300 μs; frequency: 25 Hz; duty cycles: 50%) is initiated at 200% perceptual threshold (PT) which means the minimum amount of electricity required to perceive electrical stimulation on the skin described as a pricking or tingling sensation. And the current will be automatically switched off after 15 s. All conscious patients will be told they may or may not feel any sensation from the stimulation. The stimulation will be performed between 15:00 and 17:00 on the first day before surgery, at least 30 minutes before the start of surgery and between 08:00 and 10:00 on the first to third day 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).
Time frame: At 48 and 72 hours after surgery
Quality of recovery is assessed using the 15-item Quality of Recovery (QoR-15) Scale. 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).
Time frame: Up to 3 days after surgery.
Pain intensity is assessed with a numerical rating scale (NRS, an 11-point scale where 0=no pain and 10=the worst pain) twice daily (8:00-10:00 am, 18:00-20:00 pm) after surgery.
Time frame: Up to 3 days after surgery.
Subjective sleep quality is assessed with a numerical rating scale (NRS, an 11-point scale where 0=the best sleep and 10=the worst sleep) daily (8:00-10:00 am) after surgery.
Time frame: Up to 3 days after surgery.
Opioid consumption is converted to intravenous sufentanil equivalent.
Time frame: Up to 3 days after surgery.
Pain intensity is calculated as area under curve (AUC) of NRS pain score within 3 days after surgery. Opioid consumption (OC) within 3 days after surgery is summarized. Pain intensity and opioid consumption (PIOC) index is calculated as: PIOC=[(AUCmean rank - AUCrank)/AUCmean rank] + [(OCmean rank - OCrank)/OCmean rank]. The range of the sum is from -200% to +200%. Values above 0 indicate increased summed AUC and OC in comparison to all patients.
Time frame: Up to 3 days after surgery.
Heart rate (HR) is recorded via electrocardiographic (ECG) monitoring during a 50-min period of each intervention, i.e., a 10-min period before, a 30-min period during, and a 10-min period after (sham) intervention. Heart rate variability is calculated offline from analyses of RR intervals.
Time frame: On the 5th day or before hospital discharge after surgery.
Beck Depression Inventory-II scale (scores range from 0 to 63, with higher score indicating more severe depression) is used to assess the severity of depression.
Time frame: On the 5th day or before hospital discharge after surgery.
Beck Anxiety Inventory scale (scores range from 0 to 63, with higher score indicating more severe anxiety) is used to assess the severity of anxiety.
Time frame: Up to 3 days after surgery.
Occurrence of postoperative nausea and vomiting and use of antiemetic drugs within 3 days after surgery.
Time frame: Up to 2 hours after surgery.
Time interval from PACU admission to PACU discharge after surgery.
Time frame: Up to 30 days after surgery.
Length of stay in hospital after surgery.
Time frame: Up to 30 days after surgery.
Time to first flatus and defecation after surgery.
Time frame: Up to 30 days after surgery.
Postoperative complications are generally defined as new-onset conditions that have adverse effects on postoperative recovery and require therapeutic interventions.
Time frame: Up to 30 days after surgery.
Death within 30 days after surgery from all causes.
Contact information is provided by the study sponsor or research team.
Dong-Xin Wang, MD, PhD
CONTACT
Hong Hong, MD
CONTACT
Peking University First Hospital
Other
Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Quality of Recovery After Major Noncardiac Surgery: A Randomized Trial.
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