Noncardiac Surgery, Quality of Recovery, Transcutaneous Electric Nerve Stimulation, Vagus Nerve Stimulation
Conditions
Keywords
Transcutaneous auricular vagus nerve stimulation, Noncardiac surgery, Quality of recovery
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.
Interventions
DEVICETranscutaneous auricular vagus nerve stimulation
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.
DEVICESham stimulation
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.
Sponsors
Peking University First Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Aged ≥18 years but \<85 years. 2. Scheduled for elective or limited-time noncardiac surgery with expected duration ≥2 hours.
Exclusion criteria
1. Lesions or infections of the auricle skin. 2. Recent or long-term use of cholinergic or anticholinergic medications. 3. Neurosurgery. 4. Expected mechanical ventilation with intubation for ≥1 day after surgery. 5. Diagnosed schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis before surgery. 6. 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. 7. Inability to communicate due to coma, severe dementia, or language barrier before surgery, or unable to cooperate with intervention. 8. American Society of Anesthesiologists physical status grade \>IV, or estimated survival \<24 hours.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of recovery scores at 24 hours after surgery | 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
| Measure | Time frame | Description |
|---|---|---|
| Quality of recovery scores at 48 and 72 hours after surgery | 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). |
| Pain intensity both at rest and with movement after surgery | 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. |
| Subjective sleep quality after surgery | 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. |
| Opioid consumption within 3 days after surgery | Up to 3 days after surgery. | Opioid consumption is converted to intravenous sufentanil equivalent. |
| Pain intensity and opioid consumption (PIOC) index within 3 days after surgery. | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time to first flatus and defecation after surgery | Up to 30 days after surgery. | Time to first flatus and defecation after surgery. |
| Heart rate variability (HRV) before and after each intervention. | 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. |
| All-cause mortality after surgery | Up to 30 days after surgery. | Death within 30 days after surgery from all causes. |
| Incidence of postoperative complications | 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. |
| Depression after surgery | 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. |
| Anxiety after surgery | 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. |
| Incidence of postoperative nausea and vomiting | Up to 3 days after surgery. | Occurrence of postoperative nausea and vomiting and use of antiemetic drugs within 3 days after surgery. |
| Length of stay in postanesthesia care unit (PACU) after surgery. | Up to 2 hours after surgery. | Time interval from PACU admission to PACU discharge after surgery. |
| Length of stay in hospital after surgery | Up to 30 days after surgery. | Length of stay in hospital after surgery. |
Countries
China
Contacts
Primary ContactDong-Xin Wang, MD, PhD
Backup ContactHong Hong, MD
Outcome results
None listed