Transcutaneous Auricular Vagus Nerve Stimulation and Quality of Recovery After Major Noncardiac Surgery

Официальное название

Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Quality of Recovery After Major Noncardiac Surgery: A Randomized Trial.

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Transcutaneous 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 stimulati
• Устройство Sham 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 pr

Первичные конечные точки

• Quality of recovery scores at 24 hours after surgery [Срок оценки: At 24 hours after surgery]

Вторичные конечные точки (5)

• Quality of recovery scores at 48 and 72 hours after surgery [Срок оценки: At 48 and 72 hours after surgery]
• Pain intensity both at rest and with movement after surgery [Срок оценки: Up to 3 days after surgery.]
• Subjective sleep quality after surgery [Срок оценки: Up to 3 days after surgery.]
• Opioid consumption within 3 days after surgery [Срок оценки: Up to 3 days after surgery.]
• Pain intensity and opioid consumption (PIOC) index within 3 days after surgery. [Срок оценки: Up to 3 days after surgery.]

Критерии участия

Критерии включения

• Aged ≥18 years but <85 years.
• Scheduled for elective or limited-time noncardiac surgery with expected duration ≥2 hours.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• Peking University First Hospital — Пекин

Публикации

• Ljungqvist O, de Boer HD, Balfour A, Fawcett WJ, Lobo DN, Nelson G, Scott MJ, Wainwright TW, Demartines N. Opportunities and Challenges for the Next Phase of Enhanced Recovery After Surgery: A Review. JAMA Surg. 2021 Aug 1;156(8):775-784. doi: 10.1001/jamasurg.2021.0586. PMID 33881466
• Wessels E, Perrie H, Scribante J, Jooma Z. Quality of recovery in the perioperative setting: A narrative review. J Clin Anesth. 2022 Jun;78:110685. doi: 10.1016/j.jclinane.2022.110685. Epub 2022 Feb 18. PMID 35190342
• Campfort M, Cayla C, Lasocki S, Rineau E, Leger M. Early quality of recovery according to QoR-15 score is associated with one-month postoperative complications after elective surgery. J Clin Anesth. 2022 Jun;78:110638. doi: 10.1016/j.jclinane.2021.110638. Epub 2022 Jan 13. PMID 35033845
• Kleif J, Gogenur I. Severity classification of the quality of recovery-15 score-An observational study. J Surg Res. 2018 May;225:101-107. doi: 10.1016/j.jss.2017.12.040. Epub 2018 Feb 21. PMID 29605019
• Leger M, Campfort M, Cayla C, Lasocki S, Rineau E. Postoperative quality of recovery measurements as endpoints in comparative anaesthesia studies: a systematic review. Br J Anaesth. 2021 Jun;126(6):e210-e212. doi: 10.1016/j.bja.2021.03.008. Epub 2021 Apr 21. No abstract available. PMID 33892949
• Myles PS, Boney O, Botti M, Cyna AM, Gan TJ, Jensen MP, Kehlet H, Kurz A, De Oliveira GS Jr, Peyton P, Sessler DI, Tramer MR, Wu CL; StEP-COMPAC Group; Myles P, Grocott M, Biccard B, Blazeby J, Boney O, Chan M, Diouf E, Fleisher L, Kalkman C, Kurz A, Moonesinghe R, Wijeysundera D. Systematic review and consensus definitions for the Standardised Endpoints in Perioperative Medicine (StEP) initiative PMID 29576111
• Myles PS, Shulman MA, Reilly J, Kasza J, Romero L. Measurement of quality of recovery after surgery using the 15-item quality of recovery scale: a systematic review and meta-analysis. Br J Anaesth. 2022 Jun;128(6):1029-1039. doi: 10.1016/j.bja.2022.03.009. Epub 2022 Apr 14. PMID 35430086
• Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013 Jun;118(6):1332-40. doi: 10.1097/ALN.0b013e318289b84b. PMID 23411725

Идентификаторы

NCT: NCT06957912 · 2025-066

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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