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Набор по приглашению NCT06759818

Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Myocardial Injury in Elderly Patients Undergoing Thoracoscopic Surgery: a Prospective, Randomized Controlled Study

Без фазы С лечением Myocardial Injury

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: transcutaneous vagus nerve stimulation, Sham stimulation group.
Кому может быть актуально
Состояния в реестре: Myocardial Injury. Базовые параметры: от 60 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

This research group plans to design a prospective, double-blind, randomized controlled study to explore the effect of taVNS on hs-cTnT in elderly patients undergoing thoracoscopic surgery, and to evaluate the effect on perioperative myocardial injury and postoperative analgesia during thoracoscopic surgery.

Подробное описание

A small number of studies based on transcutaneous auricular vagus nerve stimulation have shown that it has good therapeutic effects on patients with cardiovascular disease, and is simple to operate, with few complications and low risks. However, thoracic surgery is closer to the heart and has a higher incidence of perioperative myocardial injury. , and hs-cTnT has become a biomarker that predicts myocardial injury. This research group plans to design a prospective, double-blind, randomized controlled study to explore the effect of taVNS on hs-cTnT in elderly patients undergoing thoracoscopic surgery, and to evaluate the effect on perioperative myocardial injury and postoperative analgesia during thoracoscopic surgery.

Вмешательства

  • Устройство transcutaneous vagus nerve stimulation
    ①The first adjustment requires electrical stimulation to break through the skin barrier. The first intervention is the day before the operation. The initial electrical stimulation frequency is 30Hz and the pulse width is 300μs. The frequency and pulse width are adjusted according to the individual feelings of the subject until they are tolerated by the subject. Maximum current stimulation without discomfort and lasting for 30 minutes; ② second time For the intervention, the subject is connected
  • Устройство Sham stimulation group
    ① The first intervention is also the day before the operation. The frequency and pulse width are adjusted three times without turning on the machine, and the subject is asked if they have any feelings. After adjusting the frequency three times, no operation is performed for 30 minutes; ② The second intervention For the first intervention, after the monitor is connected in the operating room, the frequency and pulse width are not set, and it lasts for 30 minutes before being taken out; ③ For the

Первичные конечные точки

  • high-sensitivity troponin T [Срок оценки: The first day after surgery]
Вторичные конечные точки (3)
  • Myocardial injury after surgery [Срок оценки: 30 days after surgery]
  • high-sensitivity troponin T [Срок оценки: the third day after surgery]
  • NRS score 24 hours after surgery. [Срок оценки: The three day after surgery]

Критерии участия

Критерии включения

  • Aged ≥60 years old
  • Inpatients scheduled to undergo elective thoracoscopic lobectomy, segmentectomy, or wedge resection
  • ASA score of Ⅰ-Ⅲ
  • Able to communicate with the researcher Communicate and cooperate with patients completing assessment scales.

Критерии исключения

  • Patients with congenital heart disease, coronary heart disease, myocardial infarction, severe heart block or implanted cardiac pacemaker
  • Patients with neurological diseases such as cerebral infarction, cerebral hemorrhage or stroke
  • Patients with pain, damage, infection or unhealed ear trauma in the area near the external auricle
  • Patients with a history of severe mental illness, abuse of analgesia or addiction to psychiatric drugs
  • Patients with severe digestive system diseases
  • Patients and their families who refuse surgical anesthesia or are unable to cooperate in completing the questionnaire
  • Pregnant women.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Тройное слепое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • The First Hospital of Jiaxing — Jiaxing

Публикации

  • Ackland GL, Abbott TEF, Jones TF, Leuwer M, Pearse RM; VISION-UK Investigators; University College Hospital; Royal Liverpool University Hospital; Leeds Teaching Hospitals. Early elevation in plasma high-sensitivity troponin T and morbidity after elective noncardiac surgery: prospective multicentre observational cohort study. Br J Anaesth. 2020 May;124(5):535-543. doi: 10.1016/j.bja.2020.02.003. Ep PMID 32147104

Идентификаторы

NCT: NCT06759818 · 2024-LY-747

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗