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Идёт набор NCT06754995

Diagnostic Feasibility of 100 Hz Tetanic Stimulation

Наблюдательное Polyneuropathies

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Polyneuropathies. Базовые параметры: 18 лет — 65 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
Венгрия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Diagnostic Feasibility of 100 Hz Tetanic Stimulation in the Perioperative Setting in Patients With Normal and Abnormal ENG: a Pilot Study

Обзор

The goal of this observational study is to investigate the applicability of 100 Hz tetanic stimulation with an electromyography device in the exclusion of postoperative residual neuromuscular block. The aim is to determine whether fatigue develops with 100 Hz tetanic stimulation in anaesthetized, non-relaxed patients with normal or abnormal baseline electroneurographic (ENG) findings.

Подробное описание

The aim of the present study is to investigate the applicability of 100 Hz tetanic stimulation with an electromyography (EMG) device. The aim is to determine whether fatigue develops with 100 Hz tetanic stimulation in anaesthetized, non-relaxed patients with normal or abnormal baseline electroneurographic (ENG) findings. Electric responses of the musculus digiti minimi elicited by supramaximal stimulation of the ulnar nerve at the carpal tunnel are monitored. Alpine Biomed ENG-EMG device with Keypoint software version 5.11 is used for the examinations. The exposed arm is fixed on the armboard, the skin is degreased and then the electrodes for monitoring are mounted lege artis. After the anesthesia has been induced, ENG of the ulnar nerve is examined. Based on the results of the ENG test, patients are divided into separate groups (normal or abnormal ENG). During the ENG test, the supramaximal current is determined. Afterwards, repetitive tetanic stimulation of the defined frequency (60 and 100 Hz) and duration (5 sec) is applied to the two test groups at the current according to the test plan.

The clinical utilities of the study results are:

* Determination of the "safety margin" of neuromuscular junction, which is not provided by routine monitoring. * To investigate how comorbid status (especially chronic conditions affecting peripheral nerves such as polyneuropathy) influences the feasibility of tetanic stimulation in the diagnostics of residual neuromuscular block and safety margin.

Первичные конечные точки

  • 100 Hz tetanic fade response of abductor digiti minimi muscle to ulnar nerve stimulation in patients with normal and abnormal ENG [Срок оценки: From enrollment until end of anesthesia asessed up to 1 hour. No further ENG measurements are performed in the postoperative period.]
Вторичные конечные точки (1)
  • Diagnostic feasibility of electromyography in the examination of safety margin [Срок оценки: From enrollment until end of anesthesia assessed up to 1 hour. No further ENG measurements are performed in the postoperative period.]

Критерии участия

Критерии включения

  • ASA 1-3;
  • BMI 18.5-25 (normal body weight);
  • patient is in supine position with one arm accessible.

Критерии исключения

  • diseases with impaired neuromuscular function (myopathies, severe liver and kidney failure);
  • drugs affecting neuromuscular function (magnesium, aminoglycosides);
  • pregnancy (pregnancy tests are carried out in women of childbearing age to rule out pregnancy);
  • breast-feeding;
  • acute surgery

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Венгрия · 2 центра
  • Department of Anesthesiology and Intensive Care, University of Debrecen — Debrecen
  • University of Debrecen Medical Center, Department of Anesthesiology and Intensive Care — Debrecen

Идентификаторы

NCT: NCT06754995 · AITT 2024/2

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗