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Набор скоро начнётся NCT06770790

Effect of Thoracic Epidural Anesthesia on Left Ventricular Functions: A Strain Echocardiography Study

— Наблюдательное Thoracal Epidural Block Echocardiography

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: strain echocardiography.
Кому может быть актуально
Состояния в реестре: Thoracal Epidural Block, Echocardiography. Базовые параметры: 18 лет — 75 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
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Обзор

Post-thoracic surgery pain management thoracic epidural catheter is the most commonly used method. Thoracic epidural anesthesia, in which cardiac sympathetic nerves (T1-T5) are involved in neural blockade, is the focus of our research. Many studies have shown a decrease in inotropic status (intrinsic function) after blockade of cardiac sympathetic innervation with thoracic epidural anesthesia (TEA).We want to examine the cardiac effects of TEA with strain echocardiography, which is an advanced echocardiography method. Therefore, we aimed to investigate the effect of TEA on left ventricular functions with strain echocardiography.

Подробное описание

The study was designed as an observational study. Our study will be conducted for 12 months after receiving ethical committee approval. 23 patients are planned to be included in the study. TTE will be performed when the patients arrive at the preoperative room for the operation. Then, thoracic epidural anesthesia will be performed. After the block, all usual medications, except ACE inhibitors, will be continued according to hospital protocol for 15 days of surgery. Patients will be given up to 2 mg midazolam and 7 ml/kg 0.5% isotonic 15 minutes before the epidural catheter is administered. A TTE will be performed before the epidural catheter is placed. After appropriate local anesthesia, the epidural catheter will be placed while the patient is in a sitting position. The puncture will be performed between t6-t7 and t8-t9 using the midline approach with the "loss of resistance" technique. The catheter will be inserted 3-4 cm into the epidural space and an epidural lidocaine bolus (10 ml at 2% concentration) will be administered while the patients are in the supine position. TTE will be performed again after 15 minutes. At these stages, hemodynamic values will also be recorded. We want to examine the cardiac effects of TEA with strain echocardiography, which is an advanced echocardiography method. Therefore, we aimed to investigate the effect of TEA on left ventricular functions with strain echocardiography.

Вмешательства

  • Другое strain echocardiography
    HR, MAP, SBP, and DBP will be recorded at baseline and 15 minutes after ESP block. Cardiac output (CO) will be calculated using echocardiographic data on stroke volume (SV) (measured from the LV outflow tract) and multiplied by HR. Two transthoracic 2D echocardiographic examinations will be performed immediately before and 15 minutes after TEA. The examinations include apical four-, two-, and three-chamber projections, mitral and aortic Doppler flow velocities. Standard measurements of left vent

Первичные конечные точки

  • Echocardiographic assessment of left ventricular function [Срок оценки: Left ventricular function will be assessed by echocardiography 15 minutes before and 15 minutes after high TEA.]

Критерии участия

Критерии включения

Elective payment options ASA I-III Ages 18-75

Критерии исключения

  • Refusal at enrollment
  • Request for withdrawal from the study
  • Inability to give informed consent
  • Emergency surgery
  • Bleeding diathesis
  • Presence of contraindications to the LA agents used in this study
  • Use of chronic opioids
  • Psychiatric disorders
  • Presence of infection at the injection site

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

  • Rex S, Missant C, Segers P, Wouters PF. Thoracic epidural anesthesia impairs the hemodynamic response to acute pulmonary hypertension by deteriorating right ventricular-pulmonary arterial coupling. Crit Care Med. 2007 Jan;35(1):222-9. doi: 10.1097/01.CCM.0000250357.35250.A2. PMID 17095942

Идентификаторы

NCT: NCT06770790 · 199

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗