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Набор скоро начнётся NCT06729086

Propofol vs Sevoflurane in Cardiac Surgery

Без фазы С лечением Cardiac Complications Cardiac Surgery Neurologic Complications Respiratory Complications

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: sedation using propofol, sedation using sevoflurane.
Кому может быть актуально
Состояния в реестре: Cardiac Complications, Cardiac Surgery, Neurologic Complications, Respiratory Complications. Базовые параметры: от 18 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Propofol vs Sevoflurane in Cardiac Surgery: a Randomized Clinical Trial During the Peroperative and Postoperative Phase

Обзор

The hypothesis of our study: presence of a relationship between the type of anesthesia and complications after cardiac surgery. The aim is to assess the benefit of using intravenous or inhaled anesthesia on the patients\' stay and its complications.

Подробное описание

Cardiac surgery presents unique challenges for anesthesiologists as they are responsible for amnesia, analgesia, muscle relaxation, and maintenance of organ functions in the context of CPB-induced pathophysiological changes. Postoperative complications are vast and varied, leading to a prolonged stay in cardiac intensive care. However, the question of the superiority of one anesthesia protocol over another in cardiac surgery is debated.

The AHA (American Heart Association) recommended the use of inhalation anesthesia to reduce the risk of perioperative myocardial ischemia and infarction in 2011. However, in 2019, this recommendation lost a step in its level of proof and therefore the debate is still open.

Indeed, a "MYRIAD" study carried out on five continents determined that the administration of a halogenated volatile agent provided clinical benefit to patients undergoing coronary revascularization surgery. The study was randomized, single-blind, multicenter, carried out on patients scheduled for coronary bypass surgery with or without extracorporeal circulation (ECB).

Volatile halogenated agents (AVH) have cardioprotective properties via a pre- and post-conditioning phenomenon. Several meta-analyses have shown a benefit from the use of AVH during coronary surgery and in particular a reduction in mortality.

Note that the choice of type of anesthesia is made according to the habits of the department and the anesthetist and is in no way linked to the patient's condition or the intervention.

Given that within the HDF, there is an operating room and an intensive care unit dedicated to cardiac surgery forming an expertise and reference cell in Lebanon, it would be logical to introduce this sedation technique in order to establish new national recommendations and to report the Lebanese experience internationally. The ultimate goal is to provide the patient with optimal perioperative care.

The hypothesis of our study is that there is a relationship between the type of anesthesia and complications after cardiac surgery.

A prospective single-center randomized study targeting patients admitted to cardiovascular and thoracic intensive care for cardiac surgeries (PAC and valve replacement) at the Hôtel-Dieu de France, with the aim of evaluating the benefit of using intravenous anesthesia or inhaler on the patient stay and its complications. Two groups of patients will be formed respecting common characteristics in each group. Each sample of 50 patients will receive one type of anesthesia. All cases meeting the inclusion criteria mentioned below and spanning from 2023 to 2024 will be included in this study. Data collection will be done from the files of the patients concerned during their stay in the hospital intensive care unit.

Вмешательства

  • Препарат sedation using propofol
    The different complications studied will be for example respiratory, neurologic and cardiac based on several clinical and biological parameters.
  • Препарат sedation using sevoflurane
    The differents complications studied will be for example respiratory, neurologic and cardiac based on severl clinical and biological parameters.

Первичные конечные точки

  • determine the relationship between myocardial protection and type of anesthesia [Срок оценки: 48 hours after the surgery]
Вторичные конечные точки (5)
  • Association between the type of anesthesia and the speed of awakening [Срок оценки: 48 hours after the surgery]
  • Association between the length of stay in intensive care and the type of anesthesia [Срок оценки: 72 hours after the surgery]
  • Determine a relationship between the type of anesthesia and the hemodynamic profile [Срок оценки: 48 hours after the surgery]
  • Association between the type of anesthesia and pulmonary complications [Срок оценки: 72 hours after the surgery]
  • Association between the type of anesthesia and neurological complications [Срок оценки: 72 hours after the surgery]

Критерии участия

Критерии включения

  • all patients above 18 yeras old that will undergo a cardiac surgery

Критерии исключения

  • below 18 yeras old

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
Простое слепое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06729086 · CEHDF2230

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗