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Идёт набор NCT05939674

Effects of Flumazenil on Recovery After Total Intravenous Anesthesia With Remimazolam

Без фазы С лечением Flumazenil Adverse Reaction Remimazolam Hip Joint Elderly Patients

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: Flumazenil, normal saline.
Кому может быть актуально
Состояния в реестре: Flumazenil Adverse Reaction, Remimazolam, Hip Joint, Elderly Patients. Базовые параметры: от 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
South Korea
Следующий шаг
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Официальное название

Effects of Flumazenil on Recovery After Total Intravenous Anesthesia With Remimazolam in Elderly Patients Undergoing Hip Joint Surgery: a Prospective Randomized Controlled Study.

Обзор

Remimazolam is a medication that has the advantage of a short half-life and reversibility with flumazenil. In clinical situations, the use of flumazenil for the reversal of sedation is common, but there is no precise indication for its administration. In this study, we aim to investigate the necessity of routine flumazenil use after administering remimazolam for intravenous anesthesia.

Подробное описание

Remimazolam is a medication that has the advantage of a short half-life and reversibility with flumazenil.

Although there are advantages of using flumazenil, such as reduced recovery time and decreased occurrence of postoperative cognitive dysfunction (POCD), it can cause rebound sedation, ventricular arrhythmias, seizures, agitation, and gastrointestinal symptoms. Therefore, routine administration is not recommended.

However, in actual clinical situations, it is common to use flumazenil as a routine reversal agent for benzodiazepines, but there is no research on the routine use of flumazenil for reversing the effects of remimazolam in anesthesia or sedation.

Factors such as obesity, advanced age, and low plasma albumin concentration can prolong the time for extubation during anesthesia with remimazolam. Therefore, when considering the routine use of flumazenil in waking patients using remimazolam in elderly patients, these factors should be taken into account. However, there is also no specific indication for its accurate administration.

Therefore, this study aims to investigate the effects of flumazenil on recovery after total intravenous anesthesia with remimazolam in elderly patients undergoing hip joint surgery

Вмешательства

  • Препарат Flumazenil
    During induction, patients will receive remimazolam 6mg/kg/h with remifentanil TCI 1\~4 nanogram/mL. After patient loses consciousness, anesthesia will be maintained with remimazolam 1-2mg/kg/h combined with remifentanil. When procedure ends, infusion remimazolam stops and 0.3mg of flumazenil according to allocated groups.
  • Препарат normal saline
    During induction, patients will receive remimazolam 6mg/kg/h with remifentanil TCI 1\~4 nanogram/mL. After patient loses consciousness, anesthesia will be maintained with remimazolam 1-2mg/kg/h combined with remifentanil. When procedure ends, infusion remimazolam stops and 0.9% normal saline according to allocated groups.

Первичные конечные точки

  • Difference in eye opening time between the two groups [Срок оценки: Up to two hours]
  • Difference in extubation time between the two groups [Срок оценки: Up to two hours]
Вторичные конечные точки (3)
  • Actual dose of flumazenil [Срок оценки: Up to two hours, From end of anesthesia to discharge form the post-anestheic care unit]
  • Occurrence of re-sedation [Срок оценки: Up to two hours, From end of anesthesia to discharge form the post-anestheic care unit]
  • Side effects of flumazenil usage [Срок оценки: Up to two hours, From end of anesthesia to discharge form the post-anestheic care unit]

Критерии участия

Критерии включения

  • Patients over 65 years old scheduled for hip joint surgery

Критерии исключения

  • Patients with impaired consciousness or delirium before surgery
  • Patients who are hemodynamically unstable before surgery
  • Patients with a history of neurological or neuromuscular disorders or use of medications that affect neurological or neuromuscular function
  • Patients who have taken sedatives (anti-anxiety medications, antipsychotics, antidepressants, sleep aids) within the past 24 hours
  • Patients with known allergy to benzodiazepine, flumazenil
  • Patients with galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
  • Patients with hypersensitivity to Dextran40
  • Patients who have been taking benzodiazepine for long term
  • Patients with end stage renal disease requiring hemodialysis
  • Patients with history of acute angle glaucoma
  • Patients with alcohol or substance dependence
  • ASA classification 4 or 5

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
Двойное слепое
Основная цель
Другое

Центры проведения

South Korea · 1 центр
  • Pusan National University Yangsan Hospital — Yangsan

Идентификаторы

NCT: NCT05939674 · 05-2023-134

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗