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Идёт набор NCT07716891

Effect of Pre-injection of Rocuronium on Neuromuscular Blockade Onset Time and Hemodynamics During General Anesthesia Induction

Без фазы С лечением General Anesthesia Elective Surgery

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: Rocuronium Bromide (Pretreatment Injection), Rocuronium Bromide (Conventional Injection).
Кому может быть актуально
Состояния в реестре: General Anesthesia, Elective Surgery. 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
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 is a single-center, prospective, randomized, controlled trial comparing pre-injection versus standard bolus administration of rocuronium bromide for general anesthesia induction. A total of 108 adult patients (18-65 years, ASA I-III) scheduled for elective surgery requiring endotracheal intubation will be enrolled and randomized 1:1 to either the pre-injection group or control group. The pre-injection group will receive rocuronium 0.06 mg/kg as a priming dose followed by 0.54 mg/kg 3 minutes later. The control group will receive rocuronium 0.6 mg/kg as a single bolus. All patients will receive standardized anesthesia induction with midazolam and propofol. The primary outcome is neuromuscular blockade onset time (seconds). Secondary outcomes include hemodynamic parameters (SBP, DBP, MAP, HR, CO, SV, SVR), injection pain incidence, and adverse events. This study aims to investigate whether pre-injection of rocuronium can shorten neuromuscular blockade onset time while maintaining hemodynamic stability compared to standard bolus administration.

Вмешательства

  • Препарат Rocuronium Bromide (Pretreatment Injection)
    Low-dose rocuronium bromide is injected intravenously in advance before anesthesia induction
  • Препарат Rocuronium Bromide (Conventional Injection)
    Rocuronium bromide is administered by standard routine intravenous injection during anesthesia induction

Первичные конечные точки

  • Neuromuscular blockade onset time [Срок оценки: Within 5 minutes after completion of rocuronium-bromide injection]
Вторичные конечные точки (10)
  • Systolic Blood Pressure (SBP) [Срок оценки: Baseline (before rocuronium-bromide injection), 0.5-minute, 1-minute, 2-minute, 3-minute and 5-minute after rocuronium-bromide injection。]
  • Diastolic Blood Pressure (DBP) [Срок оценки: Baseline (before rocuronium-bromide injection), 0.5-minute, 1-minute, 2-minute, 3-minute and 5-minute after rocuronium-bromide injection。]
  • Mean Arterial Pressure (MAP) [Срок оценки: Baseline (before rocuronium-bromide injection), 0.5-minute, 1-minute, 2-minute, 3-minute and 5-minute after rocuronium-bromide injection。]
  • Heart Rate (HR) [Срок оценки: Baseline (before rocuronium-bromide injection), 0.5-minute, 1-minute, 2-minute, 3-minute and 5-minute after rocuronium-bromide injection。]
  • Cardiac Output (CO) [Срок оценки: Baseline (before rocuronium-bromide injection), 0.5-minute, 1-minute, 2-minute, 3-minute and 5-minute after rocuronium-bromide injection。]
  • Stroke Volume (SV) [Срок оценки: Baseline (before rocuronium-bromide injection), 0.5-minute, 1-minute, 2-minute, 3-minute and 5-minute after rocuronium-bromide injection。]
  • Systemic Vascular Resistance (SVR) [Срок оценки: Baseline (before rocuronium-bromide injection), 0.5-minute, 1-minute, 2-minute, 3-minute and 5-minute after rocuronium-bromide injection。]
  • Injection Pain [Срок оценки: Pain assessment is performed within 5 minutes after completion of rocuronium injection.]
  • Limb Withdrawal Response [Срок оценки: Assessment shall be completed within 5 minutes after rocuronium injection.]
  • Adverse Events [Срок оценки: Continuous assessment from the start of anesthesia induction until the end of surgery; the maximum assessment period is the perioperative period of a single operation.]

Критерии участия

Критерии включения

  • Aged from 18 to 65 years old
  • American Society of Anesthesiologists (ASA) physical status classification Ⅰ, Ⅱ or Ⅲ
  • Elective surgery requiring general anesthesia with tracheal intubation
  • Able to understand the study and voluntarily sign written informed consent
  • Male or female, no gender restriction

Критерии исключения

  • Severe hepatic dysfunction (ALT/AST > 3 times the upper limit of normal) or renal dysfunction (creatinine > 2 times the upper limit of normal)
  • Central nervous system diseases or severe neuromuscular disorders
  • Severe arrhythmia or cardiac dysfunction (NYHA class Ⅲ-Ⅳ, or ejection fraction EF < 30%)
  • Known hypersensitivity or allergy to rocuronium, midazolam, propofol or other study-related drugs
  • Refusal to participate in this clinical trial
  • Pregnant or breastfeeding women
  • History of predicted difficult airway requiring awake tracheal intubation
  • Contraindications to rapid sequence induction

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
Четверное слепое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • General Hospital of Ningxia Medical University — Иньчуань

Идентификаторы

NCT: NCT07716891 · KYLL-2026-0131

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗