Which Rapid Sequence Induction Technique Should be Used in Urgent Surgery in Children?

Обзор

The goal of our study is to compare classical Rapid Sequence Induction (RSI) and modified Rapid Sequence Induction (mRSI) in pediatric patients with a full stomach undergoing urgent surgical procedures. Due to reduced oxygen reserve in children, modified RSI incorporating gentle positive pressure ventilation has been proposed to reduce hypoxemia while maintaining protection against aspiration.

Подробное описание

This randomized clinical trial compares classical Rapid Sequence Induction (RSI) and modified Rapid Sequence Induction (mRSI) in pediatric patients with a full stomach undergoing urgent surgery. After standardized preoxygenation with 100% FiO₂ for two minutes, patients are randomized to one of two groups. In the classical RSI group, patients receive propofol (3-5 mg/kg) until loss of consciousness followed by succinylcholine (1-2 mg/kg, age-adjusted), and tracheal intubation is performed 30 seconds after induction without positive pressure ventilation. In the modified RSI group, patients receive fentanyl (4 µg/kg) prior to propofol and succinylcholine at the same doses, followed by gentle positive pressure ventilation using the anesthesia machine in inspiratory support mode (inspiratory pressure 10 cmH₂O, PEEP 5 cmH₂O) for 30 seconds before tracheal intubation. Demographic characteristics, type of surgery, heart rate, systolic and mean arterial pressure, oxygen saturation, and peri-intubation complications including aspiration and desaturation (defined as SpO₂ \< 90%) are recorded and compared between groups to evaluate safety and efficacy of the two induction techniques

Вмешательства

• Другое Classical Rapid Sequence Induction
  Patients received propofol (3-5 mg/kg) until loss of consciousness, followed by succinylcholine (1-2 mg/kg, adjusted for age). Tracheal intubation was performed 30 seconds after the completion of induction, without any positive pressure ventilation
• Другое Modified Rapid Sequence Induction
  Patients received fentanyl (4 µg/kg), followed by propofol and succinylcholine at the same doses as in the RSI group. Following induction, patients received gentle positive pressure ventilation using the anesthesia machine in inspiratory support mode (inspiratory pressure: 10 cmH₂O; PEEP: 5 cmH₂O) for 30 seconds before tracheal intubation

Первичные конечные точки

• Peri-Intubation Respiratory and Hemodynamic Complications in Children: Classical vs. Modified Rapid Sequence Induction [Срок оценки: From induction of anesthesia to 5 minutes after tracheal intubation]

Критерии участия

Критерии включения

• children under 14 years of age with a full stomach, scheduled for urgent surgery under general anesthesia

Критерии исключения

• hemodynamic instability

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

Открытое

Основная цель

Другое

Центры проведения

Tunisia · 1 центр

• Bechir Hamza Children Hospital — Tunis

Идентификаторы

NCT: NCT07428434 · 242025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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