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临床试验/NCT07428434
NCT07428434尚未招募不适用

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

Tunis University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年3月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
Peri-Intubation Respiratory and Hemodynamic Complications in Children: Classical vs. Modified Rapid Sequence Induction

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
1 Month 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • hemodynamic instability

研究组 & 干预措施

Classical Rapid Sequence Induction group

Active Comparator

Patients received propofol (3-5 mg/kg) followed by age-adjusted succinylcholine (1-2 mg/kg), and tracheal intubation was performed 30 seconds later without positive pressure ventilation.

干预措施: Classical Rapid Sequence Induction (Other)

Modified Rapid Sequence Induction (mRSI) group

Experimental

Patients received fentanyl (4 µg/kg) followed by propofol and succinylcholine at the same doses as the RSI group, then underwent 30 seconds of gentle positive pressure ventilation (inspiratory pressure 10 cmH₂O, PEEP 5 cmH₂O) before tracheal intubation.

干预措施: Modified Rapid Sequence Induction (Other)

结局指标

主要结局

Peri-Intubation Respiratory and Hemodynamic Complications in Children: Classical vs. Modified Rapid Sequence Induction

时间窗: From induction of anesthesia to 5 minutes after tracheal intubation

次要结局

未报告次要终点

研究者

发起方
Tunis University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mehdi Trifa

Professor

Tunis University

研究点 (1)

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