Timing of Withdrawal of the Laryngeal Mask Airway (LMA) in Children: Early or Late Removal?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- Occurence of respiratory adverse events
研究概览
简要总结
The purpose of this prospective, randomized study was to compare the incidence of adverse events associated with removal of the LMA either in deeply anesthetised or awake patients.
详细描述
Written informed consent was obtained from parents for this prospective, randomized study conducted on children scheduled for minor surgery. Anesthesia was induced with sevoflurane, supplemented with propofol (3mg/kg) then maintained with nitrous oxide and sevoflurane 2-4% in oxygen. Analgesia was insured by peripheral nerve blocks. Included children were randomized into 2 groups:
- Awake: the LMA was left in place until the patient fully regained consciousness
- Deeply anesthetised: the LMA was immediately removed once the halogenated anesthetic turned off, and ventilation using facial mask was carried until spontaneous ventilation recovery.
Respiratory complications that occurred during LMA removal until 20 minutes afterwards were recorded. Children with respiratory history and those for whom peripheral nerve blocks failed, were excluded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 1 Year 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children scheduled for minor surgery
排除标准
- 未提供
研究组 & 干预措施
Anesthetised
LMA removal once the halogenated anesthetic turned off
干预措施: LMA removal (Other)
Awake
LMA removal once the patient fully regained consciousness
干预措施: LMA removal (Other)
结局指标
主要结局
Occurence of respiratory adverse events
时间窗: from LMA removal to 20 minutes afterwards
次要结局
未报告次要终点
研究者
Dr Sonia ben khalifa (PhD)
Head of Anesthesia and Intensive Care Department
Hôpital d'enfants Béchir-Hamza