Remifentanil Minimum Effective Dose for Children Intubation Without Neuromuscular Blockade
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 主要终点
- Incidence of Adequate intubation condition (dichotomic) as an assessment of success rate
研究概览
简要总结
Introduction: remifentanil's optimal dose for children intubation without neuromuscular blockade is unknown. Method: phase IV adaptative trial using Dixon's up-and-down method for modeling remifentanil's dose-response curve for adequate intubation conditions as defined by previous studies.
详细描述
Introduction
remifentanil's optimal dose for children intubation without neuromuscular blockade is unknown.
Method: phase IV adaptative trial using Dixon's up-and-down method for modeling remifentanil's dose-response curve for adequate intubation conditions as defined by previous studies. Remifentanil doses starting from 2mg/kg will be infused before intubation. When a success occurs next patient's dose will be decreased by 0.25mg/kg/h. When a success does not occur the next patient's dose will be increased by 0.25mg/kg/h. Intubation will be considered adequate if patient does not cough, does not move, if vocal cords are open, if larigocsocpic Cormack grade I or II.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ASA I or II
- •Scheduled for surgery under general anesthesia.
排除标准
- •Predicted difficult airway
- •Severe neurologic or cardiologic conditions
- •Recent upper airway infectious diseases
研究组 & 干预措施
Study arm
There is a single study arm. Remifentanil will be infused before intubation. The first patient will receive remifentanil 2mg/kg. If a success occurs the next patient's dose will be decreased by 0.25mg/kg and else it will be increased by 0.25mg/kg. This rule will apply recursively as Dixon's Up-And-Down Method.
干预措施: Remifentanil (Drug)
结局指标
主要结局
Incidence of Adequate intubation condition (dichotomic) as an assessment of success rate
时间窗: intraoperative
Intubation is adequate if patient does not cough, does not try to breathe, vocal cords do not move, patient does not react and laringoscopy is Cormack class I or II
次要结局
未报告次要终点
研究者
Gabriel Magalhaes Nunes Guimaraes
MSc
Brasilia University Hospital