NCT00815048已完成4 期
Remifentanil and Atropine for Intubation in Neonates; a Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Time to Successful intubation
研究概览
简要总结
The investigators hypothesize that the use of a combination of Atropine and Remifentanil will safely facilitate non emergent intubation procedure as effectively as the protocol of Atropine, Fentanyl, and Succinylcholine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hemodynamically stable neonates of any gestational age admitted to the Neonatal Intensive Care Unit at McMaster Children's Hospital requiring an elective endotracheal intubation was anticipated.
排除标准
- •Urgent intubations
- •Cyanotic congenital heart lesions
- •Anticipated difficult airway
- •Concurrent or recently administered (within 3 hours of the procedure) intravenous opioid infusions
- •Pre-existing hyperkalemia
- •Family history of malignant hyperthermia
- •Prior enrollment
研究组 & 干预措施
Remifentanil
Active Comparator
Atropine
Remifentanil
干预措施: Atropine/Remifentanil (Drug)
Fentanyl
Placebo Comparator
Atropine
Fentanyl
Succinylcholine
干预措施: Fentanyl/Atropine/Succinylcholine (Drug)
结局指标
主要结局
Time to Successful intubation
时间窗: 15 minutes
次要结局
- Time to return of spontaneous respirations(15 minutes)
- Oxygen saturation(During the procedure up to 15 minutes)
- Heart Rate(During the procedure up to 15 minutes)
- Blood Pressure(During the procedure up to 15 minutes)
- Intubation Condition(15 minutes post procedure)
- Evidence of Trauma(15 minutes post procedure)
研究者
研究点 (1)
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