NCT00778505终止4 期
Target-Controlled Infusion of Propofol and Remifentanil During General Anaesthesia Guided by the Index Bispectral: Comparison in Pediatric Patients Between Manual Perfusion and Automated Perfusion
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Hopital Foch
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Percentage of time during which the bispectral index is between 40 and 60
研究概览
简要总结
To compare manual administration of propofol and remifentanil and dual closed-loop using bispectral index as the control variable during pediatric anesthesia
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 6 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •class ASA I, II or III
- •general anesthesia scheduled to last more than one hour
- •intraoperative hemorrhage planned to be less than 15% of the blood volume
排除标准
- •Combined general and regional anesthesia,
- •Patients with a pacemaker or scheduled for a cardiac or brain surgical procedure,
- •History of a neurological or a psychiatric disorder, or central brain lesion,
- •Patients receiving a psychotropic treatment or a a morphine agonist-antagonist,
- •Allergy to latex, propofol, remifentanil, morphine, muscle relaxant, or to a component,
- •Hypersensibility to remifentanil or to a derivate of fentanyl,
- •Scheduled postoperative ventilation or sedation.
研究组 & 干预措施
1
Experimental
closed-loop administration of propofol and remifentanil using bispectral index as the controller
干预措施: Propofol (Drug)
1
Experimental
closed-loop administration of propofol and remifentanil using bispectral index as the controller
干预措施: Remifentanil (Drug)
2
Active Comparator
manual administration of propofol and remifentanil according to bispectral index values
干预措施: Propofol (Drug)
2
Active Comparator
manual administration of propofol and remifentanil according to bispectral index values
干预措施: Remifentanil (Drug)
结局指标
主要结局
Percentage of time during which the bispectral index is between 40 and 60
时间窗: anesthesia
次要结局
- propofol and remifentanil doses(anesthesia)
研究者
研究点 (2)
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