NCT00886418已完成3 期
Effect of Continuous Myorelaxation on the Need for Hypnotic Agent During Surgical Procedures Which do Not Require it (Multicenter, Randomized and Prospective Study)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Hopital Foch
- 入组人数
- 140
- 试验地点
- 3
- 主要终点
- propofol dose
研究概览
简要总结
Total intra-venous anesthesia can be provided using a closed-loop system guided by the bispectral index. The purpose of this study is to determine if myorelaxation modifies its functioning.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients scheduled for a surgical procedure which not require a myorelaxation
排除标准
- •age less than 18 years,
- •ASA III and above,
- •pregnant woman
- •combined general and regional anesthesia,
- •history of prolonged myorelaxation due to a decrease in cholinesterase,
- •patient with a known lack in cholinesterase,
- •history of cerebral or psychiatric central,
- •allergy to latex, propofol, remifentanil, morphine, muscle relaxant or any of the excipients,
- •known hypersensitivity to remifentanil or to an other derivative of fentanyl,
- •presence of a pacemaker,
- •psychotropic or agonist-antagonist morphine treatment,
- •planned post-operative sedation.
研究组 & 干预措施
1
Active Comparator
Total intravenous anesthesia (propofol and remifentanil) is provided using the close-loop system. A muscle relaxant is used to facilitate tracheal intubation; its administration is continued throughout anesthesia.
干预措施: muscle relaxant (Drug)
2
Experimental
Total intravenous anesthesia (propofol and remifentanil) is provided using the close-loop system. No muscle relaxant is used and a placebo is infused throughout anesthesia.
干预措施: normal saline (Drug)
结局指标
主要结局
propofol dose
时间窗: one hour anesthesia
次要结局
- number of patients' movements(one hour anesthesia)
- number of automatic modifications of the propofol and remifentanil concentrations(one hour anesthesia)
- time to wake up(end of anesthesia)
- number of hemodynamic abnormalities requiring treatment(one hour anesthesia)
- intraoperative awareness(postoperative day 1 or 2)
- performance of the closed-loop system(one hour anesthesia)
- remifentanil dose(one hour anesthesia)
研究者
研究点 (3)
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