NCT00922467终止3 期
Closed-loop Delivery of Propofol and Remifentanil: Sparing Effect of Esmolol
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Hopital Foch
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- administered doses of propofol and of remifentanil during anesthesia
研究概览
简要总结
Main objective is to evaluate the sparing effect of esmolol on the required doses of propofol and remifentanil
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •male patients scheduled for a general anesthesia
排除标准
- •age lower than 18 years
- •allergy to propofol, or to soja or to peanuts, or to sufentanil, to remifentanil, or to morphine, or to a myorelaxant or to an excipient,
- •any other history of anaphylactic reaction,
- •hypersensibility to sufentanil, or to remifentanil, or to other derivate of fentanyl,
- •hypersensibility to esmolol or to an excipient,
- •history of central nervous system disease,
- •patients receiving a psychotropic treatment or an agonist-antagonist opiate,
- •hypovolemic patients,
- •patients receiving a cardio-vascular treatment,
- •patients with a pacemaker,
- •expected bleeding more than 20% of the blood volume,
- •simultaneous general and loco-regional anesthesia,
- •patients suffering from asthma, COPD, trouble of the heart rhythm or conduction, cardiac insufficiency, cardiogenogenic shock, Prinzmetal syndrome, pheochromocytoma,
- •patients with a heart rate less than 50/min and/or an arterial hypotension,
- •neurosurgical act or any other which precludes an adequate positioning of the bispectral electrode.
研究组 & 干预措施
Placebo
Placebo Comparator
patients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and a placebo
干预措施: NaCl 9/00 (Drug)
Esmolol
Experimental
patients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and esmolol
干预措施: Esmolol (Drug)
结局指标
主要结局
administered doses of propofol and of remifentanil during anesthesia
时间窗: end of anesthesia
次要结局
- hemodynamic abnormalities requiring a treatment(end of anesthesia)
- delay before recovery(at the end of anesthesia)
- postoperative morphine requirement(Third post-anesthetic hour)
- explicit memorisation(Second postoperative day)
研究者
研究点 (1)
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