A Comparison of the Perioperative Hemodynamic Effects of Remifentanil and Esmolol in Intracranial Surgery
A Comparison of the Perioperative Hemodynamic Effects of Remifentanil and Esmolol: a Double Blind Randomized Controlled Study
研究概览
详细说明
During neurosurgical procedures intubation, insertion of the head pins, extubation and the early postoperative period are the time lines in which cerebral autoregulation can be impaired by changes in heart rate and blood pressure. Several anesthetic regimens have been implied to overcome this problem. Remifentanil is used in neurosurgery since it allows early recovery and neurologic evaluation. Esmolol on the other hand is also very short acting, effective to blunt cardiovascular responses during surgery and has no significant effect on intracranial pressure and cerebral blood flow. In addition esmolol is addressed to reduce perioperative ischemia during noncardiac surgery.
It was hypothesized that the use of esmolol as an alternative to remifentanil with sevoflurane inhalation anesthesia during intracranial surgery, could provide better hemodynamic conditions and cause lesser side effects in the perioperative period. It was the main objective of this study to compare the effect of esmolol and remifentanil on the incidence of tachycardia and hypertension and the intraoperative fentanyl consumption. The comparison of postoperative troponine I and creatine phosphokinase levels and EKG changes were the secondary objectives.
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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Ankara、火鸡、06610
- Diskapi Yildirim Beyazit Teaching and Research Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Intracranial surgery
Exclusion Criteria:
- heart rate ≤ 50,
- atrioventricular block,
- sick sinus syndrome,
- heart failure,
- history of asthma,
- hypertension,
- impaired renal or hepatic function,
- patients receiving beta blockers or calcium channel blockers,
- emergency surgery.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器:GroupE/Esmolol infusion
Heart rate control, Beta blocker
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Esmolol 50 mcg/kg/min
其他名称:
|
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实验性的:GroupR/Remifentanil infusion
Heart rate control, opioid
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Remifentanil 0.5 mcg/kg/min
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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It is the main objective of this study to compare the effect of esmolol and remifentanil on the incidence of tachycardia and hypertension
大体时间:during intubation, head pin insertion, extubation, early postoperative period
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during intubation, head pin insertion, extubation, early postoperative period
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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the intraoperative fentanyl consumption
大体时间:during intubation, head pin insertion, extubation, early postoperative period
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during intubation, head pin insertion, extubation, early postoperative period
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合作者和调查者
调查人员
- 首席研究员:Dilek Yazicioglu、MD
出版物和有用的链接
一般刊物
- Heinke W, Zysset S, Hund-Georgiadis M, Olthoff D, von Cramon DY. The effect of esmolol on cerebral blood flow, cerebral vasoreactivity, and cognitive performance: a functional magnetic resonance imaging study. Anesthesiology. 2005 Jan;102(1):41-50. doi: 10.1097/00000542-200501000-00010.
- Landoni G, Turi S, Biondi-Zoccai G, Bignami E, Testa V, Belloni I, Cornero G, Zangrillo A. Esmolol reduces perioperative ischemia in noncardiac surgery: a meta-analysis of randomized controlled studies. J Cardiothorac Vasc Anesth. 2010 Apr;24(2):219-29. doi: 10.1053/j.jvca.2009.07.008. Epub 2009 Oct 2.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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