A Comparison of the Perioperative Hemodynamic Effects of Remifentanil and Esmolol: a Double Blind Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- It is the main objective of this study to compare the effect of esmolol and remifentanil on the incidence of tachycardia and hypertension
研究概览
简要总结
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.
详细描述
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
- 19 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Intracranial surgery
排除标准
- •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.
研究组 & 干预措施
GroupE/Esmolol infusion
Heart rate control, Beta blocker
干预措施: Esmolol (Drug)
GroupR/Remifentanil infusion
Heart rate control, opioid
干预措施: Remifentanil (Drug)
结局指标
主要结局
It is the main objective of this study to compare the effect of esmolol and remifentanil on the incidence of tachycardia and hypertension
时间窗: during intubation, head pin insertion, extubation, early postoperative period
次要结局
- the intraoperative fentanyl consumption(during intubation, head pin insertion, extubation, early postoperative period)
研究者
DILEK YAZICIOGLU
Doctor
Diskapi Teaching and Research Hospital
