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临床试验/NCT01628562
NCT01628562已完成4 期

A Comparison of the Perioperative Hemodynamic Effects of Remifentanil and Esmolol: a Double Blind Randomized Controlled Study

Diskapi Teaching and Research Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2012年6月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

Heart rate control, Beta blocker

干预措施: Esmolol (Drug)

GroupR/Remifentanil infusion

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

DILEK YAZICIOGLU

Doctor

Diskapi Teaching and Research Hospital

研究点 (1)

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