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临床试验/NCT00290108
NCT00290108已完成不适用

The Influence of Injection Rate on EEG Propofol Peak Effect as Measured by Bispectral Index

Technical University of Munich1 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2003年3月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
99
试验地点
1
主要终点
maximum hypnotic effect as indicated by the minimum BIS value.

研究概览

简要总结

The aim of the present study was to investigate whether injection rate of propofol has an influence on its maximum effect.

详细描述

The clinical daily routine indicates that slowing the rate of administration of propofol can lead to a reduction of up to 50% in the dose of propofol required to achieve the onset of a clinical endpoint of anesthesia (i.e. loss of consciousness) when titrating to effect. Therefore, it has been concluded that a slow injection requires a smaller dose of propofol as the graded effect is weakened by fast injection. This conclusion contradicts pharmacologic considerations, that a fast injection would lead to a higher peak concentration and in consequence, to a higher peak effect at the effect side, the brain.

The present study was designed to measure the Electroencephalogram (EEG) peak effect of a propofol bolus (2 mg/kg) injected with different infusion rates.

Although it is known that propofol has cardiovascular effects, the influence of injection rate on these cardiovascular changes is less clear. Others found that faster injection rates of propofol caused greater reductions in blood pressure. Other similar studies have shown no difference in blood pressure for different injection rates. An additional aim of this study was therefore to investigate the influence of different injection rates on hemodynamic parameters.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologists (ASA) physical status 1-3
  • scheduled for elective surgery under general anesthesia.

排除标准

  • emergency surgery
  • indication for rapid sequence induction
  • drugs that affect the central nervous system
  • history of alcohol or drug abuse
  • neurological or psychiatric diseases
  • contraindications against the use of propofol

结局指标

主要结局

maximum hypnotic effect as indicated by the minimum BIS value.

次要结局

  • time to loss of consciousness
  • time to loss of eye lash reflex
  • time to BISmin
  • BIS at LOC
  • BIS at LOL
  • BIS 30 seconds after LOC

研究者

发起方
Technical University of Munich
申办方类型
Other

研究点 (1)

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