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临床试验/NCT01131741
NCT01131741
Unknown
不适用

Comparison of Perfusion Index, T Wave Amplitude, Systolic Blood Pressure and Heart Rate as an Indicator for Detecting Intravascular Injection of Epinephrine Containing Test Dose During Operation in Anesthetized Adults

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 50 人2010年5月

概览

阶段
不适用
干预措施
Epinephrine
疾病 / 适应症
Injections, Intravenous
发起方
Seoul National University Hospital
入组人数
50
试验地点
1
主要终点
change of perfusion index from baseline
最后更新
15年前

概览

简要总结

The purpose of this study is to determine whether changes in perfusion index can be used for detecting intravascular injection of an epinephrine in anesthetized adults and to compare its reliability with criteria using changes in heart rate, systolic blood pressure or T-wave amplitude.

详细描述

Intravenous injection of local anesthetics could result in life-threatening complications during general anesthesia. Physicians usually use local anesthetics containing epinephrine to detect intravascular injection. Existing methods including heart rate, systolic blood pressure and T-wave amplitude are unreliable to detect intravascular injection during anesthesia and a method using changes in perfusion index was recently suggested. This study was designed to determine whether perfusion index is a reliable method to detect intravascular injection of epinephrine containing local anesthetics and to compare its reliability with conventional criteria in sevoflurane anesthetized adults. We will randomize patients to 2 groups: a saline group and an epinephrine group. Changes in perfusion index, systolic blood pressure, heart rate and T-wave amplitude will be measured during 5 minutes after injection of 3 mL of saline or 1% lidocaine containing epinephrine. we will determine sensitivity, specificity, positive predictive value and negative predictive value.

注册库
clinicaltrials.gov
开始日期
2010年5月
结束日期
2011年4月
最后更新
15年前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

入排标准

入选标准

  • ASA physical status 1 patients undergoing general anesthesia for elective surgery

排除标准

  • emergent operation
  • those who are taking anticoagulant medication, calcium channel blockers, or b-blockers
  • laparoscopic operation
  • history of smoking

研究组 & 干预措施

Epinephrine

干预措施: Epinephrine

Control

干预措施: Control

结局指标

主要结局

change of perfusion index from baseline

时间窗: during 5 min after injection of epinephrine containing test dose or saline

we will observe the change of perfusion index from baseline during 5 min after injection of epinephrine containing test dose or saline. Patients whose perfusion index decrease more than 25% are defined as positive response.we will obtain the sensitivity, specificity, positive predictive value, negative predictive value using perfusion index criteria to determine the reliability of perfusion index criteria.

次要结局

  • change of systolic blood pressure, heart rate, T-wave amplitude from baseline(during 5 min after injection of epinephrine containing test dose or saline)

研究点 (1)

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