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Intravenous Cannulation In Children During Sevoflurane Induction

2017年8月17日更新者：Leila mansali stambouli

Intravenous Cannulation In Children During Sevoflurane Induction: Which Time is Adequate

This interventional simple-blind,randomized trial has included 90 children of American Society of Anesthesiologist (ASA) physical status I or II aged between 1 to 12 years of either sex, scheduled for for outpatient minor surgery under general anesthesia. This study examined whether one should make iv attempts during the early induction period (at 60 seconds) or lately (90 or 120 s) and waiting until the child receives additional sevoflurane inhalation anesthesia.

研究概览

地位

完全的

条件

导尿

干预/治疗

详细说明

We conducted a prospective randomized study, after obtaining Institutional review board approval, which didn't require written parental consent. Children age 1-12 years, undergoing elective general anesthesia via an inhalation induction were randomized to one of three groups of 30 patients each one, for iv placement, either 60s (group E), 90 or 120 s (group L) following loss of lid reflex. Movement on iv placement and incidence of laryngospasm were determined. Difficulty with iv placement was also recorded. Statistical analysis included contingency testing, ANOVA, and non parametric testing. A P-value <0.05 was considered significant.

研究类型

介入性

注册 (实际的)

阶段

不适用

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

1年至 12年 (孩子)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

children with American Society of Anesthesiologist (ASA) physical status I or II
age between 1 and 12 years of either sex,
were scheduled for outpatient minor surgery under general anesthesia

Exclusion Criteria:

age <1 and >12 years
patients with full stomach
a history of gastric reflux
history of convulsions, cardiovascular or neuromuscular disease
suspected difficult airway and hyper-reactive airway disease

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：其他
分配：随机化
介入模型：交叉作业
屏蔽：三倍

手臂数量

武器和干预

参与者组/臂	干预/治疗
其他：60s (group E) The Time of catheterization at 60s (group E) was applied in this study group,after sevoflurane inhalation induction, 30 children have a catheterization after a time of 60 seconds following the eye closure and the loss of lid reflex.Difficulty with intravenous catheterization, limb movement and laryngospasm were recorded.Difficulty of catheterization in group 60 s	其他：Difficulty of catheterization in group 60 s
其他：90s (groupe L) In this study group,after sevoflurane inhalation induction, 30 children have a catheterization after a time of 90 seconds following the eye closure and the loss of lid reflex.Difficulty with intravenous catheterization, limb movement and laryngospasm were recorded.Difficulty of catheterization in group 90 s	其他：Difficulty of catheterization in group 90 s
其他：120s (groupe L) In this study group,after sevoflurane inhalation induction, 30 children have a catheterization after a time of 120 seconds following the eye closure and the loss of lid reflex.Difficulty with intravenous catheterization, limb movement and laryngospasm were recorded.Difficulty of catheterization in group 120 s	其他：Difficulty of catheterization in group 120 s

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Success of intravenous insertion 大体时间：from the end of study period of time after the loss of eyelash reflex to successful cannulation less than 30 seconds	success insertion of intravenous cannula was achieved at the first attempt less than 30 seconds	from the end of study period of time after the loss of eyelash reflex to successful cannulation less than 30 seconds

次要结果测量

结果测量	措施说明	大体时间
limb movement 大体时间：from the end of study period of time after the loss of eyelash reflex to successful cannulation less than 30 seconds	The movement was classified using the scale: (0 No movement, 1 movement) The incidence of laryngospasm was defined as the sudden complete or partial loss of air exchange with concurrent loss of a capnographic wave. The movement was classified using the scale: (0 No movement, 1 movement) The incidence of laryngospasm was defined as the sudden complete or partial loss of air exchange with concurrent loss of a capnographic wave. • The movement was classified using the scale: (0 No movement, 1 movement) • The movement was classified using the scale: (0 No movement, 1 movement) The limb movement was classified using the scale:0 No movement, 1 movement)	from the end of study period of time after the loss of eyelash reflex to successful cannulation less than 30 seconds

其他结果措施

结果测量	措施说明	大体时间
laryngospasm 大体时间：from the end of study period of time after the loss of eyelash reflex to successful cannulation less than 30 seconds	laryngospasm was defined as the sudden complete or partial loss of air exchange with concurrent loss of a capnographic wave.	from the end of study period of time after the loss of eyelash reflex to successful cannulation less than 30 seconds

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Leila mansali stambouli

调查人员

首席研究员：leila Mansali Stambouli, MD PhD、University Hospital of Fattouma Bourguiba Monastir TUNISIA

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2016年8月1日

初级完成 (实际的)

2016年10月31日

研究完成 (实际的)

2016年10月31日

研究注册日期

首次提交

2017年8月11日

首先提交符合 QC 标准的

2017年8月17日

首次发布 (实际的)

2017年8月18日

研究记录更新

最后更新发布 (实际的)

2017年8月18日

上次提交的符合 QC 标准的更新

2017年8月17日

最后验证

2017年8月1日

Intravenous Cannulation In Children During Sevoflurane Induction