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临床试验/NCT03851692
NCT03851692已完成不适用

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

University Hospital Fattouma Bourguiba0 个研究点目标入组 90 人开始时间: 2016年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
90
主要终点
laryngospasm

研究概览

简要总结

The early placement of an intravenous (iv) line in children anesthetized with halothane has been shown safe and acceptable compared with later placement. However, there's not well known with sevoflurane use (2). The aim of the investigator's study is to determine whether one should make iv attempts during the early induction period (at 60seconds) or lately (90 or 120 s) and waiting until the child receives additional sevoflurane inhalation anesthesia

详细描述

the investigators 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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
1 Year 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • ASA I, II
  • Age from 1 to 12 years old
  • Ambulatory surgery under general anesthesia.

排除标准

  • Age <1 year or> 12 years
  • non-ambulatory surgery,
  • contraindication for induction with sevoflurane

结局指标

主要结局

laryngospasm

时间窗: Time From Intravenous Cannulation to patient extubation

The incidence of laryngospasm

Movement on iv placement

时间窗: In the first 5 min after the anesthesic induction with sevoflurane

Number of children who presented movement on iv placement

次要结局

未报告次要终点

研究者

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

Ben ALI Manel

Clinical Professor

University Hospital Fattouma Bourguiba

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