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临床试验/NCT03254303
NCT03254303已完成不适用

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

Leila mansali stambouli0 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
发起方
入组人数
90
主要终点
Success of intravenous insertion

研究概览

简要总结

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.

详细描述

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.

研究设计

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

盲法说明

particippant, 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

  • 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

排除标准

  • 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

结局指标

主要结局

Success of intravenous insertion

时间窗: 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

次要结局

  • limb movement(from the end of study period of time after the loss of eyelash reflex to successful cannulation less than 30 seconds)

研究者

发起方
Leila mansali stambouli
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Leila mansali stambouli

Principal Investigator and Clinical Professor

University of Monastir

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