Intravenous Cannulation In Children During Sevoflurane Induction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-01

Study Completion Date

2016-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Catheterization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

randomized and crossover assignemnt

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

particippant, investigator, outcomes assessor

Study Groups

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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

Group Type OTHER

Difficulty of catheterization in group 60 s

Intervention Type OTHER

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

Group Type OTHER

Difficulty of catheterization in group 90 s

Intervention Type OTHER

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

Group Type OTHER

Difficulty of catheterization in group 120 s

Intervention Type OTHER

Interventions

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Difficulty of catheterization in group 60 s

Intervention Type OTHER

Difficulty of catheterization in group 90 s

Intervention Type OTHER

Difficulty of catheterization in group 120 s

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

1 Year

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No