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Completed

NCT Number: NCT03851692

Intravenous Cannulation In Children During Sevoflurane Induction

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

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Key information

Conditions

Intravenous Cannulation Child Sevoflurane Induction

Age range

1 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Intravenous Cannulation (iv placement)

Other

The aim of our study is to determine whether one should make intravenous attempts placement during the early induction period (at 60seconds) or lately (90 or 120 s) and waiting until the child receives additional sevoflurane inhalation anesthesia.

Primary outcomes

  1. Movement on iv placement

    Time frame: In the first 5 min after the anesthesic induction with sevoflurane

    Number of children who presented movement on iv placement

  2. laryngospasm

    Time frame: Time From Intravenous Cannulation to patient extubation

    The incidence of laryngospasm

Sponsors and collaborators

Lead sponsor

University Hospital Fattouma Bourguiba

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 22, 2019
Registry last updated
Feb 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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