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Completed

NCT Number: NCT03254303

Intravenous Cannulation In Children During Sevoflurane Induction

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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Key information

Conditions

Catheterization

Age range

1 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Difficulty of catheterization in group 60 s

Other

Difficulty of catheterization in group 90 s

Other

Difficulty of catheterization in group 120 s

Other

Primary outcomes

  1. Success of intravenous insertion

    Time frame: 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

Secondary outcomes

  1. limb movement

    Time frame: 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)

Other outcomes

  1. laryngospasm

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Leila mansali stambouli

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
Aug 18, 2017
Registry last updated
Aug 18, 2017

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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