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CompletedNCT03254303Updated Aug 18, 2017

Intravenous Cannulation In Children During Sevoflurane Induction

An interventional study of Difficulty of catheterization in group 60 s and Difficulty of catheterization in group 90 s in Catheterization, sponsored by Leila mansali stambouli. Completed. Open to participants aged 1 Year to 12 Years. Per ClinicalTrials.gov, last updated 2017-08-18.

Sponsored by Leila mansali stambouli · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
1 Year to 12 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Catheterization

Keywords

  • Sevoflurane, Catheterization, Anesthetics Inhalation, child
03

Who can participate

Ages eligible
1 Year to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
90 participants (actual)

Study arms

  • Other
    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

    Other: Difficulty of catheterization in group 60 s

  • 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

    Other: Difficulty of catheterization in group 90 s

  • 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

    Other: Difficulty of catheterization in group 120 s

Interventions

  • OtherDifficulty of catheterization in group 60 s
  • OtherDifficulty of catheterization in group 90 s
  • OtherDifficulty of catheterization in group 120 s
05

What researchers measure

Primary outcomes

  1. Success of intravenous insertion

    success insertion of intravenous cannula was achieved at the first attempt less than 30 seconds

    Time frame: from the end of study period of time after the loss of eyelash reflex to successful cannulation less than 30 seconds

Secondary outcomes

  1. limb movement

    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)

    Time frame: from the end of study period of time after the loss of eyelash reflex to successful cannulation less than 30 seconds

Other outcomes

  1. laryngospasm

    laryngospasm was defined as the sudden complete or partial loss of air exchange with concurrent loss of a capnographic wave.

    Time frame: from the end of study period of time after the loss of eyelash reflex to successful cannulation less than 30 seconds

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • Choudhry DK, Stayer SA, Schwartz RE, Pasquariello CA. Early intravenous cannulation in children during inhalational induction of anaesthesia. Paediatr Anaesth. 1998;8(2):123-6. doi: 10.1046/j.1460-9592.1998.00731.x. PubMed 9549737 ↗
  • Schwartz D, Connelly NR, Gutta S, Freeman K, Gibson C. Early intravenous cannulation in children during sevoflurane induction. Paediatr Anaesth. 2004 Oct;14(10):820-4. doi: 10.1111/j.1460-9592.2004.01315.x. PubMed 15385009 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03254303
Lead sponsor
Leila mansali stambouli
Responsible party
Leila mansali stambouli (Principal Investigator and Clinical Professor, University of Monastir) — Sponsor-investigator
First posted
Aug 18, 2017
Start date
Aug 1, 2016
Primary completion
Oct 31, 2016
Completion
Oct 31, 2016
Last update
Aug 18, 2017

Study contacts

leila Mansali Stambouli, MD PhD
principal investigator · University Hospital of Fattouma Bourguiba Monastir TUNISIA

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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