Intravenous Cannulation In Children During Sevoflurane Induction

Sponsor
Leila mansali stambouli (Other)
Overall Status
Completed
CT.gov ID
NCT03254303
Collaborator
(none)
90
3
3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Difficulty of catheterization in group 60 s
  • Other: Difficulty of catheterization in group 90 s
  • Other: Difficulty of catheterization in group 120 s
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
randomized and crossover assignemntrandomized and crossover assignemnt
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
particippant, investigator, outcomes assessor
Primary Purpose:
Other
Official Title:
Intravenous Cannulation In Children During Sevoflurane Induction: Which Time is Adequate
Actual Study Start Date :
Aug 1, 2016
Actual Primary Completion Date :
Oct 31, 2016
Actual Study Completion Date :
Oct 31, 2016

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Success of intravenous insertion [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 Outcome Measures

  1. limb movement [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 Outcome Measures

  1. laryngospasm [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Year to 12 Years
Sexes Eligible for Study:
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:
  • 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Leila mansali stambouli

Investigators

  • Principal Investigator: leila Mansali Stambouli, MD PhD, University Hospital of Fattouma Bourguiba Monastir TUNISIA

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Leila mansali stambouli, Principal Investigator and Clinical Professor, University of Monastir
ClinicalTrials.gov Identifier:
NCT03254303
Other Study ID Numbers:
  • OMB: 0925-0586
First Posted:
Aug 18, 2017
Last Update Posted:
Aug 18, 2017
Last Verified:
Aug 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Leila mansali stambouli, Principal Investigator and Clinical Professor, University of Monastir

Study Results

No Results Posted as of Aug 18, 2017