Intravenous Cannulation In Children During Sevoflurane Induction

Not Applicable

Completed

• Conditions: Catheterization
• Interventions: Other: Difficulty of catheterization in group 60 s; Other: Difficulty of catheterization in group 90 s; Other: Difficulty of catheterization in group 120 s

• Registration Number: NCT03254303
• Lead Sponsor: Leila mansali stambouli

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.

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 Timeline

• Study Start: 2016-08-01
• Primary Completion: 2016-10-31
• Study Completion: 2016-10-31
• Status Verified: 2017-08
• Study First Submitted: 2017-08-11
• Study First Submitted QC: 2017-08-17
• Last Update Submitted: 2017-08-17
• Study First Posted: 2017-08-18
• Last Update Posted: 2017-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
60s (group E)	Difficulty of catheterization in group 60 s	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
90s (groupe L)	Difficulty of catheterization in group 90 s	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
120s (groupe L)	Difficulty of catheterization in group 120 s	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)