Intravenous Cannulation In Children During Sevoflurane Induction

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

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.

Study Overview

• Status: Completed
• Conditions: Catheterization
• Intervention / Treatment: Other: Difficulty of catheterization in group 60 s; Other: Difficulty of catheterization in group 90 s; Other: Difficulty of catheterization in group 120 s

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success of intravenous insertion	success insertion of intravenous cannula was achieved at the first attempt less than 30 seconds	from the end of study period of time after the loss of eyelash reflex to successful cannulation less than 30 seconds

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	from the end of study period of time after the loss of eyelash reflex to successful cannulation less than 30 seconds

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
laryngospasm	laryngospasm was defined as the sudden complete or partial loss of air exchange with concurrent loss of a capnographic wave.	from the end of study period of time after the loss of eyelash reflex to successful cannulation less than 30 seconds

Collaborators and Investigators

• Sponsor: Leila mansali stambouli
• Investigators: Principal Investigator: leila Mansali Stambouli, MD PhD, University Hospital of Fattouma Bourguiba Monastir TUNISIA

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): October 31, 2016
• Study Completion (Actual): October 31, 2016

Study Registration Dates

• First Submitted: August 11, 2017
• First Submitted That Met QC Criteria: August 17, 2017
• First Posted (Actual): August 18, 2017

Study Record Updates

• Last Update Posted (Actual): August 18, 2017
• Last Update Submitted That Met QC Criteria: August 17, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Sevoflurane, Catheterization, Anesthetics Inhalation, child
• Other Study ID Numbers: OMB: 0925-0586

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No