Intravenous Cannulation In Children During Sevoflurane Induction

NCT03254303 | Completed

• 1 other identifier: OMB: 0925-0586
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Catheterization

Keywords

Sevoflurane, Catheterization, Anesthetics Inhalation, child

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• limb movement

  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

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

Study Arms (3)

60s (group E)

OTHER

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

90s (groupe L)

OTHER

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

120s (groupe L)

OTHER

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

Difficulty of catheterization in group 60 s OTHER

60s (group E)

Difficulty of catheterization in group 90 s OTHER

90s (groupe L)

Difficulty of catheterization in group 120 s OTHER

120s (groupe L)

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Leila mansali stambouli: lead

Related Publications (2)

• 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.

  PMID: 9549737 BACKGROUND

• 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.

  PMID: 15385009 RESULT

MeSH Terms

Interventions

Population Groups

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• leila Mansali Stambouli, MD PhD

  University Hospital of Fattouma Bourguiba Monastir TUNISIA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: particippant, investigator, outcomes assessor
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator and Clinical Professor

Model Details: randomized and crossover assignemnt

Study Record Dates

• First Submitted: August 11, 2017
• First Posted: August 18, 2017
• Study Start: August 1, 2016
• Primary Completion: October 31, 2016
• Study Completion: October 31, 2016
• Last Updated: August 18, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share