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Clinical Trials/NCT03851692
NCT03851692
Completed
Not Applicable

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

University Hospital Fattouma Bourguiba0 sites90 target enrollmentAugust 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intravenous Cannulation
Sponsor
University Hospital Fattouma Bourguiba
Enrollment
90
Primary Endpoint
laryngospasm
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

The early placement of an intravenous (iv) line in children anesthetized with halothane has been shown safe and acceptable compared with later placement. However, there's not well known with sevoflurane use (2). The aim of the investigator's study is to determine whether one should make iv attempts during the early induction period (at 60seconds) or lately (90 or 120 s) and waiting until the child receives additional sevoflurane inhalation anesthesia

Detailed Description

the investigators 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.

Registry
clinicaltrials.gov
Start Date
August 1, 2016
End Date
December 31, 2016
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ben ALI Manel

Clinical Professor

University Hospital Fattouma Bourguiba

Eligibility Criteria

Inclusion Criteria

  • ASA I, II
  • Age from 1 to 12 years old
  • Ambulatory surgery under general anesthesia.

Exclusion Criteria

  • Age \<1 year or\> 12 years
  • non-ambulatory surgery,
  • contraindication for induction with sevoflurane

Outcomes

Primary Outcomes

laryngospasm

Time Frame: Time From Intravenous Cannulation to patient extubation

The incidence of laryngospasm

Movement on iv placement

Time Frame: In the first 5 min after the anesthesic induction with sevoflurane

Number of children who presented movement on iv placement

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