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Clinical Trials/NCT03254303
NCT03254303
Completed
Not Applicable

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

Leila mansali stambouli0 sites90 target enrollmentAugust 1, 2016
ConditionsCatheterization

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Catheterization
Sponsor
Leila mansali stambouli
Enrollment
90
Primary Endpoint
Success of intravenous insertion
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2016
End Date
October 31, 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Leila mansali stambouli
Responsible Party
Sponsor Investigator
Principal Investigator

Leila mansali stambouli

Principal Investigator and Clinical Professor

University of Monastir

Eligibility Criteria

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

Outcomes

Primary Outcomes

Success of intravenous insertion

Time Frame: 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 Outcomes

  • limb movement(from the end of study period of time after the loss of eyelash reflex to successful cannulation less than 30 seconds)

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