Intravenous Cannulation In Children During Sevoflurane Induction

February 20, 2019 updated by: Ben ALI Manel, University Hospital Fattouma Bourguiba

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 12 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 60s (group E)
Intravenous cannulation was released either 60 s following loss of lid reflex in group E
Other: Intravenous Cannulation (iv placement)
The aim of our study is to determine whether one should make intravenous attempts placement during the early induction period (at 60seconds) or lately (90 or 120 s) and waiting until the child receives additional sevoflurane inhalation anesthesia.
ACTIVE_COMPARATOR: 90 or 120 s (groupe L)
Intravenous cannulation was released either 90 or 120 s following loss of lid reflex in group L
Other: Intravenous Cannulation (iv placement)
The aim of our study is to determine whether one should make intravenous attempts placement during the early induction period (at 60seconds) or lately (90 or 120 s) and waiting until the child receives additional sevoflurane inhalation anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
In the first 5 min after the anesthesic induction with sevoflurane
laryngospasm
Time Frame: Time From Intravenous Cannulation to patient extubation
The incidence of laryngospasm
Time From Intravenous Cannulation to patient extubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Fattouma Bourguiba

Investigators

  • Principal Investigator: Manel Ben Ali, MD, University Hospital of Fattouma Bourguiba Monastir TUNISIA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2016

Primary Completion (ACTUAL)

December 31, 2016

Study Completion (ACTUAL)

December 31, 2016

Study Registration Dates

First Submitted

October 27, 2018

First Submitted That Met QC Criteria

February 20, 2019

First Posted (ACTUAL)

February 22, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 22, 2019

Last Update Submitted That Met QC Criteria

February 20, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Child

Clinical Trials on Intravenous Cannulation (iv placement)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Russia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe