Intravenous Cannulation In Children During Sevoflurane Induction

NCT ID: NCT03851692

Last Updated: 2019-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-01

Study Completion Date

2016-12-31

Brief Summary

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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

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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.

Conditions

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Intravenous Cannulation Sevoflurane Induction Child

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective randomized single blinded parallel group controlled study
Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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60s (group E)

Intravenous cannulation was released either 60 s following loss of lid reflex in group E

Group Type ACTIVE_COMPARATOR

Intravenous Cannulation (iv placement)

Intervention Type OTHER

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.

90 or 120 s (groupe L)

Intravenous cannulation was released either 90 or 120 s following loss of lid reflex in group L

Group Type ACTIVE_COMPARATOR

Intravenous Cannulation (iv placement)

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Fattouma Bourguiba

OTHER

Sponsor Role lead

Responsible Party

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Ben ALI Manel

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Manel Ben Ali, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Fattouma Bourguiba Monastir TUNISIA

References

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Hasan AK, Sivasankar R, Nair SG, Hasan WU, Latif Z. Optimum time for intravenous cannulation after induction with sevoflurane, oxygen, and nitrous oxide in children without any premedication. Paediatr Anaesth. 2018 Feb;28(2):179-183. doi: 10.1111/pan.13308. Epub 2018 Jan 8.

Reference Type BACKGROUND
PMID: 29316032 (View on PubMed)

Kumar KR, Sinha R, Chandiran R, Pandey RK, Darlong V, Chandralekha. Evaluation of optimum time for intravenous cannulation after sevoflurane induction of anesthesia in different pediatric age groups. J Anaesthesiol Clin Pharmacol. 2017 Jul-Sep;33(3):371-374. doi: 10.4103/joacp.JOACP_58_16.

Reference Type BACKGROUND
PMID: 29109638 (View on PubMed)

Other Identifiers

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0925-0586

Identifier Type: -

Identifier Source: org_study_id

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