Intravenous Cannulation In Children During Sevoflurane Induction

NCT03851692 | Completed

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

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

Conditions

Intravenous Cannulation; Sevoflurane Induction; Child

Keywords

Sevoflurane; Intravenous Cannulation; anesthesia; child

Outcome Measures

Primary Outcomes (2)

• Movement on iv placement

  Number of children who presented movement on iv placement

  In the first 5 min after the anesthesic induction with sevoflurane

• laryngospasm

  The incidence of laryngospasm

  Time From Intravenous Cannulation to patient extubation

Study Arms (2)

60s (group E)

ACTIVE COMPARATOR

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

Other: Intravenous Cannulation (iv placement)

90 or 120 s (groupe L)

ACTIVE COMPARATOR

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

Other: Intravenous Cannulation (iv placement)

Interventions

Intravenous Cannulation (iv placement) 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.

60s (group E); 90 or 120 s (groupe L)

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Fattouma Bourguiba: lead

Related Publications (2)

• 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.

  PMID: 29316032 BACKGROUND

• 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.

  PMID: 29109638 BACKGROUND

MeSH Terms

Interventions

Drug Implants

Intervention Hierarchy (Ancestors)

Delayed-Action Preparations; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Manel Ben Ali, MD

  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
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Prospective randomized single blinded parallel group controlled study

Study Record Dates

• First Submitted: October 27, 2018
• First Posted: February 22, 2019
• Study Start: August 1, 2016
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2016
• Last Updated: February 22, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share