Intravenous Cannulation In Children During Sevoflurane Induction

Child Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03851692
• Other study ID #: 0925-0586
• Status: Completed
• Phase: N/A
• Start date: August 1, 2016
• Est. completion date: December 31, 2016

Study information

• Verified date: February 2019
• Source: University Hospital Fattouma Bourguiba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Child
• Intravenous Cannulation
• Sevoflurane Induction

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Fattouma Bourguiba

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Movement on iv placement	Number of children who presented movement on iv placement	In the first 5 min after the anesthesic induction with sevoflurane
Primary	laryngospasm	The incidence of laryngospasm	Time From Intravenous Cannulation to patient extubation