Clinical trial NCT03851692: Intravenous Cannulation In Children During Sevoflurane Induction
Official title: Intravenous Cannulation In Children During Sevoflurane Induction: Which Time is Adequate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intravenous Cannulation
Sevoflurane Induction
Child
Keywords: Sevoflurane
Intravenous Cannulation
anesthesia
child
Lead sponsor: University Hospital Fattouma Bourguiba
Sponsor class: OTHER
First posted: 2019-02-22
Enrollment: 90
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized single blinded parallel group controlled study
Primary purpose: OTHER

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Movement on iv placement
timeFrame: In the first 5 min after the anesthesic induction with sevoflurane
measure: laryngospasm
timeFrame: Time From Intravenous Cannulation to patient extubation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital of Fattouma Bourguiba Monastir TUNISIA
name: Manel Ben Ali, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.