Clinical trial NCT03254303: 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: Catheterization
Keywords: Sevoflurane, Catheterization, Anesthetics Inhalation, child
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2017-08-18
Enrollment: 90
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: randomized and crossover assignemnt
Primary purpose: OTHER

Brief summary: This interventional simple-blind,randomized trial has included 90 children of American Society of Anesthesiologist (ASA) physical status I or II aged between 1 to 12 years of either sex, scheduled for for outpatient minor surgery under general anesthesia. This study examined whether one should make iv attempts during the early induction period (at 60 seconds) or lately (90 or 120 s) and waiting until the child receives additional sevoflurane inhalation anesthesia.

Detailed description: We 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:

* children with American Society of Anesthesiologist (ASA) physical status I or II
* age between 1 and 12 years of either sex,
* were scheduled for outpatient minor surgery under general anesthesia

Exclusion Criteria:

* age \<1 and \>12 years
* patients with full stomach
* a history of gastric reflux
* history of convulsions, cardiovascular or neuromuscular disease
* suspected difficult airway and hyper-reactive airway disease

Primary outcomes:
measure: Success of intravenous insertion
timeFrame: from the end of study period of time after the loss of eyelash reflex to successful cannulation less than 30 seconds
Secondary outcomes:
measure: limb movement
timeFrame: from the end of study period of time after the loss of eyelash reflex to successful cannulation less than 30 seconds
Other outcomes:
measure: laryngospasm
timeFrame: from the end of study period of time after the loss of eyelash reflex to successful cannulation less than 30 seconds
Locations:
Study officials:
affiliation: University Hospital of Fattouma Bourguiba Monastir TUNISIA
name: leila Mansali Stambouli, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Choudhry DK, Stayer SA, Schwartz RE, Pasquariello CA. Early intravenous cannulation in children during inhalational induction of anaesthesia. Paediatr Anaesth. 1998;8(2):123-6. doi: 10.1046/j.1460-9592.1998.00731.x.
citation: Schwartz D, Connelly NR, Gutta S, Freeman K, Gibson C. Early intravenous cannulation in children during sevoflurane induction. Paediatr Anaesth. 2004 Oct;14(10):820-4. doi: 10.1111/j.1460-9592.2004.01315.x.