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Intravenous Cannulation In Children During Sevoflurane Induction

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03254303
Enrollment
90
Registered
2017-08-18
Start date
2016-08-01
Completion date
2016-10-31
Last updated
2017-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Catheterization

Keywords

Sevoflurane, Catheterization, Anesthetics Inhalation, child

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.

Interventions

OTHERDifficulty of catheterization in group 60 s
OTHERDifficulty of catheterization in group 90 s
OTHERDifficulty of catheterization in group 120 s

Sponsors

Leila mansali stambouli
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

particippant, investigator, outcomes assessor

Intervention model description

randomized and crossover assignemnt

Eligibility

Sex/Gender
ALL
Age
1 Years to 12 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Success of intravenous insertionfrom the end of study period of time after the loss of eyelash reflex to successful cannulation less than 30 secondssuccess insertion of intravenous cannula was achieved at the first attempt less than 30 seconds

Secondary

MeasureTime frameDescription
limb movementfrom the end of study period of time after the loss of eyelash reflex to successful cannulation less than 30 secondsThe movement was classified using the scale: (0 No movement, 1 movement) The incidence of laryngospasm was defined as the sudden complete or partial loss of air exchange with concurrent loss of a capnographic wave. The movement was classified using the scale: (0 No movement, 1 movement) The incidence of laryngospasm was defined as the sudden complete or partial loss of air exchange with concurrent loss of a capnographic wave. • The movement was classified using the scale: (0 No movement, 1 movement) • The movement was classified using the scale: (0 No movement, 1 movement) The limb movement was classified using the scale:0 No movement, 1 movement)

Other

MeasureTime frameDescription
laryngospasmfrom the end of study period of time after the loss of eyelash reflex to successful cannulation less than 30 secondslaryngospasm was defined as the sudden complete or partial loss of air exchange with concurrent loss of a capnographic wave.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026