Intravenous Cannulation In Children During Sevoflurane Induction

Catheterization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03254303
• Other study ID #: OMB: 0925-0586
• Status: Completed
• Phase: N/A
• First received: August 11, 2017
• Last updated: August 17, 2017
• Start date: August 1, 2016
• Est. completion date: October 31, 2016

Study information

• Verified date: August 2017
• Source: University of Monastir
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

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

Eligibility

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

Related Conditions & MeSH terms

• Catheterization

Intervention

Other:
• Difficulty of catheterization in group 60 s

• Difficulty of catheterization in group 90 s

• Difficulty of catheterization in group 120 s

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Leila mansali stambouli

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	laryngospasm	laryngospasm was defined as the sudden complete or partial loss of air exchange with concurrent loss of a capnographic wave.	from the end of study period of time after the loss of eyelash reflex to successful cannulation less than 30 seconds
Primary	Success of intravenous insertion	success insertion of intravenous cannula was achieved at the first attempt less than 30 seconds	from the end of study period of time after the loss of eyelash reflex to successful cannulation less than 30 seconds
Secondary	limb movement	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 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)	from the end of study period of time after the loss of eyelash reflex to successful cannulation less than 30 seconds