Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2025-12-27 @ 10:34 AM
Study NCT ID:
NCT03851692
Status:
COMPLETED
Last Update Posted:
2019-02-22
First Post:
2018-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intravenous Cannulation In Children During Sevoflurane Induction
Sponsor:
University Hospital Fattouma Bourguiba
Organization:
Study Overview
Official Title:
Intravenous Cannulation In Children During Sevoflurane Induction: Which Time is Adequate
Status:
COMPLETED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: