Intravenous Cannulation In Children During Sevoflurane Induction

• Sponsor: University Hospital Fattouma Bourguiba (Other)
• Overall Status: Completed
• CT.gov ID: NCT03851692
• Collaborator: (none)
• Enrollment: 90
• Arms: 2
• Actual Duration (Months): 5

Study Details

Study Description

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

1. and waiting until the child receives additional sevoflurane inhalation anesthesia

Condition or Disease	Intervention/Treatment	Phase
Intravenous Cannulation; Sevoflurane Induction; Child	Other: Intravenous Cannulation (iv placement)	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Prospective randomized single blinded parallel group controlled studyProspective randomized single blinded parallel group controlled study
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Intravenous Cannulation In Children During Sevoflurane Induction: Which Time is Adequate
• Actual Study Start Date: Aug 1, 2016
• Actual Primary Completion Date: Dec 31, 2016
• Actual Study Completion Date: Dec 31, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 60s (group E) Intravenous cannulation was released either 60 s following loss of lid reflex in group E	Other: Intravenous Cannulation (iv placement); The aim of our study is to determine whether one should make intravenous attempts placement during the early induction period (at 60seconds) or lately (90 or 120 s) and waiting until the child receives additional sevoflurane inhalation anesthesia.
Active Comparator: 90 or 120 s (groupe L) Intravenous cannulation was released either 90 or 120 s following loss of lid reflex in group L	Other: Intravenous Cannulation (iv placement); The aim of our study is to determine whether one should make intravenous attempts placement during the early induction period (at 60seconds) or lately (90 or 120 s) and waiting until the child receives additional sevoflurane inhalation anesthesia.

Outcome Measures

Primary Outcome Measures

1. Movement on iv placement [In the first 5 min after the anesthesic induction with sevoflurane]

   Number of children who presented movement on iv placement

2. laryngospasm [Time From Intravenous Cannulation to patient extubation]

   The incidence of laryngospasm

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 12 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University Hospital Fattouma Bourguiba

Investigators

• Principal Investigator: Manel Ben Ali, MD, University Hospital of Fattouma Bourguiba Monastir TUNISIA

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.

• Responsible Party: Ben ALI Manel, Clinical Professor, University Hospital Fattouma Bourguiba
• ClinicalTrials.gov Identifier: NCT03851692
• Other Study ID Numbers: 0925-0586
• First Posted: Feb 22, 2019
• Last Update Posted: Feb 22, 2019
• Last Verified: Feb 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ben ALI Manel, Clinical Professor, University Hospital Fattouma Bourguiba: Sevoflurane; Intravenous Cannulation; anesthesia; child

Study Results

No Results Posted as of Feb 22, 2019