Optimum Time for Intravenous Cannulation After Induction... | NCT04284579

Studies
Optimum Time for Intravenous Cannulation After Induction With Sevoflurane in Pediatric Patient

NCT04284579

Sponsor

Indonesia University

Status

Completed

Last Update Posted

Feb 26, 2020Actual

Enrollment

22Actual

Phase

Not Applicable

Conditions

Movement After Intravenous Cannulation

Interventions

IV cannula

Countries

Indonesia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 27, 2019Actual

Primary Completion Date

Jul 5, 2019Actual

Completion Date

Nov 30, 2019Actual

First Submitted Date

Feb 23, 2020

First Submission Date that Met QC Criteria

Feb 23, 2020

First Posted Date

Feb 26, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 23, 2020

Last Update Posted Date

Feb 26, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study aimed to determinate effective dose 95 (ED95) intravenous cannulation in pediatric patient after induction of sevoflurane 8 vol%

Detailed Description

Twenty-two subjects were given informed consent before study enrolled. Anesthesia was induced by 8% sevoflurane with 6 L flow of 100% oxygen. IV cannulation was attempted at 2 min in the first child in each group. The time for cannulation in the next child was stepped up or down by 15 s depending on positive or negative response, respectively, in the previous child. Children were recruited till a minimum of six pairs of failure-success sequence which was obtained in the group. The mean of midpoints of the failure-success sequence was calculated to obtain the time for cannulation in 50% of the group.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
time for cannulation	Experimental	intravenous cannulation after sevoflurane induction	Device: IV cannula

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IV cannula	Device	We measure the time duration needed for IV cannulation	time for cannulation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ED50 in intravenous cannulation after sevoflurane induction	using Dixon Up and Down Method	2 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 1-3 year
Physical state ASA I dan II
Parents of patients who agreed to participate and sign informed consent.

Exclusion criteria:

Patients with difficult airway
There's allergic reaction or drug's side effect after induction
There's cardiorespiratory problem such as anaphylactic shock, aritmia, severe hypotension, desaturation before-on-or after induction

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

3 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jefferson K Hidayat	Indonesia University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Indonesia University		Jakarta	DKI Jakarta	10430	Indonesia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15385009	Result	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.
29109638	Result	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.

ID	Term
D057785	Catheters
D004864	Equipment and Supplies