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

February 23, 2020 updated by: Jefferson K Hidayat, Indonesia University

Determination Effective Dose 95 (ED95) of Intravenous Cannulation With the Induction of Sevoflurane 8 Vol% in Patients Aged 1-3 Years Using Dixon up and Down Method

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta, DKI Jakarta, Indonesia, 10430
        • Indonesia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: time for cannulation
intravenous cannulation after sevoflurane induction
Device: IV cannula
We measure the time duration needed for IV cannulation

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Investigators

  • Principal Investigator: Jefferson K Hidayat, Indonesia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 27, 2019

Primary Completion (Actual)

July 5, 2019

Study Completion (Actual)

November 30, 2019

Study Registration Dates

First Submitted

February 23, 2020

First Submitted That Met QC Criteria

February 23, 2020

First Posted (Actual)

February 26, 2020

Study Record Updates

Last Update Posted (Actual)

February 26, 2020

Last Update Submitted That Met QC Criteria

February 23, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IndonesiaUAnes50

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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