A Study on Safety and Efficacy of Propofol in Small Children Under 2 Years of Age

April 26, 2017 updated by: Hee-Soo Kim, Seoul National University Hospital

A Retrospective Study on Safety and Efficacy of Propofol in Small Children

This retrospective study the safety and efficacy of intravenous propofol used in children under 2 years of age during general anesthesia for surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

EMR review of intravenous propofol used in target controlled infusion method in children under 2 years old.

Study Type

Observational

Enrollment (Actual)

100

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

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

No older than 2 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children who underwent surgery From September 2013 to December 2016 , and received intravenous propofol for general anesthesia will be enrolled.

Description

Inclusion Criteria:

  • Children under 2 years of age
  • Children who received intravenous propofol for maintenance of anesthesia

Exclusion Criteria:

  • Children who underwent general anesthesia with inhalational anesthetics

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
children < 2 years old
Children under 2 years of age who received intravenous propofol during general anesthesia.
Drug: Propofol
Intravenous administration with dose of 100-200mcg/kg/min

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety: blood pressure
Time Frame: Intraoperative 1 day
blood pressure
Intraoperative 1 day
Safety: blood pressure
Time Frame: Intraoperative 7th days
blood pressure
Intraoperative 7th days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bispectral index
Time Frame: Intraoperative
optimal surgical condition
Intraoperative

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

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)

April 20, 2017

Primary Completion (Actual)

April 22, 2017

Study Completion (Actual)

April 22, 2017

Study Registration Dates

First Submitted

February 21, 2017

First Submitted That Met QC Criteria

April 26, 2017

First Posted (Actual)

April 28, 2017

Study Record Updates

Last Update Posted (Actual)

April 28, 2017

Last Update Submitted That Met QC Criteria

April 26, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H1612-136-821

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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