Target-controlled Infusion of Propofol for Induction of Pediatric Anesthesia

May 14, 2013 updated by: Ricardo Fuentes Henriquez, Pontificia Universidad Catolica de Chile

Target-controlled Infusion (TCI) of Propofol for Induction in Children 3 to 11 Years

The purpose of this study is to determine a effect-site concentration of propofol in children 3 to 11 years effective to make a induction of general anesthesia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

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

  • Chile
    • Metropolitana
      • Santiago, Metropolitana, Chile
        • Hospital Clinico Universidad Catolica

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

3 years to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • obtained informed consent
  • children between 3 and 11 years
  • healthy
  • elective surgery under general anesthesia
  • no premedication

Exclusion Criteria:

  • body mass index for age > 95th percentile
  • chronic or acute intake of any sedative drug
  • any known adverse effect to the study drugs

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
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Grupo 1
Doses of induction: propofol 4 mcg/ml and fentanyl 3 mcg/kg
Procedure: endotracheal intubation
to perform endotracheal intubation if number of bispectral index (BIS) is 40-60,
Experimental: Grupo 2
Dose of induction: propofol 4.5 mcg/ml and fentanyl 3 mcg/kg
Procedure: endotracheal intubation
to perform endotracheal intubation if number of bispectral index (BIS) is 40-60,
Experimental: Grupo 3
Doses of propofol: propofol 5 mcg/ml and fentanyl 3 mcg/kg
Procedure: endotracheal intubation
to perform endotracheal intubation if number of bispectral index (BIS) is 40-60,
Experimental: Grupo 4
Doses of induction: propofol 5.5 mcg/ml and fentanyl 3 mcg/kg
Procedure: endotracheal intubation
to perform endotracheal intubation if number of bispectral index (BIS) is 40-60,
Experimental: Grupo 5
Doses of induction: propofol 6 mcg/ml and fentanyl 3 mcg/kg
Procedure: endotracheal intubation
to perform endotracheal intubation if number of bispectral index (BIS) is 40-60,
Experimental: Grupo 6
Doses of induction: propofol 4 mcg/ml and fentanyl 5 mcg/kg
Procedure: endotracheal intubation
to perform endotracheal intubation if number of bispectral index (BIS) is 40-60,
Experimental: Grupo 7
Doses of induction: propofol 4.5 mcg/ml and fentanyl 5 mcg/kg
Procedure: endotracheal intubation
to perform endotracheal intubation if number of bispectral index (BIS) is 40-60,
Experimental: Grupo 8
Doses of induction: propofol 5 mcg/ml and fentanyl 5 mcg/kg
Procedure: endotracheal intubation
to perform endotracheal intubation if number of bispectral index (BIS) is 40-60,
Experimental: Grupo 9
Doses of induction: propofol 5.5 mcg/ml and fentanyl 5 mcg/kg
Procedure: endotracheal intubation
to perform endotracheal intubation if number of bispectral index (BIS) is 40-60,
Experimental: Grupo 10
Doses of induction: propofol 6 mcg/ml and fentanyl 5 mcg/kg
Procedure: endotracheal intubation
to perform endotracheal intubation if number of bispectral index (BIS) is 40-60,

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
dose of propofol
Time Frame: two days (duration of hospitalization)
to obtain a dose appropriate of propofol in induction of anesthesia
two days (duration of hospitalization)

Collaborators and Investigators

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

Sponsor

Pontificia Universidad Catolica de Chile

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

October 1, 2009

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

August 3, 2011

First Submitted That Met QC Criteria

August 4, 2011

First Posted (Estimate)

August 5, 2011

Study Record Updates

Last Update Posted (Estimate)

May 15, 2013

Last Update Submitted That Met QC Criteria

May 14, 2013

Last Verified

August 1, 2009

More Information

Terms related to this study

Other Study ID Numbers

  • Ricardo Fuentes
  • Hernan Muñoz

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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