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Target-controlled Infusion of Propofol for Induction of Pediatric Anesthesia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01411020
First Posted: August 5, 2011
Last Update Posted: May 15, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ricardo Fuentes Henriquez, Pontificia Universidad Catolica de Chile
  Purpose
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.

Condition Intervention Phase
Children Under General Anesthesia Procedure: endotracheal intubation Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Target-controlled Infusion (TCI) of Propofol for Induction in Children 3 to 11 Years

Resource links provided by NLM:


Further study details as provided by Ricardo Fuentes Henriquez, Pontificia Universidad Catolica de Chile:

Primary Outcome Measures:
  • dose of propofol [ Time Frame: two days (duration of hospitalization) ]
    to obtain a dose appropriate of propofol in induction of anesthesia


Enrollment: 60
Study Start Date: October 2009
Study Completion Date: November 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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,

  Eligibility

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Ages Eligible for Study:   3 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01411020


Locations
Chile
Hospital Clinico Universidad Catolica
Santiago, Metropolitana, Chile
Sponsors and Collaborators
Pontificia Universidad Catolica de Chile
  More Information

Publications:
Responsible Party: Ricardo Fuentes Henriquez, Profesor Asistente, Departamento de Anestesiología, Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier: NCT01411020     History of Changes
Other Study ID Numbers: Ricardo Fuentes
Hernan Muñoz
First Submitted: August 3, 2011
First Posted: August 5, 2011
Last Update Posted: May 15, 2013
Last Verified: August 2009

Additional relevant MeSH terms:
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics