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Target-controlled Infusion of Propofol for Induction of Pediatric Anesthesia

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ClinicalTrials.gov Identifier: NCT01411020
Recruitment Status : Completed
First Posted : August 5, 2011
Last Update Posted : May 15, 2013
Sponsor:
Information provided by (Responsible Party):
Ricardo Fuentes Henriquez, Pontificia Universidad Catolica de Chile

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Children Under General Anesthesia Procedure: endotracheal intubation Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
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
Study Start Date : October 2009
Actual Primary Completion Date : August 2012
Actual Study Completion Date : November 2012
Arms and Interventions
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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,


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


Eligibility Criteria
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Information from the National Library of Medicine

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

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