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Target-controlled Infusion of Propofol for Induction of Pediatric Anesthesia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ricardo Fuentes Henriquez, Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier:
NCT01411020
First received: August 3, 2011
Last updated: May 14, 2013
Last verified: August 2009
History of Changes
  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
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: 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:

Drug Information available for: Propofol
U.S. FDA Resources

Further study details as provided by Pontificia Universidad Catolica de Chile:

Primary Outcome Measures:
  • dose of propofol [ Time Frame: two days (duration of hospitalization) ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   3 Years to 11 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: August 3, 2011
Last Updated: May 14, 2013
Health Authority: Chile: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 21, 2013