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

Tracking Information
First Received Date ^ICMJE	August 3, 2011
Last Updated Date	May 14, 2013
Start Date ^ICMJE	October 2009
Primary Completion Date	August 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 4, 2011)	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
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01411020 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Target-controlled Infusion of Propofol for Induction of Pediatric Anesthesia
Official Title ^ICMJE	Target-controlled Infusion (TCI) of Propofol for Induction in Children 3 to 11 Years
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Children Under General Anesthesia
Intervention ^ICMJE	Procedure: endotracheal intubation to perform endotracheal intubation if number of bispectral index (BIS) is 40-60,
Study Arm (s)	Experimental: Grupo 1 Doses of induction: propofol 4 mcg/ml and fentanyl 3 mcg/kg Intervention: Procedure: endotracheal intubation Experimental: Grupo 2 Dose of induction: propofol 4.5 mcg/ml and fentanyl 3 mcg/kg Intervention: Procedure: endotracheal intubation Experimental: Grupo 3 Doses of propofol: propofol 5 mcg/ml and fentanyl 3 mcg/kg Intervention: Procedure: endotracheal intubation Experimental: Grupo 4 Doses of induction: propofol 5.5 mcg/ml and fentanyl 3 mcg/kg Intervention: Procedure: endotracheal intubation Experimental: Grupo 5 Doses of induction: propofol 6 mcg/ml and fentanyl 3 mcg/kg Intervention: Procedure: endotracheal intubation Experimental: Grupo 6 Doses of induction: propofol 4 mcg/ml and fentanyl 5 mcg/kg Intervention: Procedure: endotracheal intubation Experimental: Grupo 7 Doses of induction: propofol 4.5 mcg/ml and fentanyl 5 mcg/kg Intervention: Procedure: endotracheal intubation Experimental: Grupo 8 Doses of induction: propofol 5 mcg/ml and fentanyl 5 mcg/kg Intervention: Procedure: endotracheal intubation Experimental: Grupo 9 Doses of induction: propofol 5.5 mcg/ml and fentanyl 5 mcg/kg Intervention: Procedure: endotracheal intubation Experimental: Grupo 10 Doses of induction: propofol 6 mcg/ml and fentanyl 5 mcg/kg Intervention: Procedure: endotracheal intubation
Publications *	Muñoz HR, León PJ, Fuentes RS, Echevarría GC, Cortínez LI. Prospective evaluation of the time to peak effect of propofol to target the effect site in children. Acta Anaesthesiol Scand. 2009 Aug;53(7):883-90. Epub 2009 Jun 3.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	60
Completion Date	November 2012
Primary Completion Date	August 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	3 Years to 11 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Chile

Administrative Information
NCT Number ^ICMJE	NCT01411020
Other Study ID Numbers ^ICMJE	Ricardo Fuentes, Hernan Muñoz
Has Data Monitoring Committee	Not Provided
Responsible Party	Ricardo Fuentes Henriquez, Pontificia Universidad Catolica de Chile
Study Sponsor ^ICMJE	Pontificia Universidad Catolica de Chile
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Pontificia Universidad Catolica de Chile
Verification Date	August 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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