Target-controlled Infusion of Propofol for Induction of Pediatric Anesthesia

Study Overview
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Brief Summary
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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.

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

Conditions
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Children Under General Anesthesia

Intervention / Treatment
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* Procedure: endotracheal intubation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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