Target-controlled Infusion of Propofol for Induction of Pediatric Anesthesia

Phase 4

Completed

• Conditions: Children Under General Anesthesia
• Interventions: Procedure: endotracheal intubation

• Registration Number: NCT01411020
• Lead Sponsor: Pontificia Universidad Catolica de Chile

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 available

Study Timeline

• Status Verified: 2009-08
• Study Start: 2009-10
• Study First Submitted: 2011-08-03
• Study First Submitted QC: 2011-08-04
• Study First Posted: 2011-08-05
• Primary Completion: 2012-08
• Study Completion: 2012-11
• Last Update Submitted: 2013-05-14
• Last Update Posted: 2013-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Grupo 1	endotracheal intubation	Doses of induction: propofol 4 mcg/ml and fentanyl 3 mcg/kg
Grupo 2	endotracheal intubation	Dose of induction: propofol 4.5 mcg/ml and fentanyl 3 mcg/kg
Grupo 3	endotracheal intubation	Doses of propofol: propofol 5 mcg/ml and fentanyl 3 mcg/kg
Grupo 4	endotracheal intubation	Doses of induction: propofol 5.5 mcg/ml and fentanyl 3 mcg/kg
Grupo 5	endotracheal intubation	Doses of induction: propofol 6 mcg/ml and fentanyl 3 mcg/kg
Grupo 6	endotracheal intubation	Doses of induction: propofol 4 mcg/ml and fentanyl 5 mcg/kg
Grupo 7	endotracheal intubation	Doses of induction: propofol 4.5 mcg/ml and fentanyl 5 mcg/kg
Grupo 8	endotracheal intubation	Doses of induction: propofol 5 mcg/ml and fentanyl 5 mcg/kg
Grupo 9	endotracheal intubation	Doses of induction: propofol 5.5 mcg/ml and fentanyl 5 mcg/kg
Grupo 10	endotracheal intubation	Doses of induction: propofol 6 mcg/ml and fentanyl 5 mcg/kg

Primary Outcome Measures

Name	Time	Method
dose of propofol	two days (duration of hospitalization)	to obtain a dose appropriate of propofol in induction of anesthesia

Trial Locations

Locations (1)

Hospital Clinico Universidad Catolica; 🇨🇱 Santiago, Metropolitana, Chile