Target-controlled Infusion of Propofol for Induction of Pediatric Anesthesia

Pontificia Universidad Catolica de Chile

Status and phase: Completed; Phase 4

Conditions: Children Under General Anesthesia

Treatments: Procedure: endotracheal intubation

Study type: Interventional

Funder types: Other

Identifiers

NCT01411020

Ricardo Fuentes

Hernan Muñoz

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 3 to 11 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 10 patient groups

Grupo 1

Experimental group

Description:

Doses of induction: propofol 4 mcg/ml and fentanyl 3 mcg/kg

Treatment:

Procedure: endotracheal intubation

Grupo 2

Experimental group

Description:

Dose of induction: propofol 4.5 mcg/ml and fentanyl 3 mcg/kg

Treatment:

Procedure: endotracheal intubation

Grupo 3

Experimental group

Description:

Doses of propofol: propofol 5 mcg/ml and fentanyl 3 mcg/kg

Treatment:

Procedure: endotracheal intubation

Grupo 4

Experimental group

Description:

Doses of induction: propofol 5.5 mcg/ml and fentanyl 3 mcg/kg

Treatment:

Procedure: endotracheal intubation

Grupo 5

Experimental group

Description:

Doses of induction: propofol 6 mcg/ml and fentanyl 3 mcg/kg

Treatment:

Procedure: endotracheal intubation

Grupo 6

Experimental group

Description:

Doses of induction: propofol 4 mcg/ml and fentanyl 5 mcg/kg

Treatment:

Procedure: endotracheal intubation

Grupo 7

Experimental group

Description:

Doses of induction: propofol 4.5 mcg/ml and fentanyl 5 mcg/kg

Treatment:

Procedure: endotracheal intubation

Grupo 8

Experimental group

Description:

Doses of induction: propofol 5 mcg/ml and fentanyl 5 mcg/kg

Treatment:

Procedure: endotracheal intubation

Grupo 9

Experimental group

Description:

Doses of induction: propofol 5.5 mcg/ml and fentanyl 5 mcg/kg

Treatment:

Procedure: endotracheal intubation

Grupo 10

Experimental group

Description:

Doses of induction: propofol 6 mcg/ml and fentanyl 5 mcg/kg

Treatment:

Procedure: endotracheal intubation