Target-controlled Infusion of Propofol for Induction of Pediatric Anesthesia

NCT ID: NCT01411020

Last Updated: 2013-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2012-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Children Under General Anesthesia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Grupo 1

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

Group Type EXPERIMENTAL

endotracheal intubation

Intervention Type PROCEDURE

to perform endotracheal intubation if number of bispectral index (BIS) is 40-60,

Grupo 2

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

Group Type EXPERIMENTAL

endotracheal intubation

Intervention Type PROCEDURE

to perform endotracheal intubation if number of bispectral index (BIS) is 40-60,

Grupo 3

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

Group Type EXPERIMENTAL

endotracheal intubation

Intervention Type PROCEDURE

to perform endotracheal intubation if number of bispectral index (BIS) is 40-60,

Grupo 4

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

Group Type EXPERIMENTAL

endotracheal intubation

Intervention Type PROCEDURE

to perform endotracheal intubation if number of bispectral index (BIS) is 40-60,

Grupo 5

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

Group Type EXPERIMENTAL

endotracheal intubation

Intervention Type PROCEDURE

to perform endotracheal intubation if number of bispectral index (BIS) is 40-60,

Grupo 6

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

Group Type EXPERIMENTAL

endotracheal intubation

Intervention Type PROCEDURE

to perform endotracheal intubation if number of bispectral index (BIS) is 40-60,

Grupo 7

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

Group Type EXPERIMENTAL

endotracheal intubation

Intervention Type PROCEDURE

to perform endotracheal intubation if number of bispectral index (BIS) is 40-60,

Grupo 8

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

Group Type EXPERIMENTAL

endotracheal intubation

Intervention Type PROCEDURE

to perform endotracheal intubation if number of bispectral index (BIS) is 40-60,

Grupo 9

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

Group Type EXPERIMENTAL

endotracheal intubation

Intervention Type PROCEDURE

to perform endotracheal intubation if number of bispectral index (BIS) is 40-60,

Grupo 10

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

Group Type EXPERIMENTAL

endotracheal intubation

Intervention Type PROCEDURE

to perform endotracheal intubation if number of bispectral index (BIS) is 40-60,

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

endotracheal intubation

to perform endotracheal intubation if number of bispectral index (BIS) is 40-60,

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

3 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pontificia Universidad Catolica de Chile

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ricardo Fuentes Henriquez

Profesor Asistente, Departamento de AnestesiologĂ­a

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital Clinico Universidad Catolica

Santiago, Santiago Metropolitan, Chile

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Chile

References

Explore related publications, articles, or registry entries linked to this study.

Munoz HR, Leon PJ, Fuentes RS, Echevarria GC, Cortinez 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. doi: 10.1111/j.1399-6576.2009.01995.x. Epub 2009 Jun 3.

Reference Type BACKGROUND
PMID: 19496767 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Hernan Muñoz

Identifier Type: -

Identifier Source: secondary_id

Ricardo Fuentes

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Propofol in Emergence Agitation
NCT00535613 COMPLETED PHASE4
Ketamine and Propofol for Upper Endoscopy
NCT02295553 COMPLETED PHASE4