Target-controlled Infusion of Propofol for Induction of Pediatric Anesthesia

Children Under General Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01411020
• Other study ID #: Ricardo Fuentes
• Secondary ID: Hernan Muñoz
• Status: Completed
• Phase: Phase 4
• First received: August 3, 2011
• Last updated: May 14, 2013
• Start date: October 2009
• Est. completion date: November 2012

Study information

• Verified date: August 2009
• Source: Pontificia Universidad Catolica de Chile
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 11 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Children Under General Anesthesia

Intervention

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

Locations

Country	Name	City	State
Chile	Hospital Clinico Universidad Catolica	Santiago	Metropolitana

Sponsors (1)

Lead Sponsor	Collaborator
Pontificia Universidad Catolica de Chile

Country where clinical trial is conducted

Chile, 

References & Publications (1)

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. doi: 10.1111/j.1399-6576.2009.01995.x. Epub 2009 Jun 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	dose of propofol	to obtain a dose appropriate of propofol in induction of anesthesia	two days (duration of hospitalization)	Yes