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Pharmacokinetic/Pharmacodynamic Model of Propofol in Children

NCT02544854 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2016-10-12

No results posted yet for this study

Summary

By measuring plasmatic concentration of propofol at different intervals during surgery of children aged 1 to 12 years old and measuring Bispectral Index (BIS) as a surrogate for cerebral activity, the investigators aim to create a pharmacokinetic/pharmacodynamic model of propofol for children.

Conditions

  • Anesthesia

Interventions

DRUG

Propofol

Propofol infusion will be started after inhalational induction by manual infusion by the following scheme: 1. First 15 minutes: 15 mg/kg/min 2. 16 to 30 minutes: 13 mg/kg/min 3. 31 to 60 minutes: 11 mg/kg/min 4. 61 to 120 minutes: 10 mg/kg/min Dose will be titrated to maintain BIS between 40 - 50. Venous sampling for plasmatic levels of propofol measuring will be made at the following moments: 1. 5, 15 and 25 minutes of starting infusion, 2. 1, 3, 5, 7, 9 and 12 minutes of bolus and, 3. 5, 25, 60 and 120 minutes of infusion ended.

Sponsors & Collaborators

  • Pontificia Universidad Catolica de Chile

    lead OTHER

Principal Investigators

  • Ricardo Fuentes, MD · Professor

  • Rose M Heider, MD · Professor

Study Design

Allocation
NON_RANDOMIZED
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • Chile

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02544854 on ClinicalTrials.gov