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Clinical Effect of Two Pharmacokinetics Model of Propofol

NCT02155517 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2014-09-23

No results posted yet for this study

Summary

Actually, Schnider and Cortinez models represent pharmacokinetics models of propofol more complete published until now. Schnider was derived from 24 healhty people, and including other covariates in addition to weight, such as age, height and lean body mass though. Schnider model should not be used in obese patients. Cortínez model was derived from 20 obese patients. The differences between both models has been founded at the initial drug distribution, that means V1 and the constant Ke0 ( pharmacokinetics factors that define the plasma-effect equilibration time). We believe that Cortinez model also could be used in No OBESE patients because is an allometric model, and one way to evaluate and to compare both pharmacokinetics models is studying the temporary course of the effect.

The main objective of our study is to evaluate BIS and Cardiac Output values during propofol-induced sedation using Schnider and Cortinez models in Target Controlled infusion in non obese healthy volunteer.

Conditions

  • Healthy

Interventions

DRUG

Evaluation of propofol effect

The study will make in two stages: STAGE I: All volunteers will receive propofol infusion with the first model randomly chosen (Schnider or Cortinez) using TCI device, and the initial effect-site target concentration of propofol will be 3 ug/ml for 20 minutes.

DRUG

Evaluation of propofol effect

STAGE II: 72 hours after stage I . All volunteers will receive propofol infusion with the first model randomly chosen (Schnider or Cortinez) using TCI devices, and the initial effect-site target concentration of propofol will be 3 ug/ml for 20 minutes.

Sponsors & Collaborators

  • Medtronic - MITG

    collaborator INDUSTRY

  • Tiva Group

    lead OTHER

Principal Investigators

  • Carlos R Ramirez, Dr

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2014-08-31
Completion
2014-08-31

Countries

  • Venezuela

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 NCT02155517 on ClinicalTrials.gov