Clinical Effect of Two Pharmacokinetics Model of Propofol

NCT02155517 | Completed Phase 4 DMC

• 1 other identifier: 019CBCEA032013
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

TCI,Schnider Model, Cortinez Model, BIS, Cardiac Output.

Outcome Measures

Primary Outcomes (1)

• Sedation Levels

  We will use Ramsey Sedation Scale to evaluate LOC at the beginning of the infusion and after 20 minutes we will evaluate the recovery of consciousness after the infusion is stopped.

  During propofol infusion period

Secondary Outcomes (2)

• Bispectral index values

  During a propofol infusion period

• Hemodynamics values

  During propofol infusion period

Study Arms (1)

Propofol Infusion

EXPERIMENTAL

Propofol will be administered using a commercially available target-controlled infusion with an incorporated pharmacokinetic model developed by Schnider and Cortinez (arcomed ag, Medical System, Switzerland ).. 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. 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.

Drug: Evaluation of propofol effect

Interventions

Evaluation of propofol effect DRUG

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.

Also known as: Propofol Induced sedation

Propofol Infusion

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ASA physical status I
• Aged 18-60 years
• Patients with Body mass Index \< 30.

You may not qualify if:

• Patients with Body mass Index \> 30.
• Patients presenting psychiatric or neurological disorders , endocrine-metabolical problems, respiratory and cardiac diseases, or with allergies problems.
• Patients who are pregnant or breastfeeding.
• Patients treated with psychotropic drugs, including alcohol, in the 48 hours prior.
• Patients with previous history of anesthetics complications

Sponsors & Collaborators

• Tiva Group: lead
• Medtronic - MITG: collaborator

Study Sites (1)

Clinica Avila

Caracas, Distrito Federal, Venezuela

Location

Study Officials

• Carlos R Ramirez, Dr

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anestesiologo

Study Record Dates

• First Submitted: May 19, 2014
• First Posted: June 4, 2014
• Study Start: May 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: September 23, 2014

Record last verified: 2013-07

Locations

VE (1)