Clinical Effect of Two Pharmacokinetics Model of Propofol

• Status: Completed
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Tiva Group
• Collaborator: Medtronic - MITG
• Treatments: Propofol

Criteria

Inclusion Criteria:

• ASA physical status I

• Aged 18-60 years

• Patients with Body mass Index < 30.

Exclusion Criteria:

• 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