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Propofol Effect-Site Target Controlled Infusion in the Obese: Characterization of the Time Profile of Bispectral Index Response

Information source: Universidad del Desarrollo
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Obesity

Intervention: Propofol (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Universidad del Desarrollo

Official(s) and/or principal investigator(s):
Pablo O SepĂșlveda, MD, Principal Investigator, Affiliation: Clinica Alemana Universidad del Desarrollo

Summary

The aim of this study is to characterize the Pharmacokinetic/Pharmacodynamic relationship of a single bolus dose of propofol in obese patients and to extract a time to peak effect (t-peak) from the estimated model parameters.

Clinical Details

Official title: Propofol Effect-Site Target Controlled Infusion in the Obese: Characterization of the Time Profile of Bispectral Index Response.

Study design: Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Primary outcome: Profile of Pharmacokinetic and Pharmacodynamic of an induction bolus dose of propofol in obese patients.

Detailed description: Target controlled infusion (TCI) is a technique to administer intravenous drugs that allows rapid achievement and maintenance of predetermined drug concentrations, either in plasma (Cp) or at the site of effect (Ce). To characterize the time profile of propofol effect an additional parameter, the equilibration half time between plasma and effect site (T1/2keo) needs to be incorporated in the pharmacokinetic (PK) model.

Eligibility

Minimum age: 20 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- IMC > 35 kg m-2

- Scheduled for laparoscopic bariatric surgery

- ASA I-II patients

- Between 20 and 60 yr of age.

Exclusion Criteria:

- Patients with allergy to study drugs

- Uncontrolled hypertension

- Heart block greater than first degree

- Take any drug acting in the central nervous system

Locations and Contacts

Clinica Alemana, Santiago, Chile
Additional Information

Starting date: April 2011
Last updated: August 14, 2012

Page last updated: August 20, 2015

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