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
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