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Performance Evaluation of Four Pharmacokinetic-Pharmacodynamic(PKPD) Models of Propofol in Elderly Patients (TCIGeriatric)

This study has been completed.
Sponsor:
Collaborator:
Pontificia Universidad Catolica de Chile
Information provided by (Responsible Party):
Pablo O. Sepulveda, Universidad del Desarrollo
ClinicalTrials.gov Identifier:
NCT01435785
First received: September 15, 2011
Last updated: March 27, 2017
Last verified: March 2017

September 15, 2011
March 27, 2017
April 2011
September 2011   (Final data collection date for primary outcome measure)
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Not Provided
Complete list of historical versions of study NCT01435785 on ClinicalTrials.gov Archive Site
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Performance Evaluation of Four Pharmacokinetic-Pharmacodynamic(PKPD) Models of Propofol in Elderly Patients
Derivation and Prospective Validation of Four Pharmacokinetic-Pharmacodynamic Models of Propofol in Elderly Patients
Despite the wide use of propofol target-controlled infusion (TCI) in elderly patients, pharmacokinetic (PK) and pharmacodynamic (PD) models performance has not been prospectively assessed in this population. The aims of this study are to derive four PKPD models using previously published PK parameters sets, and to prospectively assess their performance in elderly people. With the obtained data we propose to build a specific PKPD model for this population.
After BIS® and routine monitors were placed, 14 ASA I-II elderly patients (>65 yr) will be anesthetized with plasma TCI of propofol based on Schnider model. After partial recovery from a bolus dose a remifentanil infusion was started and continued throughout surgery. All BIS and TCI data will be continuously record. Arterial blood samples for propofol assays were collected at 1, 2, 3, 5, 10, 20, 40 and 60 min post-induction, and at 0, 1, 3, 5, and 10 min after stopping the infusion. A three compartment effect site model linked to a Sigmoidal Emax PD model, will be used to fit all the data simultaneously in NONMEM. Median performance errors(MDPE), and median absolute performance errors(MDAPE) were calculated to measure bias and accuracy of each model. Comparisons between models will be performed.
Observational
Observational Model: Case-Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
whole blood will be centrifugated, the plasma will be frozen and all the samples where analysed wiht HPLC technique
Probability Sample
Patients older than 65 years, ASA 1,2 programed for elective sugery
Propofol Overdose of Undetermined Intent
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
December 2011
September 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients older than 65 years, ASA 1,2

Exclusion Criteria:

  • Included less than 70% or more than 130% of ideal body weight
  • Neurologic disorder
  • Use of psychoactive medication, including alcohol intake during the last 48 hours
Sexes Eligible for Study: All
65 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Chile
 
 
NCT01435785
Propofol TCI in Geriatric
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Yes
Open TCI proyect
Pablo O. Sepulveda, Universidad del Desarrollo
Universidad del Desarrollo
Pontificia Universidad Catolica de Chile
Principal Investigator: Pablo O Sepulveda, MD Clinica Alemana Universidad del Desarrollo
Universidad del Desarrollo
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP