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

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

Propofol Overdose of Undetermined Intent

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Derivation and Prospective Validation of Four Pharmacokinetic-Pharmacodynamic Models of Propofol in Elderly Patients

Resource links provided by NLM:

Further study details as provided by Pablo O. Sepulveda, Universidad del Desarrollo:

Biospecimen Retention:   Samples With DNA
whole blood will be centrifugated, the plasma will be frozen and all the samples where analysed wiht HPLC technique

Enrollment: 14
Actual Study Start Date: April 2011
Study Completion Date: December 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Detailed Description:
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.

Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients older than 65 years, ASA 1,2 programed for elective sugery

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01435785

Clinica Alemana de Santiago
Santiago, Chile, 76534
Clinica Alemana Santiago
Santiago, Chile, 76534
Sponsors and Collaborators
Universidad del Desarrollo
Pontificia Universidad Catolica de Chile
Principal Investigator: Pablo O Sepulveda, MD Clinica Alemana Universidad del Desarrollo
  More Information

Responsible Party: Pablo O. Sepulveda, MD Professor, Universidad del Desarrollo Identifier: NCT01435785     History of Changes
Other Study ID Numbers: Propofol TCI in Geriatric
Study First Received: September 15, 2011
Last Updated: March 27, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Open TCI proyect

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pablo O. Sepulveda, Universidad del Desarrollo:
Elderly patients

Additional relevant MeSH terms:
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics processed this record on September 20, 2017