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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01435785
Recruitment Status : Completed
First Posted : September 19, 2011
Last Update Posted : March 29, 2017
Pontificia Universidad Catolica de Chile
Information provided by (Responsible Party):
Pablo O. Sepulveda, Universidad del Desarrollo

Brief Summary:
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.

Condition or disease
Propofol Overdose of Undetermined Intent

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.

Study Type : Observational
Actual Enrollment : 14 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Derivation and Prospective Validation of Four Pharmacokinetic-Pharmacodynamic Models of Propofol in Elderly Patients
Actual Study Start Date : April 2011
Actual Primary Completion Date : September 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Propofol

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

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Pablo O. Sepulveda, MD Professor, Universidad del Desarrollo Identifier: NCT01435785     History of Changes
Other Study ID Numbers: Propofol TCI in Geriatric
First Posted: September 19, 2011    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: March 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