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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Pontificia Universidad Catolica de Chile
Information provided by (Responsible Party):
Pablo Sepulveda, Universidad del Desarrollo
ClinicalTrials.gov Identifier:
NCT01435785
First received: September 15, 2011
Last updated: September 16, 2011
Last verified: September 2011
  Purpose

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
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 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


Estimated Enrollment: 14
Study Start Date: April 2011
Estimated 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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Patients older than 65 years, ASA 1,2 programed for elective sugery

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01435785

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

No publications provided

Responsible Party: Pablo Sepulveda, MD Professor, Universidad del Desarrollo
ClinicalTrials.gov Identifier: NCT01435785     History of Changes
Other Study ID Numbers: Propofol TCI in Geriatric
Study First Received: September 15, 2011
Last Updated: September 16, 2011
Health Authority: Chile: Institutional Review Board

Keywords provided by Universidad del Desarrollo:
PKPD
Propofol
TCI
Elderly patients

Additional relevant MeSH terms:
Overdose
Poisoning
Substance-Related Disorders
Propofol
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives

ClinicalTrials.gov processed this record on July 10, 2014