- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01435785
Performance Evaluation of Four Pharmacokinetic-Pharmacodynamic(PKPD) Models of Propofol in Elderly Patients (TCIGeriatric)
March 27, 2017 updated by: Pablo O. Sepulveda, Universidad del Desarrollo
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.
Study Overview
Status
Completed
Conditions
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
Enrollment (Actual)
14
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Santiago, Chile, 76534
- Clinica Alemana de Santiago
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Santiago, Chile, 76534
- Clinica Alemana Santiago
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
63 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients older than 65 years, ASA 1,2 programed for elective sugery
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Pablo O Sepulveda, MD, Clinica Alemana Universidad del Desarrollo
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2011
Primary Completion (Actual)
September 1, 2011
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
September 15, 2011
First Submitted That Met QC Criteria
September 16, 2011
First Posted (Estimate)
September 19, 2011
Study Record Updates
Last Update Posted (Actual)
March 29, 2017
Last Update Submitted That Met QC Criteria
March 27, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Propofol TCI in Geriatric
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
Open TCI proyect
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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