Performance Evaluation of Four Pharmacokinetic-Pharmacodynamic(PKPD) Models of Propofol in Elderly Patients (TCIGeriatric)
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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 |
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) |
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 |
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| Chile | |
| Clinica Alemana Santiago | |
| Santiago, Chile, 76534 | |
| Clinica Alemana de Santiago | |
| Santiago, Chile, 76534 | |
| 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 May 22, 2013