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

Propofol Overdose of Undetermined Intent Clinical Trial

— TCIGeriatric  

Official title:

Derivation and Prospective Validation of Four Pharmacokinetic-Pharmacodynamic Models of Propofol in Elderly Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01435785
• Other study ID #: Propofol TCI in Geriatric
• Status: Completed
• Phase: N/A
• First received: September 15, 2011
• Last updated: March 27, 2017
• Start date: April 2011
• Est. completion date: December 2011

Study information

• Verified date: March 2017
• Source: Universidad del Desarrollo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Propofol Overdose of Undetermined Intent

Locations

Country	Name	City	State
Chile	Clinica Alemana de Santiago	Santiago
Chile	Clinica Alemana Santiago	Santiago

Sponsors (2)

Lead Sponsor	Collaborator
Universidad del Desarrollo	Pontificia Universidad Catolica de Chile

Country where clinical trial is conducted

Chile,