NCT01435785

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2011

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

September 15, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 19, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

March 29, 2017

Status Verified

March 1, 2017

Enrollment Period

5 months

First QC Date

September 15, 2011

Last Update Submit

March 27, 2017

Conditions

Propofol Overdose of Undetermined Intent

Keywords

PKPDPropofolTCIElderly patients

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Patients older than 65 years, ASA 1,2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clinica Alemana de Santiago

Santiago, 76534, Chile

Location

Clinica Alemana Santiago

Santiago, 76534, Chile

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood will be centrifugated, the plasma will be frozen and all the samples where analysed wiht HPLC technique

Study Officials

  • Pablo O Sepulveda, MD

    Clinica Alemana Universidad del Desarrollo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD Professor

Study Record Dates

First Submitted

September 15, 2011

First Posted

September 19, 2011

Study Start

April 1, 2011

Primary Completion

September 1, 2011

Study Completion

December 1, 2011

Last Updated

March 29, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will share

Open TCI proyect

Locations

CL(2)