NCT01435785

Completed

Performance Evaluation of Four Pharmacokinetic-Pharmacodynam...

Universidad del Desarrollo Source

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Other study identifiers

Sponsor study identifier

Propofol TCI in Geriatric

Study Type

observational

Actual enrollment (reported)

14

Locations

1 country

Sites

2

Timeline

Study Start

April 2011

Actual (reported)

Primary Completion

September 2011

Actual (reported)

Study Completion

December 2011

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 14 participants
Study completion date: December 2011
Actual (reported)
Listed locations: 1 countries · 2 sites

Trial Relationships

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Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
April 2011
Actual (reported)
Primary Completion
September 2011
Actual (reported)
First Submitted
September 15, 2011
Actual (reported)
First Posted
September 19, 2011
Actual (reported)
Study Completion
December 2011
Actual (reported)

Last Updated: March 29, 2017
Status Verified: March 2017
Last Update Submitted: 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

Universidad del Desarrollo
Otherlead
Pontificia Universidad Catolica de Chile
Othercollaborator

Study Sites (2)

Clinica Alemana de Santiago

Santiago, 76534, Chile

Clinica Alemana Santiago

Santiago, 76534, Chile

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

Enrollment

14 participants (actual enrollment reported by the registry).

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 2011

Actual (reported)

Primary Completion

September 2011

Actual (reported)

Study Completion

December 2011

Actual (reported)

Last Updated

March 29, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing: Will share

Source record

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Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01435785
Data provider: ClinicalTrials.gov
Source updated: 2017-03-29
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:39:25 UTC

Locations

CL(2)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

First Submitted

First Posted

Study Completion

Conditions

Keywords

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (2)

Biospecimen

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations