NCT01586013

Brief Summary

This study obtains an effect site model for White (Modified Marsh) pharmacokinetic propofol model. The plasma effect-site rate constant (ke0) obtained is affected by age.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P50-P75 for phase_4 healthy

Timeline
Completed

Started Oct 2010

Geographic Reach
1 country

1 active site

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

October 1, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 26, 2012

Completed
Last Updated

April 26, 2012

Status Verified

April 1, 2012

Enrollment Period

10 months

First QC Date

April 19, 2012

Last Update Submit

April 25, 2012

Conditions

Healthy

Keywords

propofolpharmacodynamicageke0

Outcome Measures

Primary Outcomes (1)

  • pharmacodynamic model for the White propofol pharmacokinetic

    Using a propofol target controlled infusion using de White propofol model, we evaluate a complete curve of depression and recovery of the BIS

    Bispectral index

Study Arms (1)

propofol infusion

EXPERIMENTAL

Healthy adults scheduled for elective surgery will receive a computer controlled infusion until obtain the loss of counsiousness (BIS \<50). After stoping the infusion we observe the emergency of anesthesia and the correspondant BIS curve. Using the complete loss and recovery curve of BIS we can describe the course of the effect of the drug. Venous sample will be taken during the study to evaluate the pharmacokinetic performance of the model.

Drug: evaluation of propofol effect using BIS

Interventions

evaluation of propofol effect using BISDRUG

propofol administered in target controlled infusion using the pharmacokinetic model of White

Also known as: evaluation of effect of intravenous di-isopropilfenol
propofol infusion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA 1-2

You may not qualify if:

  • less than 70% or more than 130% ideal body mass index,
  • neurologic disorders,
  • pregnancy,
  • psychoactive medication intake during last 48 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinica Alemana

Santiago, 7650670, Chile

Location

Related Publications (1)

  • White M, Kenny GN, Schraag S. Use of target controlled infusion to derive age and gender covariates for propofol clearance. Clin Pharmacokinet. 2008;47(2):119-27. doi: 10.2165/00003088-200847020-00005.

    PMID: 18193918BACKGROUND

Study Officials

  • Pablo O Sepulveda, Dr

    Clinica Alemana Universidad del Desarrollo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Med

Study Record Dates

First Submitted

April 19, 2012

First Posted

April 26, 2012

Study Start

October 1, 2010

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

April 26, 2012

Record last verified: 2012-04

Locations

CL(1)