Influence of Equilibration Rate Constant (ke0) of Propofol on the Effect Site Concentration for Loss of Consciousness

May 29, 2013 updated by: Jung-Won Hwang, Seoul National University Hospital

Influence of Equilibration Rate Constant (ke0) of Propofol on the Effect-site Concentration for Loss of Consciousness

The aim of this study is to validate that an effect compartment concentration for loss of consciousness (LOC) was varied according to different Keo value.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Adult patients undergoing general anesthesia

Exclusion Criteria:

  • Hepatic or renal disease
  • Drug addiction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Diprifusor group
Propofol was infused via Diprifusor TCI (Target-controlled infusion)
Device: Diprifusor (Target-controlled infusion)
Two TCI devices with different Teo and same Marsh PK model
Other Names:
  • Diprifusor(Grasby Medical Limited, United Kingdom)
Experimental: Orchestra group
Propofol was infused via Orchestra TCI
Device: Orchestra (Target-controlled infusion)
Two TCI devices with different Teo and same Marsh PK model
Other Names:
  • OrchestraTM (Fresenius Vial, Brezins, France)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Estimated effect-site propofol concentration at loss of consciousness
Time Frame: after propofol infusion
after propofol infusion

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to loss of consciousness
Time Frame: after propofol infusion
after propofol infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

March 14, 2010

First Submitted That Met QC Criteria

March 22, 2010

First Posted (Estimate)

March 24, 2010

Study Record Updates

Last Update Posted (Estimate)

May 31, 2013

Last Update Submitted That Met QC Criteria

May 29, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Orchestra vs Diprifusor

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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