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

NCT ID: NCT01091350

Last Updated: 2013-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2009-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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General Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Participants

Study Groups

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Diprifusor group

Propofol was infused via Diprifusor TCI (Target-controlled infusion)

Group Type ACTIVE_COMPARATOR

Diprifusor (Target-controlled infusion)

Intervention Type DEVICE

Two TCI devices with different Teo and same Marsh PK model

Orchestra group

Propofol was infused via Orchestra TCI

Group Type EXPERIMENTAL

Orchestra (Target-controlled infusion)

Intervention Type DEVICE

Two TCI devices with different Teo and same Marsh PK model

Interventions

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Diprifusor (Target-controlled infusion)

Two TCI devices with different Teo and same Marsh PK model

Intervention Type DEVICE

Orchestra (Target-controlled infusion)

Two TCI devices with different Teo and same Marsh PK model

Intervention Type DEVICE

Other Intervention Names

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Diprifusor(Grasby Medical Limited, United Kingdom) OrchestraTM (Fresenius Vial, Brezins, France)

Eligibility Criteria

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Inclusion Criteria

* Adult patients undergoing general anesthesia

Exclusion Criteria

* Hepatic or renal disease
* Drug addiction
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jung-Won Hwang

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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Orchestra vs Diprifusor

Identifier Type: -

Identifier Source: org_study_id