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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01091350
First Posted: March 24, 2010
Last Update Posted: May 31, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jung-Won Hwang, Seoul National University Hospital
  Purpose
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.

Condition Intervention
General Anesthesia Device: Diprifusor (Target-controlled infusion) Device: Orchestra (Target-controlled infusion)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Official Title: Influence of Equilibration Rate Constant (ke0) of Propofol on the Effect-site Concentration for Loss of Consciousness

Resource links provided by NLM:


Further study details as provided by Jung-Won Hwang, Seoul National University Hospital:

Primary Outcome Measures:
  • Estimated effect-site propofol concentration at loss of consciousness [ Time Frame: after propofol infusion ]

Secondary Outcome Measures:
  • Time to loss of consciousness [ Time Frame: after propofol infusion ]

Enrollment: 60
Study Start Date: May 2009
Study Completion Date: November 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: OrchestraTM (Fresenius Vial, Brezins, France)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients undergoing general anesthesia

Exclusion Criteria:

  • Hepatic or renal disease
  • Drug addiction
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Jung-Won Hwang, MD, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01091350     History of Changes
Other Study ID Numbers: Orchestra vs Diprifusor
First Submitted: March 14, 2010
First Posted: March 24, 2010
Last Update Posted: May 31, 2013
Last Verified: May 2013

Additional relevant MeSH terms:
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics