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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jung-Won Hwang, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01091350
First received: March 14, 2010
Last updated: May 29, 2013
Last verified: May 2013
  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
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 Seoul National University Hospital:

Primary Outcome Measures:
  • Estimated effect-site propofol concentration at loss of consciousness [ Time Frame: after propofol infusion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to loss of consciousness [ Time Frame: after propofol infusion ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years to 60 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Jung-Won Hwang, MD, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01091350     History of Changes
Other Study ID Numbers: Orchestra vs Diprifusor
Study First Received: March 14, 2010
Last Updated: May 29, 2013
Health Authority: Korea: Institutional Review Board

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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on October 19, 2014