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Pharmacokinetic of Sevoflurane During a 48h Sedation in Intensive Care Unit With AnaConDa® (Anaconda)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01196754
First Posted: September 8, 2010
Last Update Posted: September 8, 2010
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.
Collaborators:
University Hospital, Estaing
Pharmacy, University Hospital Clermont-Fd, France
Information provided by:
University Hospital, Clermont-Ferrand
  Purpose
This is a prospective clinical monocentric study in ICU with sedated ventilated patients with sevoflurane during 48 h with the AnaConda® system, establishing pharmacokinetic model of sevoflurane.

Condition Intervention
Sedation Other: sevoflurane

Study Type: Interventional
Study Design: Primary Purpose: Screening
Official Title: Pharmacokinetic of Sevoflurane During a 48h Sedation in ICU With AnaConDa®

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • Determination of plasmatic concentrations of sévoflurane at different times of a 48h sedation of sévoflurane. [ Time Frame: during 48 hours ]

Secondary Outcome Measures:
  • Determination of plasmatic concentrations of HFIP and fluoride at different times of a 48h sedation of sévoflurane. Determination of a pharmacokinetic model of sévoflurane. [ Time Frame: during 48 hours ]

Enrollment: 12
Study Start Date: March 2008
Study Completion Date: May 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
sevoflurane Other: sevoflurane

Detailed Description:
Prospective clinical monocentric study in ICU with sedated ventilated patients with sevoflurane during 48 h with the AnaConda® system, establishing pharmacokinetic model of sévoflurane and its metabolites (hydroxyfluroisopropanol, fluoride)
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients ventilated more than 48 h
  • Stable respiratory and hemodynamic conditions
  • Consent of patients or family
  • Arterial line

Exclusion Criteria:

  • Acute kidney injury
  • Obesity
  • Sevoflurane anaphylaxia
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01196754


Locations
France
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
University Hospital, Estaing
Pharmacy, University Hospital Clermont-Fd, France
Investigators
Principal Investigator: Daniel Bourdeaux University Hospital, Clermont-Ferrand
  More Information

Responsible Party: Patrick LACARIN, CHU Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01196754     History of Changes
Other Study ID Numbers: CHU-0079
First Submitted: July 15, 2010
First Posted: September 8, 2010
Last Update Posted: September 8, 2010
Last Verified: September 2010

Keywords provided by University Hospital, Clermont-Ferrand:
Pharmacokinetics
Sevoflurane
Fluorides
Sedation
Adult patients with a predicted sedation more than 48 h
Stable respiratory and hemodynamic conditions for SBT
Consent of patients
Arterial line

Additional relevant MeSH terms:
Sevoflurane
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs