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

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ClinicalTrials.gov Identifier: NCT01196754
Recruitment Status : Completed
First Posted : September 8, 2010
Last Update Posted : September 8, 2010
Sponsor:
Collaborators:
University Hospital, Estaing
Pharmacy, University Hospital Clermont-Fd, France
Information provided by:
University Hospital, Clermont-Ferrand

Brief Summary:
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 or disease Intervention/treatment Phase
Sedation Other: sevoflurane Not Applicable

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)

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Primary Purpose: Screening
Official Title: Pharmacokinetic of Sevoflurane During a 48h Sedation in ICU With AnaConDa®
Study Start Date : March 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Sevoflurane

Arm Intervention/treatment
sevoflurane Other: sevoflurane



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

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

Responsible Party: Patrick LACARIN, CHU Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01196754     History of Changes
Other Study ID Numbers: CHU-0079
First Posted: September 8, 2010    Key Record Dates
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