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

Not Applicable

Completed

• Conditions: Sedation
• Interventions: Other: sevoflurane

• Registration Number: NCT01196754
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2008-03
• Primary Completion: 2009-04
• Study Completion: 2009-05
• Study First Submitted: 2010-07-15
• Status Verified: 2010-09
• Study First Submitted QC: 2010-09-07
• Last Update Submitted: 2010-09-07
• Study First Posted: 2010-09-08
• Last Update Posted: 2010-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
sevoflurane	sevoflurane	-

Primary Outcome Measures

Name	Time	Method
Determination of plasmatic concentrations of sévoflurane at different times of a 48h sedation of sévoflurane.	during 48 hours

Secondary Outcome Measures

Name	Time	Method
Determination of plasmatic concentrations of HFIP and fluoride at different times of a 48h sedation of sévoflurane. Determination of a pharmacokinetic model of sévoflurane.	during 48 hours

Trial Locations

Locations (1)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France