A Pharmacokinetic Study of Sevoflurane Inhalation in Burn ICU Patients

Phase 2

Completed

• Conditions: ICU Patients With Indication of Sedation
• Interventions: Drug: Short term sedation with sevoflurane in ICU

• Registration Number: NCT02048683
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief Summary

Comparing a pharmacokinetic model of a short sevoflurane sedation in burn ICU patients with control ICU patients.

Detailed Description

Prospective clinical study in ICU with sedated ventilated patients with sevoflurane with the AnaConda® system, establishing pharmacokinetic model of sevoflurane and its metabolites (hydroxyfluroisopropanol, fluoride) comparing burn and non burn ICU patients

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-01-13
• Study First Submitted QC: 2014-01-28
• Study First Posted: 2014-01-29
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-23
• Last Update Posted: 2015-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Adult patients ventilated requiring invasive procedure in ICU

  • Stable respiratory and hemodynamic conditions
  • Consent of patients or family
  • Arterial line
  • Burn patients : burn area between 20 and 50% (3rd degree) OR non burn patients

Exclusion Criteria

• BMI <30

  • Sevoflurane anaphylaxia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
burn ICU patients	Short term sedation with sevoflurane in ICU	Determination of plasmatic concentrations of sevoflurane at different times of a short term sedation of sevoflurane in burn versus non burn ICU patients
non burn ICU patients	Short term sedation with sevoflurane in ICU	Determination of plasmatic concentrations of sevoflurane at different times of a short term sedation of sevoflurane in burn versus non burn ICU patients

Primary Outcome Measures

Name	Time	Method
Determination of plasmatic concentrations of sevoflurane	at 5min, 15 min, 60 min and just before the end of sedation.

Secondary Outcome Measures

Name	Time	Method
Determination of plasmatic concentrations of HFIP and fluoride	at 5min, 15 min, 60 min and just before the end of sedation. And 5min, 10 min, 30 min, 60 min and 120 min after the end of sedation

Trial Locations

Locations (1)

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