A Pharmacokinetic Study of Sevoflurane Inhalation in Burn ICU Patients (SEVOBURN)

University Hospital, Clermont-Ferrand

Status and phase: Completed; Phase 2

Conditions: ICU Patients With Indication of Sedation

Treatments: Drug: Short term sedation with sevoflurane in ICU

Study type: Interventional

Funder types: Other

Identifiers

NCT02048683

CHU-0174

2013-000960-26

Details and patient eligibility

About

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

Full 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

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

burn ICU patients

Experimental group

Description:

Determination of plasmatic concentrations of sevoflurane at different times of a short term sedation of sevoflurane in burn versus non burn ICU patients

Treatment:

Drug: Short term sedation with sevoflurane in ICU

non burn ICU patients

Other group

Description:

Determination of plasmatic concentrations of sevoflurane at different times of a short term sedation of sevoflurane in burn versus non burn ICU patients

Treatment:

Drug: Short term sedation with sevoflurane in ICU