A Pharmacokinetic Study of Sevoflurane Inhalation in Burn ICU Patients

Phase 2CompletedNCT02048683

University Hospital, Clermont-Ferrand24 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

ICU Patients With Indication of Sedation

Interventions

Short term sedation with sevoflurane in ICUDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

CHU Clermont-Ferrand

Clermont-Ferrand, France

Outcomes

Primary Outcomes

Determination of plasmatic concentrations of sevoflurane

Time frame: at 5min, 15 min, 60 min and just before the end of sedation.

Secondary Outcomes

Determination of plasmatic concentrations of HFIP and fluoride

Time frame: 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

Data from ClinicalTrials.gov

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