Pharmacokinetic Study of 48-hour Sevoflurane Inhalation Using a Disposable Delivery System (AnaConDa©) in Obese ICU Patients

Phase 2CompletedNCT02042612

University Hospital, Clermont-Ferrand8 enrolled

Overview

Describing a pharmacokinetic model of 48-h sevoflurane sedation in obese ICU patients

Prospective clinical monocentric study in ICU with sedated ventilated obese patients with sevoflurane during 48 h with the AnaConda® system, establishing pharmacokinetic model of sévoflurane and its metabolites (hydroxyfluroisopropanol, fluoride)

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Obesity

Interventions

Sedation with sevoflurane during 48-hr in ICUDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult patients ventilated more than 48 h Stable respiratory and hemodynamic conditions Consent of patients or family Arterial line BMI \>30 Exclusion Criteria: * Acute kidney injury BMI \<30 Sevoflurane anaphylaxia

Locations (1)

CHU Clermont-Ferrand

Clermont-Ferrand, France

Outcomes

Primary Outcomes

Determination of plasmatic concentrations of sevoflurane before using AnaConda® system

Time frame: at 5min, 60 min, 24 hrs and just before the end of sedation.

Secondary Outcomes

Determination of plasmatic concentrations of HFIP and fluoride before using AnaConda® system

Time frame: at 5min, 60 min, 24 hrs and just before the end of sedation.

Data from ClinicalTrials.gov

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