Pharmacokinetic Study of 48-hour Sevoflurane Inhalation Using a Disposable Delivery System (AnaConDa©) in Obese ICU Patients
Phase 2
Completed
- Conditions
- Obesity
- Interventions
- Drug: Sedation with sevoflurane during 48-hr in ICU
- Registration Number
- NCT02042612
- Lead Sponsor
- University Hospital, Clermont-Ferrand
- Brief Summary
Describing a pharmacokinetic model of 48-h sevoflurane sedation in obese ICU patients
- Detailed Description
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)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description sevoflurane Sedation with sevoflurane during 48-hr in ICU Determination of plasmatic concentrations of sevoflurane at different times of a 48h sedation of sevoflurane in obese ICU patients
- Primary Outcome Measures
Name Time Method Determination of plasmatic concentrations of sevoflurane before using AnaConda® system at 5min, 60 min, 24 hrs and just before the end of sedation.
- Secondary Outcome Measures
Name Time Method Determination of plasmatic concentrations of HFIP and fluoride before using AnaConda® system at 5min, 60 min, 24 hrs and just before the end of sedation.
Trial Locations
- Locations (1)
CHU Clermont-Ferrand
🇫🇷Clermont-Ferrand, France