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Completed

NCT Number: NCT02042612

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

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

Completed

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sedation with sevoflurane during 48-hr in ICU

Drug

Other names: Determination of plasmatic concentrations of sevoflurane at different times of a 48h sedation of sevoflurane in obese ICU patients

Primary outcomes

  1. 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

  1. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Acronym: CISEVOB

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Jan 23, 2014
Registry last updated
Jun 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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