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CompletedNCT02042612CISEVOBUpdated Jun 27, 2016

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

A Phase 2 interventional study of Sedation with sevoflurane during 48-hr in ICU in Obesity, sponsored by University Hospital, Clermont-Ferrand. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-06-27.

Sponsored by University Hospital, Clermont-Ferrand · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
8
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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)

02

Conditions studied

  • Obesity

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Keywords

  • Pharmacokinetics
  • Sevoflurane
  • Obesity
  • Sedation
  • ICU patients
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 8 is below the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

University Hospital, Clermont-Ferrand is the lead sponsor of 841 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Acute kidney injury BMI \<30 Sevoflurane anaphylaxia
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (actual)

Study arms

  • Experimental
    sevoflurane

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

    Drug: Sedation with sevoflurane during 48-hr in ICU

Interventions

  • DrugSedation with sevoflurane during 48-hr in ICU

    Also known as: Determination of plasmatic concentrations of sevoflurane at different times of a 48h sedation of sevoflurane in obese ICU patients

06

What researchers measure

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.

07

Study locations

1 site
  • CHU Clermont-Ferrand
    Clermont-Ferrand, 63003, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 27, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02042612
Lead sponsor
University Hospital, Clermont-Ferrand
Responsible party
Sponsor
First posted
Jan 23, 2014
Start date
Oct 2013
Primary completion
Jan 2014
Completion
Feb 2015
Last update
Jun 27, 2016

Study contacts

Sébastien PERBET
principal investigator · University Hospital, Clermont-Ferrand
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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