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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02042612

Acronym

CISEVOB

Enrollment

Registered

2014-01-23

Start date

2013-10-31

Completion date

2015-02-28

Last updated

2016-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Pharmacokinetics, Sevoflurane, Obesity, Sedation, ICU patients

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)

Interventions

DRUGSedation with sevoflurane during 48-hr in ICU

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Determination of plasmatic concentrations of sevoflurane before using AnaConda® system	at 5min, 60 min, 24 hrs and just before the end of sedation.

Secondary

Measure	Time frame
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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026