ICU Patients With Indication of SedationPhase 2SEVOBURNNCT02048683
A Pharmacokinetic Study of Sevoflurane Inhalation in Burn ICU Patients
A Phase 2 study testing Short term sedation with sevoflurane in ICU in people with ICU Patients With Indication of Sedation, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Comparing a pharmacokinetic model of a short sevoflurane sedation in burn ICU patients with control ICU patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ICU Patients With Indication of Sedation
- What is being tested?
- Short term sedation with sevoflurane in ICU
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2013to Sep 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients ventilated requiring invasive procedure in ICU
- Stable respiratory and hemodynamic conditions
- Consent of patients or family
- Arterial line
- Burn patients : burn area between 20 and 50% (3rd degree) OR non burn patients
Who cannot join
- BMI <30
- Sevoflurane anaphylaxia
Trial locations and contacts
1 site in 1 country.
About this study
Comparing a pharmacokinetic model of a short sevoflurane sedation in burn ICU patients with control ICU patients.
Read the detailed description
Prospective clinical study in ICU with sedated ventilated patients with sevoflurane with the AnaConda® system, establishing pharmacokinetic model of sevoflurane and its metabolites (hydroxyfluroisopropanol, fluoride) comparing burn and non burn ICU patients
- Conditions
- ICU Patients With Indication of Sedation
- Being tested
- Short term sedation with sevoflurane in ICU
- Keywords
- Pharmacokinetics, Sevoflurane, Burn, Sedation
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short term sedation with sevoflurane in ICUDrug
| Study group | Role | What they receive |
|---|---|---|
| burn ICU patients | Experimental | Determination of plasmatic concentrations of sevoflurane at different times of a short term sedation of sevoflurane in burn versus non burn ICU patients Receives: Drug: Short term sedation with sevoflurane in ICU |
| non burn ICU patients | Other | Determination of plasmatic concentrations of sevoflurane at different times of a short term sedation of sevoflurane in burn versus non burn ICU patients Receives: Drug: Short term sedation with sevoflurane in ICU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of plasmatic concentrations of sevoflurane
Measured: at 5min, 15 min, 60 min and just before the end of sedation.
Secondary outcomes (1)
Determination of plasmatic concentrations of HFIP and fluoride
Measured: at 5min, 15 min, 60 min and just before the end of sedation. And 5min, 10 min, 30 min, 60 min and 120 min after the end of sedation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2014 (estimated)
- Study startDec 2013
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ICU Patients With Indication of SedationStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sébastien PERBET, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02048683
- Sponsor's protocol ID
- CHU-0174
- Other IDs
- 2013-000960-26
- Acronym
- SEVOBURN
- Status last verified
- Aug 2026
- First submitted
- 13 Jan 2014
- Last updated
- 7 Aug 2026
- Results posted
- No
Publications
Perbet S, Bourdeaux D, Lenoire A, Biboulet C, Pereira B, Sadoune M, Plaud B, Launay JM, Bazin JE, Sautou V, Mebazaa A, Houze P, Constantin JM, Legrand M; PRONOBURN group. Sevoflurane for procedural sedation in critically ill patients: A pharmacokinetic comparative study between burn and non-burn patients. Anaesth Crit Care Pain Med. 2018 Dec;37(6):551-556. doi: 10.1016/j.accpm.2018.02.001. Epub 2018 Feb 15.
PubMed 29455032
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacokinetic Study of Sevoflurane Inhalation in Burn ICU Patients
- ClinicalTrials.gov ID
- NCT02048683
- Acronym / sponsor ID
- SEVOBURN / CHU-0174
- Conditions
- ICU Patients With Indication of Sedation
- Keywords
- Pharmacokinetics, Sevoflurane, Burn, Sedation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 29 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparing a pharmacokinetic model of a short sevoflurane sedation in burn ICU patients with control ICU patients.
Detailed description
Prospective clinical study in ICU with sedated ventilated patients with sevoflurane with the AnaConda® system, establishing pharmacokinetic model of sevoflurane and its metabolites (hydroxyfluroisopropanol, fluoride) comparing burn and non burn ICU patients
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| burn ICU patients | Experimental | Drug: Short term sedation with sevoflurane in ICUDetermination of plasmatic concentrations of sevoflurane at different times of a short term sedation of sevoflurane in burn versus non burn ICU patients |
| non burn ICU patients | Other | Drug: Short term sedation with sevoflurane in ICUDetermination of plasmatic concentrations of sevoflurane at different times of a short term sedation of sevoflurane in burn versus non burn ICU patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients ventilated requiring invasive procedure in ICU
Key exclusion criteria (2 listed)
- BMI <30
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Short term sedation with sevoflurane in ICU | Drug | burn ICU patients, non burn ICU patients |
Primary outcome
Determination of plasmatic concentrations of sevoflurane
Time frame: at 5min, 15 min, 60 min and just before the end of sedation.
1 secondary outcome
Determination of plasmatic concentrations of HFIP and fluoride
Time frame: at 5min, 15 min, 60 min and just before the end of sedation. And 5min, 10 min, 30 min, 60 min and 120 min after the end of sedation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Results publication: PubMed 29455032Perbet S, Bourdeaux D, Lenoire A, Biboulet C, Pereira B, Sadoune M, Plaud B, Launay JM, Bazin JE, Sautou V, Mebazaa A, Houze P, Constantin JM, Legrand M; PRONOBURN group. Sevoflurane for procedural sedation in critically ill patients: A pharmacokinetic comparative study between burn and non-burn patients. Anaesth Crit Care Pain Med. 2018 Dec;37(6):551-556. doi: 10.1016/j.accpm.2018.02.001. Epub 2018 Feb 15.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sébastien PERBET principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Short term sedation with sevoflurane in ICU in people with ICU Patients With Indication of Sedation, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of plasmatic concentrations of sevoflurane (time frame: at 5min, 15 min, 60 min and just before the end of sedation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02048683, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.