Requiring Sedation by Sevoflurane in ICUPhase 2SEVORASSNCT02202720
Evaluation of Richmond Agitation Sedation Scale According to Alveolar Concentration of Sevoflurane During a Sedation With Sevoflurane in ICU Patients
A Phase 2 study testing Sevoflurane in people with Requiring Sedation by Sevoflurane in ICU and Adult Patients, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Describe the Richmond Agitation Sedation Scale (RASS) values corresponding to the values of Minimum alveolar concentration of sevoflurane during sedation of patients in ICU Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Requiring Sedation by Sevoflurane in ICU, Adult Patients, Patients Covered by French Health Care System
- What is being tested?
- Sevoflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2014to Nov 2014
- 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
- Requiring sedation by sevoflurane in ICU
- Adult patients
- Patients covered by french health care system
- Patients who have given their consent or his family
Who cannot join
- Pregnant or lactating women
- Sevoflurane anaphylaxia
- Known or suspected risk of malignant hyperthermia
- Refusal Protocol
- Brain-damaged patients
- Hemodynamic conditions not compatible with the use of sevoflurane
- ARDS patients
- Minor patients
Trial locations and contacts
1 site in 1 country.
About this study
Describe the Richmond Agitation Sedation Scale (RASS) values corresponding to the values of Minimum alveolar concentration of sevoflurane during sedation of patients in ICU
Read the detailed description
Prospective clinical study in ICU with sedated ventilated patients with sevoflurane using the Mirus® system. Pharmacological study of the concentration-effect relationship by administration at increasing and decreasing concentrations.
- Conditions
- Requiring Sedation by Sevoflurane in ICU, Adult Patients, Patients Covered by French Health Care System, Patients Who Have Given Their Consent
- Being tested
- Sevoflurane
- Keywords
- Sevoflurane, RASS score, Sedation, Minimal alveolar concentration (MAC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
Short term sedation with sevoflurane in ICU
| Study group | Role | What they receive |
|---|---|---|
| sevoflurane | Experimental | Not described Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the RASS score
Describe the RASS score corresponding to the values of sevoflurane MAC during sedation of patients in ICU : RASS score determined at the middle of each level of 30 minutes, each level correspond to determined sevoflurane MAC with ascending MAC ranging from 0 to 0.8 and then descending MAC from 0.8 to 0.
Measured: at day 1
Secondary outcomes (1)
determination of the associated hemodynamic and respiratory parameters
Determine the associated hemodynamic and respiratory parameters, bispectral index and analgesia-nociception index for each level of sevoflurane MAC (monitored at the middle of each level of 30 minutes).
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2014 (estimated)
- Study startAug 2014
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Requiring Sedation by Sevoflurane in ICUStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT02202720
- Sponsor's protocol ID
- CHU-0200
- Other IDs
- 2014-000759-10, 2014
- Acronym
- SEVORASS
- Status last verified
- Nov 2014
- First submitted
- 25 Jul 2014
- Last updated
- 26 Nov 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Richmond Agitation Sedation Scale According to Alveolar Concentration of Sevoflurane During a Sedation With Sevoflurane in ICU Patients
- ClinicalTrials.gov ID
- NCT02202720
- Acronym / sponsor ID
- SEVORASS / CHU-0200
- Conditions
- Requiring Sedation by Sevoflurane in ICU, Adult Patients, Patients Covered by French Health Care System, Patients Who Have Given Their Consent
- Keywords
- Sevoflurane, RASS score, Sedation, Minimal alveolar concentration (MAC)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 29 Jul 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.
Describe the Richmond Agitation Sedation Scale (RASS) values corresponding to the values of Minimum alveolar concentration of sevoflurane during sedation of patients in ICU
Detailed description
Prospective clinical study in ICU with sedated ventilated patients with sevoflurane using the Mirus® system. Pharmacological study of the concentration-effect relationship by administration at increasing and decreasing concentrations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sevoflurane | Experimental | Drug: Sevoflurane |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Requiring sedation by sevoflurane in ICU
- Adult patients
- Patients covered by french health care system
- Patients who have given their consent or his family
Key exclusion criteria (8 listed)
- Pregnant or lactating women
- Sevoflurane anaphylaxia
- Known or suspected risk of malignant hyperthermia
- Refusal Protocol
- Brain-damaged patients
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 |
|---|---|---|
| SevofluraneShort term sedation with sevoflurane in ICU | Drug | sevoflurane |
Primary outcome
Description of the RASS score
Time frame: at day 1
Describe the RASS score corresponding to the values of sevoflurane MAC during sedation of patients in ICU : RASS score determined at the middle of each level of 30 minutes, each level correspond to determined sevoflurane MAC with ascending MAC ranging from 0 to 0.8 and then descending MAC from 0.8 to 0.
1 secondary outcome
determination of the associated hemodynamic and respiratory parameters
Time frame: at day 1
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 26 Nov 2014.
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 Sevoflurane in people with Requiring Sedation by Sevoflurane in ICU and Adult Patients, 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 4 inclusion and 8 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 26 Nov 2014. 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?
Description of the RASS score (time frame: at day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Nov 2014.