Back to resultsEvaluation of Richmond Agitation Sedation Scale According to Alveolar Concentration of Sevoflurane During a Sedation With Sevoflurane in ICU Patients (SEVORASS)
Primary Purpose
Requiring Sedation by Sevoflurane in ICU, Adult Patients, Patients Covered by French Health Care System
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Sevoflurane
Sponsored by
About this trial
This is an interventional treatment trial for Requiring Sedation by Sevoflurane in ICU focused on measuring Sevoflurane, RASS score, Sedation, Minimal alveolar concentration (MAC)
Eligibility Criteria
Inclusion Criteria:
- Requiring sedation by sevoflurane in ICU
- Adult patients
- Patients covered by french health care system
- Patients who have given their consent or his family
Exclusion Criteria:
- 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
Sites / Locations
- CHU Clermont-Ferrand
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
sevoflurane
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
Full Information
NCT ID
NCT02202720
First Posted
July 25, 2014
Last Updated
November 25, 2014
Sponsor
University Hospital, Clermont-Ferrand
1. Study Identification
Unique Protocol Identification Number
NCT02202720
Brief Title
Evaluation of Richmond Agitation Sedation Scale According to Alveolar Concentration of Sevoflurane During a Sedation With Sevoflurane in ICU Patients
Acronym
SEVORASS
Official Title
Evaluation of Richmond Agitation Sedation Scale According to Alveolar Concentration of Sevoflurane During a Sedation With Sevoflurane in ICU Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
4. Oversight
5. Study Description
Brief 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
sevoflurane
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Intervention Description
Short term sedation with sevoflurane in ICU
Primary Outcome Measure Information:
Title
Description of the RASS score
Description
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.
Time Frame
at day 1
Secondary Outcome Measure Information:
Title
determination of the associated hemodynamic and respiratory parameters
Description
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).
Time Frame
at day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Requiring sedation by sevoflurane in ICU
Adult patients
Patients covered by french health care system
Patients who have given their consent or his family
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sébastien PERBET
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Richmond Agitation Sedation Scale According to Alveolar Concentration of Sevoflurane During a Sedation With Sevoflurane in ICU Patients
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