Evaluation of Richmond Agitation Sedation Scale According to Alveolar Concentration of Sevoflurane During a Sedation With Sevoflurane in ICU Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Richmond Agitation Sedation Scale According to Alveolar Concentration of Sevoflurane During a Sedation With Sevoflurane in ICU Patients

Conditions
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Requiring Sedation by Sevoflurane in ICU, Adult Patients, Patients Covered by French Health Care System, Patients Who Have Given Their Consent

Intervention / Treatment
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* Drug: Sevoflurane


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sevoflurane<br> | Drug: Sevoflurane<br>* Short term sedation with sevoflurane in ICU<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | at day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | at day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sevoflurane, RASS score, Sedation, Minimal alveolar concentration (MAC)