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

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ClinicalTrials.gov Identifier: NCT02202720
Recruitment Status : Completed
First Posted : July 29, 2014
Last Update Posted : November 26, 2014
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

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

Condition or disease Intervention/treatment Phase
Requiring Sedation by Sevoflurane in ICU Adult Patients Patients Covered by French Health Care System Patients Who Have Given Their Consent Drug: Sevoflurane Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Richmond Agitation Sedation Scale According to Alveolar Concentration of Sevoflurane During a Sedation With Sevoflurane in ICU Patients
Study Start Date : August 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Sevoflurane

Arm Intervention/treatment
Experimental: sevoflurane Drug: Sevoflurane
Short term sedation with sevoflurane in ICU




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. determination of the associated hemodynamic and respiratory parameters [ Time Frame: at day 1 ]
    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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02202720


Locations
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France
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
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Principal Investigator: Sébastien PERBET University Hospital, Clermont-Ferrand
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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT02202720    
Other Study ID Numbers: CHU-0200
2014-000759-10
First Posted: July 29, 2014    Key Record Dates
Last Update Posted: November 26, 2014
Last Verified: November 2014
Keywords provided by University Hospital, Clermont-Ferrand:
Sevoflurane
RASS score
Sedation
Minimal alveolar concentration (MAC)
Additional relevant MeSH terms:
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Psychomotor Agitation
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Sevoflurane
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs