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CompletedNCT02202720SEVORASSUpdated Nov 26, 2014

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

A Phase 2 interventional study of Sevoflurane in Requiring Sedation by Sevoflurane in ICU, Adult Patients and Patients Covered by French Health Care System, sponsored by University Hospital, Clermont-Ferrand. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-11-26.

Sponsored by University Hospital, Clermont-Ferrand · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

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

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Keywords

  • Sevoflurane
  • RASS score
  • Sedation
  • Minimal alveolar concentration (MAC)
03

In context

Psychomotor Agitation

500 studies on the registry are indexed under Psychomotor Agitation; 55 are open to participants now.

This study's enrollment of 30 is below the median of 90 across 413 interventional studies indexed under Psychomotor Agitation.

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Lead sponsor

University Hospital, Clermont-Ferrand is the lead sponsor of 841 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    sevoflurane

    Drug: Sevoflurane

Interventions

  • DrugSevoflurane

    Short term sedation with sevoflurane in ICU

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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).

    Time frame: at day 1

07

Study locations

1 site
  • CHU Clermont-Ferrand
    Clermont-Ferrand, 63003, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 26, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02202720
Lead sponsor
University Hospital, Clermont-Ferrand
Responsible party
Sponsor
First posted
Jul 29, 2014
Start date
Aug 2014
Primary completion
Nov 2014
Completion
Nov 2014
Last update
Nov 26, 2014

Study contacts

Sébastien PERBET
principal investigator · University Hospital, Clermont-Ferrand
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.

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