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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02202720
Acronym
SEVORASS
Enrollment
30
Registered
2014-07-29
Start date
2014-08-31
Completion date
2014-11-30
Last updated
2014-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Sevoflurane, RASS score, Sedation, Minimal alveolar concentration (MAC)

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.

Interventions

DRUGSevoflurane

Short term sedation with sevoflurane in ICU

Sponsors

University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Description of the RASS scoreat day 1Describe 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

MeasureTime frameDescription
determination of the associated hemodynamic and respiratory parametersat day 1Determine 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).

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026