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

Adult Patients Clinical Trial

— SEVORASS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02202720
• Other study ID #: CHU-0200
• Secondary ID: 2014-000759-10
• Status: Completed
• Phase: Phase 2
• First received: July 25, 2014
• Last updated: November 25, 2014
• Start date: August 2014
• Est. completion date: November 2014

Study information

• Verified date: November 2014
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• Sevoflurane
Short term sedation with sevoflurane in ICU

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No