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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 MirusĀ® 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
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