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NCT Number: NCT02202720

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

Describe the Richmond Agitation Sedation Scale (RASS) values corresponding to the values of Minimum alveolar concentration of sevoflurane during sedation of patients in ICU

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sevoflurane

Drug

Short term sedation with sevoflurane in ICU

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Acronym: SEVORASS

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jul 29, 2014
Registry last updated
Nov 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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