NCT02202720

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2014

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 29, 2014

Completed
3 days until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

November 26, 2014

Status Verified

November 1, 2014

Enrollment Period

3 months

First QC Date

July 25, 2014

Last Update Submit

November 25, 2014

Conditions

Requiring Sedation by Sevoflurane in ICUAdult PatientsPatients Covered by French Health Care SystemPatients Who Have Given Their Consent

Keywords

SevofluraneRASS scoreSedationMinimal alveolar concentration (MAC)

Outcome Measures

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.

    at day 1

Secondary Outcomes (1)

  • determination of the associated hemodynamic and respiratory parameters

    at day 1

Study Arms (1)

sevoflurane

EXPERIMENTAL
Drug: Sevoflurane

Interventions

SevofluraneDRUG

Short term sedation with sevoflurane in ICU

sevoflurane

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Requiring sedation by sevoflurane in ICU
  • Adult patients
  • Patients covered by french health care system
  • Patients who have given their consent or his family

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Interventions

Sevoflurane

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbons

Study Officials

  • Sébastien PERBET

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2014

First Posted

July 29, 2014

Study Start

August 1, 2014

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

November 26, 2014

Record last verified: 2014-11

Locations

FR(1)