Decreased time on mechanical ventilation when comparing analgesia-based sedation using remifentanil versus standard hypnotic-based sedation for up to 10 days in intensive care unit patients: a randomised trial.

ISRCTN ISRCTN47583497
DOI https://doi.org/10.1186/ISRCTN47583497
Secondary identifying numbers USA30226
Submission date
09/02/2005
Registration date
09/02/2005
Last edited
16/08/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Andrew Kirkham
Scientific

GlaxoSmithKline
Greenford Road
Greenford, Middlesex
UB6 OHE
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedMedical or surgical patients requiring intensive care.
InterventionComparing analgesia-based sedation using remifentanil versus standard hypnotic-based sedation for up to 10 days in intensive care unit patients. Titration of analgesia/sedation to achieve optimal sedation. Regular assessments of haemodynamics.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Remifentanil
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date07/06/2002
Completion date30/06/2003

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsNot provided at time of registration
Key inclusion criteriaCritically ill patients requiring 3-10 days of mechanical ventilation.
Key exclusion criteriaNot provided at time of registration
Date of first enrolment07/06/2002
Date of final enrolment30/06/2003

Locations

Countries of recruitment

  • Austria
  • Belgium
  • Denmark
  • France
  • Germany
  • Greece
  • Iran
  • Netherlands
  • Portugal
  • United Arab Emirates
  • United Kingdom

Study participating centre

GlaxoSmithKline
Greenford, Middlesex
UB6 OHE
United Kingdom

Sponsor information

GlaxoSmithKline
Not defined

Greenford Road
Greenford
UB6 0HE
United Kingdom

ROR logo "ROR" https://ror.org/01xsqw823

Funders

Funder type

Industry

GlaxoSmithKline (GSK)
Government organisation / For-profit companies (industry)
Alternative name(s)
GlaxoSmithKline plc., GSK plc., GSK
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article Results 01/06/2005 Yes No