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
Protocol serial number USA30226
Sponsor GlaxoSmithKline
Funder GlaxoSmithKline (GSK)
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

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
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
PhaseNot Specified
Drug / device / biological / vaccine name(s)Remifentanil
Primary outcome measure(s)

Not provided at time of registration

Key secondary outcome measure(s)

Not provided at time of registration

Completion date30/06/2003

Eligibility

Participant type(s)Patient
Age groupNot Specified
Sex
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

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

Study participating centre

GlaxoSmithKline
Greenford, Middlesex
UB6 OHE
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summary
IPD sharing plan

Study outputs

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