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Dexmedetomidine Versus Midazolam for Continuous Sedation in the Intensive Care Unit (ICU)

NCT00481312 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 501

Last updated 2012-05-07

No results posted yet for this study

Summary

Patients in ICU who need help with their breathing are put onto a machine called a ventilator and are also given a medicine, called a sedative, which helps them to sleep and makes them more comfortable. Midazolam is a sedative that is routinely used for these purposes.

For most patients the aim of sedation is to make them sleepy but still able to respond to nursing staff (light sedation)

Dexmedetomidine is a new sedative for use in intensive care and in this clinical study, dexmedetomidine is compared to midazolam. It is thought that dexmedetomidine might be slightly better at allowing patients to be sleepy but still respond to people around them. It also does not appear to affect patient's breathing. the purpose of this study is to test whether dexmedetomidine really does have these advantages compared to midazolam.

in this study we hope to show that: dexmedetomidine is at least as good as midazolam in helping patients to sleep better and making them more comfortable, and that they are able to co-operate better with the staff treating them, and that patients treated with dexmedetomidine require a shorter time on the ventilator than those treated with midazolam.

Conditions

  • Continuous Sedation in Initially Sedated Adults in ICU

Interventions

DRUG

Dexmedetomidine

Continuous Infusion

DRUG

Midazolam

Continuous Infusion

Sponsors & Collaborators

  • Orion Corporation, Orion Pharma

    lead INDUSTRY

Principal Investigators

  • Stephan Jakob, MD PhD · Insel Spital, Bern CH-3010 Switzerland

  • Angela Ruck, BSc PhD · Orion Pharma R&D Nottingham England

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2009-08-31
Completion
2009-10-31

Countries

  • Belgium
  • Estonia
  • Finland
  • France
  • Germany
  • Netherlands
  • Norway
  • Switzerland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00481312 on ClinicalTrials.gov