drugset / Trial / NCT00481312

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

NCT00481312

Phase 3 Completed 501 enrolled Orion Corporation, Orion Pharma
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2007-06
Primary completion
2009-08
Completion
2009-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dexmedetomidine Other / unclassified Intravenous
Comparator Midazolam Small molecule

Indications

No indication recorded.