Status:
TERMINATED
Dexmedetomidine for Continuous Sedation
Lead Sponsor:
Orion Corporation, Orion Pharma
Conditions:
Conscious Sedation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The study aims to demonstrate that dexmedetomidine is non-inferior to current best practice sedation with propofol/midazolam and daily sedation stops, in maintaining a target depth of sedation in long...
Eligibility Criteria
Inclusion
- Clinical need for sedation and mechanical ventilation
- Receiving full intensive care life support
- Expected stay in ICU of at least 48 hours (h) from time of admission
- Expected requirement for sedation of at least 24h from time of randomisation
- Written informed consent within 36h of ICU admission
Exclusion
- Acute severe neurological disorder
- Acute uncompensated circulatory failure at time of randomisation
- Severe bradycardia
- Atrioventricular (AV) conduction block (II-III) unless pacemaker fitted
- Severe hepatic impairment
- Need for muscle relaxation at time of randomisation
- Loss of hearing or vision or any condition interfering significantly with RASS assessment
- Positive pregnancy test or currently lactating
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
End Date :
July 1 2006
Estimated Enrollment :
900 Patients enrolled
Trial Details
Trial ID
NCT00226785
Start Date
October 1 2005
End Date
July 1 2006
Last Update
November 14 2006
Active Locations (4)
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1
Helsinki University Hospital
Helsinki, Finland
2
Kuopio University Hospital
Kuopio, Finland
3
Tampere University Hospital
Tampere, Finland
4
Inselspital
Bern, Switzerland