Dexmedetomidine for Continuous Sedation

• Status: Terminated
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: All

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-stay intensive care unit (ICU) patients, and that dexmedetomidine, compared with current best practice, reduces the length of ICU stay.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Orion Corporation, Orion Pharma
• Treatments: Dexmedetomidine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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