Dexmedetomidine for Continuous Sedation

Orion Pharma

Status and phase

Terminated

Phase 3

Conditions

Conscious Sedation

Treatments

Drug: Dexmedetomidine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00226785

3005011

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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