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Dexmedetomidine for Continuous Sedation

O

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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