Dexmedetomidine for Continuous Sedation

This study has been terminated.
Information provided by:
Orion Corporation, Orion Pharma Identifier:
First received: September 23, 2005
Last updated: November 10, 2006
Last verified: November 2006

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.

Condition Intervention Phase
Conscious Sedation
Drug: Dexmedetomidine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Prospective, Multi-Centre, Randomised, Double-Blind Comparison of Intravenous Dexmedetomidine With Propofol/Midazolam for Continuous Sedation (24 Hours to 14 Days) of Ventilated Patients in Intensive Care Unit

Resource links provided by NLM:

Further study details as provided by Orion Corporation, Orion Pharma:

Primary Outcome Measures:
  • Proportion of time during sedative infusion with a Richmond Agitation Sedation Scale (RASS) score within the individually-prescribed target range
  • Time from ICU admission to discharge

Secondary Outcome Measures:
  • Nurse's assessment of subject communication
  • Duration of mechanical ventilation, weaning time and ventilator-free days in ICU
  • Length of total hospital stay
  • Functional recovery during hospitalisation
  • Need for rescue medication to maintain sedation
  • Frequency of delirium
  • Frequency of organ failures and failure-free days
  • Frequency of critical illness polyneuropathy
  • ICU- and in-hospital survival
  • Cost of care in the ICU
  • Total cost of hospitalisation
  • Blood levels of dexmedetomidine seen with long-term treatment

Estimated Enrollment: 900
Study Start Date: October 2005
Estimated Study Completion Date: July 2006

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Please refer to this study by its identifier: NCT00226785

Helsinki University Hospital
Helsinki, Finland
Kuopio University Hospital
Kuopio, Finland
Tampere University Hospital
Tampere, Finland
Bern, Switzerland
Sponsors and Collaborators
Orion Corporation, Orion Pharma
Study Chair: Jukka Takala, MD, PhD University/University Hospital, Bern, Switzerland
Principal Investigator: Esko Ruokonen, MD, PhD Kuopio University Hospital, Finland
Principal Investigator: Stephan Jakob, MD, PhD University Hospital, Bern, Switzerland
  More Information

No publications provided by Orion Corporation, Orion Pharma

Additional publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00226785     History of Changes
Other Study ID Numbers: 3005011
Study First Received: September 23, 2005
Last Updated: November 10, 2006
Health Authority: Finland: Finnish Medicines Agency
Switzerland: Swissmedic

Additional relevant MeSH terms:
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on April 17, 2014