Text Size

Dexmedetomidine for Continuous Sedation

This study has been terminated.
Sponsor:
Information provided by:
Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier:
NCT00226785
First received: September 23, 2005
Last updated: November 10, 2006
Last verified: November 2006
History of Changes
  Purpose

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:

U.S. FDA Resources

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00226785

Locations
Finland
Helsinki University Hospital
Helsinki, Finland
Kuopio University Hospital
Kuopio, Finland
Tampere University Hospital
Tampere, Finland
Switzerland
Inselspital
Bern, Switzerland
Sponsors and Collaborators
Orion Corporation, Orion Pharma
Investigators
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 ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov 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:
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Analgesics, Non-Narcotic
Analgesics
 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

ClinicalTrials.gov processed this record on May 16, 2013