Dexmedetomidine for Continuous Sedation - Full Text View

Sponsored by:	Orion Corporation, Orion Pharma
Information provided by:	Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier:	NCT00226785

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 III

Drug Information available for: Midazolam Midazolam hydrochloride Midazolam maleate Propofol Dexmedetomidine Dexmedetomidine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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

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
Kuopio University Hospital
Kuopio, Finland
Tampere University Hospital
Tampere, Finland
Helsinki University Hospital
Helsinki, 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

Study ID Numbers:	3005011
Study First Received:	September 23, 2005
Last Updated:	November 10, 2006
ClinicalTrials.gov Identifier:	NCT00226785
Health Authority:	Finland: National Agency for Medicines; Switzerland: Swissmedic

Study placed in the following topic categories:

Dexmedetomidine
Propofol
Midazolam

Additional relevant MeSH terms:

Neurotransmitter Agents
Adrenergic alpha-Agonists
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Pharmacologic Actions
Adrenergic Agonists

Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Hypnotics and Sedatives
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009