Dexmedetomidine for Continuous Sedation

Phase 3

Terminated

• Conditions: Conscious Sedation

• Registration Number: NCT00226785
• Lead Sponsor: Orion Corporation, Orion Pharma

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-09-23
• Study First Submitted QC: 2005-09-23
• Study First Posted: 2005-09-27
• Study Start: 2005-10
• Study Completion: 2006-07
• Status Verified: 2006-11
• Last Update Submitted: 2006-11-10
• Last Update Posted: 2006-11-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 900

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Frequency of delirium
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
Cost of care in the ICU
Total cost of hospitalisation
Blood levels of dexmedetomidine seen with long-term treatment
Frequency of critical illness polyneuropathy
ICU- and in-hospital survival
Frequency of organ failures and failure-free days

Trial Locations

Locations (4)

Helsinki University Hospital; 🇫🇮 Helsinki, Finland

Kuopio University Hospital; 🇫🇮 Kuopio, Finland

Tampere University Hospital; 🇫🇮 Tampere, Finland

Inselspital; 🇨🇭 Bern, Switzerland