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
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
Frequency of organ failures and failure-free days
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

Trial Locations

Locations (4)

Helsinki University Hospital; 🇫🇮 Helsinki, Finland

Inselspital; 🇨🇭 Bern, Switzerland

Kuopio University Hospital; 🇫🇮 Kuopio, Finland

Tampere University Hospital; 🇫🇮 Tampere, Finland