Dexmedetomidine for Continuous Sedation

Conscious Sedation Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00226785
• Other study ID #: 3005011
• Status: Terminated
• Phase: Phase 3
• First received: September 23, 2005
• Last updated: November 10, 2006
• Start date: October 2005
• Est. completion date: July 2006

Study information

• Verified date: November 2006
• Source: Orion Corporation, Orion Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines AgencySwitzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 900
• Est. completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Conscious Sedation

Intervention

Drug:
• Dexmedetomidine

Locations

Country	Name	City	State
Finland	Helsinki University Hospital	Helsinki
Finland	Kuopio University Hospital	Kuopio
Finland	Tampere University Hospital	Tampere
Switzerland	Inselspital	Bern

Sponsors (1)

Lead Sponsor	Collaborator
Orion Corporation, Orion Pharma

Countries where clinical trial is conducted

Finland,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of time during sedative infusion with a Richmond Agitation Sedation Scale (RASS) score within the individually-prescribed target range
Primary	Time from ICU admission to discharge
Secondary	Nurse's assessment of subject communication
Secondary	Duration of mechanical ventilation, weaning time and ventilator-free days in ICU
Secondary	Length of total hospital stay
Secondary	Functional recovery during hospitalisation
Secondary	Need for rescue medication to maintain sedation
Secondary	Frequency of delirium
Secondary	Frequency of organ failures and failure-free days
Secondary	Frequency of critical illness polyneuropathy
Secondary	ICU- and in-hospital survival
Secondary	Cost of care in the ICU
Secondary	Total cost of hospitalisation
Secondary	Blood levels of dexmedetomidine seen with long-term treatment