A Prospective, Multi-Centre, Randomised, Double-Blind Comparison of intravenous Dexmedetomidine with Propofol/Midazolam for continous sedation (24 hours to 14 days) of ventilated Patients in Intensive Care Unit - Dexmedetomidine for continuous sedatio

Phase 1

• Conditions: Patients requiring mechanical ventilation and sedation in ICU.; MedDRA version: 8.0Level: LLTClassification code 10039897

• Registration Number: EUCTR2005-002541-39-GB
• Lead Sponsor: Orion Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2006-07-22
• Study Start: 2006-09-18
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

• Age = 18 years
• Clinical need for sedation and mechanical ventilation
• Receiving full intensive care life support
• Patients should have an expected stay in ICU for = 48 hours from admission
• Patients should have an expected requirement for sedation = 24 hours from time of randomisation
• Written informed consent obtained from the patient’s representative (and an independent physician where appropriate) within 36 hours of starting sedation, but not more than 72 h from the time of ICU admission
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Acute severe neurological disorder due to vascular causes, infection, intracranial expansion or injury
• Uncompensated acute circulatory failure at time of randomisation [severe hypotension with mean arterial pressure (MAP) < 55 mmHg despite volume and pressors]
• Severe bradycardia [heart rate (HR) < 50 beats/min]
• AV-conduction block II-III (unless pacemaker installed)
• Severe hepatic impairment (SOFA score >2, bilirubin > 101 µmol/L)
• Positive pregnancy test or currently lactating
• Need for muscle relaxation at the time of randomisation (except for intubation and initial stabilization)
• Loss of hearing or vision, or any other condition that would significantly interfere with Richmond Agitation-Sedation Scale (RASS) assessment
• Use of a2-agonists or antagonists at the time of randomisation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified