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-FI
• Lead Sponsor: Orion Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-07-21
• Study Completion: 2006-07-22
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

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

Inclusion Criteria

Diagnosis and main criteria for inclusion and exclusion:
Main criteria for inclusion:
•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

Main criteria for exclusion:
•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, bilirybin>101 mcgmol/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 ?2-agonists or antagonists at the time of randomisation (see prior and concomitant treatments, Section 5.7)

Study & Design

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