A PROSPECTIVE, MULTI-CENTRE, RANDOMISED, DOUBLE-BLIND COMPARISON OF INTRAVENOUS DEXMEDETOMIDINE WITH MIDAZOLAM FOR CONTINUOUS SEDATION OF VENTILATED PATIENTS IN INTENSIVE CARE UNIT - Midex
- Conditions
- Patients requiring mechanical ventilation and sedation in ICU.MedDRA version: 8.0Level: LLTClassification code 10039897
- Registration Number
- EUCTR2006-006031-50-DE
- Lead Sponsor
- Orion Corporation Orion Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 500
• Age =18 years
• Clinical need for sedation of an initially intubated (or tracheotomised) and ventilated (with inspiratory assistance) patient
• Prescribed light to moderate sedation (target RASS = 0 to -3) using midazolam infusion
• Patients should be randomised = 72 hours from ICU admission and = 48 hours of commencing continuous sedation in the ICU
• Patients should have an expected requirement for sedation = 24 hours from time of randomisation
• Written informed consent must be obtained according to local regulations before starting any study procedures other than pre-screening
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
• Acute severe intracranial or spinal neurological disorder due to vascular causes, infection, intracranial expansion or injury
• Uncompensated acute circulatory failure at time of randomisation (severe hypotension with MAP less than 55 mmHg despite volume and pressors)
• Severe bradycardia (HR less than 50 beats/min)
• AV-conduction block II-III (unless pacemaker installed)
• Severe hepatic impairment (bilirubin more than 101 µmol/L)
• Need for muscle relaxation at the time of randomisation (may only be used for intubation and initial stabilization)
• Loss of hearing or vision, or any other condition which would significantly interfere with the collection of study data
• Burn injuries and other injuries requiring regular anaesthesia or surgery
• Use of centrally acting a2 agonists or antagonists (e.g. clonidine, titzanidine, apraclonidine and brimonidine) within 24 hours prior to randomisation
• Known allergy to any of the study drugs or any excipients of the study drugs
• Patients who have or are expected to have treatment withdrawn or withheld due to poor prognosis
• Patients receiving sedation for therapeutic indications rather than to tolerate the
ventilator (e.g. epilepsy)
• Patients unlikely to require continuous sedation during mechanical ventilation (e.g. Guillain-Barre syndrome)
• Patients who are unlikely to be weaned from mechanical ventilation; e.g. diseases/injuries primarily affecting the neuromuscular function of the respiratory apparatus such as clearly irreversible disease requiring prolonged ventilatory support (e.g. high spinal cord injury or advanced amyotrophic lateral sclerosis)
• Distal paraplegia
• Positive pregnancy test or currently lactating
• Received any investigational drug within the preceding 30 days
• Concurrent participation in any other interventional study (any study in which patients are allocated to different treatment groups and/or non-routine diagnostic or monitoring procedures are performed)
• Previous participation in this study
• Any other condition which, in the investigator’s opinion, would make it detrimental for the subject to participate in the study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method