NL-OMON31109CompletedPhase 3
A PROSPECTIVE, MULTI-CENTRE, RANDOMISED, DOUBLE-BLIND COMPARISON OF INTRAVENOUS DEXMEDETOMIDINE WITH PROPOFOL FOR CONTINUOUS SEDATION OF VENTILATED PATIENTS IN INTENSIVE CARE UNIT - ProDex
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- PRA International
- Enrollment
- 100
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •Patients >=18 years, Clinical need for sedation or intubated, RASS = 0 to -3 (light to moderate sedation), patient should have an expected requirement for sedation >= 24 hours, Written informed consent
Exclusion Criteria
- •Acute severe intracranial or spinal neurological disorder, Uncompensated acute circulatory failure, Severe bradycardia, AV-conduction block II-III, Severe hepatic impairment, Need for muscle relaxation , Loss of hearing or vision, Burn injuries, Use of centrally acting a2-agonists or antagonists
Investigators
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A PROSPECTIVE, MULTI-CENTRE, RANDOMISED, DOUBLE-BLIND COMPARISON OF INTRAVENOUS DEXMEDETOMIDINE WITH MIDAZOLAM FOR CONTINUOUS SEDATION OF VENTILATED PATIENTS IN INTENSIVE CARE UNIT - MidexPatients requiring mechanical ventilation and sedation in ICU.MedDRA version: 8.0Level: LLTClassification code 10039897EUCTR2006-006031-50-FIOrion Corporation Orion Pharma500