Status:
UNKNOWN
Dexmedetomidine-based Sedation in Neurocritical Care Patients
Lead Sponsor:
University Hospital, Clermont-Ferrand
Collaborating Sponsors:
Orion Corporation, Orion Pharma
Conditions:
Acute Brain Injuries
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This will be an open, prospective pilot study with pharmacological analysis. This study is designed to assess the efficacity and safety of dexmedetomidine-based sedation in two subgroups of neurocriti...
Detailed Description
A written informed consent will be obtained from patients next-of-kin, before study enrollment according to inclusion and exclusion criterias. All consecutive brain-injured patients (traumatic brain i...
Eligibility Criteria
Inclusion
- Brain-injured patients (traumatic brain injury, subarachnoid or intracerebral hemorrhage, postoperative neurosurgical procedure)
- Older than 18 years
- Requiring sedation and analgesia for mechanical ventilation longer than 48 hours
- Written informed consent obtained from patients next-of-kin, before study enrollment
- Depending on the absence or presence of lesion which may increase intracranial pressure, patients will be included in the "light to moderate" sedation subgroup or in the "deep" sedation subgroup
Exclusion
- \- Heart rate \< 45 bpm,
- Uncontrolled shock or cardiac failure,
- High-grade AV block,
- Acute ischemic neurological injury,
- Severe liver failure,
- Drug overdose and prior enrollment in a trial with any experimental drug in the last 30 days,
- Need for ongoing neuromuscular blockade except for tracheal intubation,
- Pregnancy/lactation,
- Known allergic reaction to dexmedetomidine,
- Uncontrolled diabetes.
Key Trial Info
Start Date :
April 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2015
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT02252523
Start Date
April 1 2014
End Date
April 1 2015
Last Update
September 30 2014
Active Locations (1)
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1
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003