Overview

Dexmedetomidine-based Sedation in Neurocritical Care Patients

Status:
Unknown status
Trial end date:
2015-04-01
Target enrollment:
Participant gender:
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 neurocritically ill patients requiring mechanical ventilation for more than 48 hours. Those with or at risk for intracranial hypertension requiring deep sedation and those requiring a light to moderate sedation for early neurological evaluation. The main objective is to assess the feasability of dexmedetomidine infusion in terms of efficacy and safety (especially cardiovascular tolerance) in brain-injured patients admitted to intensive care unit and requiring sedation and mechanical ventilation for a predictable duration greater than or equal to 48 hours. Secondary objectives include the study of hemodynamic parameters evolution, dose-response relationship, blood (+/- cerebrospinal fluid) drug concentration, opioates and co-hypnotic consumption.
Phase:
Phase 2
Details
Lead Sponsor:
University Hospital, Clermont-Ferrand
Collaborators:
Orion Corporation provides financial support.
Orion Corporation, Orion Pharma
Treatments:
Dexmedetomidine