Dexmedetomidine-based Sedation in Neurocritical Care Patients

• Status: Unknown status
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: Orion Corporation provides financial support.; Orion Corporation, Orion Pharma
• Treatments: Dexmedetomidine

Criteria

Inclusion Criteria:

• 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 Criteria:

• - 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.