Use of Dexmedetomidine in Acute Stroke and Cerebral Vasospasm Interventions
Status: | Completed |
---|---|
Conditions: | Peripheral Vascular Disease, Neurology |
Therapuetic Areas: | Cardiology / Vascular Diseases, Neurology |
Healthy: | No |
Age Range: | 18 - 85 |
Updated: | 4/2/2016 |
Start Date: | April 2012 |
End Date: | December 2013 |
Contact: | Kristine A Blackham, MD |
Email: | Kristine.Blackham@UHhospitals.org |
Phone: | 1 216 844 - 1548 |
A Randomized, Controlled Trial on Dexmedetomidine for Providing Adequate Sedation and Preserved Neurologic Examination for Endovascular Treatment of Acute Ischemic Stroke or Cerebral Vasospasm.
Dexmedetomidine is a unique sedative medication able to provide sedation without causing
respiratory depression and maintaining neurological functions. Patients having an acute
ischemic stroke and need to undergo endovascular therapy require constant assessment of
their neurological status prior, during and after the interventional procedure. In this
study the investigators will compare the efficacy of Dexmedetomidine to other standard
sedative medications in providing optimal sedative effect while maintaining neurological
function.
respiratory depression and maintaining neurological functions. Patients having an acute
ischemic stroke and need to undergo endovascular therapy require constant assessment of
their neurological status prior, during and after the interventional procedure. In this
study the investigators will compare the efficacy of Dexmedetomidine to other standard
sedative medications in providing optimal sedative effect while maintaining neurological
function.
Precedex is a unique FDA-approved intravenous medication for conscious sedation in that it
allows for "arousable" sedation, which is particularly appealing for use in patients with
compromised neurologic function. While Precedex has been shown to be equivalent, if not
superior to, conventional sedation in the procedural setting, it has not yet been evaluated
in the setting of endovascular treatment of acute stroke. This setting is particularly ripe
for evaluation, as there is currently controversy over the best method for management of
patient sedation in light of the auxiliary need to preserve neurologic function. In order to
evaluate the benefit of Precedex in this setting, it must be compared to the usual standard
of care. Through the investigators double blinded randomized trial, the investigators will
obtain information on the comparison between two arms, one receiving Precedex and the other
the usual standard of care at the investigators institution, for achieving and maintaining a
pre-defined level of conscious sedation, while preserving baseline neurologic status. This
assessment will optimistically serve as the basis for future large-scale studies and
ultimately to the establishment of Precedex as a first-line sedative in the management of
acute stroke and cerebral vasospasm patients undergoing endovascular intervention.
allows for "arousable" sedation, which is particularly appealing for use in patients with
compromised neurologic function. While Precedex has been shown to be equivalent, if not
superior to, conventional sedation in the procedural setting, it has not yet been evaluated
in the setting of endovascular treatment of acute stroke. This setting is particularly ripe
for evaluation, as there is currently controversy over the best method for management of
patient sedation in light of the auxiliary need to preserve neurologic function. In order to
evaluate the benefit of Precedex in this setting, it must be compared to the usual standard
of care. Through the investigators double blinded randomized trial, the investigators will
obtain information on the comparison between two arms, one receiving Precedex and the other
the usual standard of care at the investigators institution, for achieving and maintaining a
pre-defined level of conscious sedation, while preserving baseline neurologic status. This
assessment will optimistically serve as the basis for future large-scale studies and
ultimately to the establishment of Precedex as a first-line sedative in the management of
acute stroke and cerebral vasospasm patients undergoing endovascular intervention.
Inclusion Criteria:
- Patients with acute ischemic stroke who require endovascular intervention with whom
mNIHSS score can be obtained
- Patients with cerebral vasospasm suspiciousness with or without subarachnoid
hemorrhage with whom mNIHSS score can be obtained.
Exclusion Criteria:
- History of severe hepatic disease or severe renal disease (GFR<20).
- Hemodynamic instability.
- Pregnancy.
- Known allergy to study drug.
- Evidence or history of cardiac electrophysiology instability including uncontrolled
hemodynamically unstable complex atrial/ventricular arrhythmia or conduction block at
the time of evaluation with the exception of atrial fibrillation, and heart rate less
than 60 or systolic blood pressure less than 90.
- Respiratory compromise requiring intubation.
- Any medical (including history of cardiac conduction block, major hepatic or renal
disease) or laboratory abnormality that may increase the risk associated with the
trial participation or drug administration or may interfere with interpretation of
trial results.
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