NCT01845441

Use of Dexmedetomidine in Acute Stroke and Cerebral Vasospasm Interventions

A Randomized, Controlled Trial on Dexmedetomidine for Providing Adequate Sedation and Preserved Neurologic Examination for Endovascular Treatment of Acute Ischemic Stroke or Cerebral Vasospasm.

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: University Hospitals Cleveland Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Stroke
• Brain Ischemia
• Vasospasm, Intracranial
• Hemorrhage, Intracranial

Interventions

Type	Name	Description
DRUG	Dexmedetomidine	Precedex will be given to randomized subjects in thi study to evaluate its efficacy in maintaining optimal sedation and preserving neurological exam.
DRUG	Fentanyl	Patients in the control arm will receive no medication or standard sedative drug for the interventional procedure.
DRUG	Midazolam	Patients in the control arm will receive no medication or standard sedative drug for the interventional procedure.

Timeline

• Start date: 2012-04-01
• Primary completion: 2021-12-01
• Completion: 2021-12-01
• First posted: 2013-05-03
• Last updated: 2022-12-28
• Results posted: 2022-12-28

Locations

1 site across 1 country: United States