Use of Dexmedetomidine in Acute Stroke and Cerebral Vasospasm Interventions

• Status: Unknown status
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospitals Cleveland Medical Center
• Collaborators: Hospira, Inc.; Hospira, now a wholly owned subsidiary of Pfizer
• Treatments: Dexmedetomidine; Fentanyl; Midazolam

Criteria

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.