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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.
Details
| Lead sponsor | University Hospitals Cleveland Medical Center |
|---|---|
| Phase | Phase 2 |
| Status | TERMINATED |
| Enrolment | 7 |
| Start date | 2012-04 |
| Completion | 2021-12 |
Conditions
- Stroke
- Brain Ischemia
- Vasospasm, Intracranial
- Hemorrhage, Intracranial
Interventions
- Dexmedetomidine
- Fentanyl
- Midazolam
Primary outcomes
- Numbers of Patient Movements (Events) That Delay or Adversely Affect the Procedure Performance and Safety. — Primary outcome will be assessed during the procedure, up to 4 hours.
Patient will be continuously monitored for movements that delays or adversely affect the performance of the procedure by the patient assessor in a safe and timely manner (an event). One minute interval between patient event assessments will be given to prevent subjective bias. After every one minute, it will be determined if an event has occurred. Over the length of the procedure, the total number of one-minute intervals with an event occurrence will be summed and then divided by the total of minutes in the procedure to obtain a standardized value as the primary outcome. This will allow for direct comparison of values across the procedures of varying length. This approach will be more systematic and more easily replicable than counting events directly, which requires interpretation as to when a movement event begins and ends, which can be difficult and more subjective.
Countries
United States