Stroke Clinical Trial
Official title:
A Randomized, Controlled Trial on Dexmedetomidine for Providing Adequate Sedation and Preserved Neurologic Examination for Endovascular Treatment of Acute Ischemic Stroke or Cerebral Vasospasm.
Verified date | November 2022 |
Source | University Hospitals Cleveland Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 7 |
Est. completion date | December 2021 |
Est. primary completion date | December 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | University Hospitals of Cleveland | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
University Hospitals Cleveland Medical Center | Hospira, now a wholly owned subsidiary of Pfizer |
United States,
Abou-Chebl A, Lin R, Hussain MS, Jovin TG, Levy EI, Liebeskind DS, Yoo AJ, Hsu DP, Rymer MM, Tayal AH, Zaidat OO, Natarajan SK, Nogueira RG, Nanda A, Tian M, Hao Q, Kalia JS, Nguyen TN, Chen M, Gupta R. Conscious sedation versus general anesthesia during endovascular therapy for acute anterior circulation stroke: preliminary results from a retrospective, multicenter study. Stroke. 2010 Jun;41(6):1175-9. doi: 10.1161/STROKEAHA.109.574129. Epub 2010 Apr 15. — View Citation
Arepally A, Oechsle D, Kirkwood S, Savader SJ. Safety of conscious sedation in interventional radiology. Cardiovasc Intervent Radiol. 2001 May-Jun;24(3):185-90. doi: 10.1007/s002700002549. — View Citation
Chamczuk AJ, Ogilvy CS, Snyder KV, Ohta H, Siddiqui AH, Hopkins LN, Levy EI. Elective stenting for intracranial stenosis under conscious sedation. Neurosurgery. 2010 Nov;67(5):1189-93; discussion 1194. doi: 10.1227/NEU.0b013e3181efbcac. — View Citation
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Gupta R, Vora NA, Horowitz MB, Tayal AH, Hammer MD, Uchino K, Levy EI, Wechsler LR, Jovin TG. Multimodal reperfusion therapy for acute ischemic stroke: factors predicting vessel recanalization. Stroke. 2006 Apr;37(4):986-90. doi: 10.1161/01.STR.0000209303.02474.27. Epub 2006 Mar 9. — View Citation
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Hoffman WE, Kochs E, Werner C, Thomas C, Albrecht RF. Dexmedetomidine improves neurologic outcome from incomplete ischemia in the rat. Reversal by the alpha 2-adrenergic antagonist atipamezole. Anesthesiology. 1991 Aug;75(2):328-32. doi: 10.1097/00000542-199108000-00022. — View Citation
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* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Numbers of Patient Movements (Events) That Delay or Adversely Affect the Procedure Performance and Safety. | 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. | Primary outcome will be assessed during the procedure, up to 4 hours. | |
Secondary | Preserved Neurological Examination. | Neurological status using modified NIHSS (National Institutes of Health Stroke Scale) is a 15-item neurologic examination stroke scale, between 0 and 4, with 0 being normal functioning and 4 being completely impaired. | Up to 8 hours | |
Secondary | Maintenance of Optimal Sedation Target in Both Groups. | Both arms will be assessed by the patient assessor with RASS score measurement at baseline and every 20 minutes thereafter for the length of the procedure (up to 8 hours) and then averaged together to get one over all score . In the Dexmedetomidine arm the drug will be titrated by 0.1mcg/Kg/hour by the treating physician clinical judgment, in order to achieve and maintain RASS of 0 - 1. In the control arm the drug adjustment will not be based on the RASS score, but by physician discretion only. It is a 10-point scale to determine sedation, with a score from +4 (very combative, violent, dangerous to staff) to -5 (unarousable, no response to voice or physical stimulation). | Up to 8 hours |
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