drugset / Trial / NCT01845441
Use of Dexmedetomidine in Acute Stroke and Cerebral Vasospasm Interventions
Phase 2
Terminated
7 enrolled
University Hospitals Cleveland Medical Center
Hospira, now a wholly owned subsidiary of Pfizer · collab
RandomizedParallel-groupDouble-blindSupportive care
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.
Timeline
- Start
- 2012-04
- Primary completion
- 2021-12
- Completion
- 2021-12
Publications
- Background 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.
- Background Penumbra Pivotal Stroke Trial Investigators. The penumbra pivotal stroke trial: safety and effectiveness of a new generation of mechanical devices for clot removal in intracranial large vessel occlusive disease. Stroke. 2009 Aug;40(8):2761-8. doi: 10.1161/STROKEAHA.108.544957. Epub 2009 Jul 9.
- Background Smith WS, Sung G, Saver J, Budzik R, Duckwiler G, Liebeskind DS, Lutsep HL, Rymer MM, Higashida RT, Starkman S, Gobin YP; Multi MERCI Investigators; Frei D, Grobelny T, Hellinger F, Huddle D, Kidwell C, Koroshetz W, Marks M, Nesbit G, Silverman IE. Mechanical thrombectomy for acute ischemic stroke: final results of the Multi MERCI trial. Stroke. 2008 Apr;39(4):1205-12. doi: 10.1161/STROKEAHA.107.497115. Epub 2008 Feb 28.
- Background 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.
- Background Furlan A, Higashida R, Wechsler L, Gent M, Rowley H, Kase C, Pessin M, Ahuja A, Callahan F, Clark WM, Silver F, Rivera F. Intra-arterial prourokinase for acute ischemic stroke. The PROACT II study: a randomized controlled trial. Prolyse in Acute Cerebral Thromboembolism. JAMA. 1999 Dec 1;282(21):2003-11. doi: 10.1001/jama.282.21.2003.
- Background Flaherty ML, Woo D, Kissela B, Jauch E, Pancioli A, Carrozzella J, Spilker J, Sekar P, Broderick J, Tomsick T. Combined IV and intra-arterial thrombolysis for acute ischemic stroke. Neurology. 2005 Jan 25;64(2):386-8. doi: 10.1212/01.WNL.0000149529.78396.B0.
- Background Haslam PJ, Yap B, Mueller PR, Lee MJ. Anesthesia practice and clinical trends in interventional radiology: a European survey. Cardiovasc Intervent Radiol. 2000 Jul-Aug;23(4):256-61. doi: 10.1007/s002700010065.
- Background 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.
- Background Varma MK, Price K, Jayakrishnan V, Manickam B, Kessell G. Anaesthetic considerations for interventional neuroradiology. Br J Anaesth. 2007 Jul;99(1):75-85. doi: 10.1093/bja/aem122. Epub 2007 Jun 11.
- Background 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.
- Background Stoneburner JM, Nishanian GP, Cukingnan RA, Carey JS. Carotid endarterectomy using regional anesthesia: a benchmark for stenting. Am Surg. 2002 Dec;68(12):1120-3.
- Background 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.
- Background Taiji K. [Dexmedetomidine hydrochloride (Precedex), a new sedative in intensive care, its pharmacological characteristics and clinical study result]. Nihon Yakurigaku Zasshi. 2004 Sep;124(3):171-9. doi: 10.1254/fpj.124.171. Japanese.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexmedetomidine | Other / unclassified | 0.3 ug/kg | Intravenous |
| Comparator | Fentanyl | Other / unclassified | 50 ug | Intravenous |
| Comparator | Midazolam | Small molecule | 0.5 mg | Intravenous |