MedDataX Logo

Use of Dexmedetomidine in Acute Stroke and Cerebral Vasospasm Interventions

NCT ID: NCT01845441

Last Updated: 2022-12-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2021-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke Brain Ischemia Vasospasm, Intracranial Hemorrhage, Intracranial

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Dexmedetomidine Endovascular procedure Stroke Vasospasm, intracranial Conscious sedation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Dexmedetomidine arm

Precedex will be started after randomization/prior to catheterization and will be stopped at the end of the procedure. It will be used for an average of 90 minutes and will be used as a continuous intravenous infusion started at 0.3 mcg/kg/hour. If HR \> 80 and BP \> 120/70, a full loading dose (1.0 mcg/kg/hour) will be administered over 10 minutes. If HR is 60 - 80 or systolic BP is 90 - 120, or age \> 65 years, a reduced loading dose of 0.5 mcg/kg will be given over 10 minutes. If no volume overload history, 500mL of colloid (hespan or albumin) will be bolused with 0.2mg of glycopyrrolate. Every 10 minutes, Precedex will be titrated by 0.1 mcg/kg/hour to achieve and maintain RASS of 0 to -1.

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

Precedex will be given to randomized subjects in thi study to evaluate its efficacy in maintaining optimal sedation and preserving neurological exam.

Control arm

Our usual standard of care is to attempt the intervention without sedation. As per attending physician discretion, Fentanyl (50mcg) and/or Midazolam (0.5 mg) intravenous boluses will be used to control aggressive patient movement that adversely affects the technical capacity of the procedure. The boluses will be repeated at interval of 10 minutes, as necessary. Control arm patients will receive a normal saline placebo drip for the purposes of ensuring patient assessor blindness.

Group Type ACTIVE_COMPARATOR

Fentanyl

Intervention Type DRUG

Patients in the control arm will receive no medication or standard sedative drug for the interventional procedure.

Midazolam

Intervention Type DRUG

Patients in the control arm will receive no medication or standard sedative drug for the interventional procedure.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dexmedetomidine

Precedex will be given to randomized subjects in thi study to evaluate its efficacy in maintaining optimal sedation and preserving neurological exam.

Intervention Type DRUG

Fentanyl

Patients in the control arm will receive no medication or standard sedative drug for the interventional procedure.

Intervention Type DRUG

Midazolam

Patients in the control arm will receive no medication or standard sedative drug for the interventional procedure.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Precedex Sublimaze Fentora Instanyl Dormicum Hypnovel Versed

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospira, now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role collaborator

University Hospitals Cleveland Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kristine A Blackham, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospitals of Cleveland

Cleveland, Ohio, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 11443407 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19590057 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18309168 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16527997 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10591382 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15668451 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10960537 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20395617 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17562678 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20871450 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12516822 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1677549 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15333990 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GIA#PRE-10-1003

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

09-11-10

Identifier Type: -

Identifier Source: org_study_id