Use of Dexmedetomidine in Acute Stroke and Cerebral Vasospasm Interventions

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NCT01845441

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Study Location
University Hospitals of Cleveland
Cleveland, Ohio, 44106, United States
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1 216 844 - 1548
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Stroke, Brain Ischemia, Intracranial Vasospasm, Intracranial Hemorrhage
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-85 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Stroke, Brain Ischemia, Intracranial Vasospasm, Intracranial HemorrhageUse of Dexmedetomidine in Acute Stroke and Cerebral Vasospasm Interventions
NCT01845441
  1. Cleveland, Ohio
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Use of Dexmedetomidine in Acute Stroke and Cerebral Vasospasm Interventions
Official Title  ICMJE A Randomized, Controlled Trial on Dexmedetomidine for Providing Adequate Sedation and Preserved Neurologic Examination for Endovascular Treatment of Acute Ischemic Stroke or Cerebral Vasospasm.
Brief 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Stroke
  • Brain Ischemia
  • Vasospasm, Intracranial
  • Hemorrhage, Intracranial
Intervention  ICMJE
  • Drug: Dexmedetomidine
    Precedex will be given to randomized subjects in thi study to evaluate its efficacy in maintaining optimal sedation and preserving neurological exam.
    Other Name: Precedex
  • Drug: Fentanyl
    Patients in the control arm will receive no medication or standard sedative drug for the interventional procedure.
    Other Names:
    • Sublimaze
    • Fentora
    • Instanyl
  • Drug: Midazolam
    Patients in the control arm will receive no medication or standard sedative drug for the interventional procedure.
    Other Names:
    • Dormicum
    • Hypnovel
    • Versed
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Drug: Dexmedetomidine
  • Active Comparator: 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.
    Interventions:
    • Drug: Fentanyl
    • Drug: Midazolam
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 1, 2013)		32
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2013
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01845441
Other Study ID Numbers  ICMJE 09-11-10
GIA#PRE-10-1003 ( Other Grant/Funding Number: Hospira, Inc )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kristine Blackham, MD, University Hospitals Cleveland Medical Center
Study Sponsor  ICMJE University Hospitals Cleveland Medical Center
Collaborators  ICMJE Hospira, now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Principal Investigator:Kristine A Blackham, MDUniversity Hospitals Cleveland Medical Center
PRS Account University Hospitals Cleveland Medical Center
Verification Date April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP