Use of Dexmedetomidine in Acute Stroke and Cerebral Vasospasm Interventions

April 15, 2022 updated by: University Hospitals Cleveland Medical Center

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

5

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals of Cleveland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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 Names:
  • Precedex
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.
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:
  • Versed
  • Dormicum
  • Hypnovel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numbers of patient movements (events) that delay or adversely affect the procedure performance and safety.
Time Frame: Primary outcome wil be asessed during the procedure.
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 wil be asessed during the procedure.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preserved neurological examination.
Time Frame: Assessment occurs six times: prior, during and after the procedure.
Neurological status using modified NIHSS (National Institutes of Health Stroke Scale) will be assessed six times in all patients: 1) prior to the procedure, 2) twenty minutes after starting the drug, 3) one time during the procedure, 4) at the conclusion of the procedure, 5) thirty minutes after stopping the drug drip and 6) three hours after the conclusion of the procedure. RASS score will also be concomitantly assessed with each preserved neurological exam assessment. The observed proportion of times out of the 5 trials after the start of the procedure that neurological exam is preserved will be a secondary outcome in this study.
Assessment occurs six times: prior, during and after the procedure.
Maintenance of optimal sedation target in both groups.
Time Frame: Assessed at baseline before procedure and every twenty minutes during procedure.
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. 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.
Assessed at baseline before procedure and every twenty minutes during procedure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospitals Cleveland Medical Center

Collaborators

Hospira, now a wholly owned subsidiary of Pfizer

Investigators

  • Principal Investigator: Kristine A Blackham, MD, University Hospitals Cleveland Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

December 1, 2021

Study Completion (Actual)

December 1, 2021

Study Registration Dates

First Submitted

April 29, 2013

First Submitted That Met QC Criteria

May 1, 2013

First Posted (Estimate)

May 3, 2013

Study Record Updates

Last Update Posted (Actual)

April 22, 2022

Last Update Submitted That Met QC Criteria

April 15, 2022

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-11-10
  • GIA#PRE-10-1003 (Other Grant/Funding Number: Hospira, Inc)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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