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Use of Dexmedetomidine in Acute Stroke and Cerebral Vasospasm Interventions

NCT01845441 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2022-12-28

Study results available
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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.

Conditions

  • Stroke
  • Brain Ischemia
  • Vasospasm, Intracranial
  • Hemorrhage, Intracranial

Interventions

DRUG

Dexmedetomidine

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

DRUG

Fentanyl

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

DRUG

Midazolam

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

Sponsors & Collaborators

  • Hospira, now a wholly owned subsidiary of Pfizer

    collaborator INDUSTRY

  • University Hospitals Cleveland Medical Center

    lead OTHER

Principal Investigators

  • Kristine A Blackham, MD · University Hospitals Cleveland Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01845441 on ClinicalTrials.gov