Cerebral Perfusion Pressure Using Precedex and Other Sedatives

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2013-11-30

Brief Summary

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The purpose of this study is to examine the effects of using dexmedetomidine (Precedex) in addition to the current standard-of-care for sedation.

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Detailed Description

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Primarily, this study seeks to explore whether there is a difference in mean arterial pressure (MAP) variability, incidence of intracranial hypertension, intracranial pressure (ICP) variability, cerebral perfusion pressure (CPP) and Cerebrovascular pressure reactivity index (PRx) in two groups of subjects.

Patients must be submitted to the ICU and be endotracheally intubated and receiving mechanical ventilation with continuous IV sedation for less than 24 hours after recruitment into the study.

Conditions

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Endotracheal Intubation Continuous IV Sedation ICP Monitoring

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Standard-of-Care plus Precedex

Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment.

Group Type ACTIVE_COMPARATOR

Standard-of-Care plus Dexmedetomidine

Intervention Type DRUG

Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment

Standard-of-Care

Subjects who are treated with the standard of care sedation regiment only.

Group Type PLACEBO_COMPARATOR

Standard-of-Care

Intervention Type OTHER

Subjects who are treated with the standard of care sedation regiment only.

Interventions

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Standard-of-Care plus Dexmedetomidine

Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment

Intervention Type DRUG

Standard-of-Care

Subjects who are treated with the standard of care sedation regiment only.

Intervention Type OTHER

Other Intervention Names

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Precedex

Eligibility Criteria

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Inclusion Criteria

* Admitted to Duke University Neuro Critical Care Unit (NCCU)
* Adult (18 years of age or older)
* Expected Mechanical Ventilation for \>48 hours with sedation
* Intraventricular catheter in situ

Exclusion Criteria

* Hypersensitivity to study drugs
* Prisoners
* Moribund state or death expected within 24 hours
* Surgery planned within 24 hours of subject enrollment
* Receiving study drug, Precedex, prior to entering study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No