Precedex Versus Propofol-Awakening for Reducing Brain Injury Expansion

Study Overview
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Brief Summary
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The purpose of this study is to evaluate brain injury when two different drugs (propofol and precedex) are used to sedate patients who need a neurologic exam.

Detailed Description
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The hypothesis is that a neurologic exam performed when the subject has continuous infusion of precedex will result in less brain injury (where the lactate/pyruvate ratio indicates injury) then when a neurologic exam is performed on subjects receiving propofol, because that exam requires that the propofol infusion be stopped.

Official Title
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A Phase IV Single Center Cross Over Clinical Study Comparing Two Different Sedations Strategies for Mechanically Ventilated Patients With Neurological Critical Illness

Conditions
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Brain Injury, Intracranial Pressure

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Propofol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: primary diagnosis of Traumatic Brain Injury (TBI), Subarachnoid Hemorrhage (SAH),Intracranial Hemorrhage (ICH), stroke Must require (be on) mechanical ventilation must require (have in place) intracranial pressure (ICP) monitoring must require (be receiving) continuous IV sedation Exclusion Criteria: Bleeding diathesis Glasgow Coma Scale (GCS) < 5 with fixed pupils Pregnant elevated ICP that requires deep sedation pulmonary instability Hx of Ethanol(ETOH) abuse that requires current benzodiazepine treatment for delirium - allergy to propofol or precedex status epilepticus current neuromuscular blockade

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Precedex-Propofol<br>Patients received an infusion of precedex for six hours and then a washout and then a propofol infusion for six hours. | Drug: Dexmedetomidine<br>* in this crossover study, subjects will receive 6 hours of propofol and 6 hours of precedex (randomized crossover)<br>* Other names: Precedex;Drug: Propofol<br>* in this crossover study, subjects will receive 6 hours of propofol and 6 hours of precedex (randomized crossover)<br>* Other names: Diprivan;|
| Active Comparator: Propofol- Precedex<br>Patients received an infusion of propofol for six hours and then a washout and then a precedex infusion for six hours. | Drug: Dexmedetomidine<br>* in this crossover study, subjects will receive 6 hours of propofol and 6 hours of precedex (randomized crossover)<br>* Other names: Precedex;Drug: Propofol<br>* in this crossover study, subjects will receive 6 hours of propofol and 6 hours of precedex (randomized crossover)<br>* Other names: Diprivan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lactate/Pyruvate (L/P)Ratio | L/P ratio was measured before during and after sedation assessment. The micromole value for each dialysate (lactate and pyruvate) was reported as well as the ratio (L/P). Elevated ratios (greater than 30) were attributed to metabolic distress (relative hypoxemia)during the course of the trial. | 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brain Injury