Precedex Versus Propofol-Awakening for Reducing Brain Injury Expansion

Carmelo Graffagnino8 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Brain Injury Intracranial Pressure

Interventions

DexmedetomidineDRUG

in this crossover study, subjects will receive 6 hours of propofol and 6 hours of precedex (randomized crossover)

PropofolDRUG

in this crossover study, subjects will receive 6 hours of propofol and 6 hours of precedex (randomized crossover)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Duke University

Durham, North Carolina, United States

Outcomes

Primary Outcomes

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.

Time frame: 1 hour

Data from ClinicalTrials.gov

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