Skip to main content
OpenTrials
Completed

NCT Number: NCT00538616

Precedex Versus Propofol-Awakening for Reducing Brain Injury Expansion

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Brain Injury Brain Diseases Brain Injuries Central Nervous System Diseases Craniocerebral Trauma Intracranial Pressure Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Duke University

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

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

Other names: Precedex

Propofol

Drug

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

Other names: Diprivan

Primary outcomes

  1. Lactate/Pyruvate (L/P)Ratio

    Time frame: 1 hour

    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.

Sponsors and collaborators

Lead sponsor

Carmelo Graffagnino

Other

Collaborators

  • Hospira, now a wholly owned subsidiary of Pfizer

Registry information

Official study title

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

Acronym: PrePARE

Important dates

Study start
2008
Primary completion
2008
Study completion
2010
First posted
Oct 2, 2007
Registry last updated
Apr 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.