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Precedex Versus Propofol-Awakening for Reducing Brain Injury Expansion (PrePARE)

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ClinicalTrials.gov Identifier: NCT00538616
Recruitment Status : Completed
First Posted : October 2, 2007
Results First Posted : April 11, 2013
Last Update Posted : April 11, 2013
Sponsor:
Collaborator:
Hospira, now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Carmelo Graffagnino, Duke University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Brain Injury Intracranial Pressure Drug: Dexmedetomidine Drug: Propofol Phase 1 Phase 2

Detailed Description:
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  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Phase IV Single Center Cross Over Clinical Study Comparing Two Different Sedations Strategies for Mechanically Ventilated Patients With Neurological Critical Illness
Study Start Date : January 2008
Actual Primary Completion Date : February 2008
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Precedex-Propofol
Patients received an infusion of precedex for six hours and then a washout and then a propofol infusion for six hours.
Drug: Dexmedetomidine
in this crossover study, subjects will receive 6 hours of propofol and 6 hours of precedex (randomized crossover)
Other Name: Precedex
Drug: Propofol
in this crossover study, subjects will receive 6 hours of propofol and 6 hours of precedex (randomized crossover)
Other Name: Diprivan
Active Comparator: Propofol- Precedex
Patients received an infusion of propofol for six hours and then a washout and then a precedex infusion for six hours.
Drug: Dexmedetomidine
in this crossover study, subjects will receive 6 hours of propofol and 6 hours of precedex (randomized crossover)
Other Name: Precedex
Drug: Propofol
in this crossover study, subjects will receive 6 hours of propofol and 6 hours of precedex (randomized crossover)
Other Name: Diprivan



Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00538616


Locations
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Carmelo Graffagnino
Hospira, now a wholly owned subsidiary of Pfizer
Investigators
Principal Investigator: Carmelo Graffagnino, MD Duke University
Principal Investigator: DaiWai M Olson, PhD RN Duke University

Responsible Party: Carmelo Graffagnino, Professor, Duke University
ClinicalTrials.gov Identifier: NCT00538616     History of Changes
Other Study ID Numbers: Pro00002077
First Posted: October 2, 2007    Key Record Dates
Results First Posted: April 11, 2013
Last Update Posted: April 11, 2013
Last Verified: March 2013

Keywords provided by Carmelo Graffagnino, Duke University:
Brain Injury

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Propofol
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action