Precedex Versus Propofol-Awakening for Reducing Brain Injury Expansion

NCT00538616

Last updated date
Study Location
Duke University
Durham, North Carolina, 27710, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Brain Injury, Intracranial Pressure
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Brain Injury, Intracranial PressurePrecedex Versus Propofol-Awakening for Reducing Brain Injury Expansion
NCT00538616
  1. Durham, North Carolina
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Precedex Versus Propofol-Awakening for Reducing Brain Injury Expansion
Official Title  ICMJE A Phase IV Single Center Cross Over Clinical Study Comparing Two Different Sedations Strategies for Mechanically Ventilated Patients With Neurological Critical Illness
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Brain Injury
  • Intracranial Pressure
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Dexmedetomidine
    • Drug: Propofol
  • 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.
    Interventions:
    • Drug: Dexmedetomidine
    • Drug: Propofol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 1, 2013)
8
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE April 2010
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00538616
Other Study ID Numbers  ICMJE Pro00002077
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Carmelo Graffagnino, Duke University
Study Sponsor  ICMJE Carmelo Graffagnino
Collaborators  ICMJE Hospira, now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Principal Investigator:Carmelo Graffagnino, MDDuke University
Principal Investigator:DaiWai M Olson, PhD RNDuke University
PRS Account Duke University
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP