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Spreading Depolarization and Ketamine Suppression (SAKS)

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ClinicalTrials.gov Identifier: NCT02501941
Recruitment Status : Completed
First Posted : July 17, 2015
Last Update Posted : October 25, 2017
Sponsor:
Information provided by (Responsible Party):
Andrew Phillip Carlson, University of New Mexico

Brief Summary:
Hypothesis: Cortical spreading depolarizations are inhibited by the NMDA receptor antagonist Ketamine Aim 1: To demonstrate, in a group of patients with acute severe brain injury requiring surgery including traumatic brain injury and aneurysmal subarachnoid hemorrhage, whether use of continuous infusion of ketamine decreases frequency of occurrence of cortical spreading depolarizations.

Condition or disease Intervention/treatment Phase
Cortical Spreading Depolarization Cortical Spreading Depression Subarachoid Hemorrhage Traumatic Brain Injury Drug: ketamine Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Spreading Depolarization and Ketamine Suppression
Study Start Date : July 2015
Actual Primary Completion Date : January 1, 2017
Actual Study Completion Date : May 1, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Experimental: Ketamine first
Randomization to receive ketamine as first post-operative sedative in the Neuroscience Intensive Care unit. This group will cross-over to "other sedation" after 6 hours, then alternate every 6 hours between these groups during the entirety of invasive neuromonitoring.
Drug: ketamine
Ketamine will be used as a sedative alternative to other more conventional sedatives (such as propofol, versed, or dexmedetomidine) in 6 hour blocks of time. Ketamine will be titrated at the bedside based on clinically desired Riker Sedation-Agitation Scale target. Both groups will receive the drug in this multiple crossover design. The only difference between groups is which sedation regimen is started first to minimize any bias related to differences in physiology in the early post-operative phase.

Experimental: Other sedation (typically propofol) first
Randomization to receive sedative other than ketamine as first post-operative sedative in the Neuroscience Intensive Care unit. This group will cross-over to ketamine after 6 hours, then alternate every 6 hours between these groups during the entirety of invasive neuromonitoring.
Drug: ketamine
Ketamine will be used as a sedative alternative to other more conventional sedatives (such as propofol, versed, or dexmedetomidine) in 6 hour blocks of time. Ketamine will be titrated at the bedside based on clinically desired Riker Sedation-Agitation Scale target. Both groups will receive the drug in this multiple crossover design. The only difference between groups is which sedation regimen is started first to minimize any bias related to differences in physiology in the early post-operative phase.




Primary Outcome Measures :
  1. Change in frequency of Cortical Spreading depression with use of ketamine [ Time Frame: approximately 7 days ]
    Frequency of events as defined by propagating slow potential change in adjacent leads with associated suppression of high frequency signal. Assessed by 2 experienced reviewers blinded to sedation arm.


Secondary Outcome Measures :
  1. Change in frequency of Cortical Spreading depolarization with stimulation to patient [ Time Frame: approximately 7 days ]
    Episodes of touching and other clinical manipulations will be scored by review of video EEG data and correlated with occurrence of CSD.

  2. Change in frequency of Cortical Spreading depolarization with varying doses of ketamine [ Time Frame: approximately 7 days ]
    CSD will be assessed as above, and if there is a response with Ketamine, a dose response assessment will be performed.

  3. Presence of Scalp EEG tracings correlates to cortical spreading depolarization [ Time Frame: approximately 7 days ]
    Using scalp EEG electrodes positioned above the cortical strip, propagating loss of high frequency signal in adjacent channels will be scored by an experienced EEG interpreter.

  4. Correlation between pre-operative neurologic exam (GCS) and amount and frequency of cortical spreading depolarizations [ Time Frame: approximately 7 days ]
    Glasgow Coma Scale score will be used.

  5. Correlation between post-operative neurologic exam (GCS) and amount and frequency of cortical spreading depolarizations [ Time Frame: approximately 7 days ]
    Glasgow Coma Scale will be used.

  6. Subtype of CSD will be correlated with ketamine use. This includes Isoelectric, partially isoelectric, and clusters of CSD. [ Time Frame: approximately 7 days ]
    Subtypes of CSD have previously been defined and will be scored by experienced reviewers using a standardized system. The outcome is "subtype of CSD" and so this single variable will be assessed for the effect of Ketamine.

  7. Demographic factors associated with more frequent cortical depolarizations. [ Time Frame: approximately 7 days ]
    Basic demographics including Age, Gender, injury type, and surgical procedure will be recorded.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • GCS <8
  • SAH or severe traumatic brain injury requiring craniotomy
  • Consent obtainable (via legal representative)
  • Ictus (bleed or injury) within 48 hours of enrollment
  • Clinically appropriate for multimodality monitoring

Exclusion Criteria:

  • Anticipated survival <48 hours
  • No craniotomy
  • Infratentorial craniotomy only•Unable to obtain consent
  • Absence of clinically used multimodality monitoring
  • Prisoners
  • Pregnant

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): NCT02501941


Locations
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United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
Sponsors and Collaborators
University of New Mexico
Investigators
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Principal Investigator: Andrew P Carlson, MD University of New Mexico

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Andrew Phillip Carlson, Assistant Professor, University of New Mexico
ClinicalTrials.gov Identifier: NCT02501941     History of Changes
Other Study ID Numbers: 15-056
First Posted: July 17, 2015    Key Record Dates
Last Update Posted: October 25, 2017
Last Verified: October 2017
Keywords provided by Andrew Phillip Carlson, University of New Mexico:
Ketamine
Cortical Spreading Depolarization
Cortical Spreading Depression
Additional relevant MeSH terms:
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Ketamine
Brain Injuries
Brain Injuries, Traumatic
Hemorrhage
Depression
Behavioral Symptoms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Pathologic Processes
Hypnotics and Sedatives
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action