<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02232347</url>
  </required_header>
  <id_info>
    <org_study_id>DCSSA KETABRAIN</org_study_id>
    <nct_id>NCT02232347</nct_id>
  </id_info>
  <brief_title>Ketamine and Glutamate After Brain Injury : a Microdialysis Study</brief_title>
  <acronym>KETABRAIN</acronym>
  <official_title>Effect of Ketamine Versus Sufentanil on Cerebral Glutamate After Traumatic Brain Injury : a Randomized, Double-blinded, Microdialysis Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pierre-Julien CUNGI</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Direction Centrale du Service de Santé des Armées</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of the study is to compare the effects of 48 hours ketamine infusion versus&#xD;
      sufentanil infusion on brain glutamate concentrations measured with microdialysis after&#xD;
      traumatic brain injury.&#xD;
&#xD;
      We hypothesize that ketamine infusion will decrease high glutamate values faster than&#xD;
      sufentanil.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Inclusion of 20 consecutive head trauma patients. Randomization and double-blind to compare&#xD;
      the effects of ketamine versus sufentanil on brain glutamate concentrations measured with&#xD;
      microdialysis.&#xD;
&#xD;
      Ketamine is an anti-N-methyl-D-aspartate (NMDA) medication. It is supposed to limit&#xD;
      excitotoxicity of amino-acids, especially glutamate. Glutamate is known to be elevated in&#xD;
      more than 60% of the severe head trauma patients. It induces cortical spreading depression&#xD;
      which can aggravate prognosis. It's a daily used medication in anesthesia and intensive care&#xD;
      units for sedation and induction of anesthesia. It's the recommended medication for induction&#xD;
      of unstable wounded soldiers on the field because of its neutrality on haemodynamic state.&#xD;
&#xD;
      Sufentanil is the reference opioid for sedation in ICU in Europe. It can induce hypotension&#xD;
      which is deleterious for cerebral perfusion pressure after brain trauma.&#xD;
&#xD;
      In our unit, patients with severe head injury are monitored by a triple lumen access device&#xD;
      including ICP (IntraCerebral Pressure), PtiO2 (oxygen pressure in the brain) and&#xD;
      microdialysis. This last monitoring allows measurement of brain parenchymal concentrations of&#xD;
      small molecules : glucose, lactate, pyruvate, glutamate, glycerol,.... It's a tool to&#xD;
      evaluate the metabolic state of the brain divided into 4 categories : normal,&#xD;
      hyperglycolysis, ischemia and metabolic crisis.&#xD;
&#xD;
      Then, we will detail the effects of ketamine on metabolic state of the brain, especially&#xD;
      glutamate concentration. Normal values are below 10 micromol/ml. After head trauma it can&#xD;
      dramatically increase to values up to 50 or even 100 micromol/ml, with normalization after 24&#xD;
      hours. Ketamine is expected to decrease these high values faster than described in&#xD;
      observational studies.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">May 2017</completion_date>
  <primary_completion_date type="Anticipated">October 2016</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>brain glutamate concentrations</measure>
    <time_frame>H0-H12, H12-H24, H24-H36 and H36-H48</time_frame>
    <description>To compare the kinetic of brain glutamate concentration decrease during 4 periods of 12 hours between ketamine infusion group (KET) and sufentanil standard infusion group (STD)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>metabolic profile</measure>
    <time_frame>H0-H12, H12-H24, H24-H36 and H36-H48</time_frame>
    <description>To compare the brain metabolic profile (normal, ischemic, hyperglycolytic and metabolic crisis) of the patients related to their group of treatment : ketamine (KET) and sufentanil (STD) by measuring brain glucose, brain lactate, brain glycerol concentrations and brain lactate/pyruvate ratio.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Episodes of intracranial hypertension (ICHT) and brain ischemia</measure>
    <time_frame>H0-H12, H12-H24, H24-H36 and H36-H48</time_frame>
    <description>To compare the number of ICHT episodes (ICP&gt;20 mm Hg more than 15 minutes) and to compare the number of ischemic episodes (PtiO2&lt;20 mm Hg more than 15 minutes) between the 2 groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Therapeutic Intensity Level (TIL)</measure>
    <time_frame>Days 1 and 2</time_frame>
    <description>To compare the TIL value between the 2 groups. TIL is a score developed to measure the intensity of cares for head trauma patients. Lower scores are meaning less intense cares. It is calculated for 24 hours periods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glasgow Outcome Scale (GOS) et extended Glasgow Outcome Scale (eGOS)</measure>
    <time_frame>6 months and 1 year</time_frame>
    <description>To describe the prognosis of the patients of the KETAMINE group versus SUFENTANIL group. GOS is the international validated score for evaluation of the prognosis after head trauma.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Head Trauma</condition>
  <arm_group>
    <arm_group_label>ketamine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ketamine 5 mg/kg/h, continuous infusion for 48 hours</description>
  </arm_group>
  <arm_group>
    <arm_group_label>sufentanil</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>sufentanil 0,5 mcg/kg/h, continuous infusion for 48 hours</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ketamine</intervention_name>
    <arm_group_label>ketamine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sufentanil</intervention_name>
    <arm_group_label>sufentanil</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &gt; 18 years old&#xD;
&#xD;
          -  Glasgow Coma Scale (GCS) &lt; 9&#xD;
&#xD;
          -  &gt; 3 days of sedation expected at the arrival&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  &lt; 18 years old&#xD;
&#xD;
          -  estimated survival &lt; 48 hours post-trauma&#xD;
&#xD;
          -  expected sedation &lt; 3 days&#xD;
&#xD;
          -  coagulation impairment (platelets&lt;100.000/mm3 and prothrombin time (TP) &lt;60%)&#xD;
&#xD;
          -  Cardiac arrest before ICU admission&#xD;
&#xD;
          -  Admission &gt; 12 hours after trauma&#xD;
&#xD;
          -  Multimodal monitoring implanted &gt; 24 hours post trauma&#xD;
&#xD;
          -  Participation to the study refused by the next of kind&#xD;
&#xD;
          -  No next of kind&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ambroise MONTCRIOL, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Direction Centrale du Service de Santé des Armées</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ambroise MONTCRIOL, MD</last_name>
    <phone>0483162358</phone>
    <phone_ext>0033</phone_ext>
    <email>ambroise.montcriol@free.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Sainte Anne Military Teaching Hospital</name>
      <address>
        <city>Toulon</city>
        <zip>83130</zip>
        <country>France</country>
      </address>
    </facility>
    <investigator>
      <last_name>Pierre Julien CUNGI, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Eric MEAUDRE, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Henry BORET, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Brain Trauma Foundation; American Association of Neurological Surgeons; Congress of Neurological Surgeons; Joint Section on Neurotrauma and Critical Care, AANS/CNS; Bratton SL, Chestnut RM, Ghajar J, McConnell Hammond FF, Harris OA, Hartl R, Manley GT, Nemecek A, Newell DW, Rosenthal G, Schouten J, Shutter L, Timmons SD, Ullman JS, Videtta W, Wilberger JE, Wright DW. Guidelines for the management of severe traumatic brain injury. I. Blood pressure and oxygenation. J Neurotrauma. 2007;24 Suppl 1:S7-13. doi: 10.1089/neu.2007.9995. No abstract available. Erratum In: J Neurotrauma. 2008 Mar;25(3):276-8. multiple author names added.</citation>
    <PMID>17511549</PMID>
  </reference>
  <reference>
    <citation>Hughes S. Towards evidence based emergency medicine: best BETs from the Manchester Royal Infirmary. BET 3: is ketamine a viable induction agent for the trauma patient with potential brain injury. Emerg Med J. 2011 Dec;28(12):1076-7. doi: 10.1136/emermed-2011-200891.</citation>
    <PMID>22101599</PMID>
  </reference>
  <reference>
    <citation>Filanovsky Y, Miller P, Kao J. Myth: Ketamine should not be used as an induction agent for intubation in patients with head injury. CJEM. 2010 Mar;12(2):154-7. doi: 10.1017/s1481803500012197. No abstract available.</citation>
    <PMID>20219164</PMID>
  </reference>
  <reference>
    <citation>Hudetz JA, Pagel PS. Neuroprotection by ketamine: a review of the experimental and clinical evidence. J Cardiothorac Vasc Anesth. 2010 Feb;24(1):131-42. doi: 10.1053/j.jvca.2009.05.008. Epub 2009 Jul 29. No abstract available.</citation>
    <PMID>19640746</PMID>
  </reference>
  <reference>
    <citation>Ward JL, Harting MT, Cox CS Jr, Mercer DW. Effects of ketamine on endotoxin and traumatic brain injury induced cytokine production in the rat. J Trauma. 2011 Jun;70(6):1471-9. doi: 10.1097/TA.0b013e31821c38bd.</citation>
    <PMID>21817985</PMID>
  </reference>
  <reference>
    <citation>Bhutta AT, Schmitz ML, Swearingen C, James LP, Wardbegnoche WL, Lindquist DM, Glasier CM, Tuzcu V, Prodhan P, Dyamenahalli U, Imamura M, Jaquiss RD, Anand KJ. Ketamine as a neuroprotective and anti-inflammatory agent in children undergoing surgery on cardiopulmonary bypass: a pilot randomized, double-blind, placebo-controlled trial. Pediatr Crit Care Med. 2012 May;13(3):328-37. doi: 10.1097/PCC.0b013e31822f18f9.</citation>
    <PMID>21926656</PMID>
  </reference>
  <reference>
    <citation>Sakowitz OW, Kiening KL, Krajewski KL, Sarrafzadeh AS, Fabricius M, Strong AJ, Unterberg AW, Dreier JP. Preliminary evidence that ketamine inhibits spreading depolarizations in acute human brain injury. Stroke. 2009 Aug;40(8):e519-22. doi: 10.1161/STROKEAHA.109.549303. Epub 2009 Jun 11.</citation>
    <PMID>19520992</PMID>
  </reference>
  <reference>
    <citation>Hartings JA, Bullock MR, Okonkwo DO, Murray LS, Murray GD, Fabricius M, Maas AI, Woitzik J, Sakowitz O, Mathern B, Roozenbeek B, Lingsma H, Dreier JP, Puccio AM, Shutter LA, Pahl C, Strong AJ; Co-Operative Study on Brain Injury Depolarisations. Spreading depolarisations and outcome after traumatic brain injury: a prospective observational study. Lancet Neurol. 2011 Dec;10(12):1058-64. doi: 10.1016/S1474-4422(11)70243-5. Epub 2011 Nov 3.</citation>
    <PMID>22056157</PMID>
  </reference>
  <reference>
    <citation>Raboel PH, Bartek J Jr, Andresen M, Bellander BM, Romner B. Intracranial Pressure Monitoring: Invasive versus Non-Invasive Methods-A Review. Crit Care Res Pract. 2012;2012:950393. doi: 10.1155/2012/950393. Epub 2012 Jun 8.</citation>
    <PMID>22720148</PMID>
  </reference>
  <reference>
    <citation>Stuart RM, Schmidt M, Kurtz P, Waziri A, Helbok R, Mayer SA, Lee K, Badjatia N, Hirsch LJ, Connolly ES, Claassen J. Intracranial multimodal monitoring for acute brain injury: a single institution review of current practices. Neurocrit Care. 2010 Apr;12(2):188-98. doi: 10.1007/s12028-010-9330-9.</citation>
    <PMID>20107926</PMID>
  </reference>
  <reference>
    <citation>Bourgoin A, Albanese J, Wereszczynski N, Charbit M, Vialet R, Martin C. Safety of sedation with ketamine in severe head injury patients: comparison with sufentanil. Crit Care Med. 2003 Mar;31(3):711-7. doi: 10.1097/01.CCM.0000044505.24727.16.</citation>
    <PMID>12626974</PMID>
  </reference>
  <reference>
    <citation>Bourgoin A, Albanese J, Leone M, Sampol-Manos E, Viviand X, Martin C. Effects of sufentanil or ketamine administered in target-controlled infusion on the cerebral hemodynamics of severely brain-injured patients. Crit Care Med. 2005 May;33(5):1109-13. doi: 10.1097/01.ccm.0000162491.26292.98.</citation>
    <PMID>15891344</PMID>
  </reference>
  <reference>
    <citation>Chamoun R, Suki D, Gopinath SP, Goodman JC, Robertson C. Role of extracellular glutamate measured by cerebral microdialysis in severe traumatic brain injury. J Neurosurg. 2010 Sep;113(3):564-70. doi: 10.3171/2009.12.JNS09689.</citation>
    <PMID>20113156</PMID>
  </reference>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 2, 2014</study_first_submitted>
  <study_first_submitted_qc>September 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2014</study_first_posted>
  <last_update_submitted>September 2, 2014</last_update_submitted>
  <last_update_submitted_qc>September 2, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 5, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Direction Centrale du Service de Santé des Armées</investigator_affiliation>
    <investigator_full_name>Pierre-Julien CUNGI</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>traumatic brain injury</keyword>
  <keyword>ketamine</keyword>
  <keyword>microdialysis</keyword>
  <keyword>PtiO2</keyword>
  <keyword>glutamate</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Craniocerebral Trauma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sufentanil</mesh_term>
    <mesh_term>Ketamine</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02232347
org study id: DCSSA KETABRAIN
nct id: NCT02232347
lead sponsor: 
has dmc: Yes
The objective of the study is to compare the effects of 48 hours ketamine infusion versus
      sufentanil infusion on brain glutamate concentrations measured with microdialysis after
      traumatic brain injury.

      We hypothesize that ketamine infusion will decrease high glutamate values faster than
      sufentanil.
Inclusion of 20 consecutive head trauma patients. Randomization and double-blind to compare
      the effects of ketamine versus sufentanil on brain glutamate concentrations measured with
      microdialysis.

      Ketamine is an anti-N-methyl-D-aspartate (NMDA) medication. It is supposed to limit
      excitotoxicity of amino-acids, especially glutamate. Glutamate is known to be elevated in
      more than 60% of the severe head trauma patients. It induces cortical spreading depression
      which can aggravate prognosis. It's a daily used medication in anesthesia and intensive care
      units for sedation and induction of anesthesia. It's the recommended medication for induction
      of unstable wounded soldiers on the field because of its neutrality on haemodynamic state.

      Sufentanil is the reference opioid for sedation in ICU in Europe. It can induce hypotension
      which is deleterious for cerebral perfusion pressure after brain trauma.

      In our unit, patients with severe head injury are monitored by a triple lumen access device
      including ICP (IntraCerebral Pressure), PtiO2 (oxygen pressure in the brain) and
      microdialysis. This last monitoring allows measurement of brain parenchymal concentrations of
      small molecules : glucose, lactate, pyruvate, glutamate, glycerol,.... It's a tool to
      evaluate the metabolic state of the brain divided into 4 categories : normal,
      hyperglycolysis, ischemia and metabolic crisis.

      Then, we will detail the effects of ketamine on metabolic state of the brain, especially
      glutamate concentration. Normal values are below 10 micromol/ml. After head trauma it can
      dramatically increase to values up to 50 or even 100 micromol/ml, with normalization after 24
      hours. Ketamine is expected to decrease these high values faster than described in
      observational studies.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: brain glutamate concentrations
time frame: H0-H12, H12-H24, H24-H36 and H36-H48
description: To compare the kinetic of brain glutamate concentration decrease during 4 periods of 12 hours between ketamine infusion group (KET) and sufentanil standard infusion group (STD)
measure: metabolic profile
time frame: H0-H12, H12-H24, H24-H36 and H36-H48
description: To compare the brain metabolic profile (normal, ischemic, hyperglycolytic and metabolic crisis) of the patients related to their group of treatment : ketamine (KET) and sufentanil (STD) by measuring brain glucose, brain lactate, brain glycerol concentrations and brain lactate/pyruvate ratio.
measure: Episodes of intracranial hypertension (ICHT) and brain ischemia
time frame: H0-H12, H12-H24, H24-H36 and H36-H48
description: To compare the number of ICHT episodes (ICP>20 mm Hg more than 15 minutes) and to compare the number of ischemic episodes (PtiO2<20 mm Hg more than 15 minutes) between the 2 groups
measure: Therapeutic Intensity Level (TIL)
time frame: Days 1 and 2
description: To compare the TIL value between the 2 groups. TIL is a score developed to measure the intensity of cares for head trauma patients. Lower scores are meaning less intense cares. It is calculated for 24 hours periods.
measure: Glasgow Outcome Scale (GOS) et extended Glasgow Outcome Scale (eGOS)
time frame: 6 months and 1 year
description: To describe the prognosis of the patients of the KETAMINE group versus SUFENTANIL group. GOS is the international validated score for evaluation of the prognosis after head trauma.
arm group label: ketamine
arm group type: Experimental
description: ketamine 5 mg/kg/h, continuous infusion for 48 hours
arm group label: sufentanil
arm group type: Active Comparator
description: sufentanil 0,5 mcg/kg/h, continuous infusion for 48 hours
intervention type: Drug
intervention name: Ketamine
arm group label: ketamine
intervention type: Drug
intervention name: Sufentanil
arm group label: sufentanil
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ambroise MONTCRIOL, MD
role: Principal Investigator
affiliation: Direction Centrale du Service de Santé des Armées
last name: Ambroise MONTCRIOL, MD
phone: 0483162358
phone ext: 0033
email: ambroise.montcriol@free.fr
facility: 
investigator: 
investigator: 
investigator: 
country: France
citation: Brain Trauma Foundation; American Association of Neurological Surgeons; Congress of Neurological Surgeons; Joint Section on Neurotrauma and Critical Care, AANS/CNS; Bratton SL, Chestnut RM, Ghajar J, McConnell Hammond FF, Harris OA, Hartl R, Manley GT, Nemecek A, Newell DW, Rosenthal G, Schouten J, Shutter L, Timmons SD, Ullman JS, Videtta W, Wilberger JE, Wright DW. Guidelines for the management of severe traumatic brain injury. I. Blood pressure and oxygenation. J Neurotrauma. 2007;24 Suppl 1:S7-13. doi: 10.1089/neu.2007.9995. No abstract available. Erratum In: J Neurotrauma. 2008 Mar;25(3):276-8. multiple author names added.
PMID: 17511549
citation: Hughes S. Towards evidence based emergency medicine: best BETs from the Manchester Royal Infirmary. BET 3: is ketamine a viable induction agent for the trauma patient with potential brain injury. Emerg Med J. 2011 Dec;28(12):1076-7. doi: 10.1136/emermed-2011-200891.
PMID: 22101599
citation: Filanovsky Y, Miller P, Kao J. Myth: Ketamine should not be used as an induction agent for intubation in patients with head injury. CJEM. 2010 Mar;12(2):154-7. doi: 10.1017/s1481803500012197. No abstract available.
PMID: 20219164
citation: Hudetz JA, Pagel PS. Neuroprotection by ketamine: a review of the experimental and clinical evidence. J Cardiothorac Vasc Anesth. 2010 Feb;24(1):131-42. doi: 10.1053/j.jvca.2009.05.008. Epub 2009 Jul 29. No abstract available.
PMID: 19640746
citation: Ward JL, Harting MT, Cox CS Jr, Mercer DW. Effects of ketamine on endotoxin and traumatic brain injury induced cytokine production in the rat. J Trauma. 2011 Jun;70(6):1471-9. doi: 10.1097/TA.0b013e31821c38bd.
PMID: 21817985
citation: Bhutta AT, Schmitz ML, Swearingen C, James LP, Wardbegnoche WL, Lindquist DM, Glasier CM, Tuzcu V, Prodhan P, Dyamenahalli U, Imamura M, Jaquiss RD, Anand KJ. Ketamine as a neuroprotective and anti-inflammatory agent in children undergoing surgery on cardiopulmonary bypass: a pilot randomized, double-blind, placebo-controlled trial. Pediatr Crit Care Med. 2012 May;13(3):328-37. doi: 10.1097/PCC.0b013e31822f18f9.
PMID: 21926656
citation: Sakowitz OW, Kiening KL, Krajewski KL, Sarrafzadeh AS, Fabricius M, Strong AJ, Unterberg AW, Dreier JP. Preliminary evidence that ketamine inhibits spreading depolarizations in acute human brain injury. Stroke. 2009 Aug;40(8):e519-22. doi: 10.1161/STROKEAHA.109.549303. Epub 2009 Jun 11.
PMID: 19520992
citation: Hartings JA, Bullock MR, Okonkwo DO, Murray LS, Murray GD, Fabricius M, Maas AI, Woitzik J, Sakowitz O, Mathern B, Roozenbeek B, Lingsma H, Dreier JP, Puccio AM, Shutter LA, Pahl C, Strong AJ; Co-Operative Study on Brain Injury Depolarisations. Spreading depolarisations and outcome after traumatic brain injury: a prospective observational study. Lancet Neurol. 2011 Dec;10(12):1058-64. doi: 10.1016/S1474-4422(11)70243-5. Epub 2011 Nov 3.
PMID: 22056157
citation: Raboel PH, Bartek J Jr, Andresen M, Bellander BM, Romner B. Intracranial Pressure Monitoring: Invasive versus Non-Invasive Methods-A Review. Crit Care Res Pract. 2012;2012:950393. doi: 10.1155/2012/950393. Epub 2012 Jun 8.
PMID: 22720148
citation: Stuart RM, Schmidt M, Kurtz P, Waziri A, Helbok R, Mayer SA, Lee K, Badjatia N, Hirsch LJ, Connolly ES, Claassen J. Intracranial multimodal monitoring for acute brain injury: a single institution review of current practices. Neurocrit Care. 2010 Apr;12(2):188-98. doi: 10.1007/s12028-010-9330-9.
PMID: 20107926
citation: Bourgoin A, Albanese J, Wereszczynski N, Charbit M, Vialet R, Martin C. Safety of sedation with ketamine in severe head injury patients: comparison with sufentanil. Crit Care Med. 2003 Mar;31(3):711-7. doi: 10.1097/01.CCM.0000044505.24727.16.
PMID: 12626974
citation: Bourgoin A, Albanese J, Leone M, Sampol-Manos E, Viviand X, Martin C. Effects of sufentanil or ketamine administered in target-controlled infusion on the cerebral hemodynamics of severely brain-injured patients. Crit Care Med. 2005 May;33(5):1109-13. doi: 10.1097/01.ccm.0000162491.26292.98.
PMID: 15891344
citation: Chamoun R, Suki D, Gopinath SP, Goodman JC, Robertson C. Role of extracellular glutamate measured by cerebral microdialysis in severe traumatic brain injury. J Neurosurg. 2010 Sep;113(3):564-70. doi: 10.3171/2009.12.JNS09689.
PMID: 20113156
responsible party type: Sponsor-Investigator
investigator affiliation: Direction Centrale du Service de Santé des Armées
investigator full name: Pierre-Julien CUNGI
investigator title: MD
mesh term: Brain Injuries
mesh term: Craniocerebral Trauma
mesh term: Sufentanil
mesh term: Ketamine