<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/NCT03285165</url>
  </required_header>
  <id_info>
    <org_study_id>17200002</org_study_id>
    <nct_id>NCT03285165</nct_id>
  </id_info>
  <brief_title>Cerebral Vascular Effects of Dexmedetomidine Versus Propofol Sedation in Intubated Mechanically Ventilated ICU Patients</brief_title>
  <acronym>DEXSEDATION</acronym>
  <official_title>Cerebral Vascular Effects of Dexmedetomidine Versus Propofol Sedation in Intubated Mechanically Ventilated ICU Patients With and Without Traumatic Brain Injury.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Serial transcranial Doppler (TCD) exams in healthy volunteers and in animal models showed a&#xD;
      strong linear relationship between middle cerebral artery (MCA) flow velocity (FV) and&#xD;
      dexmedetomidine infusion. The concomitant elevation of pulsatility index (PI) indicates&#xD;
      vasoconstriction of the cerebral vasculature as the most profound underlying mechanism.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Available clinical evidence on the use of dexmedetomidine sedation in neurosurgical and&#xD;
      neurocritical care is limited and no definite conclusion can be drawn. There is a need for&#xD;
      The use of dexmedetomidine might be a useful adjunct in clinical situations when the increase&#xD;
      in CBF could be detrimental such as vasogenic cerebral edema (i.e., TBI, large brain tumors).&#xD;
      However, dexmedetomidine sedation is questionable in patients with subarachnoid hemorrhage&#xD;
      and acute stroke, since the associate drop in arterial pressure could worsen the coexisting&#xD;
      increase in circulating catecholamines and massive sympathetic outflow. Further high-quality&#xD;
      RCTs to evaluate the use of dexmedetomidine as a sedative agent both in general ICU patients&#xD;
      and in patients with TBI.&#xD;
&#xD;
      Transcranial Doppler (TCD) is a simple noninvasive bedside tool to assess the cerebral blood&#xD;
      flow pattern. The new development of transcranial color Doppler with angle correction option&#xD;
      helps to improve the sensitivity of test results. TCD can assess the evolution of CBF&#xD;
      alterations and possibly cerebral autoregulation performance and ICP estimation in patients&#xD;
      presenting with cerebral pathology.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    NO AVAILABLE FUND&#xD;
  </why_stopped>
  <start_date type="Actual">September 14, 2017</start_date>
  <completion_date type="Anticipated">September 16, 2021</completion_date>
  <primary_completion_date type="Anticipated">September 16, 2021</primary_completion_date>
  <phase>Phase 2/Phase 3</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>
    <intervention_model_description>this study will be accomplished to investigate the effect of dexmedetomidine sedation on the cerebral blood flow in intubated mechanically ventilated trauma patients with and without traumatic brain injury, in comparison with propofol.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>double-blind</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Middle cerebral artery flow velocity</measure>
    <time_frame>24 hours</time_frame>
    <description>1. Right and left middle cerebral artery (MCA) will be measured via trans-temporal window and the depth of insinuation will be between 30-60 mm with the subject's head in neutral position. Mean values of simultaneously measured invasive blood pressure recordings and the outer envelope of time averaged MCA flow velocity (FV) recordings during ten consecutive cardiac cycles</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Sedation</condition>
  <arm_group>
    <arm_group_label>DEX I</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Trauma Patients without TBI received 0.2-0.7 mcg/kg/h dexmedetomedine infusion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DEX II</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Trauma Patients with TBI received 0.2-0.7 mcg/kg/h dexmedetomedine infusion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Propofol I</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Trauma Patients without TBI received 10-70 mcg/kg/h propofol infusion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Propofol II</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Trauma Patients with TBI received 10-70 mcg/kg/h propofol infusion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>0.2-0.7 mcg/kg/h dexmedetomedine infusion.</intervention_name>
    <description>patients will receive dexmedetomidine 0.2-0.7 mcg/kg/h infusion for 24h.</description>
    <arm_group_label>DEX I</arm_group_label>
    <arm_group_label>DEX II</arm_group_label>
    <other_name>Precedex</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>10-70 mcg/kg/h propofol infusion.</intervention_name>
    <description>Patients will receive 10-70 mcg/kg/h propofol infusion for 24h.</description>
    <arm_group_label>Propofol I</arm_group_label>
    <arm_group_label>Propofol II</arm_group_label>
    <other_name>Deprivan</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult trauma patients (18-50 years old, ASA I-II).&#xD;
&#xD;
          -  With and without mild TBI.&#xD;
&#xD;
          -  Mild traumatic brain injury will include; brain edema, brain contusion, fracture base,&#xD;
             fissure fracture and depressed fracture.&#xD;
&#xD;
          -  The severity of traumatic brain injury will be defined as mild based on basal Glasgow&#xD;
             Coma Scale and basal Computerized tomography scanning.&#xD;
&#xD;
          -  Requirements of endotracheal intubation, mechanical ventilation and light to moderate&#xD;
             sedation because of associated abdominal or chest traumatic injuries.&#xD;
&#xD;
          -  The sedation needed should of an estimated duration not less than 24h.&#xD;
&#xD;
          -  Baseline hemodynamic parameters within the normal range.&#xD;
&#xD;
          -  Baseline middle cerebral artery flow velocity within the normal range.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe traumatic brain injury, subarachnoid hemorrhage and Intra-cerebral hemorrhage.&#xD;
&#xD;
          -  Spinal cord injury.&#xD;
&#xD;
          -  Hemodynamically unstable patients and patients on inotropes.&#xD;
&#xD;
          -  Patients who have a cardiac pacemaker or automatic implantable cardioverter&#xD;
             defibrillator.&#xD;
&#xD;
          -  Patients with hepatic or renal impairment.&#xD;
&#xD;
          -  Pregnant females.&#xD;
&#xD;
          -  Patients who are incarcerated.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hala S Abdelghaffar, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assisstant professor in anesthesia and intensive care, faculty of medicine, Assiut university, Egypt</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Assiut university main hospital, Trauma ICU</name>
      <address>
        <city>Assiut</city>
        <state>Assiut Governorate</state>
        <zip>715715</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <last_update_submitted>July 13, 2020</last_update_submitted>
  <last_update_submitted_qc>July 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Hala Saad Abdel-Ghaffar</investigator_full_name>
    <investigator_title>Assisstant professor in anesthesia and intensive care, Faculty of medicine, Assiut university, Egypt.</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Propofol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03285165
org study id: 17200002
nct id: NCT03285165
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Serial transcranial Doppler (TCD) exams in healthy volunteers and in animal models showed a
      strong linear relationship between middle cerebral artery (MCA) flow velocity (FV) and
      dexmedetomidine infusion. The concomitant elevation of pulsatility index (PI) indicates
      vasoconstriction of the cerebral vasculature as the most profound underlying mechanism.
Available clinical evidence on the use of dexmedetomidine sedation in neurosurgical and
      neurocritical care is limited and no definite conclusion can be drawn. There is a need for
      The use of dexmedetomidine might be a useful adjunct in clinical situations when the increase
      in CBF could be detrimental such as vasogenic cerebral edema (i.e., TBI, large brain tumors).
      However, dexmedetomidine sedation is questionable in patients with subarachnoid hemorrhage
      and acute stroke, since the associate drop in arterial pressure could worsen the coexisting
      increase in circulating catecholamines and massive sympathetic outflow. Further high-quality
      RCTs to evaluate the use of dexmedetomidine as a sedative agent both in general ICU patients
      and in patients with TBI.

      Transcranial Doppler (TCD) is a simple noninvasive bedside tool to assess the cerebral blood
      flow pattern. The new development of transcranial color Doppler with angle correction option
      helps to improve the sensitivity of test results. TCD can assess the evolution of CBF
      alterations and possibly cerebral autoregulation performance and ICP estimation in patients
      presenting with cerebral pathology.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: this study will be accomplished to investigate the effect of dexmedetomidine sedation on the cerebral blood flow in intubated mechanically ventilated trauma patients with and without traumatic brain injury, in comparison with propofol.
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: double-blind
measure: Middle cerebral artery flow velocity
time frame: 24 hours
description: 1. Right and left middle cerebral artery (MCA) will be measured via trans-temporal window and the depth of insinuation will be between 30-60 mm with the subject's head in neutral position. Mean values of simultaneously measured invasive blood pressure recordings and the outer envelope of time averaged MCA flow velocity (FV) recordings during ten consecutive cardiac cycles
arm group label: DEX I
arm group type: Active Comparator
description: Trauma Patients without TBI received 0.2-0.7 mcg/kg/h dexmedetomedine infusion.
arm group label: DEX II
arm group type: Active Comparator
description: Trauma Patients with TBI received 0.2-0.7 mcg/kg/h dexmedetomedine infusion.
arm group label: Propofol I
arm group type: Active Comparator
description: Trauma Patients without TBI received 10-70 mcg/kg/h propofol infusion.
arm group label: Propofol II
arm group type: Active Comparator
description: Trauma Patients with TBI received 10-70 mcg/kg/h propofol infusion.
intervention type: Drug
intervention name: 0.2-0.7 mcg/kg/h dexmedetomedine infusion.
description: patients will receive dexmedetomidine 0.2-0.7 mcg/kg/h infusion for 24h.
arm group label: DEX I
arm group label: DEX II
other name: Precedex
intervention type: Drug
intervention name: 10-70 mcg/kg/h propofol infusion.
description: Patients will receive 10-70 mcg/kg/h propofol infusion for 24h.
arm group label: Propofol I
arm group label: Propofol II
other name: Deprivan
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Hala S Abdelghaffar, MD
role: Principal Investigator
affiliation: Assisstant professor in anesthesia and intensive care, faculty of medicine, Assiut university, Egypt
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Hala Saad Abdel-Ghaffar
investigator title: Assisstant professor in anesthesia and intensive care, Faculty of medicine, Assiut university, Egypt.
mesh term: Propofol
sharing ipd: No