<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/NCT03817112</url>
  </required_header>
  <id_info>
    <org_study_id>ASCSH86/17</org_study_id>
    <nct_id>NCT03817112</nct_id>
  </id_info>
  <brief_title>Effect of Dexmedetomidine and Propofol on Regional Cerebral Tissue Oxygen Saturation</brief_title>
  <official_title>The Effect of Continuous Propofol Versus Dexmedetomidine Infusion on Regional Cerebral Tissue Oxygen Saturation During Cardiopulmonary Bypass</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      50 patients divided into 2 groups&#xD;
&#xD;
      .Group I Dexmedetomidine infusion. Group II with Propofol infusion&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      : 50 patients anticipated for open heart surgeries were encompassed in the study. Patients&#xD;
      were divided into 2 groups, group P (receiving propofol) and group D (receiving&#xD;
      dexmedetomidine) during CPB. Both groups were studied for variations in right and left rScO2&#xD;
      as well as postoperative cognitive dysfunction using the Mini Mental State Examination Score&#xD;
      (MMSE) test.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 15, 2017</start_date>
  <completion_date type="Actual">January 21, 2019</completion_date>
  <primary_completion_date type="Actual">September 30, 2018</primary_completion_date>
  <phase>N/A</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>Prevention</primary_purpose>
    <masking>Single (Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>cognitive function assessment</measure>
    <time_frame>24 hours postoperative</time_frame>
    <description>Mini Mental State Examination Score (MMSE) test to assess orientation to time and place with ability to speak, think and draw. with highest ability 32 and lowest o</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Regional Cerebral Tissue Oxygen Saturation</condition>
  <arm_group>
    <arm_group_label>Dexmedetomidine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Infusion of dexmedetomidine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Propofol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Propofol infusion</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexmedetomidine Hydrochloride 0.1 MG/ML</intervention_name>
    <description>Dexmedetomidine Hydrochloride 0.1 MG/ML infusion at 0.2-0.7 mcg/kg/min</description>
    <arm_group_label>Dexmedetomidine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Propofol 10 MG/ML</intervention_name>
    <description>Propofol 10 MG/ML infusion at 0.3 -4 mg/kg/h</description>
    <arm_group_label>Propofol</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing valve surgeries&#xD;
&#xD;
          -  Patients undergoing on pump coronary artery bypass grafting surgeries&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  emergency cases, patients with cervical spine pathology (cervical stenosis, cervical&#xD;
             disc herniation, carotid stenosis), patients with cerebral pathology (cerebral&#xD;
             strokes, ischemic attacks), patients with Mini Mental State Examination Score (MMSE)&#xD;
             of 23 or less, complicated cases with prolongation of the cardiopulmonary bypass&#xD;
             period, patients needing moderate hypothermia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ain Shams Cardiothoracic hospital</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 23, 2019</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>January 23, 2019</last_update_submitted>
  <last_update_submitted_qc>January 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Ayman Anis Metry</investigator_full_name>
    <investigator_title>Clinical professor</investigator_title>
  </responsible_party>
  <keyword>cerebral oxygen saturation</keyword>
  <keyword>cardiopulmonary bypass</keyword>
  <keyword>dexmedetomidine</keyword>
  <keyword>propofol</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexmedetomidine</mesh_term>
    <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/NCT03817112
org study id: ASCSH86/17
nct id: NCT03817112
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
50 patients divided into 2 groups

      .Group I Dexmedetomidine infusion. Group II with Propofol infusion
: 50 patients anticipated for open heart surgeries were encompassed in the study. Patients
      were divided into 2 groups, group P (receiving propofol) and group D (receiving
      dexmedetomidine) during CPB. Both groups were studied for variations in right and left rScO2
      as well as postoperative cognitive dysfunction using the Mini Mental State Examination Score
      (MMSE) test.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Care Provider)
measure: cognitive function assessment
time frame: 24 hours postoperative
description: Mini Mental State Examination Score (MMSE) test to assess orientation to time and place with ability to speak, think and draw. with highest ability 32 and lowest o
arm group label: Dexmedetomidine
arm group type: Active Comparator
description: Infusion of dexmedetomidine
arm group label: Propofol
arm group type: Active Comparator
description: Propofol infusion
intervention type: Drug
intervention name: Dexmedetomidine Hydrochloride 0.1 MG/ML
description: Dexmedetomidine Hydrochloride 0.1 MG/ML infusion at 0.2-0.7 mcg/kg/min
arm group label: Dexmedetomidine
intervention type: Drug
intervention name: Propofol 10 MG/ML
description: Propofol 10 MG/ML infusion at 0.3 -4 mg/kg/h
arm group label: Propofol
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Ayman Anis Metry
investigator title: Clinical professor
mesh term: Dexmedetomidine
mesh term: Propofol
sharing ipd: No