xml: <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/NCT06010927</url>
    </required_header>
    <id_info>
      <org_study_id>MS-92-2023</org_study_id>
      <nct_id>NCT06010927</nct_id>
    </id_info>
    <brief_title>Effect of Ketamine/Midazolam Premedication Versus Pre-extubation Ketofol on Recovery Profile in Pediatrics Undergoing Adenotonsillectomy.</brief_title>
    <official_title>Ketamine/Midazolam Premedication Versus Pre-extubation Ketofol. Effect on Emergence Agitation and Recovery Profile After Pediatric Adenotonsillectomy: A Randomized Comparative Study.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cairo University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cairo University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        An optimum recovery profile after AT includes a rapid, smooth awakening without emergence&#xD;
        agitation (EA), stable vital signs and oxygenation, reduced postoperative nausea and vomiting&#xD;
        (PONV), controlled postoperative pain, and patient or parents' satisfaction. Ketamine is a&#xD;
        low-cost drug with a wide therapeutic window. Ketamine is a competitive N-methyl-D-aspartate&#xD;
        receptor antagonist with good analgesic properties and periprocedural amnesia.&#xD;
  &#xD;
        The ketamine/midazolam combination was administered in different ways with controversial&#xD;
        results about their effect on the EA and recovery profile.&#xD;
  &#xD;
        Ketofol, a mixture of ketamine and propofol, has been used in different favorable recovery&#xD;
        profiles regarding postoperative EA and PONV.&#xD;
  &#xD;
        This study aims to evaluate the effect of premedication with an intramuscular ketamine/&#xD;
        midazolam combination versus pre-extubation ketofol on the EA and the recovery profile.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 25, 2023</start_date>
    <completion_date type="Anticipated">December 2023</completion_date>
    <primary_completion_date type="Anticipated">November 2023</primary_completion_date>
    <phase>Phase 4</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>Double (Care Provider, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>incidence of Emergence agitation</measure>
      <time_frame>starting from time of PACU admission after recover from anesthesia till 6 hours postoperative</time_frame>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">140</enrollment>
    <condition>Emergence Delirium</condition>
    <arm_group>
      <arm_group_label>Group-A; ketamine/midazolam premedication</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Group-B: Ketofol pre-extubation</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>ketamine/midazolam</intervention_name>
      <description>premedication</description>
      <arm_group_label>Group-A; ketamine/midazolam premedication</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Ketofol</intervention_name>
      <description>Pre-extubation</description>
      <arm_group_label>Group-B: Ketofol pre-extubation</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  ASA physical status I or II&#xD;
  &#xD;
            -  Children scheduled for AT under general anesthesia (GA).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Congenital cardiovascular anomalies&#xD;
  &#xD;
            -  Behavioral changes&#xD;
  &#xD;
            -  Delayed physical development&#xD;
  &#xD;
            -  Children receiving sedatives or anticonvulsants therapy&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>3 Years</minimum_age>
      <maximum_age>10 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Abeer Ahmed</last_name>
      <phone>01005244590</phone>
      <email>abeer_ahmed@kasralainy.edu.eg</email>
    </overall_contact>
    <location>
      <facility>
        <name>Abeer Ahmed</name>
        <address>
          <city>Maadi</city>
          <state>Cairo</state>
          <zip>11562</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Abeer Ahmed</last_name>
        <phone>01005244590</phone>
        <email>abeer_ahmed@kasralainy.edu.eg</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Anesthesia department - Faculty of medicine- Cairo University</name>
        <address>
          <city>Cairo</city>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <investigator>
        <last_name>Abeer Ahmed, Anesthesia lecturer</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>June 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cairo University</investigator_affiliation>
      <investigator_full_name>Abeer Ahmed, MD</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Emergence Delirium</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Midazolam</mesh_term>
      <mesh_term>Ketamine</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06010927
  org study id: MS-92-2023
  nct id: NCT06010927
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  An optimum recovery profile after AT includes a rapid, smooth awakening without emergence
        agitation (EA), stable vital signs and oxygenation, reduced postoperative nausea and vomiting
        (PONV), controlled postoperative pain, and patient or parents' satisfaction. Ketamine is a
        low-cost drug with a wide therapeutic window. Ketamine is a competitive N-methyl-D-aspartate
        receptor antagonist with good analgesic properties and periprocedural amnesia.
  
        The ketamine/midazolam combination was administered in different ways with controversial
        results about their effect on the EA and recovery profile.
  
        Ketofol, a mixture of ketamine and propofol, has been used in different favorable recovery
        profiles regarding postoperative EA and PONV.
  
        This study aims to evaluate the effect of premedication with an intramuscular ketamine/
        midazolam combination versus pre-extubation ketofol on the EA and the recovery profile.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Double (Care Provider, Outcomes Assessor)
  measure: incidence of Emergence agitation
  time frame: starting from time of PACU admission after recover from anesthesia till 6 hours postoperative
  arm group label: Group-A; ketamine/midazolam premedication
  arm group type: Active Comparator
  arm group label: Group-B: Ketofol pre-extubation
  arm group type: Active Comparator
  intervention type: Drug
  intervention name: ketamine/midazolam
  description: premedication
  arm group label: Group-A; ketamine/midazolam premedication
  intervention type: Drug
  intervention name: Ketofol
  description: Pre-extubation
  arm group label: Group-B: Ketofol pre-extubation
  criteria: 
  gender: All
  minimum age: 3 Years
  maximum age: 10 Years
  healthy volunteers: No
  last name: Abeer Ahmed
  phone: 01005244590
  email: abeer_ahmed@kasralainy.edu.eg
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  investigator: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Cairo University
  investigator full name: Abeer Ahmed, MD
  investigator title: Professor
  mesh term: Emergence Delirium
  mesh term: Midazolam
  mesh term: Ketamine
  sharing ipd: Undecided