<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/NCT03762785</url>
  </required_header>
  <id_info>
    <org_study_id>435</org_study_id>
    <nct_id>NCT03762785</nct_id>
  </id_info>
  <brief_title>Pharmacokinetics and Dynamics of Nebulized Dexmedetomidine</brief_title>
  <official_title>Pharmacokinetics and Dynamics of Nebulized Dexmedetomidine in Preschool Children Undergoing Abdominal Cancer Surgery</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>No</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>
      the aim of this study is to study the pharmacokinetics and dynamics of nebulized&#xD;
      dexmetedomidine in children undergoing major abdominal cancer surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Inhalation of nebulized drug is an alternative route of administration that is relatively&#xD;
      easy to set up, does not require venpuncture, but is associated with high bioavailability of&#xD;
      the administered drug. Information on the pharmacokinetics of dexmedetomidine in the&#xD;
      pediatric population is very limited, especially in children. To the best of investigators&#xD;
      knowledge, there are no published reports on the pharmacokinetics of nebulized&#xD;
      dexmedetomidine in children.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 10, 2018</start_date>
  <completion_date type="Anticipated">January 2021</completion_date>
  <primary_completion_date type="Anticipated">January 2020</primary_completion_date>
  <phase>Phase 1/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>Prevention</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>pharmacokinitics of dexmedetomidine</measure>
    <time_frame>at the basline and after the end of nebuization of the drug at 5 minutes,15 minutes,30 minutes, 45 minutes, 60 minutes, 90 minutes and 120 minutes</time_frame>
    <description>serum level of dexmedetomidine</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>sedation score</measure>
    <time_frame>baseline and after end of the drug adminstration by 30 mininute</time_frame>
    <description>Ramsy sedation score&#xD;
1 = Anxious or restless or both Unacceptable; increase sedation 2=Cooperative, orientated and tranquil Acceptable; no action necessary 3=Responding to commands Acceptable; no action necessary 4=Brisk response to stimulus Acceptable; no action necessary 5=Sluggish response to stimulus Unacceptable; monitor respiratory status and sedation level until stable at 2 or 3 6= No response to stimulus Unacceptable; monitor respiratory status and sedation level until stable at 2 or 3</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">16</enrollment>
  <condition>Abdominal Cancer</condition>
  <arm_group>
    <arm_group_label>nebulized dexmedetomidine 2ug/kg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>inhalation of dexmedetomidine in the dose of 2ug/kg by nebulization</description>
  </arm_group>
  <arm_group>
    <arm_group_label>nebulized dexmedetomidine 3ug/kg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>inhalation of dexmedetomidine in the dose of 3ug/kg by nebulization</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>nebulized Dexmedetomidine</intervention_name>
    <description>inhalation of dexmedetomidine by nebulizer. the study drug will be prepared in 3 ml of 0.9% saline and will be administered by standard hospital jet nebulizer via face-mask with continuous flow of 100%oxygen at 6 l/m for 10 to 15 min</description>
    <arm_group_label>nebulized dexmedetomidine 2ug/kg</arm_group_label>
    <arm_group_label>nebulized dexmedetomidine 3ug/kg</arm_group_label>
    <other_name>pharmacokinitics of nebulized dexmedetomidine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  child aged 2-7 years&#xD;
&#xD;
          -  ASA I or II&#xD;
&#xD;
          -  scheduled for abdominal surgery&#xD;
&#xD;
          -  with average weight, height, normal serum albumin&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with allergy to the study drug&#xD;
&#xD;
          -  patients with significant organ dysfunction&#xD;
&#xD;
          -  patients with cardiac arrhythmia&#xD;
&#xD;
          -  patients with congenital heart disease&#xD;
&#xD;
          -  use of psychotropic medication and mental retardation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>7 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shereen M Kamal, Lecturer</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ministry of higher education</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Shereen M Kamal, Lecturer</last_name>
    <phone>+201006279209</phone>
    <email>sheridouh79@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hala S Abdelgafar, Profesor</last_name>
    <phone>+201003812011</phone>
    <email>hallasaad@yahoo.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>South Egypt Cancer Institute</name>
      <address>
        <city>Assiut</city>
        <zip>11715</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shereen M Kamal, Lecturer</last_name>
      <phone>01006279209</phone>
      <email>sheridouh79@yahoo.com</email>
    </contact>
    <contact_backup>
      <last_name>Hala S Abdelgafar, Professor</last_name>
      <phone>01003812011</phone>
      <email>hallasaad@yahoo.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>November 29, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>January 9, 2019</last_update_submitted>
  <last_update_submitted_qc>January 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Shereen Mamdouh</investigator_full_name>
    <investigator_title>lecturer of anesthesia, ICU and pain manegement</investigator_title>
  </responsible_party>
  <keyword>pharmacokinitics</keyword>
  <keyword>nebulized</keyword>
  <keyword>dexmedetomidine</keyword>
  <keyword>preschool children</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Abdominal Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexmedetomidine</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/NCT03762785
org study id: 435
nct id: NCT03762785
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
the aim of this study is to study the pharmacokinetics and dynamics of nebulized
      dexmetedomidine in children undergoing major abdominal cancer surgery.
Inhalation of nebulized drug is an alternative route of administration that is relatively
      easy to set up, does not require venpuncture, but is associated with high bioavailability of
      the administered drug. Information on the pharmacokinetics of dexmedetomidine in the
      pediatric population is very limited, especially in children. To the best of investigators
      knowledge, there are no published reports on the pharmacokinetics of nebulized
      dexmedetomidine in children.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
measure: pharmacokinitics of dexmedetomidine
time frame: at the basline and after the end of nebuization of the drug at 5 minutes,15 minutes,30 minutes, 45 minutes, 60 minutes, 90 minutes and 120 minutes
description: serum level of dexmedetomidine
measure: sedation score
time frame: baseline and after end of the drug adminstration by 30 mininute
description: Ramsy sedation score
1 = Anxious or restless or both Unacceptable; increase sedation 2=Cooperative, orientated and tranquil Acceptable; no action necessary 3=Responding to commands Acceptable; no action necessary 4=Brisk response to stimulus Acceptable; no action necessary 5=Sluggish response to stimulus Unacceptable; monitor respiratory status and sedation level until stable at 2 or 3 6= No response to stimulus Unacceptable; monitor respiratory status and sedation level until stable at 2 or 3
arm group label: nebulized dexmedetomidine 2ug/kg
arm group type: Active Comparator
description: inhalation of dexmedetomidine in the dose of 2ug/kg by nebulization
arm group label: nebulized dexmedetomidine 3ug/kg
arm group type: Active Comparator
description: inhalation of dexmedetomidine in the dose of 3ug/kg by nebulization
intervention type: Drug
intervention name: nebulized Dexmedetomidine
description: inhalation of dexmedetomidine by nebulizer. the study drug will be prepared in 3 ml of 0.9% saline and will be administered by standard hospital jet nebulizer via face-mask with continuous flow of 100%oxygen at 6 l/m for 10 to 15 min
arm group label: nebulized dexmedetomidine 2ug/kg
arm group label: nebulized dexmedetomidine 3ug/kg
other name: pharmacokinitics of nebulized dexmedetomidine
criteria: 
gender: All
minimum age: 3 Years
maximum age: 7 Years
healthy volunteers: No
last name: Shereen M Kamal, Lecturer
role: Principal Investigator
affiliation: Ministry of higher education
last name: Shereen M Kamal, Lecturer
phone: +201006279209
email: sheridouh79@yahoo.com
last name: Hala S Abdelgafar, Profesor
phone: +201003812011
email: hallasaad@yahoo.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Shereen Mamdouh
investigator title: lecturer of anesthesia, ICU and pain manegement
mesh term: Abdominal Neoplasms
mesh term: Dexmedetomidine