<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/NCT04426552</url>
  </required_header>
  <id_info>
    <org_study_id>0304285</org_study_id>
    <nct_id>NCT04426552</nct_id>
  </id_info>
  <brief_title>Dexmedetomidine Versus Sevoflurane in Children With Anticipated Difficult Intubation</brief_title>
  <official_title>Dexmedetomidine Versus Sevoflurane Inhalation for Fibreoptic Nasotracheal Intubation in Children With Anticipated Difficult Intubation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alexandria University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Alexandria 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>
      difficult problem in the paediatric age group because of their small mouth opening and&#xD;
      un-cooperativeness.Currently used methods of sedation for fibreoptic intubation such as&#xD;
      benzodiazepines, propofol or opioids may cause respiratory depression, especially when used&#xD;
      in high doses&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Dexmedetomidine, an a2-agonist, has none-to-minimal respiratory depressant effects, which is&#xD;
      clearly a great advantage in handling a critical (unstable, difficult) airway while inducing&#xD;
      sedation in both adult and infants. The aim is to compare intubation conditions between&#xD;
      dexmedetomidine and sevoflurane inhalation during fibreoptic intubation in pediatric patients&#xD;
      with an anticipated difficult intubation&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Anticipated">October 20, 2020</completion_date>
  <primary_completion_date type="Anticipated">September 20, 2020</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>Diagnostic</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of intubation</measure>
    <time_frame>At intubation time</time_frame>
    <description>as assessed by vocal cord movement</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Craniofacial Abnormalities</condition>
  <condition>Mandibular Hypoplasia</condition>
  <arm_group>
    <arm_group_label>Dexmedetomidine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>have a bolus of dexmedetomidine one μg/kg (Precedex; Hospira, Inc, Lake Forest, IL) administered for 10 minutes, followed by a continuous infusion at 0.7 μg • kg-1 • h-1 during FOI</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sevoflurane</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>(sevoflurane) will be preoxygenated using face mask with 100% oxygen for 3 min to increase oxygen reserve and then inhalational induction will be started with sevoflurane in 100% oxygen using Ayre's piece circuit/MapelsonD circuit according to age and weight of the patient while performing fiberoptic intubation</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>dexmedetomidine</intervention_name>
    <description>will have a bolus of dexmedetomidine one μg/kg (Precedex; Hospira, Inc, Lake Forest, IL) administered for 10 minutes, followed by a continuous infusion at 0.7 μg • kg-1 • h-1 during FOI</description>
    <arm_group_label>Dexmedetomidine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>sevoflurane</intervention_name>
    <description>preoxygenated using face mask with 100% oxygen for 3 min to increase oxygen reserve and then inhalational induction will be started with sevoflurane in 100% oxygen using Ayre's piece circuit/MapelsonD circuit according to age and weight of the patient while performing fiberoptic intubation</description>
    <arm_group_label>Sevoflurane</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA physical status I and II&#xD;
&#xD;
          -  aged 1 year to 3 years&#xD;
&#xD;
          -  require general anaesthesia with tracheal intubation for surgical correction of the&#xD;
             congenital or acquired pathology that created the difficult airway&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  parents refusal&#xD;
&#xD;
          -  Allergy to drugs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>3 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rehab A. Abd Elaziz, Ass.Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Alexandria University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Rehab A. Abd Elaziz, Ass. Prof.</last_name>
    <phone>01001073703</phone>
    <phone_ext>020</phone_ext>
    <email>trcium2002@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Rehab Abd Elraof Abd Elaziz</name>
      <address>
        <city>Alexandria</city>
        <state>Smouha</state>
        <zip>000000</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rehab A. Abd Elaziz, Ass. Prof.</last_name>
      <phone>01001073703</phone>
      <phone_ext>020</phone_ext>
      <email>trcium2002@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 11, 2020</last_update_submitted>
  <last_update_submitted_qc>June 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Alexandria University</investigator_affiliation>
    <investigator_full_name>rehab zayed</investigator_full_name>
    <investigator_title>Assisstant Professor of Anesthesia</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Craniofacial Abnormalities</mesh_term>
    <mesh_term>Micrognathism</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexmedetomidine</mesh_term>
    <mesh_term>Sevoflurane</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/NCT04426552
org study id: 0304285
nct id: NCT04426552
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
difficult problem in the paediatric age group because of their small mouth opening and
      un-cooperativeness.Currently used methods of sedation for fibreoptic intubation such as
      benzodiazepines, propofol or opioids may cause respiratory depression, especially when used
      in high doses
Dexmedetomidine, an a2-agonist, has none-to-minimal respiratory depressant effects, which is
      clearly a great advantage in handling a critical (unstable, difficult) airway while inducing
      sedation in both adult and infants. The aim is to compare intubation conditions between
      dexmedetomidine and sevoflurane inhalation during fibreoptic intubation in pediatric patients
      with an anticipated difficult intubation
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Participant)
measure: Assessment of intubation
time frame: At intubation time
description: as assessed by vocal cord movement
arm group label: Dexmedetomidine
arm group type: Experimental
description: have a bolus of dexmedetomidine one μg/kg (Precedex; Hospira, Inc, Lake Forest, IL) administered for 10 minutes, followed by a continuous infusion at 0.7 μg • kg-1 • h-1 during FOI
arm group label: Sevoflurane
arm group type: Active Comparator
description: (sevoflurane) will be preoxygenated using face mask with 100% oxygen for 3 min to increase oxygen reserve and then inhalational induction will be started with sevoflurane in 100% oxygen using Ayre's piece circuit/MapelsonD circuit according to age and weight of the patient while performing fiberoptic intubation
intervention type: Drug
intervention name: dexmedetomidine
description: will have a bolus of dexmedetomidine one μg/kg (Precedex; Hospira, Inc, Lake Forest, IL) administered for 10 minutes, followed by a continuous infusion at 0.7 μg • kg-1 • h-1 during FOI
arm group label: Dexmedetomidine
intervention type: Drug
intervention name: sevoflurane
description: preoxygenated using face mask with 100% oxygen for 3 min to increase oxygen reserve and then inhalational induction will be started with sevoflurane in 100% oxygen using Ayre's piece circuit/MapelsonD circuit according to age and weight of the patient while performing fiberoptic intubation
arm group label: Sevoflurane
criteria: 
gender: All
minimum age: 1 Year
maximum age: 3 Years
healthy volunteers: No
last name: Rehab A. Abd Elaziz, Ass.Prof.
role: Principal Investigator
affiliation: Alexandria University
last name: Rehab A. Abd Elaziz, Ass. Prof.
phone: 01001073703
phone ext: 020
email: trcium2002@yahoo.com
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Alexandria University
investigator full name: rehab zayed
investigator title: Assisstant Professor of Anesthesia
mesh term: Craniofacial Abnormalities
mesh term: Micrognathism
mesh term: Dexmedetomidine
mesh term: Sevoflurane