<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/NCT04483258</url>
  </required_header>
  <id_info>
    <org_study_id>E1-20-884</org_study_id>
    <nct_id>NCT04483258</nct_id>
  </id_info>
  <brief_title>Sevoflurane Insufflation vs Intravenous Sedation for Radiotherapy in Pediatric Patients</brief_title>
  <official_title>Cross-over Analysis of Sevoflurane Insufflation and Intravenous Sedation for Radiotherapy in Pediatric Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ankara City Hospital Bilkent</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ankara City Hospital Bilkent</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>
      aim of this cross-over study is to compare sedation with insufflated sevoflurane and&#xD;
      intravenous sedation for pediatric radiotherapy patients&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      aim of this cross-over study is to compare sedation with insufflated sevoflurane and&#xD;
      intravenous sedation for pediatric radiotherapy(RT) patients in terms of success of the&#xD;
      procedure (continuous completion of the RT session by providing inactivity) and complications&#xD;
      such as desaturation, hypoventilation, airway spasm, bradycardia, tachycardia In addition, we&#xD;
      aimed to investigate the incidence of anesthesia complications in RT patients and possible&#xD;
      related factors with complications.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 5, 2020</start_date>
  <completion_date type="Anticipated">December 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 20, 2020</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>Crossover Assignment</intervention_model>
    <intervention_model_description>Sevoflurane insufflation and intravenous sedation will be applied to the patients by changing them sequentially during each radiotherapy session.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>number of the successful radiotherapy sessions</measure>
    <time_frame>during radiotherapy session</time_frame>
    <description>succesful: radiotherapy session without interruption unsuccesful: radiotherapy session with any interruption</description>
  </primary_outcome>
  <primary_outcome>
    <measure>number of interruptions</measure>
    <time_frame>during radiotherapy session</time_frame>
    <description>number of interruptions related to inadequate sedation and patient's movement in radiotherapy session</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PSSS</measure>
    <time_frame>during radiotherapy session</time_frame>
    <description>5:Patient is moving 4: gentle immobilization for positioning. 3: do not require restraint to stop movement during the procedure. 2: Quiet (asleep or awake), not moving during procedure&#xD;
1: Deeply asleep with normal vital signs, but requiring airway intervention 0: Sedation associated with abnormal physiologic parameters that require acute intervention</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>sPO2</measure>
    <time_frame>during radiotherapy session</time_frame>
    <description>peripheral oxygen saturation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HR</measure>
    <time_frame>during radiotherapy session</time_frame>
    <description>Heart Rate</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Pediatric Sedation</condition>
  <condition>Radiotherapy</condition>
  <condition>Inhalation Anesthesia</condition>
  <arm_group>
    <arm_group_label>Sedation with Insufflation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Sedation induction via oxygen mask %8 sevoflurane and reducing %3 concentration after rediotherapy start</description>
  </arm_group>
  <arm_group>
    <arm_group_label>İntravenous sedation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Midazolam+ Ketamine sedation</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Sedation with sevoflurane insufflation</intervention_name>
    <description>Induction with %8sevoflurane after adequate sedation reducing %3</description>
    <arm_group_label>Sedation with Insufflation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>intravenous sedation</intervention_name>
    <description>midazolam +ketamine + atropine</description>
    <arm_group_label>İntravenous sedation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  undergoing radiotherapy session&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  family refusal&#xD;
&#xD;
          -  chronic nausea and vomiting&#xD;
&#xD;
          -  apnea history, pneumonia, asthma, bronchiolitis etc. respiratory tract infection or&#xD;
             diseases&#xD;
&#xD;
          -  cardiac disease&#xD;
&#xD;
          -  kidney failure&#xD;
&#xD;
          -  liver failure&#xD;
&#xD;
          -  anticipated difficult airway&#xD;
&#xD;
          -  metabolic diseases&#xD;
&#xD;
          -  neurological or muscular diseases.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>İsmail Aytac</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ankara City Hospital Anesthesiology Department</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>İsmail Aytac</last_name>
    <phone>05056340369</phone>
    <email>aytacismail1972@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Ankara City Hospital</name>
      <address>
        <city>Ankara</city>
        <zip>06800</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>İsmail Aytac</last_name>
      <phone>+905056340369</phone>
      <email>aytacismail1972@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 18, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>July 22, 2020</last_update_submitted>
  <last_update_submitted_qc>July 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ankara City Hospital Bilkent</investigator_affiliation>
    <investigator_full_name>ismail aytaç</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>insufflation sedation</keyword>
  <keyword>intravenous sedation</keyword>
  <keyword>radiotherapy anesthesia</keyword>
  <keyword>pediatric sedation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Aspiration</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sevoflurane</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/NCT04483258
org study id: E1-20-884
nct id: NCT04483258
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
aim of this cross-over study is to compare sedation with insufflated sevoflurane and
      intravenous sedation for pediatric radiotherapy patients
aim of this cross-over study is to compare sedation with insufflated sevoflurane and
      intravenous sedation for pediatric radiotherapy(RT) patients in terms of success of the
      procedure (continuous completion of the RT session by providing inactivity) and complications
      such as desaturation, hypoventilation, airway spasm, bradycardia, tachycardia In addition, we
      aimed to investigate the incidence of anesthesia complications in RT patients and possible
      related factors with complications.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Sevoflurane insufflation and intravenous sedation will be applied to the patients by changing them sequentially during each radiotherapy session.
primary purpose: Supportive Care
masking: None (Open Label)
measure: number of the successful radiotherapy sessions
time frame: during radiotherapy session
description: succesful: radiotherapy session without interruption unsuccesful: radiotherapy session with any interruption
measure: number of interruptions
time frame: during radiotherapy session
description: number of interruptions related to inadequate sedation and patient's movement in radiotherapy session
measure: PSSS
time frame: during radiotherapy session
description: 5:Patient is moving 4: gentle immobilization for positioning. 3: do not require restraint to stop movement during the procedure. 2: Quiet (asleep or awake), not moving during procedure
1: Deeply asleep with normal vital signs, but requiring airway intervention 0: Sedation associated with abnormal physiologic parameters that require acute intervention
measure: sPO2
time frame: during radiotherapy session
description: peripheral oxygen saturation
measure: HR
time frame: during radiotherapy session
description: Heart Rate
arm group label: Sedation with Insufflation
arm group type: Active Comparator
description: Sedation induction via oxygen mask %8 sevoflurane and reducing %3 concentration after rediotherapy start
arm group label: İntravenous sedation
arm group type: Active Comparator
description: Midazolam+ Ketamine sedation
intervention type: Procedure
intervention name: Sedation with sevoflurane insufflation
description: Induction with %8sevoflurane after adequate sedation reducing %3
arm group label: Sedation with Insufflation
intervention type: Procedure
intervention name: intravenous sedation
description: midazolam +ketamine + atropine
arm group label: İntravenous sedation
criteria: 
gender: All
minimum age: 1 Year
maximum age: 12 Years
healthy volunteers: No
last name: İsmail Aytac
role: Principal Investigator
affiliation: Ankara City Hospital Anesthesiology Department
last name: İsmail Aytac
phone: 05056340369
email: aytacismail1972@gmail.com
facility: 
status: Recruiting
contact: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Ankara City Hospital Bilkent
investigator full name: ismail aytaç
investigator title: Principal Investigator
mesh term: Respiratory Aspiration
mesh term: Sevoflurane
sharing ipd: No