<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/NCT02971254</url>
  </required_header>
  <id_info>
    <org_study_id>8174</org_study_id>
    <nct_id>NCT02971254</nct_id>
  </id_info>
  <brief_title>The Effects of Inhalational Anaesthetics in Cognitive Functions in Down Syndrome Patients</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Asklepieion Voulas General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Asklepieion Voulas General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Recovery of the cognitive functions and recovery features after general anaesthesia in Down&#xD;
      syndrome patients. A comparison of Sevoflurane and Desflurane.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2016</start_date>
  <completion_date type="Actual">May 30, 2019</completion_date>
  <primary_completion_date type="Actual">January 6, 2019</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>Supportive Care</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Cognitive Functions</measure>
    <time_frame>Baseline (12 to 24 hours before surgery), 1,5 hours after surgery and 4 hours after surgery</time_frame>
    <description>Quantitative result measured by Prudhoe Cognitive Function Test (PCFT), a scale to assess cognitive function in adults with Down's syndrome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Spontaneous breathing</measure>
    <time_frame>Interval between discontinuation of inhaled agent and first spontaneous breath and up to 1 hour.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Eye opening</measure>
    <time_frame>Interval between discontinuation of inhaled agent and first eye opening and up to 1 hour.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Extubation</measure>
    <time_frame>Interval between discontinuation of inhaled agent and extubation and up to 1 hour.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Orientation</measure>
    <time_frame>Interval between discontinuation of inhaled agent and orientation in place, time, people and up to 1 hour.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respond to commands</measure>
    <time_frame>Interval between discontinuation of inhaled agent and respond to commands and up to 1 hour.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>modified Aldrete Scoring System (mASS)</measure>
    <time_frame>Interval between entrance in Post Operative Care Unit (PACU) and fulfillment of the criteria mASS to discharge PACU and up to 2 hours.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Orientation in PACU</measure>
    <time_frame>30 minutes after PACU entrance</time_frame>
    <description>Orientation in place, time and people in Post Operative Care Unit (PACU).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Orientation in PACU</measure>
    <time_frame>60 minutes after PACU entrance</time_frame>
    <description>Orientation in place, time and people in Post Operative Care Unit (PACU).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antiemetics necessity.</measure>
    <time_frame>Interval between entrance in PACU and administer antiemetic medication and up to 4 hours.</time_frame>
    <description>Note if additional antiemetics was needed up to 4 hours postoperatively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Painkillers necessity.</measure>
    <time_frame>Interval between entrance in PACU and administration of antiemetic medication and up to 4 hours.</time_frame>
    <description>Note if additional painkillers was needed up to 4 hours postoperatively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Alertness, Wellness, Energy</measure>
    <time_frame>Baseline, 12 to 24 hours before surgery</time_frame>
    <description>Assessment of the accompanying persons.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Alertness, Wellness, Energy</measure>
    <time_frame>1,5 hours after surgery</time_frame>
    <description>Assessment of the accompanying persons.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Alertness, Wellness, Energy</measure>
    <time_frame>4 hours after surgery</time_frame>
    <description>Assessment of the accompanying persons.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction over anaesthesia.</measure>
    <time_frame>4 hours after surgery</time_frame>
    <description>Assessment of the accompanying persons.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postanesthesia Discharge Scoring System (PADSS)</measure>
    <time_frame>Fulfillment of the criteria of PADSS from discontinuation of inhaled agent and up to 1 day.</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">39</enrollment>
  <condition>Down Syndrome</condition>
  <arm_group>
    <arm_group_label>Sevoflurane group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>inhalation anaesthetic Sevoflurane, 1 M.A.C. during surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Desflurane group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>inhalation anaesthetic Desflurane, 1 M.A.C. during surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sevoflurane</intervention_name>
    <arm_group_label>Sevoflurane group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Desflurane</intervention_name>
    <arm_group_label>Desflurane group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) classification I, II or III&#xD;
&#xD;
          -  Down syndrome patients&#xD;
&#xD;
          -  must be able to undergone general anaesthesia&#xD;
&#xD;
          -  dental surgery necessity&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe dementia&#xD;
&#xD;
          -  severe hearing, vision, speaking problems&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Emmanouil Gkliatis, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>GH Asklepieio Voulas</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gkliatis Emmanouil</name>
      <address>
        <city>Athens</city>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>November 11, 2016</study_first_submitted>
  <study_first_submitted_qc>November 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2016</study_first_posted>
  <last_update_submitted>June 6, 2020</last_update_submitted>
  <last_update_submitted_qc>June 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Asklepieion Voulas General Hospital</investigator_affiliation>
    <investigator_full_name>Gkliatis Emmanouil</investigator_full_name>
    <investigator_title>Anaesthetist</investigator_title>
  </responsible_party>
  <keyword>cognitive functions</keyword>
  <keyword>anaesthesia recovery</keyword>
  <keyword>sevoflurane</keyword>
  <keyword>desflurane</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Down Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sevoflurane</mesh_term>
    <mesh_term>Desflurane</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02971254
org study id: 8174
nct id: NCT02971254
lead sponsor: 
has dmc: No
Recovery of the cognitive functions and recovery features after general anaesthesia in Down
      syndrome patients. A comparison of Sevoflurane and Desflurane.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Participant, Investigator)
measure: Change in Cognitive Functions
time frame: Baseline (12 to 24 hours before surgery), 1,5 hours after surgery and 4 hours after surgery
description: Quantitative result measured by Prudhoe Cognitive Function Test (PCFT), a scale to assess cognitive function in adults with Down's syndrome.
measure: Spontaneous breathing
time frame: Interval between discontinuation of inhaled agent and first spontaneous breath and up to 1 hour.
measure: Eye opening
time frame: Interval between discontinuation of inhaled agent and first eye opening and up to 1 hour.
measure: Extubation
time frame: Interval between discontinuation of inhaled agent and extubation and up to 1 hour.
measure: Orientation
time frame: Interval between discontinuation of inhaled agent and orientation in place, time, people and up to 1 hour.
measure: Respond to commands
time frame: Interval between discontinuation of inhaled agent and respond to commands and up to 1 hour.
measure: modified Aldrete Scoring System (mASS)
time frame: Interval between entrance in Post Operative Care Unit (PACU) and fulfillment of the criteria mASS to discharge PACU and up to 2 hours.
measure: Orientation in PACU
time frame: 30 minutes after PACU entrance
description: Orientation in place, time and people in Post Operative Care Unit (PACU).
measure: Orientation in PACU
time frame: 60 minutes after PACU entrance
description: Orientation in place, time and people in Post Operative Care Unit (PACU).
measure: Antiemetics necessity.
time frame: Interval between entrance in PACU and administer antiemetic medication and up to 4 hours.
description: Note if additional antiemetics was needed up to 4 hours postoperatively.
measure: Painkillers necessity.
time frame: Interval between entrance in PACU and administration of antiemetic medication and up to 4 hours.
description: Note if additional painkillers was needed up to 4 hours postoperatively.
measure: Patient Alertness, Wellness, Energy
time frame: Baseline, 12 to 24 hours before surgery
description: Assessment of the accompanying persons.
measure: Patient Alertness, Wellness, Energy
time frame: 1,5 hours after surgery
description: Assessment of the accompanying persons.
measure: Patient Alertness, Wellness, Energy
time frame: 4 hours after surgery
description: Assessment of the accompanying persons.
measure: Patient satisfaction over anaesthesia.
time frame: 4 hours after surgery
description: Assessment of the accompanying persons.
measure: Postanesthesia Discharge Scoring System (PADSS)
time frame: Fulfillment of the criteria of PADSS from discontinuation of inhaled agent and up to 1 day.
arm group label: Sevoflurane group
arm group type: Active Comparator
description: inhalation anaesthetic Sevoflurane, 1 M.A.C. during surgery
arm group label: Desflurane group
arm group type: Active Comparator
description: inhalation anaesthetic Desflurane, 1 M.A.C. during surgery
intervention type: Drug
intervention name: Sevoflurane
arm group label: Sevoflurane group
intervention type: Drug
intervention name: Desflurane
arm group label: Desflurane group
criteria: 
gender: All
minimum age: 16 Years
maximum age: 75 Years
healthy volunteers: No
last name: Emmanouil Gkliatis, MD
role: Principal Investigator
affiliation: GH Asklepieio Voulas
facility: 
country: Greece
responsible party type: Principal Investigator
investigator affiliation: Asklepieion Voulas General Hospital
investigator full name: Gkliatis Emmanouil
investigator title: Anaesthetist
mesh term: Down Syndrome
mesh term: Syndrome
mesh term: Sevoflurane
mesh term: Desflurane
sharing ipd: Undecided