<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/NCT03800641</url>
  </required_header>
  <id_info>
    <org_study_id>EyeEntFudan</org_study_id>
    <nct_id>NCT03800641</nct_id>
  </id_info>
  <brief_title>A Study of Dexmedetomidine Pharmacokinetics for Preoperative Sedation</brief_title>
  <official_title>A Study of Dexmedetomidine Pharmacokinetics for Preoperative Sedation With Administration of Oral, Intravenous and Nasal Drops</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eye &amp; ENT Hospital of Fudan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eye &amp; ENT Hospital of Fudan 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>
      Proper preoperative sedation can reduce patients' anxiety, enhance patients' cooperation and&#xD;
      reduce perioperative complications. The investigators would explore the sedative effects of&#xD;
      dexmedetomidine (DEX) with the administration of oral, intravenous and nasal drops, and&#xD;
      detect DEX blood concentration in 15 participants, respectively. Pharmacokinetic parameters&#xD;
      are detected at 8 time points ( before DEX administration, 10 min, 20 min, 30 min, 45 min,&#xD;
      60min, 90min and 120 min after administration). 3 ml arterial blood was collected at each&#xD;
      time point. The blood samples are detected by mass spectrometer. The aim of this study is to&#xD;
      investigate appropriate administration time and route for DEX sedation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 11, 2019</start_date>
  <completion_date type="Actual">January 23, 2020</completion_date>
  <primary_completion_date type="Actual">March 29, 2019</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Dexmedetomidine pharmacokinetic curve</measure>
    <time_frame>120 min DEX pharmacokinetics</time_frame>
    <description>Dexmedetomidine (DEX) blood concentration are detected at 8 time points (before DEX administration, 10 min, 20 min, 30 min, 45 min, 60min, 90min and 120 min after administration) in the groups of oral, intravenous and nasal drops administration of DEX. 3 ml arterial blood was collected at each time point. The blood samples are detected by mass spectrometer to detect blood concentration of DEX. Then DEX pharmacokinetic curve is made according to the DEX blood concentration.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effect of sedation</measure>
    <time_frame>10min after administration</time_frame>
    <description>Evaluated with Ramsay sedation scale Score Response&#xD;
Anxious or restless or both&#xD;
Cooperative, orientated and tranquil&#xD;
Responding to commands&#xD;
Brisk response to stimulus&#xD;
Sluggish response to stimulus&#xD;
No response to stimulus</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of surgical field</measure>
    <time_frame>30min after administration</time_frame>
    <description>Surgical field was evaluated according to the report Boezaart A.P.，van der Merwe J.，Coetzee A. Comparison of sodium nitroprusside- and esmolol-induced controlled hypotension for functional endoscopic sinus surgery. Can J Anaesth，1995，42(5 Pt 1): 373-376.&#xD;
0 No bleeding.&#xD;
Slight bleeding - no suctioning of blood required.&#xD;
Slight bleeding - occasional suctioning required. Surgical field not threatened.&#xD;
Slight bleeding - frequent suctioning required. Bleeding threatens surgical field a few seconds after suction is removed.&#xD;
Moderate bleeding - frequent suctioning required. Bleeding threatens surgical field directly after suction is removed.&#xD;
Severe bleeding - constant suctioning required. Bleeding appears faster than can be removed by suction. Surgical field severely threatened and surgery not possible.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Anxiety</condition>
  <condition>Preoperative Care</condition>
  <condition>Pharmacokinetics</condition>
  <condition>Emergence Delirium</condition>
  <arm_group>
    <arm_group_label>oral administration</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>oral administration of dexmedetomidine 4μg/kg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>intravenous administration</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>intravenous administration of dexmedetomidine 0.8μg/kg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>nasal administration</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>nasal administration of dexmedetomidine 1μg/kg</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexmedetomidine</intervention_name>
    <description>oral, intravenous and nasal administration of Dexmedetomidine</description>
    <arm_group_label>intravenous administration</arm_group_label>
    <arm_group_label>nasal administration</arm_group_label>
    <arm_group_label>oral administration</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  45 participants who undergo tympanoplasty would be enrolled after signment the&#xD;
             informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The participants were excluded with any diseases about respiration, circulation, liver&#xD;
             and kidney.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Eye, Ear, Nose and Throat Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200031</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>January 7, 2022</last_update_submitted>
  <last_update_submitted_qc>January 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Eye &amp; ENT Hospital of Fudan University</investigator_affiliation>
    <investigator_full_name>Jinhong Wu</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Dexmedetomidine</keyword>
  <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>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/NCT03800641
org study id: EyeEntFudan
nct id: NCT03800641
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Proper preoperative sedation can reduce patients' anxiety, enhance patients' cooperation and
      reduce perioperative complications. The investigators would explore the sedative effects of
      dexmedetomidine (DEX) with the administration of oral, intravenous and nasal drops, and
      detect DEX blood concentration in 15 participants, respectively. Pharmacokinetic parameters
      are detected at 8 time points ( before DEX administration, 10 min, 20 min, 30 min, 45 min,
      60min, 90min and 120 min after administration). 3 ml arterial blood was collected at each
      time point. The blood samples are detected by mass spectrometer. The aim of this study is to
      investigate appropriate administration time and route for DEX sedation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Dexmedetomidine pharmacokinetic curve
time frame: 120 min DEX pharmacokinetics
description: Dexmedetomidine (DEX) blood concentration are detected at 8 time points (before DEX administration, 10 min, 20 min, 30 min, 45 min, 60min, 90min and 120 min after administration) in the groups of oral, intravenous and nasal drops administration of DEX. 3 ml arterial blood was collected at each time point. The blood samples are detected by mass spectrometer to detect blood concentration of DEX. Then DEX pharmacokinetic curve is made according to the DEX blood concentration.
measure: Effect of sedation
time frame: 10min after administration
description: Evaluated with Ramsay sedation scale Score Response
Anxious or restless or both
Cooperative, orientated and tranquil
Responding to commands
Brisk response to stimulus
Sluggish response to stimulus
No response to stimulus
measure: Evaluation of surgical field
time frame: 30min after administration
description: Surgical field was evaluated according to the report Boezaart A.P.，van der Merwe J.，Coetzee A. Comparison of sodium nitroprusside- and esmolol-induced controlled hypotension for functional endoscopic sinus surgery. Can J Anaesth，1995，42(5 Pt 1): 373-376.
0 No bleeding.
Slight bleeding - no suctioning of blood required.
Slight bleeding - occasional suctioning required. Surgical field not threatened.
Slight bleeding - frequent suctioning required. Bleeding threatens surgical field a few seconds after suction is removed.
Moderate bleeding - frequent suctioning required. Bleeding threatens surgical field directly after suction is removed.
Severe bleeding - constant suctioning required. Bleeding appears faster than can be removed by suction. Surgical field severely threatened and surgery not possible.
arm group label: oral administration
arm group type: Experimental
description: oral administration of dexmedetomidine 4μg/kg
arm group label: intravenous administration
arm group type: Active Comparator
description: intravenous administration of dexmedetomidine 0.8μg/kg
arm group label: nasal administration
arm group type: Experimental
description: nasal administration of dexmedetomidine 1μg/kg
intervention type: Drug
intervention name: Dexmedetomidine
description: oral, intravenous and nasal administration of Dexmedetomidine
arm group label: intravenous administration
arm group label: nasal administration
arm group label: oral administration
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Eye & ENT Hospital of Fudan University
investigator full name: Jinhong Wu
investigator title: Principal Investigator
mesh term: Emergence Delirium
mesh term: Dexmedetomidine