<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/NCT01722409</url>
  </required_header>
  <id_info>
    <org_study_id>20121009</org_study_id>
    <nct_id>NCT01722409</nct_id>
  </id_info>
  <brief_title>A Better Choice for Patients Undergoing Endovascular Coil Embolization</brief_title>
  <official_title>Sevoflurane, Laryngeal Mask Airway and Single-dose Dexmedetomidine: A Better Choice for Patients Undergoing Endovascular Coil Embolization</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>China Medical University, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>China Medical University, China</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators designed a double-blind, randomized placebo-controlled study to determine&#xD;
      the effects of dexmedetomidine on the recovery characteristics of patients who were scheduled&#xD;
      to undergo endovascular coil embolization.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</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>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Observing the recovery characteristics of patients who were scheduled to undergo endovascular coil embolization.</measure>
    <time_frame>At the end of the operation and 24 hours later</time_frame>
    <description>The time from termination of the general anesthetic to the time that the patient's eyes opened. Anesthesiologists collected information on emergence agitation, postoperative nausea and vomiting for 24 hours after the surgery.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Intracranial Aneurysms</condition>
  <arm_group>
    <arm_group_label>sevoflurane and saline infusion</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>After induction of general anesthesia, Group S received a placebo infusion of normal saline.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>sevoflurane and 0.5 μg/kg dexmedetomidine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After induction of general anesthesia, Group DEX1 received a single dexmedetomidine dose of 0.5 μg/kg over 10 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>sevoflurane and 1 μg/kg dexmedetomidine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After induction of general anesthesia, Group DEX2 received a single dexmedetomidine dose of 1 μg/kg over 10 minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>sevoflurane and 0.5 μg/kg dexmedetomidine</intervention_name>
    <description>After induction of general anesthesia, Group DEX1 received a single dexmedetomidine dose of 0.5 μg/kg over 10 minutes.</description>
    <arm_group_label>sevoflurane and 0.5 μg/kg dexmedetomidine</arm_group_label>
    <other_name>DEX1</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>sevoflurane and 1 μg/kg dexmedetomidine</intervention_name>
    <description>After induction of general anesthesia, Group DEX2 received a single dexmedetomidine dose of 1 μg/kg over 10 minutes.</description>
    <arm_group_label>sevoflurane and 1 μg/kg dexmedetomidine</arm_group_label>
    <other_name>DEX2</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:18-65 years old ASA I or ASA II patients undergoing ECE treatment for&#xD;
        intracranial aneurysms were included.&#xD;
&#xD;
        Exclusion Criteria:Patients were excluded based on the following parameters: older than 65&#xD;
        yrs, a history of mental illness, recent use of sedatives or analgesics and with sensation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hong Ma, M.D.,PhD.</last_name>
    <role>Study Chair</role>
    <affiliation>Dept. of Anesthesiology, the First Hospital of CMU</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Wen-fei Tan</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <zip>110001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2013</verification_date>
  <study_first_submitted>November 3, 2012</study_first_submitted>
  <study_first_submitted_qc>November 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 6, 2012</study_first_posted>
  <last_update_submitted>June 23, 2015</last_update_submitted>
  <last_update_submitted_qc>June 23, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 25, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>China Medical University, China</investigator_affiliation>
    <investigator_full_name>Wen-fei Tan</investigator_full_name>
    <investigator_title>Associate professor</investigator_title>
  </responsible_party>
  <keyword>dexmedetomidine, endovascular coil embolization</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intracranial Aneurysm</mesh_term>
    <mesh_term>Aneurysm</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/NCT01722409
org study id: 20121009
nct id: NCT01722409
lead sponsor: 
has dmc: Yes
The investigators designed a double-blind, randomized placebo-controlled study to determine
      the effects of dexmedetomidine on the recovery characteristics of patients who were scheduled
      to undergo endovascular coil embolization.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Observing the recovery characteristics of patients who were scheduled to undergo endovascular coil embolization.
time frame: At the end of the operation and 24 hours later
description: The time from termination of the general anesthetic to the time that the patient's eyes opened. Anesthesiologists collected information on emergence agitation, postoperative nausea and vomiting for 24 hours after the surgery.
arm group label: sevoflurane and saline infusion
arm group type: No Intervention
description: After induction of general anesthesia, Group S received a placebo infusion of normal saline.
arm group label: sevoflurane and 0.5 μg/kg dexmedetomidine
arm group type: Experimental
description: After induction of general anesthesia, Group DEX1 received a single dexmedetomidine dose of 0.5 μg/kg over 10 minutes.
arm group label: sevoflurane and 1 μg/kg dexmedetomidine
arm group type: Experimental
description: After induction of general anesthesia, Group DEX2 received a single dexmedetomidine dose of 1 μg/kg over 10 minutes.
intervention type: Drug
intervention name: sevoflurane and 0.5 μg/kg dexmedetomidine
description: After induction of general anesthesia, Group DEX1 received a single dexmedetomidine dose of 0.5 μg/kg over 10 minutes.
arm group label: sevoflurane and 0.5 μg/kg dexmedetomidine
other name: DEX1
intervention type: Drug
intervention name: sevoflurane and 1 μg/kg dexmedetomidine
description: After induction of general anesthesia, Group DEX2 received a single dexmedetomidine dose of 1 μg/kg over 10 minutes.
arm group label: sevoflurane and 1 μg/kg dexmedetomidine
other name: DEX2
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Hong Ma, M.D.,PhD.
role: Study Chair
affiliation: Dept. of Anesthesiology, the First Hospital of CMU
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: China Medical University, China
investigator full name: Wen-fei Tan
investigator title: Associate professor
mesh term: Intracranial Aneurysm
mesh term: Aneurysm
mesh term: Dexmedetomidine
mesh term: Sevoflurane