<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/NCT02974712</url>
  </required_header>
  <id_info>
    <org_study_id>20161114</org_study_id>
    <nct_id>NCT02974712</nct_id>
  </id_info>
  <brief_title>The Effects of Two Induction Means on Emergence After General Anesthesia</brief_title>
  <official_title>The Effects of Two Induction Means on Emergence After General Anesthesia for Elderly Patients Undergoing Transurethral Endoscopic Operation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RenJi Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>RenJi Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to investigate the effects of different methods of administration on&#xD;
      emergence period after laryngeal mask anesthesia in elderly patients undergoing transurethral&#xD;
      endoscopic operation&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">March 2017</completion_date>
  <primary_completion_date type="Anticipated">March 2017</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>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean arterial pressure (MAP)</measure>
    <time_frame>One hour after surgery</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Lengths of stays in the Post anesthesia care unit(PACU)</measure>
    <time_frame>One hour after surgery</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Mean Arterial Pressure</condition>
  <condition>Heart Rate</condition>
  <arm_group>
    <arm_group_label>Fentanyl</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After routine Induction, fentanyl was administrated.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Saline</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>After routine Induction, same volume saline was administrated.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fentanyl</intervention_name>
    <arm_group_label>Fentanyl</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Saline</intervention_name>
    <arm_group_label>Saline</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA level I or II,&#xD;
&#xD;
          -  Aged from 65 to 79,&#xD;
&#xD;
          -  With a duration of anesthesia &lt;90 min.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chronic obstructive pulmonary diseases (COPD),&#xD;
&#xD;
          -  Severe heart disease,&#xD;
&#xD;
          -  Difficult airway&#xD;
&#xD;
          -  Liver and kidney dysfunction,&#xD;
&#xD;
          -  Cerebrovascular disease,&#xD;
&#xD;
          -  Bleeding volume &gt;20 ml.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 14, 2016</study_first_submitted>
  <study_first_submitted_qc>November 25, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2016</study_first_posted>
  <last_update_submitted>November 25, 2016</last_update_submitted>
  <last_update_submitted_qc>November 25, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 28, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Arterial blood gases</keyword>
  <keyword>MAP</keyword>
  <keyword>HR</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fentanyl</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/NCT02974712
org study id: 20161114
nct id: NCT02974712
lead sponsor: 
has dmc: Yes
This study aims to investigate the effects of different methods of administration on
      emergence period after laryngeal mask anesthesia in elderly patients undergoing transurethral
      endoscopic operation
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
measure: Mean arterial pressure (MAP)
time frame: One hour after surgery
measure: Lengths of stays in the Post anesthesia care unit(PACU)
time frame: One hour after surgery
arm group label: Fentanyl
arm group type: Experimental
description: After routine Induction, fentanyl was administrated.
arm group label: Saline
arm group type: Placebo Comparator
description: After routine Induction, same volume saline was administrated.
intervention type: Drug
intervention name: Fentanyl
arm group label: Fentanyl
intervention type: Drug
intervention name: Saline
arm group label: Saline
criteria: 
gender: All
minimum age: 65 Years
maximum age: 79 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Fentanyl