<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/NCT01715857</url>
  </required_header>
  <id_info>
    <org_study_id>P13-934</org_study_id>
    <nct_id>NCT01715857</nct_id>
  </id_info>
  <brief_title>Clinical Practice of Inhalation Anesthesia With Sevoflurane in China</brief_title>
  <official_title>A Multicenter Registry on the Clinical Practice of Inhalation Anesthesia With Sevoflurane in China</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AbbVie (prior sponsor, Abbott)</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AbbVie</source>
  <brief_summary>
    <textblock>
      Until recently, there was a lack of understanding and consensus among Chinese&#xD;
      anesthesiologists how they should practice general anesthesia with volatile anesthetics,&#xD;
      since there was no standard of inhalation practice. In August 2011, the Anesthesiology branch&#xD;
      of the Chinese Medical Association launched the first version of Chinese Consensus of&#xD;
      Standard Clinical Practice for Inhalation Anesthesia (Consensus) in order to standardize the&#xD;
      practice in China.&#xD;
&#xD;
      The proposed registry is aimed to evaluate the current inhalation practice one year after the&#xD;
      Consensus has been released, and related patient outcome. This registry evaluated sevoflurane&#xD;
      anesthesia, including screening, induction, maintenance, emergence, and follow-up within 24&#xD;
      hours post-operation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">July 2013</completion_date>
  <primary_completion_date type="Actual">July 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Anesthesiologist Satisfaction With the Anesthesia Using a Numeric Analog Scale (NAS)</measure>
    <time_frame>End of surgery</time_frame>
    <description>Anesthesiologist satisfaction with the anesthesia was recorded by the anesthesiologist at the end of the operation using a NAS from 0 (not satisfied at all) to 10 (completely satisfied). The satisfaction of induction, maintenance, and emergence accounts for 20%, 50%, and 30% of the score, respectively.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Participant Satisfaction With the Anesthesia Using a Numeric Analog Scale (NAS)</measure>
    <time_frame>24 hours after end of surgery</time_frame>
    <description>Participant satisfaction with the anesthesia recorded approximately 24 hours after the end of the operation using a NAS from 0 (not satisfied at all) to 10 (completely satisfied).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to Eye Opening</measure>
    <time_frame>From cessation of sevoflurane administration until the participant opened their eyes, up to 80 minutes</time_frame>
    <description>After cessation of anesthesia, the investigators lightly tapped on the participant's forehead or shoulder and asked the participant to open their eyes. This process was repeated approximately every minute until eye opening occurred.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Extubation</measure>
    <time_frame>From cessation of sevoflurane administration until tracheal extubation occurred, up to 80 minutes</time_frame>
    <description>Time to extubation was measured from the time sevoflurane administration had stopped until tracheal extubation or laryngeal mask airway (LMA) removal occurred.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost of Anesthetics Including Sevoflurane (Yuan Renminbi [RMB]/Hour)</measure>
    <time_frame>Anesthetic duration between 1 to 5 hours</time_frame>
    <description>Cost of anesthetics is the sum of the cost of sevoflurane and other anesthetics including narcotics and muscle relaxants. Cost of sevoflurane = unit price of sevoflurane multiplied by the used volume of sevoflurane. Cost of other anesthetics = unit price of anesthetics multiplied by the total volume of anesthetics in the ampoule.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Non-compliance of Sevoflurane End Tidal Concentration Following the Consensus</measure>
    <time_frame>During maintenance (up to 5 hours)</time_frame>
    <description>Non-compliance of sevoflurane end tidal concentration was defined as the percentage of time points for the maintenance period (excluding washout phase) that were below the sevoflurane end tidal concentration boundary of 0.6 minimal alveolar concentration (MAC) based on the Consensus. A higher percentage indicates a higher degree of non-compliance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Non-compliance of Sevoflurane Vaporizer Setting Following the Consensus</measure>
    <time_frame>During maintenance (up to 5 hours)</time_frame>
    <description>Non-compliance of sevoflurane vaporizer setting was defined as the percentage of time points for the maintenance period outside the range of 1.0 - 1.5 minimal alveolar concentration (MAC) during the maintenance period (excluding washout phase) based on the Consensus. A higher percentage indicates a higher degree of non-compliance.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">4100</enrollment>
  <condition>Anesthesia, General</condition>
  <arm_group>
    <arm_group_label>Chinese Patients Requiring Surgery with Sevoflurane Anesthesia</arm_group_label>
    <description>Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Chinese patients undergoing surgery require general anesthesia (sevoflurane) with&#xD;
        endotracheal intubation or laryngeal mask.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Man or woman, aged from 18 to 70 years old.&#xD;
&#xD;
          2. American Society of Anesthesiologists (ASA) physical status: I, II and III.&#xD;
&#xD;
          3. Surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal&#xD;
             mask airway (LMA).&#xD;
&#xD;
          4. The type of surgery is either general surgery, or orthopedics, or gynecology.&#xD;
&#xD;
          5. The duration of anesthesia ranges from 1 to 5 hours.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of clinically significant cardiovascular, pulmonary, renal, hepatic or central&#xD;
             nervous system or muscle disease.&#xD;
&#xD;
          2. Known hypersensitivity or history of unusual response to any halogenated anesthetics.&#xD;
&#xD;
          3. Personal or familial history of malignant hyperthermia.&#xD;
&#xD;
          4. Female patients who are either pregnant or breast feeding.&#xD;
&#xD;
          5. General anesthesia is administered with total intravenous anesthesia (TIVA) of&#xD;
             propofol or sevoflurane maintenance combined with propofol continuous infusion during&#xD;
             maintenance.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yue Kang, MD</last_name>
    <role>Study Director</role>
    <affiliation>AbbVie</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 84316</name>
      <address>
        <city>Beijing, Xicheng District</city>
        <zip>100044</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 84317</name>
      <address>
        <city>Beijing</city>
        <zip>100000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 86755</name>
      <address>
        <city>Beijing</city>
        <zip>100029</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 96155</name>
      <address>
        <city>Beijing</city>
        <zip>100191</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 84320</name>
      <address>
        <city>Beijing</city>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 84321</name>
      <address>
        <city>Changchun, Jilin</city>
        <zip>130031</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 86754</name>
      <address>
        <city>Changchun, Jilin</city>
        <zip>130033</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 86764</name>
      <address>
        <city>Changsha, Hunan</city>
        <zip>410008</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 86767</name>
      <address>
        <city>Changsha, Hunan</city>
        <zip>410013</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 100206</name>
      <address>
        <city>Chengdu</city>
        <zip>610041</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 86762</name>
      <address>
        <city>Chongqing</city>
        <zip>400042</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 84333</name>
      <address>
        <city>Guangzhou, Guangdong</city>
        <zip>510010</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 100095</name>
      <address>
        <city>Guangzhou, Guangdong</city>
        <zip>510655</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 84338</name>
      <address>
        <city>Guangzhou</city>
        <zip>510030</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 106416</name>
      <address>
        <city>Guangzhou</city>
        <zip>510405</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 84337</name>
      <address>
        <city>Guangzhou</city>
        <zip>510515</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 102457</name>
      <address>
        <city>Guangzhou</city>
        <zip>511400</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 84334</name>
      <address>
        <city>Harbin, Heilongjiang</city>
        <zip>150081</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 86759</name>
      <address>
        <city>Jinan, Shandong</city>
        <zip>250014</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 84318</name>
      <address>
        <city>Kunming, Yunnan</city>
        <zip>650032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 86757</name>
      <address>
        <city>Kunming, Yunnan</city>
        <zip>650101</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 84336</name>
      <address>
        <city>Lanzhou, Gansu</city>
        <zip>730000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 84322</name>
      <address>
        <city>Lanzhou, Gansu</city>
        <zip>730030</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 86761</name>
      <address>
        <city>Nanchang, Jiangxi</city>
        <zip>330006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 102455</name>
      <address>
        <city>Qingdao</city>
        <zip>266011</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 78434</name>
      <address>
        <city>Shanghai</city>
        <zip>200025</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 86073</name>
      <address>
        <city>Shanghai</city>
        <zip>200127</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 84342</name>
      <address>
        <city>Shanghai</city>
        <zip>200438</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 84314</name>
      <address>
        <city>Shenyang, Liao Ning</city>
        <zip>110042</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 84319</name>
      <address>
        <city>Shijiazhuang Hebei</city>
        <zip>500011</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 100207</name>
      <address>
        <city>Tianjin</city>
        <zip>300052</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 95295</name>
      <address>
        <city>Tianjin</city>
        <zip>300162</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 86760</name>
      <address>
        <city>Wuhan, Hubei</city>
        <zip>430022</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 86766</name>
      <address>
        <city>Zhengzhou, Henan</city>
        <zip>450000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 86763</name>
      <address>
        <city>Zhengzhou, Henan</city>
        <zip>450008</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 86769</name>
      <address>
        <city>Zunyi, Guizhou</city>
        <zip>563099</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <link>
    <url>http://rxabbvie.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>September 2, 2012</study_first_submitted>
  <study_first_submitted_qc>October 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 29, 2012</study_first_posted>
  <results_first_submitted>July 23, 2014</results_first_submitted>
  <results_first_submitted_qc>July 23, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">August 13, 2014</results_first_posted>
  <last_update_submitted>August 15, 2014</last_update_submitted>
  <last_update_submitted_qc>August 15, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 19, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Economics, Pharmaceutical</keyword>
  <keyword>Physician's Practice Patterns</keyword>
  <keyword>Chinese</keyword>
  <keyword>Sevoflurane</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Aspiration</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Chinese Patients Requiring Surgery With Sevoflurane Anesthesia</title>
          <description>Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="4100"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4004"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="96"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Did Not Meet Eligibility Criteria</title>
              <participants_list>
                <participants group_id="P1" count="96"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Chinese Patients Requiring Surgery With Sevoflurane Anesthesia</title>
          <description>Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="4004"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45.54" spread="12.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2720"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1284"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>American Society of Anesthesiologist (ASA) Physical Status</title>
          <description>ASA Physical Status Classification System: ASA Physical Status I = A normal healthy patient; ASA Physical Status II = A patient with mild systemic disease; ASA Physical Status III = A patient with severe systemic disease; ASA Physical Status IV = A patient with severe systemic disease that is a constant threat to life; ASA Physical Status V = A moribund patient who is not expected to survive without the operation; ASA Physical Status VI = A declared brain-dead patient whose organs are being removed for donor purposes</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>ASA Physical Status I</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="47.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ASA Physical Status II</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="49.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ASA Physical Status III</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ASA Physical Status IV</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ASA Physical Status V</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Type of Surgery</title>
          <units>percentage of participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>General Surgery</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Gynecologic Surgery</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Orthopedic Surgery</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Weight</title>
          <units>kilograms</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="62.19" spread="10.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Anesthesiologist Satisfaction With the Anesthesia Using a Numeric Analog Scale (NAS)</title>
        <description>Anesthesiologist satisfaction with the anesthesia was recorded by the anesthesiologist at the end of the operation using a NAS from 0 (not satisfied at all) to 10 (completely satisfied). The satisfaction of induction, maintenance, and emergence accounts for 20%, 50%, and 30% of the score, respectively.</description>
        <time_frame>End of surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Chinese Patients Requiring Surgery With Sevoflurane Anesthesia</title>
            <description>Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China</description>
          </group>
        </group_list>
        <measure>
          <title>Anesthesiologist Satisfaction With the Anesthesia Using a Numeric Analog Scale (NAS)</title>
          <description>Anesthesiologist satisfaction with the anesthesia was recorded by the anesthesiologist at the end of the operation using a NAS from 0 (not satisfied at all) to 10 (completely satisfied). The satisfaction of induction, maintenance, and emergence accounts for 20%, 50%, and 30% of the score, respectively.</description>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4004"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.14" spread="0.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Participant Satisfaction With the Anesthesia Using a Numeric Analog Scale (NAS)</title>
        <description>Participant satisfaction with the anesthesia recorded approximately 24 hours after the end of the operation using a NAS from 0 (not satisfied at all) to 10 (completely satisfied).</description>
        <time_frame>24 hours after end of surgery</time_frame>
        <population>All participants who received study drug and with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Chinese Patients Requiring Surgery With Sevoflurane Anesthesia</title>
            <description>Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China</description>
          </group>
        </group_list>
        <measure>
          <title>Participant Satisfaction With the Anesthesia Using a Numeric Analog Scale (NAS)</title>
          <description>Participant satisfaction with the anesthesia recorded approximately 24 hours after the end of the operation using a NAS from 0 (not satisfied at all) to 10 (completely satisfied).</description>
          <population>All participants who received study drug and with available data.</population>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4004"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.21" spread="0.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Eye Opening</title>
        <description>After cessation of anesthesia, the investigators lightly tapped on the participant's forehead or shoulder and asked the participant to open their eyes. This process was repeated approximately every minute until eye opening occurred.</description>
        <time_frame>From cessation of sevoflurane administration until the participant opened their eyes, up to 80 minutes</time_frame>
        <population>All participants who received study drug and with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Chinese Patients Requiring Surgery With Sevoflurane Anesthesia</title>
            <description>Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Eye Opening</title>
          <description>After cessation of anesthesia, the investigators lightly tapped on the participant's forehead or shoulder and asked the participant to open their eyes. This process was repeated approximately every minute until eye opening occurred.</description>
          <population>All participants who received study drug and with available data.</population>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3982"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.30" spread="11.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Extubation</title>
        <description>Time to extubation was measured from the time sevoflurane administration had stopped until tracheal extubation or laryngeal mask airway (LMA) removal occurred.</description>
        <time_frame>From cessation of sevoflurane administration until tracheal extubation occurred, up to 80 minutes</time_frame>
        <population>All participants who received study drug and with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Chinese Patients Requiring Surgery With Sevoflurane Anesthesia</title>
            <description>Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Extubation</title>
          <description>Time to extubation was measured from the time sevoflurane administration had stopped until tracheal extubation or laryngeal mask airway (LMA) removal occurred.</description>
          <population>All participants who received study drug and with available data.</population>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3981"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.28" spread="13.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cost of Anesthetics Including Sevoflurane (Yuan Renminbi [RMB]/Hour)</title>
        <description>Cost of anesthetics is the sum of the cost of sevoflurane and other anesthetics including narcotics and muscle relaxants. Cost of sevoflurane = unit price of sevoflurane multiplied by the used volume of sevoflurane. Cost of other anesthetics = unit price of anesthetics multiplied by the total volume of anesthetics in the ampoule.</description>
        <time_frame>Anesthetic duration between 1 to 5 hours</time_frame>
        <population>All participants who received study drug and with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Chinese Patients Requiring Surgery With Sevoflurane Anesthesia</title>
            <description>Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China</description>
          </group>
        </group_list>
        <measure>
          <title>Cost of Anesthetics Including Sevoflurane (Yuan Renminbi [RMB]/Hour)</title>
          <description>Cost of anesthetics is the sum of the cost of sevoflurane and other anesthetics including narcotics and muscle relaxants. Cost of sevoflurane = unit price of sevoflurane multiplied by the used volume of sevoflurane. Cost of other anesthetics = unit price of anesthetics multiplied by the total volume of anesthetics in the ampoule.</description>
          <population>All participants who received study drug and with available data.</population>
          <units>Yuan renminbi [RMB]/hour</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3874"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="249.79" spread="168.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Non-compliance of Sevoflurane End Tidal Concentration Following the Consensus</title>
        <description>Non-compliance of sevoflurane end tidal concentration was defined as the percentage of time points for the maintenance period (excluding washout phase) that were below the sevoflurane end tidal concentration boundary of 0.6 minimal alveolar concentration (MAC) based on the Consensus. A higher percentage indicates a higher degree of non-compliance.</description>
        <time_frame>During maintenance (up to 5 hours)</time_frame>
        <population>All participants who received study drug and with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Chinese Patients Requiring Surgery With Sevoflurane Anesthesia</title>
            <description>Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China</description>
          </group>
        </group_list>
        <measure>
          <title>Non-compliance of Sevoflurane End Tidal Concentration Following the Consensus</title>
          <description>Non-compliance of sevoflurane end tidal concentration was defined as the percentage of time points for the maintenance period (excluding washout phase) that were below the sevoflurane end tidal concentration boundary of 0.6 minimal alveolar concentration (MAC) based on the Consensus. A higher percentage indicates a higher degree of non-compliance.</description>
          <population>All participants who received study drug and with available data.</population>
          <units>percentage of timepoints</units>
          <param>Number</param>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3941"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Timepoints for Maintenance Period</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44374"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Non-compliance of Sevoflurane Vaporizer Setting Following the Consensus</title>
        <description>Non-compliance of sevoflurane vaporizer setting was defined as the percentage of time points for the maintenance period outside the range of 1.0 - 1.5 minimal alveolar concentration (MAC) during the maintenance period (excluding washout phase) based on the Consensus. A higher percentage indicates a higher degree of non-compliance.</description>
        <time_frame>During maintenance (up to 5 hours)</time_frame>
        <population>All participants who received study drug and with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Chinese Patients Requiring Surgery With Sevoflurane Anesthesia</title>
            <description>Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China</description>
          </group>
        </group_list>
        <measure>
          <title>Non-compliance of Sevoflurane Vaporizer Setting Following the Consensus</title>
          <description>Non-compliance of sevoflurane vaporizer setting was defined as the percentage of time points for the maintenance period outside the range of 1.0 - 1.5 minimal alveolar concentration (MAC) during the maintenance period (excluding washout phase) based on the Consensus. A higher percentage indicates a higher degree of non-compliance.</description>
          <population>All participants who received study drug and with available data.</population>
          <units>percentage of timepoints</units>
          <param>Number</param>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3972"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Timepoints During Maintenance</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54454"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>All serious adverse events (SAEs) were required to be collected in the registry from the time the physician obtained the participant's informed consent until 30 days following treatment (approximately 31 days).</time_frame>
      <desc>Spontaneous adverse events (AEs) were also to be collected from the time the physician obtained the participant's informed consent until 30 days following treatment (total of approximately 31 days); there were no spontaneously reported AEs from the registry.</desc>
      <group_list>
        <group group_id="E1">
          <title>Chinese Patients Requiring Surgery With Sevoflurane Anesthesia</title>
          <description>Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4004"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4004"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Global Medical Services</name_or_title>
      <organization>AbbVie (prior sponsor, Abbott)</organization>
      <phone>800-633-9110</phone>
    </point_of_contact>
  </clinical_results>
</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/NCT01715857
org study id: P13-934
nct id: NCT01715857
lead sponsor: 
Until recently, there was a lack of understanding and consensus among Chinese
      anesthesiologists how they should practice general anesthesia with volatile anesthetics,
      since there was no standard of inhalation practice. In August 2011, the Anesthesiology branch
      of the Chinese Medical Association launched the first version of Chinese Consensus of
      Standard Clinical Practice for Inhalation Anesthesia (Consensus) in order to standardize the
      practice in China.

      The proposed registry is aimed to evaluate the current inhalation practice one year after the
      Consensus has been released, and related patient outcome. This registry evaluated sevoflurane
      anesthesia, including screening, induction, maintenance, emergence, and follow-up within 24
      hours post-operation.
observational model: Case-Only
time perspective: Prospective
measure: Anesthesiologist Satisfaction With the Anesthesia Using a Numeric Analog Scale (NAS)
time frame: End of surgery
description: Anesthesiologist satisfaction with the anesthesia was recorded by the anesthesiologist at the end of the operation using a NAS from 0 (not satisfied at all) to 10 (completely satisfied). The satisfaction of induction, maintenance, and emergence accounts for 20%, 50%, and 30% of the score, respectively.
measure: Participant Satisfaction With the Anesthesia Using a Numeric Analog Scale (NAS)
time frame: 24 hours after end of surgery
description: Participant satisfaction with the anesthesia recorded approximately 24 hours after the end of the operation using a NAS from 0 (not satisfied at all) to 10 (completely satisfied).
measure: Time to Eye Opening
time frame: From cessation of sevoflurane administration until the participant opened their eyes, up to 80 minutes
description: After cessation of anesthesia, the investigators lightly tapped on the participant's forehead or shoulder and asked the participant to open their eyes. This process was repeated approximately every minute until eye opening occurred.
measure: Time to Extubation
time frame: From cessation of sevoflurane administration until tracheal extubation occurred, up to 80 minutes
description: Time to extubation was measured from the time sevoflurane administration had stopped until tracheal extubation or laryngeal mask airway (LMA) removal occurred.
measure: Cost of Anesthetics Including Sevoflurane (Yuan Renminbi [RMB]/Hour)
time frame: Anesthetic duration between 1 to 5 hours
description: Cost of anesthetics is the sum of the cost of sevoflurane and other anesthetics including narcotics and muscle relaxants. Cost of sevoflurane = unit price of sevoflurane multiplied by the used volume of sevoflurane. Cost of other anesthetics = unit price of anesthetics multiplied by the total volume of anesthetics in the ampoule.
measure: Non-compliance of Sevoflurane End Tidal Concentration Following the Consensus
time frame: During maintenance (up to 5 hours)
description: Non-compliance of sevoflurane end tidal concentration was defined as the percentage of time points for the maintenance period (excluding washout phase) that were below the sevoflurane end tidal concentration boundary of 0.6 minimal alveolar concentration (MAC) based on the Consensus. A higher percentage indicates a higher degree of non-compliance.
measure: Non-compliance of Sevoflurane Vaporizer Setting Following the Consensus
time frame: During maintenance (up to 5 hours)
description: Non-compliance of sevoflurane vaporizer setting was defined as the percentage of time points for the maintenance period outside the range of 1.0 - 1.5 minimal alveolar concentration (MAC) during the maintenance period (excluding washout phase) based on the Consensus. A higher percentage indicates a higher degree of non-compliance.
arm group label: Chinese Patients Requiring Surgery with Sevoflurane Anesthesia
description: Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Yue Kang, MD
role: Study Director
affiliation: AbbVie
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country: China
url: http://rxabbvie.com
description: Related Info
responsible party type: Sponsor
mesh term: Respiratory Aspiration
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 