<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/NCT03782233</url>
  </required_header>
  <id_info>
    <org_study_id>He Huang</org_study_id>
    <nct_id>NCT03782233</nct_id>
  </id_info>
  <brief_title>Study on the Level of Neuromuscular Blockade</brief_title>
  <official_title>Effect to Gastrointestinal Barrier Function During Laparoscopic Gastrectomy With Deep vs Moderate Neuromuscular Blockade.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The First Affiliated Hospital with Nanjing Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Wu Jieping Medical Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The First Affiliated Hospital with Nanjing Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      On the basis of moderate pneumoperitoneum pressure(10 mmHg), this study evaluates the effect&#xD;
      of different level of neuromuscular blockade to gastrointestinal barrier function during&#xD;
      laparoscopic gastrectomy. 83 patients are randomized to 2 arms ,The patients in deep&#xD;
      neuromuscular blockade group（group D, PTC=1-2）will receive high dose rocuronium (0.5-0.6&#xD;
      mg/kg/h) ;While the patients in moderate neuromuscular blockade group（group M, TOF=1-2）will&#xD;
      receive moderate dose rocuronium (0.2-0.3 mg/kg/h)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">July 31, 2019</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Plasma Concentration of D-lactic Acid Before the Surgery</measure>
    <time_frame>1 day before the surgery</time_frame>
    <description>The level of D-lactic acid can indicate the damage to the gastrointestinal barrier .</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma Concentration of Diamine Oxidase (DAO) Before the Surgery</measure>
    <time_frame>1 day Before the Surgery</time_frame>
    <description>The level of DAO can indicate the damage to the gastrointestinal barrier .</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total Number of Operational Taxonomic Units (OUTs) of Intestinal Microbiota</measure>
    <time_frame>the first time of defecation after operation</time_frame>
    <description>Intestinal microbiota was analyzed by 16S rRNA sequencing. To be specific, first, DNA was extracted and quantified. Bacterial 16S rRNA genes of the V3-V4 region were amplified from extracted DNA using the barcoded primers (5'- CCTACGGRRBGCASCAGKVRVGAAT-3') and (5'- GGACTACNVGGGTWTCTAATCC-3'). PCR reactions were performed and the PCR mixture applied to the PCR amplifier. Then, the PCR products were checked for size and specificity by agarose gel electrophoresis and purified. Finally, high-throughput sequencing was performed using the Illumina MiSeq platform.&#xD;
The raw reads were filtered to remove low quality sequences and the filtered data were further merged into tags by FLASH(Version 1.2.7). Then the Uchime algorithm in Usearch software was applied to remove chimeric tags. Resulting tags for each sample were clustered into operational taxonomic units(OTUs) at the level of 97% similarity.&#xD;
Higher values represent a more abundant amount of bacteria in gut.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postoperative Exhaust Time</measure>
    <time_frame>It is calculated from the end of the operation to the time of exhaust.</time_frame>
    <description>It's a regular measurement to evaluate the function of gastrointestinal tract . It is calculated from the end of the operation to the time of exhaust.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma Concentration of D-lactic Acid 24 h After the Surgery</measure>
    <time_frame>24 h after the surgery</time_frame>
    <description>The level of D-lactic acid can indicate the damage to the gastrointestinal barrier .</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma Concentration of Diamine Oxidase (DAO) 24 h After the Surgery</measure>
    <time_frame>24 h after the Surgery</time_frame>
    <description>The level of DAO can indicate the damage to the gastrointestinal barrier .</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Relative Abundance of Intestinal Microbiota</measure>
    <time_frame>the first time of defecation after operation</time_frame>
    <description>Intestinal microbiota is one of the factors related to the recovery of intestinal function. It can be analyzed by 16S rRNA sequencing of the postoperative feces.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>16s rRNA Sequencing of Postoperative Feces</measure>
    <time_frame>the first time of defecation after operation</time_frame>
    <description>Alpha and Beta diversity; relative abundance of gut microbiota. Alpha diversity includes Chao 1 index, Shannon index, and Simpson index. A higher value of Chao 1 index corresponds to more abundant number of microbiota. A higher value of Shannon index corresponds to more abundance. And A higher value of Simpson index corresponds to less diversity.&#xD;
Bata diversity was assessed by PCoA analysis. A three dimensional scatter plot was presented to visualize the similarities and differences between the two groups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of Surgery</measure>
    <time_frame>From the first dose of anesthetic to the end of the surgery</time_frame>
    <description>Time from the first dose of anesthetic to the end of the surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgical Condition Scores Rated by Surgeons</measure>
    <time_frame>During operation, within 2 hours</time_frame>
    <description>evaluation of the surgical condition by 5 point scale: 5 points: optimal; 4 points: good; 3 points: acceptable; 2 points: poor; 1 point: extremely poor.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of CO2 Pneumoperitoneum</measure>
    <time_frame>from the beginning to the end of CO2 pneumoperitoneum</time_frame>
    <description>Time from the beginning to the end of CO2 pneumoperitoneum</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Postoperative Hospital Stay</measure>
    <time_frame>from the end of surgery to the time of being discharged from hospital</time_frame>
    <description>Duration from the day of surgery to the day the patient discharged from the hospital</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative VAS (12 h After Surgery, Rest State)</measure>
    <time_frame>12 h after surgery</time_frame>
    <description>VAS pain score: 0 - completely painless, 10 - unbearable pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative VAS (12 h After Surgery, Active State)</measure>
    <time_frame>12 h after surgery</time_frame>
    <description>VAS pain score: 0 - completely painless, 10 - unbearable pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative VAS (24 h After Surgery, Rest State)</measure>
    <time_frame>24 h after surgery</time_frame>
    <description>VAS pain score: 0 - completely painless, 10 - unbearable pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative VAS (24 h After Surgery, Active State)</measure>
    <time_frame>24 h after surgery</time_frame>
    <description>VAS pain score: 0 - completely painless, 10 - unbearable pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative VAS (48 h After Surgery, Rest State)</measure>
    <time_frame>48 h after surgery</time_frame>
    <description>VAS pain score: 0 - completely painless, 10 - unbearable pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative VAS (48 h After Surgery, Active State)</measure>
    <time_frame>48 h after surgery</time_frame>
    <description>VAS pain score: 0 - completely painless, 10 - unbearable pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgical Condition Scores Rated by Surgeons (Average Scores)</measure>
    <time_frame>during surgery</time_frame>
    <description>evaluation of the surgical condition by 5 point scale: 5 points: optimal; 4 points: good; 3 points: acceptable; 2 points: poor; 1 point: extremely poor.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">83</enrollment>
  <condition>Neuromuscular Blockade</condition>
  <arm_group>
    <arm_group_label>deep neuromuscular blockade group (Group D)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergoing elective laparoscopic surgery for gastrectomy will be randomized to receive deep neuromuscular blockade (post-tetanic count = 1-2) using high dose rocuronium.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>moderate neuromuscular blockade group (Group M)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients undergoing elective laparoscopic surgery for gastrectomy will be randomized to receive moderate neuromuscular blockade (train-of-four count = 1-2) using moderate dose rocuronium.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>A continuous intravenous infusion of 0.5-0.6 mg/kg/h Rocuronium Bromide Intravenous Solution (50 Mg/5 mL) to keep the target neuromuscular blockade (PTC = 1-2).</intervention_name>
    <description>50 patients undergoing laparoscopic gastrectomy surgery will be allocated to group D. A continuous intravenous infusion of 0.5-0.6 mg/kg/h rocuronium to keep the target neuromuscular blockade (PTC = 1-2).</description>
    <arm_group_label>deep neuromuscular blockade group (Group D)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>A continuous intravenous infusion of 0.2-0.3 mg/kg/h Rocuronium Bromide Intravenous Solution (50 Mg/5 mL) to keep the target neuromuscular blockade (TOF = 1-2).</intervention_name>
    <description>33 patients undergoing laparoscopic gastrectomy surgery will be allocated to group M. A continuous intravenous infusion of 0.2-0.3 mg/kg/h rocuronium to keep the target neuromuscular blockade (TOF = 1-2).</description>
    <arm_group_label>moderate neuromuscular blockade group (Group M)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age:40-80;&#xD;
&#xD;
          2. BMI &lt; 30kg/m2；&#xD;
&#xD;
          3. ASA classification:Ⅰ-Ⅲ；&#xD;
&#xD;
          4. Undergoing elective laparoscopic gastrectomy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Preoperative history of inflammatory intestinal diseases, intestinal flora disorders,&#xD;
             obstructive jaundice, intestinal obstruction, irritable bowel syndrome and other&#xD;
             digestive diseases;&#xD;
&#xD;
          2. Severe heart, lung, liver, kidney, brain and other diseases;&#xD;
&#xD;
          3. Serious infection, pancreatitis, burns, trauma, need a large dose, long-term use of&#xD;
             antibiotics before the operation;&#xD;
&#xD;
          4. A history of abdominal surgery;&#xD;
&#xD;
          5. Combined with gravis myasthenia, serious electrolyte disorders or neuromuscular&#xD;
             diseases.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The First Affiliated Hospital with Nanjing Medical University</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <results_first_submitted>July 26, 2020</results_first_submitted>
  <results_first_submitted_qc>September 1, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">September 24, 2020</results_first_posted>
  <last_update_submitted>September 1, 2020</last_update_submitted>
  <last_update_submitted_qc>September 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Neuromuscular Blockade</keyword>
  <keyword>Gastrointestinal Barrier Function</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bromides</mesh_term>
    <mesh_term>Pharmaceutical Solutions</mesh_term>
    <mesh_term>Rocuronium</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 5, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/33/NCT03782233/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 4, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/33/NCT03782233/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Deep Neuromuscular Blockade（Group D）</title>
          <description>50 patients undergoing laparoscopic gastrectomy surgery will be allocated to group D. A continuous intravenous infusion of 0.6 mg/kg/h rocuronium to keep the target neuromuscular blockade (PTC = 1-2).</description>
        </group>
        <group group_id="P2">
          <title>Moderate Neuromuscular Blockade (Group M)</title>
          <description>33 patients undergoing laparoscopic gastrectomy surgery will be allocated to group M. A continuous intravenous infusion of 0.2 mg/kg/h rocuronium to keep the target neuromuscular blockade (TOF = 1-2).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
                <participants group_id="P2" count="33"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="46"/>
                <participants group_id="P2" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Deep Neuromuscular Blockade（Group D）</title>
          <description>50 patients undergoing laparoscopic gastrectomy surgery will be allocated to group D. A continuous intravenous infusion of 0.6 mg/kg/h rocuronium to keep the target neuromuscular blockade (PTC = 1-2).</description>
        </group>
        <group group_id="B2">
          <title>Moderate Neuromuscular Blockade (Group M)</title>
          <description>33 patients undergoing laparoscopic gastrectomy surgery will be allocated to group M. A continuous intravenous infusion of 0.2 mg/kg/h rocuronium to keep the target neuromuscular blockade (TOF = 1-2).</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="46"/>
            <count group_id="B2" value="31"/>
            <count group_id="B3" value="77"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="46"/>
                    <count group_id="B2" value="31"/>
                    <count group_id="B3" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60.6" spread="10.8"/>
                    <measurement group_id="B2" value="60.0" spread="8.1"/>
                    <measurement group_id="B3" value="60.4" spread="9.8"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="46"/>
                    <count group_id="B2" value="31"/>
                    <count group_id="B3" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>China</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="46"/>
                    <count group_id="B2" value="31"/>
                    <count group_id="B3" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="46"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body mass index (BMI)</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="46"/>
                    <count group_id="B2" value="31"/>
                    <count group_id="B3" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23.6" spread="2.8"/>
                    <measurement group_id="B2" value="24.3" spread="2.7"/>
                    <measurement group_id="B3" value="23.92" spread="2.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Plasma Concentration of D-lactic Acid Before the Surgery</title>
        <description>The level of D-lactic acid can indicate the damage to the gastrointestinal barrier .</description>
        <time_frame>1 day before the surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Deep Neuromuscular Blockade（Group D）</title>
            <description>50 patients undergoing laparoscopic gastrectomy surgery will be allocated to group D. A continuous intravenous infusion of 0.6 mg/kg/h rocuronium to keep the target neuromuscular blockade (PTC = 1-2).</description>
          </group>
          <group group_id="O2">
            <title>Moderate Neuromuscular Blockade (Group M)</title>
            <description>33 patients undergoing laparoscopic gastrectomy surgery will be allocated to group M. A continuous intravenous infusion of 0.2 mg/kg/h rocuronium to keep the target neuromuscular blockade (TOF = 1-2).</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Concentration of D-lactic Acid Before the Surgery</title>
          <description>The level of D-lactic acid can indicate the damage to the gastrointestinal barrier .</description>
          <units>ng/ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1100.4" spread="156.6"/>
                    <measurement group_id="O2" value="1087.8" spread="146.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Plasma Concentration of Diamine Oxidase (DAO) Before the Surgery</title>
        <description>The level of DAO can indicate the damage to the gastrointestinal barrier .</description>
        <time_frame>1 day Before the Surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Deep Neuromuscular Blockade（Group D）</title>
            <description>50 patients undergoing laparoscopic gastrectomy surgery will be allocated to group D. A continuous intravenous infusion of 0.6 mg/kg/h rocuronium to keep the target neuromuscular blockade (PTC = 1-2).</description>
          </group>
          <group group_id="O2">
            <title>Moderate Neuromuscular Blockade (Group M)</title>
            <description>33 patients undergoing laparoscopic gastrectomy surgery will be allocated to group M. A continuous intravenous infusion of 0.2 mg/kg/h rocuronium to keep the target neuromuscular blockade (TOF = 1-2).</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Concentration of Diamine Oxidase (DAO) Before the Surgery</title>
          <description>The level of DAO can indicate the damage to the gastrointestinal barrier .</description>
          <units>U/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.5" spread="3.0"/>
                    <measurement group_id="O2" value="16.4" spread="3.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Total Number of Operational Taxonomic Units (OUTs) of Intestinal Microbiota</title>
        <description>Intestinal microbiota was analyzed by 16S rRNA sequencing. To be specific, first, DNA was extracted and quantified. Bacterial 16S rRNA genes of the V3-V4 region were amplified from extracted DNA using the barcoded primers (5'- CCTACGGRRBGCASCAGKVRVGAAT-3') and (5'- GGACTACNVGGGTWTCTAATCC-3'). PCR reactions were performed and the PCR mixture applied to the PCR amplifier. Then, the PCR products were checked for size and specificity by agarose gel electrophoresis and purified. Finally, high-throughput sequencing was performed using the Illumina MiSeq platform.&#xD;
The raw reads were filtered to remove low quality sequences and the filtered data were further merged into tags by FLASH(Version 1.2.7). Then the Uchime algorithm in Usearch software was applied to remove chimeric tags. Resulting tags for each sample were clustered into operational taxonomic units(OTUs) at the level of 97% similarity.&#xD;
Higher values represent a more abundant amount of bacteria in gut.</description>
        <time_frame>the first time of defecation after operation</time_frame>
        <population>There were only 8 patients in group D and 5 patients in group M defecating before discharged from hospital.</population>
        <group_list>
          <group group_id="O1">
            <title>Deep Neuromuscular Blockade（Group D）</title>
            <description>50 patients undergoing laparoscopic gastrectomy surgery will be allocated to group D. A continuous intravenous infusion of 0.6 mg/kg/h rocuronium to keep the target neuromuscular blockade (PTC = 1-2).</description>
          </group>
          <group group_id="O2">
            <title>Moderate Neuromuscular Blockade (Group M)</title>
            <description>33 patients undergoing laparoscopic gastrectomy surgery will be allocated to group M. A continuous intravenous infusion of 0.2 mg/kg/h rocuronium to keep the target neuromuscular blockade (TOF = 1-2).</description>
          </group>
        </group_list>
        <measure>
          <title>Total Number of Operational Taxonomic Units (OUTs) of Intestinal Microbiota</title>
          <description>Intestinal microbiota was analyzed by 16S rRNA sequencing. To be specific, first, DNA was extracted and quantified. Bacterial 16S rRNA genes of the V3-V4 region were amplified from extracted DNA using the barcoded primers (5'- CCTACGGRRBGCASCAGKVRVGAAT-3') and (5'- GGACTACNVGGGTWTCTAATCC-3'). PCR reactions were performed and the PCR mixture applied to the PCR amplifier. Then, the PCR products were checked for size and specificity by agarose gel electrophoresis and purified. Finally, high-throughput sequencing was performed using the Illumina MiSeq platform.&#xD;
The raw reads were filtered to remove low quality sequences and the filtered data were further merged into tags by FLASH(Version 1.2.7). Then the Uchime algorithm in Usearch software was applied to remove chimeric tags. Resulting tags for each sample were clustered into operational taxonomic units(OTUs) at the level of 97% similarity.&#xD;
Higher values represent a more abundant amount of bacteria in gut.</description>
          <population>There were only 8 patients in group D and 5 patients in group M defecating before discharged from hospital.</population>
          <units>units</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1695"/>
                    <measurement group_id="O2" value="1287"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Postoperative Exhaust Time</title>
        <description>It's a regular measurement to evaluate the function of gastrointestinal tract . It is calculated from the end of the operation to the time of exhaust.</description>
        <time_frame>It is calculated from the end of the operation to the time of exhaust.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Deep Neuromuscular Blockade（Group D）</title>
            <description>50 patients undergoing laparoscopic gastrectomy surgery will be allocated to group D. A continuous intravenous infusion of 0.6 mg/kg/h rocuronium to keep the target neuromuscular blockade (PTC = 1-2).</description>
          </group>
          <group group_id="O2">
            <title>Moderate Neuromuscular Blockade (Group M)</title>
            <description>33 patients undergoing laparoscopic gastrectomy surgery will be allocated to group M. A continuous intravenous infusion of 0.2 mg/kg/h rocuronium to keep the target neuromuscular blockade (TOF = 1-2).</description>
          </group>
        </group_list>
        <measure>
          <title>Postoperative Exhaust Time</title>
          <description>It's a regular measurement to evaluate the function of gastrointestinal tract . It is calculated from the end of the operation to the time of exhaust.</description>
          <units>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="46"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.9" spread="15.9"/>
                    <measurement group_id="O2" value="70.5" spread="26.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Plasma Concentration of D-lactic Acid 24 h After the Surgery</title>
        <description>The level of D-lactic acid can indicate the damage to the gastrointestinal barrier .</description>
        <time_frame>24 h after the surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Deep Neuromuscular Blockade（Group D）</title>
            <description>50 patients undergoing laparoscopic gastrectomy surgery will be allocated to group D. A continuous intravenous infusion of 0.6 mg/kg/h rocuronium to keep the target neuromuscular blockade (PTC = 1-2).</description>
          </group>
          <group group_id="O2">
            <title>Moderate Neuromuscular Blockade (Group M)</title>
            <description>33 patients undergoing laparoscopic gastrectomy surgery will be allocated to group M. A continuous intravenous infusion of 0.2 mg/kg/h rocuronium to keep the target neuromuscular blockade (TOF = 1-2).</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Concentration of D-lactic Acid 24 h After the Surgery</title>
          <description>The level of D-lactic acid can indicate the damage to the gastrointestinal barrier .</description>
          <units>ng/ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1230.7" spread="138.4"/>
                    <measurement group_id="O2" value="1297.5" spread="147.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Plasma Concentration of Diamine Oxidase (DAO) 24 h After the Surgery</title>
        <description>The level of DAO can indicate the damage to the gastrointestinal barrier .</description>
        <time_frame>24 h after the Surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Deep Neuromuscular Blockade（Group D）</title>
            <description>50 patients undergoing laparoscopic gastrectomy surgery will be allocated to group D. A continuous intravenous infusion of 0.6 mg/kg/h rocuronium to keep the target neuromuscular blockade (PTC = 1-2).</description>
          </group>
          <group group_id="O2">
            <title>Moderate Neuromuscular Blockade (Group M)</title>
            <description>33 patients undergoing laparoscopic gastrectomy surgery will be allocated to group M. A continuous intravenous infusion of 0.2 mg/kg/h rocuronium to keep the target neuromuscular blockade (TOF = 1-2).</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Concentration of Diamine Oxidase (DAO) 24 h After the Surgery</title>
          <description>The level of DAO can indicate the damage to the gastrointestinal barrier .</description>
          <units>U/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.1" spread="3.3"/>
                    <measurement group_id="O2" value="26.5" spread="4.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Relative Abundance of Intestinal Microbiota</title>
        <description>Intestinal microbiota is one of the factors related to the recovery of intestinal function. It can be analyzed by 16S rRNA sequencing of the postoperative feces.</description>
        <time_frame>the first time of defecation after operation</time_frame>
        <population>There were 8 patients group D and 5 patients in group M defecating before being discharged from the hospital.</population>
        <group_list>
          <group group_id="O1">
            <title>Deep Neuromuscular Blockade（Group D）</title>
            <description>50 patients undergoing laparoscopic gastrectomy surgery will be allocated to group D. A continuous intravenous infusion of 0.6 mg/kg/h rocuronium to keep the target neuromuscular blockade (PTC = 1-2).</description>
          </group>
          <group group_id="O2">
            <title>Moderate Neuromuscular Blockade (Group M)</title>
            <description>33 patients undergoing laparoscopic gastrectomy surgery will be allocated to group M. A continuous intravenous infusion of 0.2 mg/kg/h rocuronium to keep the target neuromuscular blockade (TOF = 1-2).</description>
          </group>
        </group_list>
        <measure>
          <title>Relative Abundance of Intestinal Microbiota</title>
          <description>Intestinal microbiota is one of the factors related to the recovery of intestinal function. It can be analyzed by 16S rRNA sequencing of the postoperative feces.</description>
          <population>There were 8 patients group D and 5 patients in group M defecating before being discharged from the hospital.</population>
          <units>percentage of all intestinal microbiota</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Class-Deltaproteobacteria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0010483424321" spread="0.00"/>
                    <measurement group_id="O2" value="0.0010483424321" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Class-Flavobacteriia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                    <measurement group_id="O2" value="0.000019780046" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Order-Desulfovibrionales</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0081493789065" spread="0"/>
                    <measurement group_id="O2" value="0.0010483424321" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Order-Flavobacteriales</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                    <measurement group_id="O2" value="0.00003956" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Family-[Tissierellaceae]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0021362449560" spread="0"/>
                    <measurement group_id="O2" value="0.0001186802753" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Family-Fusobacteriaceae</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0005340612390" spread="0"/>
                    <measurement group_id="O2" value="0.0196020254767" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Family-Desulfovibrionaceae</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0081493789065" spread="0"/>
                    <measurement group_id="O2" value="0.0010285623862" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Family-[Weeksellaceae]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                    <measurement group_id="O2" value="0.000019780046" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Genus-Blautia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0097021125088" spread="0"/>
                    <measurement group_id="O2" value="0.0024725057362" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Genus-Dialister</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0002175805047" spread="0"/>
                    <measurement group_id="O2" value="0.0042724899121" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Genus-Collinsella</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0024329456444" spread="0"/>
                    <measurement group_id="O2" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Genus-Fusobacterium</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0005340612390" spread="0"/>
                    <measurement group_id="O2" value="0.0196020254767" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Genus-Bilophila</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0050636917477" spread="0"/>
                    <measurement group_id="O2" value="0.0010087823403" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Genus-Aggregatibacter</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                    <measurement group_id="O2" value="0.0007120816520" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Genus-Megasphaera</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.000059340138" spread="0"/>
                    <measurement group_id="O2" value="0.0019780045889" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Genus-Neisseria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                    <measurement group_id="O2" value="0.000019780046" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Genus-Selenomonas</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                    <measurement group_id="O2" value="0.000039560092" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Genus-Roseburia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.000019780046" spread="0"/>
                    <measurement group_id="O2" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Genus-TG5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                    <measurement group_id="O2" value="0.000019780045" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>16s rRNA Sequencing of Postoperative Feces</title>
        <description>Alpha and Beta diversity; relative abundance of gut microbiota. Alpha diversity includes Chao 1 index, Shannon index, and Simpson index. A higher value of Chao 1 index corresponds to more abundant number of microbiota. A higher value of Shannon index corresponds to more abundance. And A higher value of Simpson index corresponds to less diversity.&#xD;
Bata diversity was assessed by PCoA analysis. A three dimensional scatter plot was presented to visualize the similarities and differences between the two groups.</description>
        <time_frame>the first time of defecation after operation</time_frame>
        <population>There were 8 patients group D and 5 patients in group M defecating before being discharged from the hospital. There are so much basic data about the 16s rRNA sequencing that we can not upload them. The amount of work was formidable. You may contact with me if necessary for all the sequencing data.</population>
        <group_list>
          <group group_id="O1">
            <title>Deep Neuromuscular Blockade Group (Group D)</title>
            <description>Patients undergoing elective laparoscopic surgery for gastrectomy will be randomized to receive deep neuromuscular blockade (post-tetanic count = 1-2) using high dose rocuronium.&#xD;
A continuous intravenous infusion of 0.5-0.6 mg/kg/h Rocuronium Bromide Intravenous Solution (50 Mg/5 mL) to keep the target neuromuscular blockade (PTC = 1-2).: 50 patients undergoing laparoscopic gastrectomy surgery will be allocated to group D. A continuous intravenous infusion of 0.5-0.6 mg/kg/h rocuronium to keep the target neuromuscular blockade (PTC = 1-2).</description>
          </group>
          <group group_id="O2">
            <title>Moderate Neuromuscular Blockade Group (Group M)</title>
            <description>Patients undergoing elective laparoscopic surgery for gastrectomy will be randomized to receive moderate neuromuscular blockade (train-of-four count = 1-2) using moderate dose rocuronium.&#xD;
A continuous intravenous infusion of 0.2-0.3 mg/kg/h Rocuronium Bromide Intravenous Solution (50 Mg/5 mL) to keep the target neuromuscular blockade (TOF = 1-2).: 33 patients undergoing laparoscopic gastrectomy surgery will be allocated to group M. A continuous intravenous infusion of 0.2-0.3 mg/kg/h rocuronium to keep the target neuromuscular blockade (TOF = 1-2).</description>
          </group>
        </group_list>
        <measure>
          <title>16s rRNA Sequencing of Postoperative Feces</title>
          <description>Alpha and Beta diversity; relative abundance of gut microbiota. Alpha diversity includes Chao 1 index, Shannon index, and Simpson index. A higher value of Chao 1 index corresponds to more abundant number of microbiota. A higher value of Shannon index corresponds to more abundance. And A higher value of Simpson index corresponds to less diversity.&#xD;
Bata diversity was assessed by PCoA analysis. A three dimensional scatter plot was presented to visualize the similarities and differences between the two groups.</description>
          <population>There were 8 patients group D and 5 patients in group M defecating before being discharged from the hospital. There are so much basic data about the 16s rRNA sequencing that we can not upload them. The amount of work was formidable. You may contact with me if necessary for all the sequencing data.</population>
          <units>score 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="8"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>alpha diversity - Chao1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="763.7" spread="183.7"/>
                    <measurement group_id="O2" value="599.3" spread="164.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>alpha diversity - Shannon index</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.93" spread="1.0"/>
                    <measurement group_id="O2" value="4.15" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>alpha diversity - Simpson index</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="0.07"/>
                    <measurement group_id="O2" value="0.83" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Surgery</title>
        <description>Time from the first dose of anesthetic to the end of the surgery</description>
        <time_frame>From the first dose of anesthetic to the end of the surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Deep Neuromuscular Blockade（Group D）</title>
            <description>50 patients undergoing laparoscopic gastrectomy surgery will be allocated to group D. A continuous intravenous infusion of 0.6 mg/kg/h rocuronium to keep the target neuromuscular blockade (PTC = 1-2).</description>
          </group>
          <group group_id="O2">
            <title>Moderate Neuromuscular Blockade (Group M)</title>
            <description>33 patients undergoing laparoscopic gastrectomy surgery will be allocated to group M. A continuous intravenous infusion of 0.2 mg/kg/h rocuronium to keep the target neuromuscular blockade (TOF = 1-2).</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Surgery</title>
          <description>Time from the first dose of anesthetic to the end of the surgery</description>
          <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="46"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="155.0" spread="34.2"/>
                    <measurement group_id="O2" value="174.6" spread="34.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Surgical Condition Scores Rated by Surgeons</title>
        <description>evaluation of the surgical condition by 5 point scale: 5 points: optimal; 4 points: good; 3 points: acceptable; 2 points: poor; 1 point: extremely poor.</description>
        <time_frame>During operation, within 2 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Deep Neuromuscular Blockade（Group D）</title>
            <description>50 patients undergoing laparoscopic gastrectomy surgery will be allocated to group D. A continuous intravenous infusion of 0.6 mg/kg/h rocuronium to keep the target neuromuscular blockade (PTC = 1-2).</description>
          </group>
          <group group_id="O2">
            <title>Moderate Neuromuscular Blockade (Group M)</title>
            <description>33 patients undergoing laparoscopic gastrectomy surgery will be allocated to group M. A continuous intravenous infusion of 0.2 mg/kg/h rocuronium to keep the target neuromuscular blockade (TOF = 1-2).</description>
          </group>
        </group_list>
        <measure>
          <title>Surgical Condition Scores Rated by Surgeons</title>
          <description>evaluation of the surgical condition by 5 point scale: 5 points: optimal; 4 points: good; 3 points: acceptable; 2 points: poor; 1 point: extremely poor.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>1 point</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2 points</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>3 points</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>4 points</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>5 points</title>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of CO2 Pneumoperitoneum</title>
        <description>Time from the beginning to the end of CO2 pneumoperitoneum</description>
        <time_frame>from the beginning to the end of CO2 pneumoperitoneum</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Deep Neuromuscular Blockade（Group D）</title>
            <description>50 patients undergoing laparoscopic gastrectomy surgery will be allocated to group D. A continuous intravenous infusion of 0.6 mg/kg/h rocuronium to keep the target neuromuscular blockade (PTC = 1-2).</description>
          </group>
          <group group_id="O2">
            <title>Moderate Neuromuscular Blockade (Group M)</title>
            <description>33 patients undergoing laparoscopic gastrectomy surgery will be allocated to group M. A continuous intravenous infusion of 0.2 mg/kg/h rocuronium to keep the target neuromuscular blockade (TOF = 1-2).</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of CO2 Pneumoperitoneum</title>
          <description>Time from the beginning to the end of CO2 pneumoperitoneum</description>
          <units>minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="132.3" spread="31.2"/>
                    <measurement group_id="O2" value="147.0" spread="34.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Postoperative Hospital Stay</title>
        <description>Duration from the day of surgery to the day the patient discharged from the hospital</description>
        <time_frame>from the end of surgery to the time of being discharged from hospital</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Deep Neuromuscular Blockade（Group D）</title>
            <description>50 patients undergoing laparoscopic gastrectomy surgery will be allocated to group D. A continuous intravenous infusion of 0.6 mg/kg/h rocuronium to keep the target neuromuscular blockade (PTC = 1-2).</description>
          </group>
          <group group_id="O2">
            <title>Moderate Neuromuscular Blockade (Group M)</title>
            <description>33 patients undergoing laparoscopic gastrectomy surgery will be allocated to group M. A continuous intravenous infusion of 0.2 mg/kg/h rocuronium to keep the target neuromuscular blockade (TOF = 1-2).</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Postoperative Hospital Stay</title>
          <description>Duration from the day of surgery to the day the patient discharged from the hospital</description>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.2" spread="4.0"/>
                    <measurement group_id="O2" value="9.1" spread="5.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Postoperative VAS (12 h After Surgery, Rest State)</title>
        <description>VAS pain score: 0 - completely painless, 10 - unbearable pain.</description>
        <time_frame>12 h after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Deep Neuromuscular Blockade（Group D）</title>
            <description>50 patients undergoing laparoscopic gastrectomy surgery will be allocated to group D. A continuous intravenous infusion of 0.6 mg/kg/h rocuronium to keep the target neuromuscular blockade (PTC = 1-2).</description>
          </group>
          <group group_id="O2">
            <title>Moderate Neuromuscular Blockade (Group M)</title>
            <description>33 patients undergoing laparoscopic gastrectomy surgery will be allocated to group M. A continuous intravenous infusion of 0.2 mg/kg/h rocuronium to keep the target neuromuscular blockade (TOF = 1-2).</description>
          </group>
        </group_list>
        <measure>
          <title>Postoperative VAS (12 h After Surgery, Rest State)</title>
          <description>VAS pain score: 0 - completely painless, 10 - unbearable pain.</description>
          <units>units 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="46"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2" spread="1.4"/>
                    <measurement group_id="O2" value="2.1" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Postoperative VAS (12 h After Surgery, Active State)</title>
        <description>VAS pain score: 0 - completely painless, 10 - unbearable pain.</description>
        <time_frame>12 h after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Deep Neuromuscular Blockade（Group D）</title>
            <description>50 patients undergoing laparoscopic gastrectomy surgery will be allocated to group D. A continuous intravenous infusion of 0.6 mg/kg/h rocuronium to keep the target neuromuscular blockade (PTC = 1-2).</description>
          </group>
          <group group_id="O2">
            <title>Moderate Neuromuscular Blockade (Group M)</title>
            <description>33 patients undergoing laparoscopic gastrectomy surgery will be allocated to group M. A continuous intravenous infusion of 0.2 mg/kg/h rocuronium to keep the target neuromuscular blockade (TOF = 1-2).</description>
          </group>
        </group_list>
        <measure>
          <title>Postoperative VAS (12 h After Surgery, Active State)</title>
          <description>VAS pain score: 0 - completely painless, 10 - unbearable pain.</description>
          <units>units 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="46"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6" spread="1.6"/>
                    <measurement group_id="O2" value="3.8" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Postoperative VAS (24 h After Surgery, Rest State)</title>
        <description>VAS pain score: 0 - completely painless, 10 - unbearable pain.</description>
        <time_frame>24 h after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Deep Neuromuscular Blockade（Group D）</title>
            <description>50 patients undergoing laparoscopic gastrectomy surgery will be allocated to group D. A continuous intravenous infusion of 0.6 mg/kg/h rocuronium to keep the target neuromuscular blockade (PTC = 1-2).</description>
          </group>
          <group group_id="O2">
            <title>Moderate Neuromuscular Blockade (Group M)</title>
            <description>33 patients undergoing laparoscopic gastrectomy surgery will be allocated to group M. A continuous intravenous infusion of 0.2 mg/kg/h rocuronium to keep the target neuromuscular blockade (TOF = 1-2).</description>
          </group>
        </group_list>
        <measure>
          <title>Postoperative VAS (24 h After Surgery, Rest State)</title>
          <description>VAS pain score: 0 - completely painless, 10 - unbearable pain.</description>
          <units>points</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3" spread="1.0"/>
                    <measurement group_id="O2" value="1.5" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Postoperative VAS (24 h After Surgery, Active State)</title>
        <description>VAS pain score: 0 - completely painless, 10 - unbearable pain.</description>
        <time_frame>24 h after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Deep Neuromuscular Blockade（Group D）</title>
            <description>50 patients undergoing laparoscopic gastrectomy surgery will be allocated to group D. A continuous intravenous infusion of 0.6 mg/kg/h rocuronium to keep the target neuromuscular blockade (PTC = 1-2).</description>
          </group>
          <group group_id="O2">
            <title>Moderate Neuromuscular Blockade (Group M)</title>
            <description>33 patients undergoing laparoscopic gastrectomy surgery will be allocated to group M. A continuous intravenous infusion of 0.2 mg/kg/h rocuronium to keep the target neuromuscular blockade (TOF = 1-2).</description>
          </group>
        </group_list>
        <measure>
          <title>Postoperative VAS (24 h After Surgery, Active State)</title>
          <description>VAS pain score: 0 - completely painless, 10 - unbearable pain.</description>
          <units>units 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="46"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7" spread="1.3"/>
                    <measurement group_id="O2" value="3.1" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Postoperative VAS (48 h After Surgery, Rest State)</title>
        <description>VAS pain score: 0 - completely painless, 10 - unbearable pain.</description>
        <time_frame>48 h after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Deep Neuromuscular Blockade（Group D）</title>
            <description>50 patients undergoing laparoscopic gastrectomy surgery will be allocated to group D. A continuous intravenous infusion of 0.6 mg/kg/h rocuronium to keep the target neuromuscular blockade (PTC = 1-2).</description>
          </group>
          <group group_id="O2">
            <title>Moderate Neuromuscular Blockade (Group M)</title>
            <description>33 patients undergoing laparoscopic gastrectomy surgery will be allocated to group M. A continuous intravenous infusion of 0.2 mg/kg/h rocuronium to keep the target neuromuscular blockade (TOF = 1-2).</description>
          </group>
        </group_list>
        <measure>
          <title>Postoperative VAS (48 h After Surgery, Rest State)</title>
          <description>VAS pain score: 0 - completely painless, 10 - unbearable pain.</description>
          <units>units 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="46"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" spread="0.8"/>
                    <measurement group_id="O2" value="0.7" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Postoperative VAS (48 h After Surgery, Active State)</title>
        <description>VAS pain score: 0 - completely painless, 10 - unbearable pain.</description>
        <time_frame>48 h after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Deep Neuromuscular Blockade（Group D）</title>
            <description>50 patients undergoing laparoscopic gastrectomy surgery will be allocated to group D. A continuous intravenous infusion of 0.6 mg/kg/h rocuronium to keep the target neuromuscular blockade (PTC = 1-2).</description>
          </group>
          <group group_id="O2">
            <title>Moderate Neuromuscular Blockade (Group M)</title>
            <description>33 patients undergoing laparoscopic gastrectomy surgery will be allocated to group M. A continuous intravenous infusion of 0.2 mg/kg/h rocuronium to keep the target neuromuscular blockade (TOF = 1-2).</description>
          </group>
        </group_list>
        <measure>
          <title>Postoperative VAS (48 h After Surgery, Active State)</title>
          <description>VAS pain score: 0 - completely painless, 10 - unbearable pain.</description>
          <units>units 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="46"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5" spread="1.1"/>
                    <measurement group_id="O2" value="1.5" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Surgical Condition Scores Rated by Surgeons (Average Scores)</title>
        <description>evaluation of the surgical condition by 5 point scale: 5 points: optimal; 4 points: good; 3 points: acceptable; 2 points: poor; 1 point: extremely poor.</description>
        <time_frame>during surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Deep Neuromuscular Blockade（Group D）</title>
            <description>50 patients undergoing laparoscopic gastrectomy surgery will be allocated to group D. A continuous intravenous infusion of 0.6 mg/kg/h rocuronium to keep the target neuromuscular blockade (PTC = 1-2).</description>
          </group>
          <group group_id="O2">
            <title>Moderate Neuromuscular Blockade (Group M)</title>
            <description>33 patients undergoing laparoscopic gastrectomy surgery will be allocated to group M. A continuous intravenous infusion of 0.2 mg/kg/h rocuronium to keep the target neuromuscular blockade (TOF = 1-2).</description>
          </group>
        </group_list>
        <measure>
          <title>Surgical Condition Scores Rated by Surgeons (Average Scores)</title>
          <description>evaluation of the surgical condition by 5 point scale: 5 points: optimal; 4 points: good; 3 points: acceptable; 2 points: poor; 1 point: extremely poor.</description>
          <units>units 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="46"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.6" spread="0.6"/>
                    <measurement group_id="O2" value="3.2" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>through study completion, an average of 2 weeks</time_frame>
      <desc>Our definitions are consistent with the clinicaltrials.gov.</desc>
      <group_list>
        <group group_id="E1">
          <title>Deep Neuromuscular Blockade（Group D）</title>
          <description>50 patients undergoing laparoscopic gastrectomy surgery will be allocated to group D. A continuous intravenous infusion of 0.6 mg/kg/h rocuronium to keep the target neuromuscular blockade (PTC = 1-2).</description>
        </group>
        <group group_id="E2">
          <title>Moderate Neuromuscular Blockade (Group M)</title>
          <description>33 patients undergoing laparoscopic gastrectomy surgery will be allocated to group M. A continuous intravenous infusion of 0.2 mg/kg/h rocuronium to keep the target neuromuscular blockade (TOF = 1-2).</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="77"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="77"/>
              </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="77"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="77"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. He Huang</name_or_title>
      <organization>The First Affiliated Hospital of Nanjing Medical University</organization>
      <phone>13852476684</phone>
      <email>hh19871117@126.com</email>
    </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/NCT03782233
org study id: He Huang
nct id: NCT03782233
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
On the basis of moderate pneumoperitoneum pressure(10 mmHg), this study evaluates the effect
      of different level of neuromuscular blockade to gastrointestinal barrier function during
      laparoscopic gastrectomy. 83 patients are randomized to 2 arms ,The patients in deep
      neuromuscular blockade group（group D, PTC=1-2）will receive high dose rocuronium (0.5-0.6
      mg/kg/h) ;While the patients in moderate neuromuscular blockade group（group M, TOF=1-2）will
      receive moderate dose rocuronium (0.2-0.3 mg/kg/h)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Plasma Concentration of D-lactic Acid Before the Surgery
time frame: 1 day before the surgery
description: The level of D-lactic acid can indicate the damage to the gastrointestinal barrier .
measure: Plasma Concentration of Diamine Oxidase (DAO) Before the Surgery
time frame: 1 day Before the Surgery
description: The level of DAO can indicate the damage to the gastrointestinal barrier .
measure: Total Number of Operational Taxonomic Units (OUTs) of Intestinal Microbiota
time frame: the first time of defecation after operation
description: Intestinal microbiota was analyzed by 16S rRNA sequencing. To be specific, first, DNA was extracted and quantified. Bacterial 16S rRNA genes of the V3-V4 region were amplified from extracted DNA using the barcoded primers (5'- CCTACGGRRBGCASCAGKVRVGAAT-3') and (5'- GGACTACNVGGGTWTCTAATCC-3'). PCR reactions were performed and the PCR mixture applied to the PCR amplifier. Then, the PCR products were checked for size and specificity by agarose gel electrophoresis and purified. Finally, high-throughput sequencing was performed using the Illumina MiSeq platform.
The raw reads were filtered to remove low quality sequences and the filtered data were further merged into tags by FLASH(Version 1.2.7). Then the Uchime algorithm in Usearch software was applied to remove chimeric tags. Resulting tags for each sample were clustered into operational taxonomic units(OTUs) at the level of 97% similarity.
Higher values represent a more abundant amount of bacteria in gut.
measure: Postoperative Exhaust Time
time frame: It is calculated from the end of the operation to the time of exhaust.
description: It's a regular measurement to evaluate the function of gastrointestinal tract . It is calculated from the end of the operation to the time of exhaust.
measure: Plasma Concentration of D-lactic Acid 24 h After the Surgery
time frame: 24 h after the surgery
description: The level of D-lactic acid can indicate the damage to the gastrointestinal barrier .
measure: Plasma Concentration of Diamine Oxidase (DAO) 24 h After the Surgery
time frame: 24 h after the Surgery
description: The level of DAO can indicate the damage to the gastrointestinal barrier .
measure: Relative Abundance of Intestinal Microbiota
time frame: the first time of defecation after operation
description: Intestinal microbiota is one of the factors related to the recovery of intestinal function. It can be analyzed by 16S rRNA sequencing of the postoperative feces.
measure: 16s rRNA Sequencing of Postoperative Feces
time frame: the first time of defecation after operation
description: Alpha and Beta diversity; relative abundance of gut microbiota. Alpha diversity includes Chao 1 index, Shannon index, and Simpson index. A higher value of Chao 1 index corresponds to more abundant number of microbiota. A higher value of Shannon index corresponds to more abundance. And A higher value of Simpson index corresponds to less diversity.
Bata diversity was assessed by PCoA analysis. A three dimensional scatter plot was presented to visualize the similarities and differences between the two groups.
measure: Duration of Surgery
time frame: From the first dose of anesthetic to the end of the surgery
description: Time from the first dose of anesthetic to the end of the surgery
measure: Surgical Condition Scores Rated by Surgeons
time frame: During operation, within 2 hours
description: evaluation of the surgical condition by 5 point scale: 5 points: optimal; 4 points: good; 3 points: acceptable; 2 points: poor; 1 point: extremely poor.
measure: Duration of CO2 Pneumoperitoneum
time frame: from the beginning to the end of CO2 pneumoperitoneum
description: Time from the beginning to the end of CO2 pneumoperitoneum
measure: Duration of Postoperative Hospital Stay
time frame: from the end of surgery to the time of being discharged from hospital
description: Duration from the day of surgery to the day the patient discharged from the hospital
measure: Postoperative VAS (12 h After Surgery, Rest State)
time frame: 12 h after surgery
description: VAS pain score: 0 - completely painless, 10 - unbearable pain.
measure: Postoperative VAS (12 h After Surgery, Active State)
time frame: 12 h after surgery
description: VAS pain score: 0 - completely painless, 10 - unbearable pain.
measure: Postoperative VAS (24 h After Surgery, Rest State)
time frame: 24 h after surgery
description: VAS pain score: 0 - completely painless, 10 - unbearable pain.
measure: Postoperative VAS (24 h After Surgery, Active State)
time frame: 24 h after surgery
description: VAS pain score: 0 - completely painless, 10 - unbearable pain.
measure: Postoperative VAS (48 h After Surgery, Rest State)
time frame: 48 h after surgery
description: VAS pain score: 0 - completely painless, 10 - unbearable pain.
measure: Postoperative VAS (48 h After Surgery, Active State)
time frame: 48 h after surgery
description: VAS pain score: 0 - completely painless, 10 - unbearable pain.
measure: Surgical Condition Scores Rated by Surgeons (Average Scores)
time frame: during surgery
description: evaluation of the surgical condition by 5 point scale: 5 points: optimal; 4 points: good; 3 points: acceptable; 2 points: poor; 1 point: extremely poor.
arm group label: deep neuromuscular blockade group (Group D)
arm group type: Experimental
description: Patients undergoing elective laparoscopic surgery for gastrectomy will be randomized to receive deep neuromuscular blockade (post-tetanic count = 1-2) using high dose rocuronium.
arm group label: moderate neuromuscular blockade group (Group M)
arm group type: Other
description: Patients undergoing elective laparoscopic surgery for gastrectomy will be randomized to receive moderate neuromuscular blockade (train-of-four count = 1-2) using moderate dose rocuronium.
intervention type: Drug
intervention name: A continuous intravenous infusion of 0.5-0.6 mg/kg/h Rocuronium Bromide Intravenous Solution (50 Mg/5 mL) to keep the target neuromuscular blockade (PTC = 1-2).
description: 50 patients undergoing laparoscopic gastrectomy surgery will be allocated to group D. A continuous intravenous infusion of 0.5-0.6 mg/kg/h rocuronium to keep the target neuromuscular blockade (PTC = 1-2).
arm group label: deep neuromuscular blockade group (Group D)
intervention type: Drug
intervention name: A continuous intravenous infusion of 0.2-0.3 mg/kg/h Rocuronium Bromide Intravenous Solution (50 Mg/5 mL) to keep the target neuromuscular blockade (TOF = 1-2).
description: 33 patients undergoing laparoscopic gastrectomy surgery will be allocated to group M. A continuous intravenous infusion of 0.2-0.3 mg/kg/h rocuronium to keep the target neuromuscular blockade (TOF = 1-2).
arm group label: moderate neuromuscular blockade group (Group M)
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor
mesh term: Bromides
mesh term: Pharmaceutical Solutions
mesh term: Rocuronium
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 