<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/NCT03039543</url>
  </required_header>
  <id_info>
    <org_study_id>B-1701-378-006</org_study_id>
    <nct_id>NCT03039543</nct_id>
  </id_info>
  <brief_title>Neuromuscular Blockade During Transurethral Resection of Bladder Cancer</brief_title>
  <official_title>The Effect of Neuromuscular Blockade During Transurethral Resection of Bladder Cancer on Surgical Condition and Recovery Profiles : A Prospective, Randomized and Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Bundang Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>MSD Korea Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Seoul National University Bundang Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Transurethral resection of the bladder tumor (TURB) for bladder tumor excision is the&#xD;
      mainstream treatment. However, the beneficial effects of sugammadex after general anesthesia&#xD;
      for TURB have not been thoroughly evaluated. Investigators hypothesized that deep NMB and the&#xD;
      use of sugammadex as a reversal agent may be associated with better endoscopic surgical&#xD;
      condition and recovery profile compared with moderate NMB during TURB.&#xD;
&#xD;
      This study was designed to compare patients with deep neuromuscular blockade (NMB) with&#xD;
      moderate NMB during transurethral resection of the bladder tumor (TURB) in terms of surgical&#xD;
      condition and postoperative recovery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Transurethral resection of the bladder tumor (TURB) is the mainstream treatment of bladder&#xD;
      cancer. TURB may be performed under regional anesthesia or general anesthesia. During&#xD;
      regional anesthesia for TURB, obturator nerve block should be performed to prevent adductor&#xD;
      contraction and possible inadvertent bladder perforation. Additionally, some patients prefer&#xD;
      not to be conscious during the surgery and patients with spinal deformity or previous spinal&#xD;
      fusion surgery are prone to fail regional anesthesia. Therefore, general anesthesia with&#xD;
      neuromuscular blockade (NMB) is frequently conducted for patients with TURB.&#xD;
&#xD;
      During general anesthesia for TURB, NMB is needed for intubation and optimal endoscopic&#xD;
      surgical condition via obturator nerve block. TURB is a relatively short procedure but&#xD;
      patients with NMB usually need sufficient time to be reversed with the conventional NMB&#xD;
      reversal agents (anticholinesterases). Additionally, inadequate reversal from NMB may result&#xD;
      in respiratory complication during recovery. Sugammadex, a newer reversal agent, is a&#xD;
      selective relaxant-binding agent that allows for rapid reversal of rocuronium-induced NMB.&#xD;
      With the introduction of sugammadex, immediate reversal of deep NMB has become possible&#xD;
      without residual NMB.&#xD;
&#xD;
      Several previous studies evaluated the effect of NMB on surgical condition for relative short&#xD;
      surgeries such as laparoscopic cholecystectomy or laryngeal micro-surgery. They suggested&#xD;
      that deep NMB and reversal with sugammadex improved surgical condition without postop&#xD;
      respiratory complications. TURB is a urological endoscopic procedure performed in a narrow&#xD;
      bladder space but the beneficial effects of deep NMB with sugammadex reversal for TURB have&#xD;
      not been thoroughly evaluated. We hypothesized that deep NMB and the use of sugammadex as a&#xD;
      reversal agent may be associated with better endoscopic surgical condition compared with&#xD;
      moderate NMB during TURB. Therefore, this study was designed to compare deep NMB with&#xD;
      moderate NMB during TURB in terms of surgical condition and recovery profiles in patients&#xD;
      with general anesthesia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2017</start_date>
  <completion_date type="Actual">November 10, 2017</completion_date>
  <primary_completion_date type="Actual">November 10, 2017</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Attaining a 5 (Optimal) Surgical Condition Score</measure>
    <time_frame>immediately following the operation, an average of 5 minutes</time_frame>
    <description>5-point surgical condition scale was evaluated as follows.&#xD;
Extremely poor&#xD;
unable to work because of coughing or because of the inability to obtain a endoscopic view because of inadequate muscle relaxation. Additional neuromuscular blocking agents (NMB) must be given.&#xD;
Poor&#xD;
severely hampered by inadequate muscle relaxation with continuous muscle contractions, movements, or both with the hazard of tissue damage. Additional NMB is needed.&#xD;
Acceptable&#xD;
a wide endoscopic view but bladder contractions, movements, or both occur regularly causing some interference with the surgeon's work. There is the need for additional NMB to prevent deterioration.&#xD;
Good&#xD;
a wide endoscopic working field with sporadic muscle contractions, movements, or both. No immediate need for additional NMB unless there is the fear of deterioration.&#xD;
Optimal&#xD;
a wide endoscopic working field without any movement or contractions. No additional NMB is needed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of Postoperative Residual Curarization</measure>
    <time_frame>at the arrival of postoperative post-anesthesia care unit (PACU), an average of 5 minutes</time_frame>
    <description>the number of participant with Postoperative residual curarization (PORC, TOF ratio &lt; 0.9 )</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recovery Time (PACU Discharge)</measure>
    <time_frame>During PACU stay (An average of 15 minutes)</time_frame>
    <description>time needed to reach a modified Aldrete score of 9</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the Incidence of Desaturation</measure>
    <time_frame>During PACU stay (An average of 15 minutes)</time_frame>
    <description>Respiratory complication such as desaturation (SpO2 &lt; 90%) were recorded during PACU stay.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other Postoperative Adverse Events</measure>
    <time_frame>During PACU stay (An average of 15 minutes)</time_frame>
    <description>Pain, postoperative nausea and vomiting, dry mouth, Postoperative bladder discomfort</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">108</enrollment>
  <condition>Neuromuscular Blockade</condition>
  <arm_group>
    <arm_group_label>moderate neuromuscular blockade</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>During operation, intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2). Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>deep neuromuscular blockade</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>During operation, intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade. Patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rocuronium</intervention_name>
    <description>Intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2) neuromuscular blockade for patients with moderate neuromuscular blockade whereas intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade for patients with deep neuromuscular blockade.</description>
    <arm_group_label>deep neuromuscular blockade</arm_group_label>
    <arm_group_label>moderate neuromuscular blockade</arm_group_label>
    <other_name>Esmeron</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sugammadex</intervention_name>
    <description>Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2 and patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2.</description>
    <arm_group_label>deep neuromuscular blockade</arm_group_label>
    <arm_group_label>moderate neuromuscular blockade</arm_group_label>
    <other_name>Bridion</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged more than 18 years&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) physical status I and II&#xD;
&#xD;
          -  scheduled to undergo elective Transurethral resection of the bladder tumor (TURB)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of neuromuscular, renal, or hepatic disease&#xD;
&#xD;
          -  a body mass index (BMI) of &lt; 18.5 or &gt; C 30.0 kg/m2&#xD;
&#xD;
          -  treatment with drugs known to interfere with neuromuscular function&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Junghee Ryu, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Bundang Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam-si</city>
        <state>Gyeonggi-do</state>
        <zip>13620</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <results_reference>
    <citation>Koo BW, Oh AY, Seo KS, Han JW, Han HS, Yoon YS. Randomized Clinical Trial of Moderate Versus Deep Neuromuscular Block for Low-Pressure Pneumoperitoneum During Laparoscopic Cholecystectomy. World J Surg. 2016 Dec;40(12):2898-2903. doi: 10.1007/s00268-016-3633-8.</citation>
    <PMID>27405749</PMID>
  </results_reference>
  <results_reference>
    <citation>Naguib M, Kopman AF, Ensor JE. Neuromuscular monitoring and postoperative residual curarisation: a meta-analysis. Br J Anaesth. 2007 Mar;98(3):302-16. doi: 10.1093/bja/ael386.</citation>
    <PMID>17307778</PMID>
  </results_reference>
  <results_reference>
    <citation>Martini CH, Boon M, Bevers RF, Aarts LP, Dahan A. Evaluation of surgical conditions during laparoscopic surgery in patients with moderate vs deep neuromuscular block. Br J Anaesth. 2014 Mar;112(3):498-505. doi: 10.1093/bja/aet377. Epub 2013 Nov 15.</citation>
    <PMID>24240315</PMID>
  </results_reference>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>January 25, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <results_first_submitted>January 8, 2018</results_first_submitted>
  <results_first_submitted_qc>April 23, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">May 22, 2018</results_first_posted>
  <last_update_submitted>April 23, 2018</last_update_submitted>
  <last_update_submitted_qc>April 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 22, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Bundang Hospital</investigator_affiliation>
    <investigator_full_name>Junghee Ryu</investigator_full_name>
    <investigator_title>Associate professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Bladder Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rocuronium</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 15, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/43/NCT03039543/SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 15, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/43/NCT03039543/Prot_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Moderate Neuromuscular Blockade</title>
          <description>During operation, intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2). Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2.&#xD;
Rocuronium: Intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2) neuromuscular blockade for patients with moderate neuromuscular blockade whereas intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade for patients with deep neuromuscular blockade.&#xD;
Sugammadex: Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2 and patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2.</description>
        </group>
        <group group_id="P2">
          <title>Deep Neuromuscular Blockade</title>
          <description>During operation, intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade. Patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2.&#xD;
Rocuronium: Intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2) neuromuscular blockade for patients with moderate neuromuscular blockade whereas intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade for patients with deep neuromuscular blockade.&#xD;
Sugammadex: Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2 and patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 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="54"/>
                <participants group_id="P2" count="54"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="53"/>
                <participants group_id="P2" count="51"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Asian</population>
      <group_list>
        <group group_id="B1">
          <title>Moderate Neuromuscular Blockade</title>
          <description>During operation, intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2). Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2.&#xD;
Rocuronium: Intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2) neuromuscular blockade for patients with moderate neuromuscular blockade whereas intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade for patients with deep neuromuscular blockade.&#xD;
Sugammadex: Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2 and patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2.</description>
        </group>
        <group group_id="B2">
          <title>Deep Neuromuscular Blockade</title>
          <description>During operation, intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade. Patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2.&#xD;
Rocuronium: Intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2) neuromuscular blockade for patients with moderate neuromuscular blockade whereas intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade for patients with deep neuromuscular blockade.&#xD;
Sugammadex: Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2 and patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 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="53"/>
            <count group_id="B2" value="51"/>
            <count group_id="B3" value="104"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</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="53"/>
                    <count group_id="B2" value="51"/>
                    <count group_id="B3" value="104"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="48"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <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="53"/>
                    <count group_id="B2" value="51"/>
                    <count group_id="B3" value="104"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="70" spread="11"/>
                    <measurement group_id="B2" value="68" spread="10"/>
                    <measurement group_id="B3" value="69" spread="11"/>
                  </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="53"/>
                    <count group_id="B2" value="51"/>
                    <count group_id="B3" value="104"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="46"/>
                    <measurement group_id="B2" value="42"/>
                    <measurement group_id="B3" value="88"/>
                  </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>Count of Participants</param>
          <class_list>
            <class>
              <title>South Korea</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="53"/>
                    <count group_id="B2" value="51"/>
                    <count group_id="B3" value="104"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                    <measurement group_id="B2" value="51"/>
                    <measurement group_id="B3" value="104"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>operation time</title>
          <units>min</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="53"/>
                    <count group_id="B2" value="51"/>
                    <count group_id="B3" value="104"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23" spread="13"/>
                    <measurement group_id="B2" value="22" spread="13"/>
                    <measurement group_id="B3" value="23" spread="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Attaining a 5 (Optimal) Surgical Condition Score</title>
        <description>5-point surgical condition scale was evaluated as follows.&#xD;
Extremely poor&#xD;
unable to work because of coughing or because of the inability to obtain a endoscopic view because of inadequate muscle relaxation. Additional neuromuscular blocking agents (NMB) must be given.&#xD;
Poor&#xD;
severely hampered by inadequate muscle relaxation with continuous muscle contractions, movements, or both with the hazard of tissue damage. Additional NMB is needed.&#xD;
Acceptable&#xD;
a wide endoscopic view but bladder contractions, movements, or both occur regularly causing some interference with the surgeon's work. There is the need for additional NMB to prevent deterioration.&#xD;
Good&#xD;
a wide endoscopic working field with sporadic muscle contractions, movements, or both. No immediate need for additional NMB unless there is the fear of deterioration.&#xD;
Optimal&#xD;
a wide endoscopic working field without any movement or contractions. No additional NMB is needed.</description>
        <time_frame>immediately following the operation, an average of 5 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Moderate Neuromuscular Blockade</title>
            <description>During operation, intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2). Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2.&#xD;
Rocuronium: Intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2) neuromuscular blockade for patients with moderate neuromuscular blockade whereas intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade for patients with deep neuromuscular blockade.&#xD;
Sugammadex: Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2 and patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2.</description>
          </group>
          <group group_id="O2">
            <title>Deep Neuromuscular Blockade</title>
            <description>During operation, intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade. Patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2.&#xD;
Rocuronium: Intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2) neuromuscular blockade for patients with moderate neuromuscular blockade whereas intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade for patients with deep neuromuscular blockade.&#xD;
Sugammadex: Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2 and patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Attaining a 5 (Optimal) Surgical Condition Score</title>
          <description>5-point surgical condition scale was evaluated as follows.&#xD;
Extremely poor&#xD;
unable to work because of coughing or because of the inability to obtain a endoscopic view because of inadequate muscle relaxation. Additional neuromuscular blocking agents (NMB) must be given.&#xD;
Poor&#xD;
severely hampered by inadequate muscle relaxation with continuous muscle contractions, movements, or both with the hazard of tissue damage. Additional NMB is needed.&#xD;
Acceptable&#xD;
a wide endoscopic view but bladder contractions, movements, or both occur regularly causing some interference with the surgeon's work. There is the need for additional NMB to prevent deterioration.&#xD;
Good&#xD;
a wide endoscopic working field with sporadic muscle contractions, movements, or both. No immediate need for additional NMB unless there is the fear of deterioration.&#xD;
Optimal&#xD;
a wide endoscopic working field without any movement or contractions. No additional NMB is needed.</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="53"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence of Postoperative Residual Curarization</title>
        <description>the number of participant with Postoperative residual curarization (PORC, TOF ratio &lt; 0.9 )</description>
        <time_frame>at the arrival of postoperative post-anesthesia care unit (PACU), an average of 5 minutes</time_frame>
        <population>One patient in the moderate NMB group and 3 patients in the deep NMB group were excluded from the final analysis (1 in deep NMB group: unexpected co-operation; 1 in moderate NMB group and 2 in deep NMB group: did not maintain moderate or deep NMB)</population>
        <group_list>
          <group group_id="O1">
            <title>Moderate Neuromuscular Blockade</title>
            <description>During operation, intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2). Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2.&#xD;
Rocuronium: Intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2) neuromuscular blockade for patients with moderate neuromuscular blockade whereas intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade for patients with deep neuromuscular blockade.&#xD;
Sugammadex: Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2 and patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2.</description>
          </group>
          <group group_id="O2">
            <title>Deep Neuromuscular Blockade</title>
            <description>During operation, intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade. Patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2.&#xD;
Rocuronium: Intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2) neuromuscular blockade for patients with moderate neuromuscular blockade whereas intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade for patients with deep neuromuscular blockade.&#xD;
Sugammadex: Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2 and patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Postoperative Residual Curarization</title>
          <description>the number of participant with Postoperative residual curarization (PORC, TOF ratio &lt; 0.9 )</description>
          <population>One patient in the moderate NMB group and 3 patients in the deep NMB group were excluded from the final analysis (1 in deep NMB group: unexpected co-operation; 1 in moderate NMB group and 2 in deep NMB group: did not maintain moderate or deep NMB)</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Recovery Time (PACU Discharge)</title>
        <description>time needed to reach a modified Aldrete score of 9</description>
        <time_frame>During PACU stay (An average of 15 minutes)</time_frame>
        <population>One patient in the moderate NMB group and 3 patients in the deep NMB group were excluded from the final analysis (1 in deep NMB group: unexpected co-operation; 1 in moderate NMB group and 2 in deep NMB group: did not maintain moderate or deep NMB)</population>
        <group_list>
          <group group_id="O1">
            <title>Moderate Neuromuscular Blockade</title>
            <description>During operation, intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2). Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2.&#xD;
Rocuronium: Intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2) neuromuscular blockade for patients with moderate neuromuscular blockade whereas intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade for patients with deep neuromuscular blockade.&#xD;
Sugammadex: Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2 and patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2.</description>
          </group>
          <group group_id="O2">
            <title>Deep Neuromuscular Blockade</title>
            <description>During operation, intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade. Patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2.&#xD;
Rocuronium: Intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2) neuromuscular blockade for patients with moderate neuromuscular blockade whereas intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade for patients with deep neuromuscular blockade.&#xD;
Sugammadex: Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2 and patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Recovery Time (PACU Discharge)</title>
          <description>time needed to reach a modified Aldrete score of 9</description>
          <population>One patient in the moderate NMB group and 3 patients in the deep NMB group were excluded from the final analysis (1 in deep NMB group: unexpected co-operation; 1 in moderate NMB group and 2 in deep NMB group: did not maintain moderate or deep NMB)</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="53"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15" spread="0"/>
                    <measurement group_id="O2" value="15" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>the Incidence of Desaturation</title>
        <description>Respiratory complication such as desaturation (SpO2 &lt; 90%) were recorded during PACU stay.</description>
        <time_frame>During PACU stay (An average of 15 minutes)</time_frame>
        <population>One patient in the moderate NMB group and 3 patients in the deep NMB group were excluded from the final analysis (1 in deep NMB group: unexpected co-operation; 1 in moderate NMB group and 2 in deep NMB group: did not maintain moderate or deep NMB)</population>
        <group_list>
          <group group_id="O1">
            <title>Moderate Neuromuscular Blockade</title>
            <description>During operation, intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2). Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2.&#xD;
Rocuronium: Intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2) neuromuscular blockade for patients with moderate neuromuscular blockade whereas intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade for patients with deep neuromuscular blockade.&#xD;
Sugammadex: Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2 and patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2.</description>
          </group>
          <group group_id="O2">
            <title>Deep Neuromuscular Blockade</title>
            <description>During operation, intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade. Patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2.&#xD;
Rocuronium: Intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2) neuromuscular blockade for patients with moderate neuromuscular blockade whereas intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade for patients with deep neuromuscular blockade.&#xD;
Sugammadex: Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2 and patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2.</description>
          </group>
        </group_list>
        <measure>
          <title>the Incidence of Desaturation</title>
          <description>Respiratory complication such as desaturation (SpO2 &lt; 90%) were recorded during PACU stay.</description>
          <population>One patient in the moderate NMB group and 3 patients in the deep NMB group were excluded from the final analysis (1 in deep NMB group: unexpected co-operation; 1 in moderate NMB group and 2 in deep NMB group: did not maintain moderate or deep NMB)</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Other Postoperative Adverse Events</title>
        <description>Pain, postoperative nausea and vomiting, dry mouth, Postoperative bladder discomfort</description>
        <time_frame>During PACU stay (An average of 15 minutes)</time_frame>
        <population>One patient in the moderate NMB group and 3 patients in the deep NMB group were excluded from the final analysis (1 in deep NMB group: unexpected co-operation; 1 in moderate NMB group and 2 in deep NMB group: did not maintain moderate or deep NMB)</population>
        <group_list>
          <group group_id="O1">
            <title>Moderate Neuromuscular Blockade</title>
            <description>During operation, intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2). Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2.&#xD;
Rocuronium: Intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2) neuromuscular blockade for patients with moderate neuromuscular blockade whereas intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade for patients with deep neuromuscular blockade.&#xD;
Sugammadex: Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2 and patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2.</description>
          </group>
          <group group_id="O2">
            <title>Deep Neuromuscular Blockade</title>
            <description>During operation, intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade. Patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2.&#xD;
Rocuronium: Intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2) neuromuscular blockade for patients with moderate neuromuscular blockade whereas intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade for patients with deep neuromuscular blockade.&#xD;
Sugammadex: Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2 and patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Other Postoperative Adverse Events</title>
          <description>Pain, postoperative nausea and vomiting, dry mouth, Postoperative bladder discomfort</description>
          <population>One patient in the moderate NMB group and 3 patients in the deep NMB group were excluded from the final analysis (1 in deep NMB group: unexpected co-operation; 1 in moderate NMB group and 2 in deep NMB group: did not maintain moderate or deep NMB)</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>During study period (induction of anesthesia-PACU stay)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Moderate Neuromuscular Blockade</title>
          <description>During operation, intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2). Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2.&#xD;
Rocuronium: Intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2) neuromuscular blockade for patients with moderate neuromuscular blockade whereas intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade for patients with deep neuromuscular blockade.&#xD;
Sugammadex: Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2 and patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2.</description>
        </group>
        <group group_id="E2">
          <title>Deep Neuromuscular Blockade</title>
          <description>During operation, intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade. Patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2.&#xD;
Rocuronium: Intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2) neuromuscular blockade for patients with moderate neuromuscular blockade whereas intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade for patients with deep neuromuscular blockade.&#xD;
Sugammadex: Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2 and patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 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="53"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
              </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="53"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
              </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>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. Junghee Ryu, Associate Professor</name_or_title>
      <organization>Seoul National University Bundang Hospital</organization>
      <phone>82-31-787-7497</phone>
      <email>jinaryu74@gmail.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/NCT03039543
org study id: B-1701-378-006
nct id: NCT03039543
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
Transurethral resection of the bladder tumor (TURB) for bladder tumor excision is the
      mainstream treatment. However, the beneficial effects of sugammadex after general anesthesia
      for TURB have not been thoroughly evaluated. Investigators hypothesized that deep NMB and the
      use of sugammadex as a reversal agent may be associated with better endoscopic surgical
      condition and recovery profile compared with moderate NMB during TURB.

      This study was designed to compare patients with deep neuromuscular blockade (NMB) with
      moderate NMB during transurethral resection of the bladder tumor (TURB) in terms of surgical
      condition and postoperative recovery.
Transurethral resection of the bladder tumor (TURB) is the mainstream treatment of bladder
      cancer. TURB may be performed under regional anesthesia or general anesthesia. During
      regional anesthesia for TURB, obturator nerve block should be performed to prevent adductor
      contraction and possible inadvertent bladder perforation. Additionally, some patients prefer
      not to be conscious during the surgery and patients with spinal deformity or previous spinal
      fusion surgery are prone to fail regional anesthesia. Therefore, general anesthesia with
      neuromuscular blockade (NMB) is frequently conducted for patients with TURB.

      During general anesthesia for TURB, NMB is needed for intubation and optimal endoscopic
      surgical condition via obturator nerve block. TURB is a relatively short procedure but
      patients with NMB usually need sufficient time to be reversed with the conventional NMB
      reversal agents (anticholinesterases). Additionally, inadequate reversal from NMB may result
      in respiratory complication during recovery. Sugammadex, a newer reversal agent, is a
      selective relaxant-binding agent that allows for rapid reversal of rocuronium-induced NMB.
      With the introduction of sugammadex, immediate reversal of deep NMB has become possible
      without residual NMB.

      Several previous studies evaluated the effect of NMB on surgical condition for relative short
      surgeries such as laparoscopic cholecystectomy or laryngeal micro-surgery. They suggested
      that deep NMB and reversal with sugammadex improved surgical condition without postop
      respiratory complications. TURB is a urological endoscopic procedure performed in a narrow
      bladder space but the beneficial effects of deep NMB with sugammadex reversal for TURB have
      not been thoroughly evaluated. We hypothesized that deep NMB and the use of sugammadex as a
      reversal agent may be associated with better endoscopic surgical condition compared with
      moderate NMB during TURB. Therefore, this study was designed to compare deep NMB with
      moderate NMB during TURB in terms of surgical condition and recovery profiles in patients
      with general anesthesia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Number of Participants Attaining a 5 (Optimal) Surgical Condition Score
time frame: immediately following the operation, an average of 5 minutes
description: 5-point surgical condition scale was evaluated as follows.
Extremely poor
unable to work because of coughing or because of the inability to obtain a endoscopic view because of inadequate muscle relaxation. Additional neuromuscular blocking agents (NMB) must be given.
Poor
severely hampered by inadequate muscle relaxation with continuous muscle contractions, movements, or both with the hazard of tissue damage. Additional NMB is needed.
Acceptable
a wide endoscopic view but bladder contractions, movements, or both occur regularly causing some interference with the surgeon's work. There is the need for additional NMB to prevent deterioration.
Good
a wide endoscopic working field with sporadic muscle contractions, movements, or both. No immediate need for additional NMB unless there is the fear of deterioration.
Optimal
a wide endoscopic working field without any movement or contractions. No additional NMB is needed.
measure: Incidence of Postoperative Residual Curarization
time frame: at the arrival of postoperative post-anesthesia care unit (PACU), an average of 5 minutes
description: the number of participant with Postoperative residual curarization (PORC, TOF ratio < 0.9 )
measure: Recovery Time (PACU Discharge)
time frame: During PACU stay (An average of 15 minutes)
description: time needed to reach a modified Aldrete score of 9
measure: the Incidence of Desaturation
time frame: During PACU stay (An average of 15 minutes)
description: Respiratory complication such as desaturation (SpO2 < 90%) were recorded during PACU stay.
measure: Other Postoperative Adverse Events
time frame: During PACU stay (An average of 15 minutes)
description: Pain, postoperative nausea and vomiting, dry mouth, Postoperative bladder discomfort
arm group label: moderate neuromuscular blockade
arm group type: Active Comparator
description: During operation, intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2). Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2.
arm group label: deep neuromuscular blockade
arm group type: Experimental
description: During operation, intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade. Patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2.
intervention type: Drug
intervention name: Rocuronium
description: Intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2) neuromuscular blockade for patients with moderate neuromuscular blockade whereas intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade for patients with deep neuromuscular blockade.
arm group label: deep neuromuscular blockade
arm group label: moderate neuromuscular blockade
other name: Esmeron
intervention type: Drug
intervention name: Sugammadex
description: Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2 and patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2.
arm group label: deep neuromuscular blockade
arm group label: moderate neuromuscular blockade
other name: Bridion
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Junghee Ryu, MD, PhD
role: Principal Investigator
affiliation: Seoul National University Bundang Hospital
facility: 
country: Korea, Republic of
citation: Koo BW, Oh AY, Seo KS, Han JW, Han HS, Yoon YS. Randomized Clinical Trial of Moderate Versus Deep Neuromuscular Block for Low-Pressure Pneumoperitoneum During Laparoscopic Cholecystectomy. World J Surg. 2016 Dec;40(12):2898-2903. doi: 10.1007/s00268-016-3633-8.
PMID: 27405749
citation: Naguib M, Kopman AF, Ensor JE. Neuromuscular monitoring and postoperative residual curarisation: a meta-analysis. Br J Anaesth. 2007 Mar;98(3):302-16. doi: 10.1093/bja/ael386.
PMID: 17307778
citation: Martini CH, Boon M, Bevers RF, Aarts LP, Dahan A. Evaluation of surgical conditions during laparoscopic surgery in patients with moderate vs deep neuromuscular block. Br J Anaesth. 2014 Mar;112(3):498-505. doi: 10.1093/bja/aet377. Epub 2013 Nov 15.
PMID: 24240315
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Bundang Hospital
investigator full name: Junghee Ryu
investigator title: Associate professor
mesh term: Urinary Bladder Neoplasms
mesh term: Rocuronium
sharing ipd: Undecided
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