<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/NCT01690338</url>
  </required_header>
  <id_info>
    <org_study_id>CSA-NMB-001</org_study_id>
    <nct_id>NCT01690338</nct_id>
  </id_info>
  <brief_title>A Study of Residual Curarization Incidence in China</brief_title>
  <official_title>A Perspective, Multicentre, Randomized，Blind Study of Residual Curarization Incidence in China</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University First Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ruijin Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>RenJi Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shanghai Zhongshan Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Affiliated Hospital of Guangzhou Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>West China Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Eastern Hepatobiliary Surgery Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Wuhan Union Hospital, China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Zhujiang Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Chinese PLA General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>First Affiliated Hospital, Sun Yat-Sen University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Affiliated Hospital of Zhengzhou University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tianjin Medical University General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Xiangya Hospital of Central South University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Central South University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>First Affiliated Hospital of Xinjiang Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>First Affiliated Hospital of Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>China Medical University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hebei Medical University Fourth Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tongji Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Peking University First Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the incidence of residual curarization in PACU and&#xD;
      relevant risk factors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the last twenty years, residual curarization in PACU (Post Anesthesia Care Unit) has&#xD;
      become a common problem in clinical practice and poses high risk to patients. The residual&#xD;
      curarization incidence of Neuromuscular blocking agents (NMBA) varies very much between&#xD;
      different studies. These differences indicates the necessity of further study. In China,&#xD;
      there is no common view of the harmfulness of residual curarization and its complications.&#xD;
      The consensus on the necessity of neuromuscular transmission monitoring and neuromuscular&#xD;
      blockade antagonist has not been reached yet. There is also no similar large-scale survey in&#xD;
      China. In this case, the investigators conduct this large scale multicentre study, which is&#xD;
      designed to learn the incidence of residual curarization and its complications. Further&#xD;
      analysis of risk factors will also been made. All these efforts are hoped to fill the data&#xD;
      gap and provide reliable evidences for rational use of NMBA.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2012</start_date>
  <completion_date type="Anticipated">December 2014</completion_date>
  <primary_completion_date type="Anticipated">October 2014</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>incidence of TOFr&lt;0.9</measure>
    <time_frame>From tracheal extubation to 1 minute after extubation</time_frame>
    <description>Once tracheal extubation is performed after the surgery is over, monitor the neuromuscular transmission function (TOF ratio) immediately.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of TOFr&lt;0.9</measure>
    <time_frame>One minute after arriving at PACU</time_frame>
    <description>When patients arrive at PACU(an expected average of 15 minutes after surgery is over), monitor the neuromuscular transmission function (TOF ratio) immediately</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of TOFr&lt;0.7</measure>
    <time_frame>From tracheal extubation to 1 minute after extubation</time_frame>
    <description>Once tracheal extubation is performed after the surgery is over, monitor the neuromuscular transmission function (TOF ratio) immediately.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of TOFr&lt;0.7</measure>
    <time_frame>One minute after arriving at PACU</time_frame>
    <description>When patients arrive at PACU(an expected average of 15 minutes after surgery is over), monitor the neuromuscular transmission function (TOF ratio) immediately</description>
  </secondary_outcome>
  <other_outcome>
    <measure>any sign of residual curarization (listed in description below)</measure>
    <time_frame>First 24h after surgery</time_frame>
    <description>Sign of residual curarization :&#xD;
dyspnea&#xD;
weak hand-grip force&#xD;
Head lift or leg lift time shorter than 5s&#xD;
aspiration&#xD;
respiratory rate &gt;20/min&#xD;
hypoxemia (SpO2&lt;90% when O2&gt;3L/min)</description>
  </other_outcome>
  <other_outcome>
    <measure>pulmonary complications (See description)</measure>
    <time_frame>participants will be followed for the duration of hospital stay, an expected average of one week</time_frame>
    <description>pulmonary complications&#xD;
pneumonia&#xD;
pulmonary atelectasis&#xD;
mechanical ventilation required</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">6090</enrollment>
  <condition>Perioperative/Postoperative Complications</condition>
  <condition>PORC (Postoperative Residual Curarization)</condition>
  <arm_group>
    <arm_group_label>Vecuronium Bromide</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients who will be performed general anesthesia and tracheal intubation. Vecuronium will be used during surgery and tracheal extubation is scheduled when surgery is over.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>cisatracurium</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients who will be performed general anesthesia and tracheal intubation. Cisatracurium will be used during surgery and tracheal extubation is scheduled when surgery is over.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>rocuronium</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients who will be performed general anesthesia and tracheal intubation. Rocuronium will be used during surgery and tracheal extubation is scheduled when surgery is over.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vecuronium Bromide</intervention_name>
    <description>Administrative protocol of Vecuronium Bromide is determined by each caregiver's clinical experience.</description>
    <arm_group_label>Vecuronium Bromide</arm_group_label>
    <other_name>Norcuron</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rocuronium</intervention_name>
    <description>Administrative protocol of rocuronium is determined by each caregiver's clinical experience.</description>
    <arm_group_label>rocuronium</arm_group_label>
    <other_name>Esmeron</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cisatracurium</intervention_name>
    <description>Administrative protocol of cisatracurium is determined by each caregiver's clinical experience</description>
    <arm_group_label>cisatracurium</arm_group_label>
    <other_name>Nimbex</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 18 or older&#xD;
&#xD;
          -  Nondepolarized NMBA will be given during surgery and tracheal extubation will be&#xD;
             performed after surgery&#xD;
&#xD;
          -  Willing to comply with all study procedures and provide signed and dated informed&#xD;
             consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergic reaction to gel electrode&#xD;
&#xD;
          -  Neuromuscular disorders and hepatic or renal dysfunction&#xD;
&#xD;
          -  Scheduled to receive mechanical ventilation therapy&#xD;
&#xD;
          -  Involved in other clinical trials&#xD;
&#xD;
          -  Body position and surgical procedure affecting TOF-Watch SX normal function&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xinmin Wu, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking University First Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xinmin Wu, Doctor</last_name>
    <phone>+86 13910616740</phone>
    <email>xmwu2784@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Chinese PLA General Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Weidong Mi, Doctor</last_name>
      <phone>+86 13381082966</phone>
      <email>wwdd1962@yahoo.com.cn</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jing Zhao, Doctor</last_name>
      <phone>+86 13901048114</phone>
      <email>Zhaojing1009@yahoo.com.cn</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Peking University First Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100034</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yuan Zeng, Doctor</last_name>
      <phone>+86 13520703600</phone>
      <email>yuan_zeng@sina.com</email>
    </contact>
    <investigator>
      <last_name>Yuan Zeng, Doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>First Affiliated Hospital, Sun Yat-Sen University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wenqi Huang, Doctor</last_name>
      <phone>+86 13802963182</phone>
      <email>huangwenqi86@yahoo.com.cn</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Guangzhou Medical University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Qinglong Dong, Doctor</last_name>
      <phone>13602837397</phone>
      <email>qldong@163.net</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Zhujiang Hospital Southern Medical University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shiyuan Xu, Doctor</last_name>
      <phone>+86 13609727860</phone>
      <email>xushiyuan355@yahoo.com.cn</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hebei Medical University Fourth Hospital</name>
      <address>
        <city>Shijiazhuang</city>
        <state>Hebei</state>
        <zip>050000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zixian Song, Doctor</last_name>
      <phone>+86 13400312688</phone>
      <email>zixiansong@126.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Zhengzhou University</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wei Zhang, Doctor</last_name>
      <phone>+86 13673996966</phone>
      <email>Zhangw571012@126.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Tongji Hospital, Tongji Medical College of HUST</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ailin Luo, Doctor</last_name>
      <phone>+86 13507122565</phone>
      <email>ailinluo@yahoo.cn</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Qingping Wu, Doctor</last_name>
      <phone>+86 13971605283</phone>
      <email>Wqp1968@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Second Xiangya Hospital of Central South University</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Junmei Xu, Doctor</last_name>
      <phone>+86 13975148864</phone>
      <email>13975148864@139.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Xiangya Hospital of Central South University</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Qulian Guo, Doctor</last_name>
      <phone>+86 13707315866</phone>
      <email>qulianguo@hotmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>China Medical University Hospital</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <zip>110000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hong Ma, Doctor</last_name>
      <phone>+86 13840366406</phone>
      <email>mahong5466@yahoo.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Eastern Hepatobiliary Surgery Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Weifeng Yu, Doctor</last_name>
      <phone>+86 13901961704</phone>
      <email>Ywf808@yeah.net</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>RenJi Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiangrui Wang, Doctor</last_name>
      <phone>13701901953</phone>
      <email>xiangrui68@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ruijin Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Qingsheng Xue, Doctor</last_name>
      <phone>+86 13611909814</phone>
      <email>xueqingsheng@yahoo.com.cn</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shanghai First People's Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yingtian Wang, Doctor</last_name>
      <phone>+86 13386259639</phone>
      <email>wang_didi26@yahoo.com.cn</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shanghai Zhongshan Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhanggang Xue, Doctor</last_name>
      <phone>13601914601</phone>
      <email>xuezgang@yahoo.com.cn</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>West China Hospital, Sichuan University</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bin Liu, Doctor</last_name>
      <phone>+86 13808186401</phone>
      <email>benbinliu@yahoo.com.cn</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Tianjin Medical University General Hospital</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Guolin Wang, Doctor</last_name>
      <phone>+86 15822855556</phone>
      <email>wang_guolin@hotmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>The First Teaching Hospital of Xinjiang Medical University</name>
      <address>
        <city>Urumchi</city>
        <state>Xinjiang</state>
        <zip>830000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital Of College of Medicine, Zhejiang University</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shenmei Zhu, Doctor</last_name>
      <phone>13857169801</phone>
      <email>smzhu20088@yahoo.com.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Cammu G, De Witte J, De Veylder J, Byttebier G, Vandeput D, Foubert L, Vandenbroucke G, Deloof T. Postoperative residual paralysis in outpatients versus inpatients. Anesth Analg. 2006 Feb;102(2):426-9. doi: 10.1213/01.ane.0000195543.61123.1f.</citation>
    <PMID>16428537</PMID>
  </reference>
  <reference>
    <citation>Naguib M, Kopman AF, Lien CA, Hunter JM, Lopez A, Brull SJ. A survey of current management of neuromuscular block in the United States and Europe. Anesth Analg. 2010 Jul;111(1):110-9. doi: 10.1213/ANE.0b013e3181c07428. Epub 2009 Nov 12.</citation>
    <PMID>19910616</PMID>
  </reference>
  <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>
  </reference>
  <reference>
    <citation>Hayes AH, Mirakhur RK, Breslin DS, Reid JE, McCourt KC. Postoperative residual block after intermediate-acting neuromuscular blocking drugs. Anaesthesia. 2001 Apr;56(4):312-8. doi: 10.1046/j.1365-2044.2001.01921.x.</citation>
    <PMID>11284816</PMID>
  </reference>
  <reference>
    <citation>Baillard C, Clec'h C, Catineau J, Salhi F, Gehan G, Cupa M, Samama CM. Postoperative residual neuromuscular block: a survey of management. Br J Anaesth. 2005 Nov;95(5):622-6. doi: 10.1093/bja/aei240. Epub 2005 Sep 23.</citation>
    <PMID>16183681</PMID>
  </reference>
  <reference>
    <citation>Cammu G, de Baerdemaeker L, den Blauwen N, de Mey JC, Struys M, Mortier E. Postoperative residual curarization with cisatracurium and rocuronium infusions. Eur J Anaesthesiol. 2002 Feb;19(2):129-34. doi: 10.1017/s0265021502000236.</citation>
    <PMID>11999596</PMID>
  </reference>
  <reference>
    <citation>Baillard C, Gehan G, Reboul-Marty J, Larmignat P, Samama CM, Cupa M. Residual curarization in the recovery room after vecuronium. Br J Anaesth. 2000 Mar;84(3):394-5. doi: 10.1093/oxfordjournals.bja.a013445.</citation>
    <PMID>10793602</PMID>
  </reference>
  <reference>
    <citation>Murphy GS, Szokol JW, Marymont JH, Franklin M, Avram MJ, Vender JS. Residual paralysis at the time of tracheal extubation. Anesth Analg. 2005 Jun;100(6):1840-1845. doi: 10.1213/01.ANE.0000151159.55655.CB.</citation>
    <PMID>15920224</PMID>
  </reference>
  <reference>
    <citation>Debaene B, Plaud B, Dilly MP, Donati F. Residual paralysis in the PACU after a single intubating dose of nondepolarizing muscle relaxant with an intermediate duration of action. Anesthesiology. 2003 May;98(5):1042-8. doi: 10.1097/00000542-200305000-00004.</citation>
    <PMID>12717123</PMID>
  </reference>
  <reference>
    <citation>Srivastava A, Hunter JM. Reversal of neuromuscular block. Br J Anaesth. 2009 Jul;103(1):115-29. doi: 10.1093/bja/aep093. Epub 2009 May 24. Erratum In: Br J Anaesth. 2009 Oct;103(4):622. Dosage error in article text.</citation>
    <PMID>19468024</PMID>
  </reference>
  <verification_date>May 2013</verification_date>
  <study_first_submitted>September 4, 2012</study_first_submitted>
  <study_first_submitted_qc>September 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <last_update_submitted>May 22, 2013</last_update_submitted>
  <last_update_submitted_qc>May 22, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 24, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking University First Hospital</investigator_affiliation>
    <investigator_full_name>Xinmin Wu</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>TOFr (train of four ratio)</keyword>
  <keyword>airway extubation</keyword>
  <keyword>PACU (postanesthesia care unit)</keyword>
  <keyword>PORC (postoperative residual curarization)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Postoperative Complications</mesh_term>
    <mesh_term>Delayed Emergence from Anesthesia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bromides</mesh_term>
    <mesh_term>Rocuronium</mesh_term>
    <mesh_term>Vecuronium Bromide</mesh_term>
    <mesh_term>Cisatracurium</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01690338
org study id: CSA-NMB-001
nct id: NCT01690338
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has dmc: Yes
The purpose of this study is to determine the incidence of residual curarization in PACU and
      relevant risk factors.
In the last twenty years, residual curarization in PACU (Post Anesthesia Care Unit) has
      become a common problem in clinical practice and poses high risk to patients. The residual
      curarization incidence of Neuromuscular blocking agents (NMBA) varies very much between
      different studies. These differences indicates the necessity of further study. In China,
      there is no common view of the harmfulness of residual curarization and its complications.
      The consensus on the necessity of neuromuscular transmission monitoring and neuromuscular
      blockade antagonist has not been reached yet. There is also no similar large-scale survey in
      China. In this case, the investigators conduct this large scale multicentre study, which is
      designed to learn the incidence of residual curarization and its complications. Further
      analysis of risk factors will also been made. All these efforts are hoped to fill the data
      gap and provide reliable evidences for rational use of NMBA.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: incidence of TOFr<0.9
time frame: From tracheal extubation to 1 minute after extubation
description: Once tracheal extubation is performed after the surgery is over, monitor the neuromuscular transmission function (TOF ratio) immediately.
measure: Incidence of TOFr<0.9
time frame: One minute after arriving at PACU
description: When patients arrive at PACU(an expected average of 15 minutes after surgery is over), monitor the neuromuscular transmission function (TOF ratio) immediately
measure: Incidence of TOFr<0.7
time frame: From tracheal extubation to 1 minute after extubation
description: Once tracheal extubation is performed after the surgery is over, monitor the neuromuscular transmission function (TOF ratio) immediately.
measure: Incidence of TOFr<0.7
time frame: One minute after arriving at PACU
description: When patients arrive at PACU(an expected average of 15 minutes after surgery is over), monitor the neuromuscular transmission function (TOF ratio) immediately
measure: any sign of residual curarization (listed in description below)
time frame: First 24h after surgery
description: Sign of residual curarization :
dyspnea
weak hand-grip force
Head lift or leg lift time shorter than 5s
aspiration
respiratory rate >20/min
hypoxemia (SpO2<90% when O2>3L/min)
measure: pulmonary complications (See description)
time frame: participants will be followed for the duration of hospital stay, an expected average of one week
description: pulmonary complications
pneumonia
pulmonary atelectasis
mechanical ventilation required
arm group label: Vecuronium Bromide
arm group type: Active Comparator
description: Patients who will be performed general anesthesia and tracheal intubation. Vecuronium will be used during surgery and tracheal extubation is scheduled when surgery is over.
arm group label: cisatracurium
arm group type: Active Comparator
description: Patients who will be performed general anesthesia and tracheal intubation. Cisatracurium will be used during surgery and tracheal extubation is scheduled when surgery is over.
arm group label: rocuronium
arm group type: Active Comparator
description: Patients who will be performed general anesthesia and tracheal intubation. Rocuronium will be used during surgery and tracheal extubation is scheduled when surgery is over.
intervention type: Drug
intervention name: Vecuronium Bromide
description: Administrative protocol of Vecuronium Bromide is determined by each caregiver's clinical experience.
arm group label: Vecuronium Bromide
other name: Norcuron
intervention type: Drug
intervention name: Rocuronium
description: Administrative protocol of rocuronium is determined by each caregiver's clinical experience.
arm group label: rocuronium
other name: Esmeron
intervention type: Drug
intervention name: Cisatracurium
description: Administrative protocol of cisatracurium is determined by each caregiver's clinical experience
arm group label: cisatracurium
other name: Nimbex
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Xinmin Wu, Doctor
role: Principal Investigator
affiliation: Peking University First Hospital
last name: Xinmin Wu, Doctor
phone: +86 13910616740
email: xmwu2784@hotmail.com
facility: 
status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Withdrawn
facility: 
status: Recruiting
contact: 
country: China
citation: Cammu G, De Witte J, De Veylder J, Byttebier G, Vandeput D, Foubert L, Vandenbroucke G, Deloof T. Postoperative residual paralysis in outpatients versus inpatients. Anesth Analg. 2006 Feb;102(2):426-9. doi: 10.1213/01.ane.0000195543.61123.1f.
PMID: 16428537
citation: Naguib M, Kopman AF, Lien CA, Hunter JM, Lopez A, Brull SJ. A survey of current management of neuromuscular block in the United States and Europe. Anesth Analg. 2010 Jul;111(1):110-9. doi: 10.1213/ANE.0b013e3181c07428. Epub 2009 Nov 12.
PMID: 19910616
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: Hayes AH, Mirakhur RK, Breslin DS, Reid JE, McCourt KC. Postoperative residual block after intermediate-acting neuromuscular blocking drugs. Anaesthesia. 2001 Apr;56(4):312-8. doi: 10.1046/j.1365-2044.2001.01921.x.
PMID: 11284816
citation: Baillard C, Clec'h C, Catineau J, Salhi F, Gehan G, Cupa M, Samama CM. Postoperative residual neuromuscular block: a survey of management. Br J Anaesth. 2005 Nov;95(5):622-6. doi: 10.1093/bja/aei240. Epub 2005 Sep 23.
PMID: 16183681
citation: Cammu G, de Baerdemaeker L, den Blauwen N, de Mey JC, Struys M, Mortier E. Postoperative residual curarization with cisatracurium and rocuronium infusions. Eur J Anaesthesiol. 2002 Feb;19(2):129-34. doi: 10.1017/s0265021502000236.
PMID: 11999596
citation: Baillard C, Gehan G, Reboul-Marty J, Larmignat P, Samama CM, Cupa M. Residual curarization in the recovery room after vecuronium. Br J Anaesth. 2000 Mar;84(3):394-5. doi: 10.1093/oxfordjournals.bja.a013445.
PMID: 10793602
citation: Murphy GS, Szokol JW, Marymont JH, Franklin M, Avram MJ, Vender JS. Residual paralysis at the time of tracheal extubation. Anesth Analg. 2005 Jun;100(6):1840-1845. doi: 10.1213/01.ANE.0000151159.55655.CB.
PMID: 15920224
citation: Debaene B, Plaud B, Dilly MP, Donati F. Residual paralysis in the PACU after a single intubating dose of nondepolarizing muscle relaxant with an intermediate duration of action. Anesthesiology. 2003 May;98(5):1042-8. doi: 10.1097/00000542-200305000-00004.
PMID: 12717123
citation: Srivastava A, Hunter JM. Reversal of neuromuscular block. Br J Anaesth. 2009 Jul;103(1):115-29. doi: 10.1093/bja/aep093. Epub 2009 May 24. Erratum In: Br J Anaesth. 2009 Oct;103(4):622. Dosage error in article text.
PMID: 19468024
responsible party type: Principal Investigator
investigator affiliation: Peking University First Hospital
investigator full name: Xinmin Wu
investigator title: Clinical Professor
mesh term: Postoperative Complications
mesh term: Delayed Emergence from Anesthesia
mesh term: Bromides
mesh term: Rocuronium
mesh term: Vecuronium Bromide
mesh term: Cisatracurium