<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/NCT02226809</url>
  </required_header>
  <id_info>
    <org_study_id>CEO-BNM-2014-01</org_study_id>
    <nct_id>NCT02226809</nct_id>
  </id_info>
  <brief_title>Multi-center Study of Residual Neuromuscular Block Incidence in the Post-anesthesia Care Unit</brief_title>
  <acronym>ReCuSS</acronym>
  <official_title>Incidence of Residual Neuromuscular Block in Adult Patients in the Postanesthesia Care Unit. An Observational Cross-sectional Study of a Multicenter Cohort. The Residual Curarization in Spain Study (ReCuSS).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Valencia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>General University Hospital of Valencia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital General Universitario Gregorio Marañon</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Valencia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Residual neuromuscular block (RNMB) is frequent in the immediate postoperative period and is&#xD;
      a source of complications, mainly respiratory. The incidence is variable due to multiple&#xD;
      factors. In Spain the incidence is unknown.&#xD;
&#xD;
      The investigators hypothesize that a number of patients in the postanesthesia care unit&#xD;
      (PACU) present with RNMB after general anesthesia using intermediate action neuromuscular&#xD;
      block agents (NMBA).&#xD;
&#xD;
      The main objective is to know the incidence of RNMB in Spanish hospitals. Secondary&#xD;
      objectives are to observe the possible relationship with other pre- and intraoperative&#xD;
      factors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Residual neuromuscular block (RNMB) is frequent in the immediate postoperative period and is&#xD;
      a source of complications, mainly respiratory. This includes recovery delay or hospital&#xD;
      discharge delays, respiratory insufficiency or infections, unforeseen ICU admissions, and&#xD;
      prolonged ICU stays.&#xD;
&#xD;
      The incidence is variable due to multiple factors. Age, gender, surgery, NMBA type and doses,&#xD;
      temperature, medications, etc.&#xD;
&#xD;
      In several studies it has been found and incidence between 6-80%. Few studies have been&#xD;
      focused in evaluating the incidence in the whole country, as representing a global anesthesia&#xD;
      practice. In Spain the incidence is unknown.&#xD;
&#xD;
      The investigators hypothesize that a number of patients in the postanesthesia care unit&#xD;
      (PACU) present with RNMB after general anesthesia using intermediate action NMBA.&#xD;
&#xD;
      The main objective is to know the incidence of RNMB in Spanish hospitals, by means of an&#xD;
      observational cross-sectional multicenter study .&#xD;
&#xD;
      Secondary objectives are to observe the possible relationship with other pre- and&#xD;
      intraoperative factors.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">July 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Residual neuromuscular block incidence (TOFr&lt;0.9) measured by accelerometry in the PACU</measure>
    <time_frame>Upon arrival to the PACU. Single evaluation.</time_frame>
    <description>Patients operated on under general anesthesia including intermediate duration NMBA were evaluated by means of an accelerometer in the PACU immediately upon arrival. Train-of-four ratio (TOFr) is evaluated.&#xD;
The evaluator does'nt know the patient-related information, including intraoperative management.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Respiratory or airway postoperative complications in the PACU</measure>
    <time_frame>During PACU stay, an expected average of 4 hours</time_frame>
    <description>Evaluation of respiratory complications or events in the PACU (asking the anesthesiologist in charge or PACU medical record) to discharge to the ward.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Relationship of RNMB with preoperative patient related factors</measure>
    <time_frame>Upon patients arrival to the PACU</time_frame>
    <description>Analysis of the preoperative visit record and anesthesia record: ASA class, and patient's demographics and characteristics</description>
  </other_outcome>
  <other_outcome>
    <measure>Relationship of RNMB with intraoperative anesthesia-related factors</measure>
    <time_frame>Upon PACU arrival</time_frame>
    <description>anesthesiologist-in-charge experience, type of anesthesia, intraoperative drugs administered and doses, reversal drugs and doses.</description>
  </other_outcome>
  <other_outcome>
    <measure>Relationship of RNMB with surgery-related factors</measure>
    <time_frame>Upon PACU arrival</time_frame>
    <description>Relationship of RNMB with surgery related factors (surgical speciality, type of surgery -high risk vs low to intermedium risk, laparoscopic vs no laparoscopic-, duration), blood losses.</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">763</enrollment>
  <condition>Incomplete Reversal of Neuromuscular Block</condition>
  <condition>Postoperative Respiratory Complications</condition>
  <arm_group>
    <arm_group_label>General anesthesia</arm_group_label>
    <description>Evaluation of RNMB. Application of accelerometry to patients after general anesthesia receiving at least one intermediate action nondepolarizing neuromuscular blocking agent dose</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Accelerometry</intervention_name>
    <description>Application of TOF stimulus (40 mA, three to four times) and recording TOFr in the PACU</description>
    <arm_group_label>General anesthesia</arm_group_label>
    <other_name>TOF-Watch</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Surgical patients under general anesthesia&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients &gt;18 years-old&#xD;
&#xD;
          -  General anesthesia with non-depolarizing NMBA&#xD;
&#xD;
          -  Transferred extubated on spontaneous ventilation to the PACU&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologists physical status IV-V&#xD;
&#xD;
          -  emergency and cardiac surgery&#xD;
&#xD;
          -  patients unable to respond adequately at the moment of pre- or postoperative&#xD;
             evaluation (psychiatric diseases, excessive somnolence, agitation, etc.)&#xD;
&#xD;
          -  noncompensated diabetes mellitus or diabetic neuropathy&#xD;
&#xD;
          -  symptomatic severe hypothyroidism (or untreated), or scheduled for total thyroidectomy&#xD;
&#xD;
          -  chronic or acute renal insufficiency&#xD;
&#xD;
          -  severe hepatopathy (Child-Pugh B, C)&#xD;
&#xD;
          -  intraoperative blood transfusion &gt;3 blood units&#xD;
&#xD;
          -  intraoperative maintained arterial hypotension&#xD;
&#xD;
          -  arrival to the PACU intubated or with instrumented airway (including surgical)&#xD;
&#xD;
          -  pre- or perioperative drugs intake affecting the neuromuscular transmission&#xD;
&#xD;
          -  neuromuscular diseases affecting the physiology of the neuromuscular system&#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>Carlos L Errando, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Servicio de Anestesiologia. Consorcio Hospital General Universitario de Valencia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ignacio Garutti, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Servicio de Anestesiologia. Hospital Universitario Gregorio Marañon</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital General de Elda</name>
      <address>
        <city>Elda</city>
        <state>Alicante</state>
        <zip>03600</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Bellvitge</name>
      <address>
        <city>Badalona</city>
        <state>Barcelona</state>
        <zip>08907</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Germans Trias i Pujol</name>
      <address>
        <city>Badalona</city>
        <state>Barcelona</state>
        <zip>08916</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario Universitario</name>
      <address>
        <city>A Coruña</city>
        <state>Coruña</state>
        <zip>15006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Severo Ochoa</name>
      <address>
        <city>Leganés</city>
        <state>Madrid</state>
        <zip>28911</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Manacor</name>
      <address>
        <city>Manacor</city>
        <state>Palma de Mallorca</state>
        <zip>07500</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Xeral de Vigo</name>
      <address>
        <city>Vigo</city>
        <state>Pontevedra</state>
        <zip>36204</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Basurto</name>
      <address>
        <city>Basurto</city>
        <state>Vizcaya</state>
        <zip>48013</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinic Universitari</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General de Castellón</name>
      <address>
        <city>Castellón</city>
        <zip>12004</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Reina Sofía</name>
      <address>
        <city>Córdoba</city>
        <zip>14004</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen de las Nieves</name>
      <address>
        <city>Granada</city>
        <zip>18014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital San Pedro</name>
      <address>
        <city>Logroño</city>
        <zip>26006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Lucus Augusti</name>
      <address>
        <city>Lugo</city>
        <zip>27003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de la Princesa</name>
      <address>
        <city>Madrid</city>
        <zip>28006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario Gregorio Marañón</name>
      <address>
        <city>Madrid</city>
        <zip>28007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Ramón y Cajal</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Fundación Jiménez Díaz</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Son Espases</name>
      <address>
        <city>Palma de Mallorca</city>
        <zip>07010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Marqués de Valdecilla</name>
      <address>
        <city>Santander</city>
        <zip>39008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico Universitario de Valencia</name>
      <address>
        <city>Valencia</city>
        <zip>46010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Arnau de Vilanova</name>
      <address>
        <city>Valencia</city>
        <zip>46015</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Dr Peset</name>
      <address>
        <city>Valencia</city>
        <zip>46017</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Politécnico La Fe</name>
      <address>
        <city>Valencia</city>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Miguel Servet</name>
      <address>
        <city>Zaragoza</city>
        <zip>50009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 20, 2014</study_first_submitted>
  <study_first_submitted_qc>August 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2014</study_first_posted>
  <last_update_submitted>August 26, 2014</last_update_submitted>
  <last_update_submitted_qc>August 26, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 27, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>General University Hospital of Valencia</investigator_affiliation>
    <investigator_full_name>Carlos Luis Errando</investigator_full_name>
    <investigator_title>MD, PhD, staff anesthesiologist</investigator_title>
  </responsible_party>
  <keyword>Muscle relaxants</keyword>
  <keyword>Postoperative complications, respiratory</keyword>
  <keyword>General anesthesia</keyword>
  <keyword>Postanesthesia care unit</keyword>
  <keyword>Neuromuscular block reversal</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Delayed Emergence from Anesthesia</mesh_term>
  </condition_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/NCT02226809
org study id: CEO-BNM-2014-01
nct id: NCT02226809
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Residual neuromuscular block (RNMB) is frequent in the immediate postoperative period and is
      a source of complications, mainly respiratory. The incidence is variable due to multiple
      factors. In Spain the incidence is unknown.

      The investigators hypothesize that a number of patients in the postanesthesia care unit
      (PACU) present with RNMB after general anesthesia using intermediate action neuromuscular
      block agents (NMBA).

      The main objective is to know the incidence of RNMB in Spanish hospitals. Secondary
      objectives are to observe the possible relationship with other pre- and intraoperative
      factors.
Residual neuromuscular block (RNMB) is frequent in the immediate postoperative period and is
      a source of complications, mainly respiratory. This includes recovery delay or hospital
      discharge delays, respiratory insufficiency or infections, unforeseen ICU admissions, and
      prolonged ICU stays.

      The incidence is variable due to multiple factors. Age, gender, surgery, NMBA type and doses,
      temperature, medications, etc.

      In several studies it has been found and incidence between 6-80%. Few studies have been
      focused in evaluating the incidence in the whole country, as representing a global anesthesia
      practice. In Spain the incidence is unknown.

      The investigators hypothesize that a number of patients in the postanesthesia care unit
      (PACU) present with RNMB after general anesthesia using intermediate action NMBA.

      The main objective is to know the incidence of RNMB in Spanish hospitals, by means of an
      observational cross-sectional multicenter study .

      Secondary objectives are to observe the possible relationship with other pre- and
      intraoperative factors.
observational model: Cohort
time perspective: Cross-Sectional
measure: Residual neuromuscular block incidence (TOFr<0.9) measured by accelerometry in the PACU
time frame: Upon arrival to the PACU. Single evaluation.
description: Patients operated on under general anesthesia including intermediate duration NMBA were evaluated by means of an accelerometer in the PACU immediately upon arrival. Train-of-four ratio (TOFr) is evaluated.
The evaluator does'nt know the patient-related information, including intraoperative management.
measure: Respiratory or airway postoperative complications in the PACU
time frame: During PACU stay, an expected average of 4 hours
description: Evaluation of respiratory complications or events in the PACU (asking the anesthesiologist in charge or PACU medical record) to discharge to the ward.
measure: Relationship of RNMB with preoperative patient related factors
time frame: Upon patients arrival to the PACU
description: Analysis of the preoperative visit record and anesthesia record: ASA class, and patient's demographics and characteristics
measure: Relationship of RNMB with intraoperative anesthesia-related factors
time frame: Upon PACU arrival
description: anesthesiologist-in-charge experience, type of anesthesia, intraoperative drugs administered and doses, reversal drugs and doses.
measure: Relationship of RNMB with surgery-related factors
time frame: Upon PACU arrival
description: Relationship of RNMB with surgery related factors (surgical speciality, type of surgery -high risk vs low to intermedium risk, laparoscopic vs no laparoscopic-, duration), blood losses.
arm group label: General anesthesia
description: Evaluation of RNMB. Application of accelerometry to patients after general anesthesia receiving at least one intermediate action nondepolarizing neuromuscular blocking agent dose
intervention type: Device
intervention name: Accelerometry
description: Application of TOF stimulus (40 mA, three to four times) and recording TOFr in the PACU
arm group label: General anesthesia
other name: TOF-Watch
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Carlos L Errando, MD, PhD
role: Principal Investigator
affiliation: Servicio de Anestesiologia. Consorcio Hospital General Universitario de Valencia
last name: Ignacio Garutti, MD, PhD
role: Principal Investigator
affiliation: Servicio de Anestesiologia. Hospital Universitario Gregorio Marañon
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country: Spain
responsible party type: Principal Investigator
investigator affiliation: General University Hospital of Valencia
investigator full name: Carlos Luis Errando
investigator title: MD, PhD, staff anesthesiologist
mesh term: Delayed Emergence from Anesthesia