<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/NCT02256280</url>
  </required_header>
  <id_info>
    <org_study_id>INT-91/14</org_study_id>
    <secondary_id>2014-002021-35</secondary_id>
    <nct_id>NCT02256280</nct_id>
  </id_info>
  <brief_title>A Randomized Double Blind Controlled Trial Comparing Sugammadex and Neostigmine After Thoracic Anesthesia</brief_title>
  <acronym>DATA</acronym>
  <official_title>Decurarization After Thoracic Anesthesia - A Prospective Multicenter Double-blind Randomized Trial Comparing Sugammadex vs Neostigmine Reversal After Thoracic Anesthesia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondazione IRCCS Istituto Nazionale dei Tumori, Milano</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fondazione IRCCS Istituto Nazionale dei Tumori, Milano</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      At the end of anesthesia it's important to avoid residual neuromuscular block to ensure&#xD;
      adequate respiratory function preventing postoperative pulmonary complications. This trial&#xD;
      compares the neuromuscular block reversal with different drugs (sugammadex vs neostigmine)&#xD;
      after thoracic anesthesia. The trial main objective is to demonstrate that sugammadex is&#xD;
      faster than neostigmine to reach a Train-of-four-Ratio (TOF-ratio) of 0.9 after thoracic&#xD;
      anesthesia, demonstrating that sugammadex allows a faster extubation. Other main purpose is&#xD;
      to verify if there is a difference between sugammadex and neostigmine as regards adverse&#xD;
      events after extubation and in the postoperative period (until the 30th day after surgery).&#xD;
&#xD;
      Note: TOF-ratio is defined as the ratio of the fourth muscular twitch/first twitch value&#xD;
      during an accelerometric train-of-four stimulation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients undergoing thoracic surgery will receive rocuronium as neuromuscular blocking agent.&#xD;
      Anesthesia and neuromuscular blockade will be managed freely until the end of surgery. Then&#xD;
      patients will be randomized to receive intravenous sugammadex or neostigmine/atropine as&#xD;
      follows:&#xD;
&#xD;
      Sugammadex group:&#xD;
&#xD;
        -  If Post tetanic count (PTC)=1-15: sugammadex 4 mg/kg&#xD;
&#xD;
        -  If at least 1 twitch at the Train-of-four stimulation: sugammadex 2 mg/kg&#xD;
&#xD;
      Neostigmine group:&#xD;
&#xD;
        -  If PTC=1-15: neostigmine 0.07 mg/kg + atropine 0.02 mg/kg&#xD;
&#xD;
        -  If at least 1 twitch at the Train-of-four (TOF) stimulation: neostigmine 0.07 mg/kg +&#xD;
           atropine 0.02 mg/kg&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Low recruiting rate due to not activation of some collaborator centers&#xD;
  </why_stopped>
  <start_date type="Actual">January 2015</start_date>
  <completion_date type="Actual">March 2020</completion_date>
  <primary_completion_date type="Actual">March 2020</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, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean time from reversal administration to Train-of-four-ratio (TOF-ratio) = 0.9</measure>
    <time_frame>At the end of general anesthesia</time_frame>
    <description>Time from reversal administration to at least 3 TOF-ratio value = or &gt; 0.9</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean time from reversal administration to TOF-ratio = 1.0</measure>
    <time_frame>At the end of general anesthesia</time_frame>
    <description>Time from reversal administration to at least 3 TOF-ratio value = or &gt; 1.0</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean time from reversal administration to extubation</measure>
    <time_frame>At the end of anesthesia</time_frame>
    <description>Time from reversal administration to tracheal extubation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscular weakness incidence</measure>
    <time_frame>In the first 60 minutes after extubation</time_frame>
    <description>Measured by the tongue depressor test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hypoxemia or hypercapnia incidence</measure>
    <time_frame>In the first 60 minutes after extubation</time_frame>
    <description>Hypoxemia defined as Partial pressure of oxygen in arterial blood/Fraction of inspired oxygen ratio (PaO2/FiO2) &lt; 300. Hypercapnia defined as Partial pressure of carbon dioxide in arterial blood (PaCO2) &gt; 45 mmHg.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events incidence</measure>
    <time_frame>In the first 60 minutes after extubation</time_frame>
    <description>Incidence of nausea or vomit, abdominal pain, cardiac arrhythmias, hypotension coded according to the Medical Dictionary for Regulatory Activities (MedDRA) terminology</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative complications incidence</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 7 days</time_frame>
    <description>Incidence of medical and surgical complications coded according to the MedDRA terminology</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Mean time of hospital discharge</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 7 days</time_frame>
    <description>Time from intervention date to the hospital discharge</description>
  </other_outcome>
  <other_outcome>
    <measure>Postoperative complications incidence</measure>
    <time_frame>At 30 days after surgery</time_frame>
    <description>Incidence of medical and surgical complications coded according to the MedDRA terminology</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Neuromuscular Blockade</condition>
  <arm_group>
    <arm_group_label>S Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sugammadex 2 or 4 mg/kg iv once at the end of surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>N Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Neostigmine 0.05 or 0.07 mg/kg (+ atropine 0.02 mg/kg) iv once at the end of surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sugammadex</intervention_name>
    <description>Sugammadex will be diluted in a saline water solution in a 10 mL syringe.&#xD;
Administration will be according to the neuromuscular blockade:&#xD;
If Post tetanic count = 1-15: 4 mg/kg&#xD;
If at least 1 twitch at the Train-of-four stimulation: 2 mg/kg</description>
    <arm_group_label>S Group</arm_group_label>
    <other_name>Bridion</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Neostigmine</intervention_name>
    <description>Neostigmine will be diluted with atropine in a saline water solution in a 10 mL syringe.&#xD;
Administration will be according to the neuromuscular blockade:&#xD;
If Post tetanic count = 1-15: 0.07 mg/kg&#xD;
If at least 1 twitch at the Train-of-four stimulation: 0.05 mg/kg Atropine will be administered at a 0.02 mg/kg dosage.</description>
    <arm_group_label>N Group</arm_group_label>
    <other_name>Intrastigmina</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects scheduled for pulmonary resection, lobectomy, pneumonectomy, bullectomy,&#xD;
             pleurodesis&#xD;
&#xD;
          -  Age 18-70 years&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) class 1, 2, 3&#xD;
&#xD;
          -  Body mass Index (BMI) = 18-30 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects scheduled for esophagectomy, thoracectomy, vascular resection&#xD;
&#xD;
          -  Chronic Obstructive Pulmonary Disease (COPD) Gold class III e IV, respiratory&#xD;
             infection, asthma&#xD;
&#xD;
          -  Preoperative Forced Expiratory Volume in 1 second (FEV1) &lt; 60% of predicted, Forced&#xD;
             Expiratory Volume in 1 second/Forced Vital Capacity ratio (FEV1/FVC) &lt;70%&#xD;
&#xD;
          -  Preoperative Diffusion Lung capacity for carbon monoxide/Alveolar Volume ratio&#xD;
             (DLCO/VA) &lt; 60% of predicted&#xD;
&#xD;
          -  Preoperative oxygen saturation (SpO2) &lt;92% or Partial pressure of oxygen in arterial&#xD;
             blood/Fraction of inspired oxygen (PaO2/FiO2) ratio &lt;300&#xD;
&#xD;
          -  Cardiovascular disease with Metabolic Equivalent of Tasks (METS) score less than 4&#xD;
&#xD;
          -  Neuromuscular disorder&#xD;
&#xD;
          -  Kidney failure defined as Estimated Glomerular Filtration Rate (eGFR) &lt; 30 ml/min/1,73&#xD;
             m2&#xD;
&#xD;
          -  Pregnant women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Federico Piccioni, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fondazione IRCCS Istituto Nazionale dei Tumori, Milano</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fondazione IRCCS Istituto Nazionale dei Tumori</name>
      <address>
        <city>Milan</city>
        <state>Mi</state>
        <zip>20133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>September 24, 2014</study_first_submitted>
  <study_first_submitted_qc>October 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2014</study_first_posted>
  <last_update_submitted>June 12, 2021</last_update_submitted>
  <last_update_submitted_qc>June 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fondazione IRCCS Istituto Nazionale dei Tumori, Milano</investigator_affiliation>
    <investigator_full_name>Federico Piccioni, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Neuromuscular blockade</keyword>
  <keyword>Thoracic surgery</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neostigmine</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/NCT02256280
org study id: INT-91/14
secondary id: 2014-002021-35
nct id: NCT02256280
lead sponsor: 
has dmc: No
At the end of anesthesia it's important to avoid residual neuromuscular block to ensure
      adequate respiratory function preventing postoperative pulmonary complications. This trial
      compares the neuromuscular block reversal with different drugs (sugammadex vs neostigmine)
      after thoracic anesthesia. The trial main objective is to demonstrate that sugammadex is
      faster than neostigmine to reach a Train-of-four-Ratio (TOF-ratio) of 0.9 after thoracic
      anesthesia, demonstrating that sugammadex allows a faster extubation. Other main purpose is
      to verify if there is a difference between sugammadex and neostigmine as regards adverse
      events after extubation and in the postoperative period (until the 30th day after surgery).

      Note: TOF-ratio is defined as the ratio of the fourth muscular twitch/first twitch value
      during an accelerometric train-of-four stimulation.
Patients undergoing thoracic surgery will receive rocuronium as neuromuscular blocking agent.
      Anesthesia and neuromuscular blockade will be managed freely until the end of surgery. Then
      patients will be randomized to receive intravenous sugammadex or neostigmine/atropine as
      follows:

      Sugammadex group:

        -  If Post tetanic count (PTC)=1-15: sugammadex 4 mg/kg

        -  If at least 1 twitch at the Train-of-four stimulation: sugammadex 2 mg/kg

      Neostigmine group:

        -  If PTC=1-15: neostigmine 0.07 mg/kg + atropine 0.02 mg/kg

        -  If at least 1 twitch at the Train-of-four (TOF) stimulation: neostigmine 0.07 mg/kg +
           atropine 0.02 mg/kg
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Triple (Participant, Care Provider, Investigator)
measure: Mean time from reversal administration to Train-of-four-ratio (TOF-ratio) = 0.9
time frame: At the end of general anesthesia
description: Time from reversal administration to at least 3 TOF-ratio value = or > 0.9
measure: Mean time from reversal administration to TOF-ratio = 1.0
time frame: At the end of general anesthesia
description: Time from reversal administration to at least 3 TOF-ratio value = or > 1.0
measure: Mean time from reversal administration to extubation
time frame: At the end of anesthesia
description: Time from reversal administration to tracheal extubation
measure: Muscular weakness incidence
time frame: In the first 60 minutes after extubation
description: Measured by the tongue depressor test
measure: Hypoxemia or hypercapnia incidence
time frame: In the first 60 minutes after extubation
description: Hypoxemia defined as Partial pressure of oxygen in arterial blood/Fraction of inspired oxygen ratio (PaO2/FiO2) < 300. Hypercapnia defined as Partial pressure of carbon dioxide in arterial blood (PaCO2) > 45 mmHg.
measure: Adverse events incidence
time frame: In the first 60 minutes after extubation
description: Incidence of nausea or vomit, abdominal pain, cardiac arrhythmias, hypotension coded according to the Medical Dictionary for Regulatory Activities (MedDRA) terminology
measure: Postoperative complications incidence
time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
description: Incidence of medical and surgical complications coded according to the MedDRA terminology
measure: Mean time of hospital discharge
time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
description: Time from intervention date to the hospital discharge
measure: Postoperative complications incidence
time frame: At 30 days after surgery
description: Incidence of medical and surgical complications coded according to the MedDRA terminology
arm group label: S Group
arm group type: Experimental
description: Sugammadex 2 or 4 mg/kg iv once at the end of surgery
arm group label: N Group
arm group type: Active Comparator
description: Neostigmine 0.05 or 0.07 mg/kg (+ atropine 0.02 mg/kg) iv once at the end of surgery
intervention type: Drug
intervention name: Sugammadex
description: Sugammadex will be diluted in a saline water solution in a 10 mL syringe.
Administration will be according to the neuromuscular blockade:
If Post tetanic count = 1-15: 4 mg/kg
If at least 1 twitch at the Train-of-four stimulation: 2 mg/kg
arm group label: S Group
other name: Bridion
intervention type: Drug
intervention name: Neostigmine
description: Neostigmine will be diluted with atropine in a saline water solution in a 10 mL syringe.
Administration will be according to the neuromuscular blockade:
If Post tetanic count = 1-15: 0.07 mg/kg
If at least 1 twitch at the Train-of-four stimulation: 0.05 mg/kg Atropine will be administered at a 0.02 mg/kg dosage.
arm group label: N Group
other name: Intrastigmina
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Federico Piccioni, MD
role: Principal Investigator
affiliation: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
investigator full name: Federico Piccioni, MD
investigator title: Principal Investigator
mesh term: Neostigmine