<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/NCT03791801</url>
  </required_header>
  <id_info>
    <org_study_id>2019-4576</org_study_id>
    <nct_id>NCT03791801</nct_id>
  </id_info>
  <brief_title>The Use of Sugammadex in the Critically Ill</brief_title>
  <official_title>Recovery From Optimal Neuromuscular Blockade in the Critically Ill: Randomized Control Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>McGill University Health Centre/Research Institute of the McGill University Health Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>McGill University Health Centre/Research Institute of the McGill University Health Centre</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Moderate and Deep neuromuscular blockade (rocuronium administered to a train of four count 0&#xD;
      and post-tetanic count of 1-2) in critically ill patients needing intubation or procedures&#xD;
      can be reversed immediately and effectively by sugammadex avoiding unnecessary paralysis in&#xD;
      an already weakened population&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Critically ill is a special population needing immediate and aggressive treatments and&#xD;
      interventions. Neuromuscular blockade is frequently used to secure an airway, optimize&#xD;
      ventilation/oxygenation in ARDS, aid in maintaining hypothermia in patients post-cardiac&#xD;
      arrest. Muscle relaxants can also contribute to neuromuscular weakness in the critically ill&#xD;
      which can be a devastating condition. Appropriate depth of neuromuscular blockade is&#xD;
      important but unnecessary paralysis need to be avoided. Rocuronium is one of the most popular&#xD;
      neuromuscular blockade agents used in the critically ill (1). Sugammadex is a modified&#xD;
      γ-cyclodextrin that reverses the effect of the steroidal nondepolarizing neuromuscular&#xD;
      blocking agents rocuronium and vecuronium (2). Sugammadex results in rapid, predictable&#xD;
      recovery from moderate and deep neuromuscular blockade. Sugammadex has been mostly studied&#xD;
      and used in the surgical population but its use outside the operating room is still very&#xD;
      relevant. The investigators set up to evaluate the potential benefit that may result from the&#xD;
      reversal of NMB with sugammadex compared to neostigmine.&#xD;
&#xD;
      Objectives&#xD;
&#xD;
      In critically ill patients undergoing intubation receiving appropriate depth of NMB (moderate&#xD;
      and deep blockade) the investigators will assess:&#xD;
&#xD;
      Primary objective:&#xD;
&#xD;
      1. To determine if choice of reversal agent affects time from intubation to return of a train&#xD;
      of four (TOF) count of 1, and, separately, to return of a TOF ratio &gt;0.9&#xD;
&#xD;
      Secondary objectives:&#xD;
&#xD;
        1. To document the ability of 1.0 mg/kg rocuronium (maximum 100 mg) to achieve satisfactory&#xD;
           intubation conditions in the ICU, based on measurement of the number of intubation&#xD;
           attempts and intubation grades in the entire cohort&#xD;
&#xD;
        2. To document General adverse effects: Hemodynamic instability, need for vasopressors etc&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">September 1, 2019</start_date>
  <completion_date type="Anticipated">July 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>RCT</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Train of four ratio &gt;0.9</measure>
    <time_frame>up to 12 weeks</time_frame>
    <description>time from intubation to return of a train of four (TOF) count of 1, and, separately, to return of a TOF ratio &gt;0.9</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Critical Illness</condition>
  <arm_group>
    <arm_group_label>Neostigmine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Will receive rocuronium and neostigmine (5-70microg/kg) + glycopyrrolate (10microg/kg) at train of four 1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sugammadex</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Will receive rocuronium and sugammadex (4mg/kg) after a successful intubation (ETT is in the trachea and secure).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sugammadex</intervention_name>
    <description>the reversal of neuromuscular blockade with sugammadex compared to neostigmine.</description>
    <arm_group_label>Sugammadex</arm_group_label>
    <other_name>Bridion</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Neostigmine</intervention_name>
    <description>the reversal of neuromuscular blockade with sugammadex compared to neostigmine.</description>
    <arm_group_label>Neostigmine</arm_group_label>
    <other_name>Prostigmin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rocuronium</intervention_name>
    <description>Both groups will receive rocuronium for paralysis during intubation</description>
    <arm_group_label>Neostigmine</arm_group_label>
    <arm_group_label>Sugammadex</arm_group_label>
    <other_name>Zemuron</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Glycopyrrolate</intervention_name>
    <description>The reversal of neuromuscular blockade with sugammadex compared to neostigmine/glycopyrrolate</description>
    <arm_group_label>Neostigmine</arm_group_label>
    <other_name>Robinul</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients requiring intubation in the intensive care unit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients younger than 18 yr, to have known or suspected neuromuscular disease,&#xD;
             allergies to medications to be used during intubation, a (family) history of malignant&#xD;
             hyperthermia or severe renal insufficiency (glomerular filtration rate &lt;30 ml/h) will&#xD;
             not be eligible.&#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>Roupen Hatzakorzian, MD MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>McGill University Health Centre/Research Institute of the McGill University Health Centre</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Roupen Hatzakorzian, MD MSc</last_name>
    <phone>514 934 1934</phone>
    <phone_ext>31104</phone_ext>
    <email>roupenhatz@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>McGill University Health Center</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3A 1A1</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Roupen Hatzakorzian, MD, MSc</last_name>
      <phone>514 934 1934</phone>
      <phone_ext>34880</phone_ext>
      <email>roupenhatz@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>Roupen Hatzakorzian, MD, MSc</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>MUHC</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H4A 3J1</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>December 18, 2018</study_first_submitted>
  <study_first_submitted_qc>December 31, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">January 3, 2019</study_first_posted>
  <last_update_submitted>August 19, 2019</last_update_submitted>
  <last_update_submitted_qc>August 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>McGill University Health Centre/Research Institute of the McGill University Health Centre</investigator_affiliation>
    <investigator_full_name>Roupen Hatzakorzian, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>sugammadex</keyword>
  <keyword>rocuronium</keyword>
  <keyword>critically ill</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Critical Illness</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glycopyrrolate</mesh_term>
    <mesh_term>Rocuronium</mesh_term>
    <mesh_term>Neostigmine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03791801
org study id: 2019-4576
nct id: NCT03791801
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Moderate and Deep neuromuscular blockade (rocuronium administered to a train of four count 0
      and post-tetanic count of 1-2) in critically ill patients needing intubation or procedures
      can be reversed immediately and effectively by sugammadex avoiding unnecessary paralysis in
      an already weakened population
The Critically ill is a special population needing immediate and aggressive treatments and
      interventions. Neuromuscular blockade is frequently used to secure an airway, optimize
      ventilation/oxygenation in ARDS, aid in maintaining hypothermia in patients post-cardiac
      arrest. Muscle relaxants can also contribute to neuromuscular weakness in the critically ill
      which can be a devastating condition. Appropriate depth of neuromuscular blockade is
      important but unnecessary paralysis need to be avoided. Rocuronium is one of the most popular
      neuromuscular blockade agents used in the critically ill (1). Sugammadex is a modified
      γ-cyclodextrin that reverses the effect of the steroidal nondepolarizing neuromuscular
      blocking agents rocuronium and vecuronium (2). Sugammadex results in rapid, predictable
      recovery from moderate and deep neuromuscular blockade. Sugammadex has been mostly studied
      and used in the surgical population but its use outside the operating room is still very
      relevant. The investigators set up to evaluate the potential benefit that may result from the
      reversal of NMB with sugammadex compared to neostigmine.

      Objectives

      In critically ill patients undergoing intubation receiving appropriate depth of NMB (moderate
      and deep blockade) the investigators will assess:

      Primary objective:

      1. To determine if choice of reversal agent affects time from intubation to return of a train
      of four (TOF) count of 1, and, separately, to return of a TOF ratio >0.9

      Secondary objectives:

        1. To document the ability of 1.0 mg/kg rocuronium (maximum 100 mg) to achieve satisfactory
           intubation conditions in the ICU, based on measurement of the number of intubation
           attempts and intubation grades in the entire cohort

        2. To document General adverse effects: Hemodynamic instability, need for vasopressors etc
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: RCT
primary purpose: Supportive Care
masking: Double (Participant, Outcomes Assessor)
measure: Train of four ratio >0.9
time frame: up to 12 weeks
description: time from intubation to return of a train of four (TOF) count of 1, and, separately, to return of a TOF ratio >0.9
arm group label: Neostigmine
arm group type: Active Comparator
description: Will receive rocuronium and neostigmine (5-70microg/kg) + glycopyrrolate (10microg/kg) at train of four 1
arm group label: Sugammadex
arm group type: Active Comparator
description: Will receive rocuronium and sugammadex (4mg/kg) after a successful intubation (ETT is in the trachea and secure).
intervention type: Drug
intervention name: Sugammadex
description: the reversal of neuromuscular blockade with sugammadex compared to neostigmine.
arm group label: Sugammadex
other name: Bridion
intervention type: Drug
intervention name: Neostigmine
description: the reversal of neuromuscular blockade with sugammadex compared to neostigmine.
arm group label: Neostigmine
other name: Prostigmin
intervention type: Drug
intervention name: Rocuronium
description: Both groups will receive rocuronium for paralysis during intubation
arm group label: Neostigmine
arm group label: Sugammadex
other name: Zemuron
intervention type: Drug
intervention name: Glycopyrrolate
description: The reversal of neuromuscular blockade with sugammadex compared to neostigmine/glycopyrrolate
arm group label: Neostigmine
other name: Robinul
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Roupen Hatzakorzian, MD MSc
role: Principal Investigator
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
last name: Roupen Hatzakorzian, MD MSc
phone: 514 934 1934
phone ext: 31104
email: roupenhatz@hotmail.com
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
country: Canada
responsible party type: Principal Investigator
investigator affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
investigator full name: Roupen Hatzakorzian, MD
investigator title: Principal Investigator
mesh term: Critical Illness
mesh term: Glycopyrrolate
mesh term: Rocuronium
mesh term: Neostigmine
sharing ipd: No