<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/NCT03043157</url>
  </required_header>
  <id_info>
    <org_study_id>CAAE 60322116.2.0000.0025</org_study_id>
    <nct_id>NCT03043157</nct_id>
  </id_info>
  <brief_title>Rocuronium Effective Dose for Laparoscopic Cholecystectomy</brief_title>
  <official_title>Rocuronium ED50 for Excellent Laparoscopic Conditions for Cholecistectomy: Dose-finding Adaptative Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brasilia University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Brasilia University Hospital</source>
  <oversight_info>
    <has_dmc>No</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>
      This is an adaptative study where each participant's rocuronium dose will depend on the&#xD;
      previous patient's response, being higher if it was not enough and lower if it was more than&#xD;
      enough.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rocuronium is one of the most used neuromuscular blockers to help intubation and to relax&#xD;
      abdominal wall for laparoscopic surgery.&#xD;
&#xD;
      Rocuronium intubation dose can be enough for intubation but not last enough for excellent&#xD;
      laparoscopic conditions. There is little variation in time from anesthesia induction to the&#xD;
      end of the laparoscopy for cholecystectomy and avoiding excess rocuronium dose can help&#xD;
      providing excellent conditions and fast track extubation.&#xD;
&#xD;
      Dixon's up-and-down method will guide this dose-finding study for the ED50.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 15, 2017</start_date>
  <completion_date type="Actual">March 2, 2017</completion_date>
  <primary_completion_date type="Actual">March 2, 2017</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Dose-finding using Dixon's up-and-down adaptative clinical trial</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Participant receives hypnotic (propofol) before we use the drug</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Excellent laparoscopic conditions</measure>
    <time_frame>30 minutes</time_frame>
    <description>Subjective laparoscopic conditions for surgery, assessed by the main surgeon, as excellent or not</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Muscle Relaxation</condition>
  <arm_group>
    <arm_group_label>Dose-finding group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The first patient will receive rocuronium 0,6mg/kg. After that, every patient's dose will depend on the outcome of the previous patient. It will go up 0,1mg/kg if the laparoscopic conditions were not excellent or go down 0,1mg/kg otherwise.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>rocuronium</intervention_name>
    <description>intravenous rocuronium infusion</description>
    <arm_group_label>Dose-finding group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  general anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  deny participation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gabriel MN Guimaraes, MsC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidade de Brasilia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital das Forças armadas</name>
      <address>
        <city>Brasilia</city>
        <state>Distrito Federal</state>
        <zip>700000000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>February 2, 2017</study_first_submitted>
  <study_first_submitted_qc>February 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>September 12, 2017</last_update_submitted>
  <last_update_submitted_qc>September 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brasilia University Hospital</investigator_affiliation>
    <investigator_full_name>Gabriel Magalhaes Nunes Guimaraes</investigator_full_name>
    <investigator_title>Head of Anesthesiology</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rocuronium</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/NCT03043157
org study id: CAAE 60322116.2.0000.0025
nct id: NCT03043157
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is an adaptative study where each participant's rocuronium dose will depend on the
      previous patient's response, being higher if it was not enough and lower if it was more than
      enough.
Rocuronium is one of the most used neuromuscular blockers to help intubation and to relax
      abdominal wall for laparoscopic surgery.

      Rocuronium intubation dose can be enough for intubation but not last enough for excellent
      laparoscopic conditions. There is little variation in time from anesthesia induction to the
      end of the laparoscopy for cholecystectomy and avoiding excess rocuronium dose can help
      providing excellent conditions and fast track extubation.

      Dixon's up-and-down method will guide this dose-finding study for the ED50.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Dose-finding using Dixon's up-and-down adaptative clinical trial
primary purpose: Supportive Care
masking: None (Open Label)
masking description: Participant receives hypnotic (propofol) before we use the drug
measure: Excellent laparoscopic conditions
time frame: 30 minutes
description: Subjective laparoscopic conditions for surgery, assessed by the main surgeon, as excellent or not
arm group label: Dose-finding group
arm group type: Other
description: The first patient will receive rocuronium 0,6mg/kg. After that, every patient's dose will depend on the outcome of the previous patient. It will go up 0,1mg/kg if the laparoscopic conditions were not excellent or go down 0,1mg/kg otherwise.
intervention type: Drug
intervention name: rocuronium
description: intravenous rocuronium infusion
arm group label: Dose-finding group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Gabriel MN Guimaraes, MsC
role: Principal Investigator
affiliation: Universidade de Brasilia
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Brasilia University Hospital
investigator full name: Gabriel Magalhaes Nunes Guimaraes
investigator title: Head of Anesthesiology
mesh term: Rocuronium
sharing ipd: No