<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/NCT02989272</url>
  </required_header>
  <id_info>
    <org_study_id>HFBonsucesso</org_study_id>
    <nct_id>NCT02989272</nct_id>
  </id_info>
  <brief_title>Effect of Pre-treatment With Magnesium Sulfate on the Duration of Deep Neuromuscular Blockade With Rocuronium</brief_title>
  <official_title>Effect of Pre-treatment With Magnesium Sulfate on the Duration of Deep Neuromuscular Blockade With Rocuronium: Random and Double-blind Clinical Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Federal de Bonsucesso</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Federal de Bonsucesso</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      It is a prospective, comparative, randomized, double-blind clinical trial whose hypothesis is&#xD;
      that pre-treatment with magnesium sulfate, due to its action at the neuromuscular&#xD;
      junction,potentiate the duration of deep neuromuscular block following rocuronium&#xD;
      curarization in patients undergoing general anesthesia. Magnesium sulphate has gained&#xD;
      prominence as an adjuvant drug in anesthesia. Its use is associated with potentiation of&#xD;
      neuromuscular blockade among other functions.&#xD;
&#xD;
      The deep neuromuscular block is defined as the one obtained by the absence of response to the&#xD;
      sequence of four Stimuli and the presence of one or more simple stimuli in post-tetanic&#xD;
      counts . There is no literature description of the role of magnesium sulphate in Duration of&#xD;
      the deep neuromuscular block obtained after the muscle relaxation of patients with rocuronium&#xD;
      This study is justified because extending the clinical duration of neuromuscular blockers may&#xD;
      translate into gains for surgeries that require deep and long-lasting muscle relaxation as in&#xD;
      laparoscopic and robotic surgeries. This block allows lower inflation pressures of the&#xD;
      pneumoperitoneum to be obtained, as a result, there is a lower inflammatory and&#xD;
      cardiorespiratory repercussion for the patient&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients will be selected from those who use the General Surgery Service of the Federal&#xD;
      Hospital of Bonsucesso for medical indication or own will, obeying the inclusion and&#xD;
      exclusion criteria. After signing the informed consent, they will be evaluated clinically and&#xD;
      laboratorially, according to the routine of preoperative exams and pre-anesthetic outpatient&#xD;
      evaluation. Patients will be allocated to one of two groups: control group (30 patients), who&#xD;
      will receive pretreatment by venous infusion of saline solution; And magnesium group (30&#xD;
      patients) who will receive pretreatment by intravenous infusion of magnesium sulfate 60 mg /&#xD;
      kg according to the random number sequence generated electronically through the QuickCalcs&#xD;
      program (GraphPad Software, San Diego, CA) Because it is a double-blind study, both the&#xD;
      researcher and the patient will not know which of the groups will be studied.&#xD;
&#xD;
      The principal investigator will be responsible for the delivery of sealed envelope containing&#xD;
      the sequence of cases allocated in each of the groups to another anesthesiologist who will&#xD;
      prepare the solution (saline or magnesium sulphate) and will record in a specific file in&#xD;
      which group the volunteer was Allocated. Again the envelope will be sealed for tabulation&#xD;
      later, without the knowledge of the researcher. The same principal investigator will be in&#xD;
      charge of the measurement and recording of the data collected.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">November 2017</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>duration of deep neuromuscular block</measure>
    <time_frame>perioperative</time_frame>
    <description>To determine the duration of deep neuromuscular block following a single dose of rocuronium</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>onset time and recovery time of rocuronium</measure>
    <time_frame>perioperative- until 48h</time_frame>
    <description>to determine the pharmacodynamic parameters of rocuronium</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>residual neuromuscular block in PACU</measure>
    <time_frame>6h</time_frame>
    <description>Evaluate the eventual occurrence of residual neuromuscular block in PACU</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>evolution of the height of T1</measure>
    <time_frame>perioperative- until 48h</time_frame>
    <description>Record the evolution of the height of T1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>postoperative pain</measure>
    <time_frame>perioperative- until 48h</time_frame>
    <description>Evaluate postoperative pain with questionnaire and visual scale of pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>episodes of nausea and vomiting and treatment of surgery to discharge</measure>
    <time_frame>perioperative- until 48h</time_frame>
    <description>Assess the frequency of individual episodes of nausea and vomiting and treatment during the period from the end of surgery to discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>frequency of pain or unpleasant sensation</measure>
    <time_frame>perioperative- until 48h</time_frame>
    <description>Evaluate frequency of pain or unpleasant sensation during the infusion of the studied solutions</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Magnesium Sulfate</condition>
  <condition>Neuromuscular Blockade</condition>
  <condition>Rocuronium</condition>
  <condition>Deep Neuromuscular Blockade</condition>
  <arm_group>
    <arm_group_label>saline group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Control group (30 patients), who will receive Treatment by venous infusion of saline solution</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sulfate group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>magnesium group (30 patients) who will receive pre- Venous infusion of magnesium sulphate 60 mg / kg</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sulfate, Magnesium</intervention_name>
    <description>magnesium group (30 patients) who will receive pretreatment by intravenous infusion of magnesium sulfate 60 mg / kg</description>
    <arm_group_label>Sulfate group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>saline group</intervention_name>
    <description>saline group (30 patients) who will receive pretreatment by saline solution</description>
    <arm_group_label>saline group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Physical State American Society of Anesthesiologists (ASA) I, II and III; Body mass&#xD;
             index between 18.5 and 24.9;Otorhinolaryngological surgeries&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Refusal to participate in the study;&#xD;
&#xD;
          -  Pregnancy or suspected pregnancy; Neuromuscular diseases, renal or hepatic impairment;&#xD;
&#xD;
          -  Hepatic dysfunction;&#xD;
&#xD;
          -  History or predictors of difficult airway; Hypermagnesemia (Mg&gt; 2.5 mEq / L);&#xD;
&#xD;
          -  Hypomagnesemia (Mg &lt;1.7 mEq / L);&#xD;
&#xD;
          -  Use of furosemide, aminoglycosides, aminophylline, azathioprine; Cyclophosphamide,&#xD;
             anti-inflammatories and magnesium;&#xD;
&#xD;
          -  Allergy to the drugs used in the study;&#xD;
&#xD;
          -  Participants from other clinical studies.&#xD;
&#xD;
          -  Emergency surgeries.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nubia V Figueiredo, master</last_name>
    <role>Study Director</role>
    <affiliation>Universidade Federal do Rio de Janeiro</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ismar L Cavalcanti, master</last_name>
    <role>Study Director</role>
    <affiliation>Federal Fluminense University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Angelo Jorge Q R Micuci, doctor anesthesiology</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital federal of Bonsucesso</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Angelo Jorge Q R Micuci, doctor anesthesiology</last_name>
    <phone>21997828668</phone>
    <phone_ext>55</phone_ext>
    <email>angelojorgemicuci@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ismar L Cavalcanti, master</last_name>
    <phone>999822993</phone>
    <phone_ext>55</phone_ext>
    <email>ismarcavalcanti@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Bonsucesso Federal Hospital</name>
      <address>
        <city>Rio de Janeiro</city>
        <zip>21.041-030</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 5, 2016</study_first_submitted>
  <study_first_submitted_qc>December 9, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 12, 2016</study_first_posted>
  <last_update_submitted>December 9, 2016</last_update_submitted>
  <last_update_submitted_qc>December 9, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 12, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Federal de Bonsucesso</investigator_affiliation>
    <investigator_full_name>angelo jorge queiroz rangel micuci</investigator_full_name>
    <investigator_title>Doctor Anesthesiologist</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Magnesium Sulfate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>October 9, 2018</submitted>
    <submission_canceled>November 29, 2018</submission_canceled>
    <submitted>November 29, 2018</submitted>
    <returned>March 14, 2019</returned>
    <submitted>March 16, 2019</submitted>
    <returned>June 13, 2019</returned>
  </pending_results>
  <!-- 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/NCT02989272
org study id: HFBonsucesso
nct id: NCT02989272
lead sponsor: 
has dmc: Yes
It is a prospective, comparative, randomized, double-blind clinical trial whose hypothesis is
      that pre-treatment with magnesium sulfate, due to its action at the neuromuscular
      junction,potentiate the duration of deep neuromuscular block following rocuronium
      curarization in patients undergoing general anesthesia. Magnesium sulphate has gained
      prominence as an adjuvant drug in anesthesia. Its use is associated with potentiation of
      neuromuscular blockade among other functions.

      The deep neuromuscular block is defined as the one obtained by the absence of response to the
      sequence of four Stimuli and the presence of one or more simple stimuli in post-tetanic
      counts . There is no literature description of the role of magnesium sulphate in Duration of
      the deep neuromuscular block obtained after the muscle relaxation of patients with rocuronium
      This study is justified because extending the clinical duration of neuromuscular blockers may
      translate into gains for surgeries that require deep and long-lasting muscle relaxation as in
      laparoscopic and robotic surgeries. This block allows lower inflation pressures of the
      pneumoperitoneum to be obtained, as a result, there is a lower inflammatory and
      cardiorespiratory repercussion for the patient
Patients will be selected from those who use the General Surgery Service of the Federal
      Hospital of Bonsucesso for medical indication or own will, obeying the inclusion and
      exclusion criteria. After signing the informed consent, they will be evaluated clinically and
      laboratorially, according to the routine of preoperative exams and pre-anesthetic outpatient
      evaluation. Patients will be allocated to one of two groups: control group (30 patients), who
      will receive pretreatment by venous infusion of saline solution; And magnesium group (30
      patients) who will receive pretreatment by intravenous infusion of magnesium sulfate 60 mg /
      kg according to the random number sequence generated electronically through the QuickCalcs
      program (GraphPad Software, San Diego, CA) Because it is a double-blind study, both the
      researcher and the patient will not know which of the groups will be studied.

      The principal investigator will be responsible for the delivery of sealed envelope containing
      the sequence of cases allocated in each of the groups to another anesthesiologist who will
      prepare the solution (saline or magnesium sulphate) and will record in a specific file in
      which group the volunteer was Allocated. Again the envelope will be sealed for tabulation
      later, without the knowledge of the researcher. The same principal investigator will be in
      charge of the measurement and recording of the data collected.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: duration of deep neuromuscular block
time frame: perioperative
description: To determine the duration of deep neuromuscular block following a single dose of rocuronium
measure: onset time and recovery time of rocuronium
time frame: perioperative- until 48h
description: to determine the pharmacodynamic parameters of rocuronium
measure: residual neuromuscular block in PACU
time frame: 6h
description: Evaluate the eventual occurrence of residual neuromuscular block in PACU
measure: evolution of the height of T1
time frame: perioperative- until 48h
description: Record the evolution of the height of T1
measure: postoperative pain
time frame: perioperative- until 48h
description: Evaluate postoperative pain with questionnaire and visual scale of pain
measure: episodes of nausea and vomiting and treatment of surgery to discharge
time frame: perioperative- until 48h
description: Assess the frequency of individual episodes of nausea and vomiting and treatment during the period from the end of surgery to discharge
measure: frequency of pain or unpleasant sensation
time frame: perioperative- until 48h
description: Evaluate frequency of pain or unpleasant sensation during the infusion of the studied solutions
arm group label: saline group
arm group type: Placebo Comparator
description: Control group (30 patients), who will receive Treatment by venous infusion of saline solution
arm group label: Sulfate group
arm group type: Experimental
description: magnesium group (30 patients) who will receive pre- Venous infusion of magnesium sulphate 60 mg / kg
intervention type: Drug
intervention name: Sulfate, Magnesium
description: magnesium group (30 patients) who will receive pretreatment by intravenous infusion of magnesium sulfate 60 mg / kg
arm group label: Sulfate group
intervention type: Other
intervention name: saline group
description: saline group (30 patients) who will receive pretreatment by saline solution
arm group label: saline group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Nubia V Figueiredo, master
role: Study Director
affiliation: Universidade Federal do Rio de Janeiro
last name: Ismar L Cavalcanti, master
role: Study Director
affiliation: Federal Fluminense University
last name: Angelo Jorge Q R Micuci, doctor anesthesiology
role: Principal Investigator
affiliation: Hospital federal of Bonsucesso
last name: Angelo Jorge Q R Micuci, doctor anesthesiology
phone: 21997828668
phone ext: 55
email: angelojorgemicuci@gmail.com
last name: Ismar L Cavalcanti, master
phone: 999822993
phone ext: 55
email: ismarcavalcanti@gmail.com
facility: 
status: Recruiting
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Hospital Federal de Bonsucesso
investigator full name: angelo jorge queiroz rangel micuci
investigator title: Doctor Anesthesiologist
mesh term: Magnesium Sulfate
sharing ipd: Yes
submitted: October 9, 2018
submission canceled: November 29, 2018
submitted: November 29, 2018
returned: March 14, 2019
submitted: March 16, 2019
returned: June 13, 2019