<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/NCT03831815</url>
  </required_header>
  <id_info>
    <org_study_id>CAAE: 71086417.3.0000.5121</org_study_id>
    <nct_id>NCT03831815</nct_id>
  </id_info>
  <brief_title>Evaluation of Residual Neuromuscular Blockade and of Late Recurarization in the Post Anesthesia Care Unit in Patients Undergoing Videolaparoscopic Cholecystectomy</brief_title>
  <official_title>Evaluation of Residual Neuromuscular Blockade and of Late Recurarization in the Post Anesthesia Care Unit in Patients Undergoing Videolaparoscopic Cholecystectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of Minas Gerais</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federal University of Minas Gerais</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Neuromuscular blockade is essential to provide optimal conditions for tracheal intubation and&#xD;
      also to facilitate the performance of surgeries involving mainly the abdominal cavity. The&#xD;
      introduction of neuromuscular blockers in clinical practice optimized the execution of&#xD;
      mechanical ventilation. Since the use of these drugs, increased intercurrences such as&#xD;
      prolonged muscle paralysis and respiratory complications have been observed, resulting in&#xD;
      unfavorable outcomes with residual neuromuscular blockade and delayed recurrence due to the&#xD;
      occurrence of these complications. The present study aims to evaluate the incidence of&#xD;
      residual neuromuscular blockade and late recurarization in the post-anesthetic recovery room&#xD;
      in patients submitted to videolaparoscopic cholecystectomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an observational and prospective study in which patients aged 18-50 years classified&#xD;
      as ASA (American Society of Anesthesiologists) I and II, body mass index below 35 and who&#xD;
      will undergo cholecystectomy will be included. Patients will be allocated to two groups based&#xD;
      on the neuromuscular blocker used by the anesthesiologist who participates in the surgery, ie&#xD;
      in group C patients will participate in the administration of cisatracurium and the group R&#xD;
      will consist of the patients in whom rocuronium was administered. General anesthesia and&#xD;
      assessment of muscle function will be performed by measuring the four-stimulus sequence (SQE)&#xD;
      / train of four (TOF) at pre-established times. A residual neuromuscular block is considered&#xD;
      to be the patient presenting the value of the four-stimulus sequence of T4 / T1 of less than&#xD;
      0.9.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 3, 2017</start_date>
  <completion_date type="Actual">May 18, 2018</completion_date>
  <primary_completion_date type="Actual">May 18, 2018</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>7 Months</target_duration>
  <primary_outcome>
    <measure>Residual Neuromuscular Blockade</measure>
    <time_frame>Immediate postoperative period in the post anesthetic recovery room.</time_frame>
    <description>The patient who presented the value of the sequence of four T4 / T1 stimuli of less than 0.9 was considered to have residual neuromuscular block.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">85</enrollment>
  <condition>Neuromuscular Block, Residual</condition>
  <arm_group>
    <arm_group_label>Grupo C: cisatracurium</arm_group_label>
    <description>Patients were allocated to two groups based on the neuromuscular blocker used by the anesthesiologist who participated in the surgery. In group C, patients received cisatracurium and in group R, rocuronium was administered to patients.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Grupo R: rocuronium</arm_group_label>
    <description>Patients were allocated to two groups based on the neuromuscular blocker used by the anesthesiologist who participated in the surgery. In group C, patients received cisatracurium and in group R, rocuronium was administered to patients.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cisatracurium</intervention_name>
    <description>Patients were allocated to two groups based on the neuromuscular blocker used by the anesthesiologist participating in the surgery. In group C, the patients in whom cisatracurium was given and the R group consisted of the patients in whom rocuronium was administered. It is emphasized that the choice of the neuromuscular blocker was made by the preference and experience of the anesthesiologist of the case and not by randomization or lottery of the patients.</description>
    <arm_group_label>Grupo C: cisatracurium</arm_group_label>
    <other_name>Rocuronium</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients of both sexes and who underwent videolaparoscopic cholecystectomy under balanced&#xD;
        general anesthesia. ASA (American Society of Anesthesiologists) patients, class I and II,&#xD;
        age group of 18 to 50 years, body mass index below 35.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients submitted to videolaparoscopic cholecystectomy under balanced general&#xD;
             anesthesia. ASA (American Society of Anesthesiologists) patients, class I and II, age&#xD;
             group of 18 to 50 years, body mass index below 35.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients ASA III or higher; ASA II patients with respiratory comorbidities. Patients&#xD;
             with neuromuscular diseases or severe renal or hepatic diseases. Patients submitted to&#xD;
             total venous anesthesia. Patients with body temperature below 36 ° C. Replication of&#xD;
             the neuromuscular blocker. Use of drugs that accentuate neuromuscular blockade such as&#xD;
             calcium channel blockers, inorganic ions (Mg ++, Li ++), aminoglycoside antibiotics,&#xD;
             halogenated anesthetics (except sevoflurane), local anesthetics (except lidocaine),&#xD;
             benzodiazepines and opioids (except morphine or remifentanil) .&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Universidade Federal de Minas Gerais, Faculdade de Medicina, Departamento de Cirurgia.</name>
      <address>
        <city>Belo Horizonte</city>
        <state>Minas Gerais</state>
        <zip>30130100</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 4, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>February 4, 2019</last_update_submitted>
  <last_update_submitted_qc>February 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of Minas Gerais</investigator_affiliation>
    <investigator_full_name>Renato Santiago Gomez</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Delayed Emergence from Anesthesia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rocuronium</mesh_term>
    <mesh_term>Cisatracurium</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/NCT03831815
org study id: CAAE: 71086417.3.0000.5121
nct id: NCT03831815
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Neuromuscular blockade is essential to provide optimal conditions for tracheal intubation and
      also to facilitate the performance of surgeries involving mainly the abdominal cavity. The
      introduction of neuromuscular blockers in clinical practice optimized the execution of
      mechanical ventilation. Since the use of these drugs, increased intercurrences such as
      prolonged muscle paralysis and respiratory complications have been observed, resulting in
      unfavorable outcomes with residual neuromuscular blockade and delayed recurrence due to the
      occurrence of these complications. The present study aims to evaluate the incidence of
      residual neuromuscular blockade and late recurarization in the post-anesthetic recovery room
      in patients submitted to videolaparoscopic cholecystectomy.
This is an observational and prospective study in which patients aged 18-50 years classified
      as ASA (American Society of Anesthesiologists) I and II, body mass index below 35 and who
      will undergo cholecystectomy will be included. Patients will be allocated to two groups based
      on the neuromuscular blocker used by the anesthesiologist who participates in the surgery, ie
      in group C patients will participate in the administration of cisatracurium and the group R
      will consist of the patients in whom rocuronium was administered. General anesthesia and
      assessment of muscle function will be performed by measuring the four-stimulus sequence (SQE)
      / train of four (TOF) at pre-established times. A residual neuromuscular block is considered
      to be the patient presenting the value of the four-stimulus sequence of T4 / T1 of less than
      0.9.
observational model: Other
time perspective: Prospective
measure: Residual Neuromuscular Blockade
time frame: Immediate postoperative period in the post anesthetic recovery room.
description: The patient who presented the value of the sequence of four T4 / T1 stimuli of less than 0.9 was considered to have residual neuromuscular block.
arm group label: Grupo C: cisatracurium
description: Patients were allocated to two groups based on the neuromuscular blocker used by the anesthesiologist who participated in the surgery. In group C, patients received cisatracurium and in group R, rocuronium was administered to patients.
arm group label: Grupo R: rocuronium
description: Patients were allocated to two groups based on the neuromuscular blocker used by the anesthesiologist who participated in the surgery. In group C, patients received cisatracurium and in group R, rocuronium was administered to patients.
intervention type: Drug
intervention name: Cisatracurium
description: Patients were allocated to two groups based on the neuromuscular blocker used by the anesthesiologist participating in the surgery. In group C, the patients in whom cisatracurium was given and the R group consisted of the patients in whom rocuronium was administered. It is emphasized that the choice of the neuromuscular blocker was made by the preference and experience of the anesthesiologist of the case and not by randomization or lottery of the patients.
arm group label: Grupo C: cisatracurium
other name: Rocuronium
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Federal University of Minas Gerais
investigator full name: Renato Santiago Gomez
investigator title: Doctor
mesh term: Delayed Emergence from Anesthesia
mesh term: Rocuronium
mesh term: Cisatracurium