<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/NCT03270696</url>
  </required_header>
  <id_info>
    <org_study_id>JHSeo_MV</org_study_id>
    <nct_id>NCT03270696</nct_id>
  </id_info>
  <brief_title>Simultaneous Injection of Propofol and Rocuronium in Inducing General Anesthesia</brief_title>
  <official_title>Efficacy of Neuromuscular Blockade Before Facemask Ventilation in Inducing General Anesthesia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is conducted to evaluate the efficacy of simultaneous injection of propofol and&#xD;
      rocuronium in inducing general anesthesia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 23, 2017</start_date>
  <completion_date type="Actual">January 30, 2018</completion_date>
  <primary_completion_date type="Actual">January 30, 2018</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>mean tidal volume</measure>
    <time_frame>from starting facemask ventilation for 1 minute</time_frame>
    <description>mean tidal volume of facemask ventilation in 1 minute</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">114</enrollment>
  <condition>Anesthesia; Functional</condition>
  <arm_group>
    <arm_group_label>simultaneous administration of propofol and rocuronium</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this group, the investigator will administrate propofol (2ml/kg) and rocuronium (0.6mg/kg) simultaneously, and start facemask ventilation after patient loss consciousness to induce general anesthesia.&#xD;
The investigator will measure the mean tidal volume (TV) applied during facemask ventilation for 1 minute.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ordinal administration of propofol and rocuronium</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this group, the investigator will administrate propofol (2ml/kg) first, and follow injection of rocuronium (0.6mg/kg) after patient loss consciousness and confirming facemask ventilation.&#xD;
The investigator will measure the mean tidal volume (TV) applied during facemask ventilation for 1 minute.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>administration of propofol and rocuronium</intervention_name>
    <description>compare the tidal volume applied from starting facemask ventilation under 15cmH2O of PCV for 1 minute according to administrating propofol and rocuronium simultaneously, or ordinally</description>
    <arm_group_label>ordinal administration of propofol and rocuronium</arm_group_label>
    <arm_group_label>simultaneous administration of propofol and rocuronium</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients undergoing elective surgery requiring endotracheal intubation&#xD;
&#xD;
          -  ASA I, II, and III&#xD;
&#xD;
          -  above 20 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  refuse to enroll&#xD;
&#xD;
          -  patients with risk of aspirating gastric contents&#xD;
&#xD;
          -  patients in whom NMBs are contraindicated&#xD;
&#xD;
          -  patients with predictors of difficult mask ventilation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>JH Seo</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>April 11, 2018</last_update_submitted>
  <last_update_submitted_qc>April 11, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 12, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Jeong-Hwa Seo</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Propofol</mesh_term>
    <mesh_term>Rocuronium</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/NCT03270696
org study id: JHSeo_MV
nct id: NCT03270696
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study is conducted to evaluate the efficacy of simultaneous injection of propofol and
      rocuronium in inducing general anesthesia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: mean tidal volume
time frame: from starting facemask ventilation for 1 minute
description: mean tidal volume of facemask ventilation in 1 minute
arm group label: simultaneous administration of propofol and rocuronium
arm group type: Experimental
description: In this group, the investigator will administrate propofol (2ml/kg) and rocuronium (0.6mg/kg) simultaneously, and start facemask ventilation after patient loss consciousness to induce general anesthesia.
The investigator will measure the mean tidal volume (TV) applied during facemask ventilation for 1 minute.
arm group label: ordinal administration of propofol and rocuronium
arm group type: Experimental
description: In this group, the investigator will administrate propofol (2ml/kg) first, and follow injection of rocuronium (0.6mg/kg) after patient loss consciousness and confirming facemask ventilation.
The investigator will measure the mean tidal volume (TV) applied during facemask ventilation for 1 minute.
intervention type: Drug
intervention name: administration of propofol and rocuronium
description: compare the tidal volume applied from starting facemask ventilation under 15cmH2O of PCV for 1 minute according to administrating propofol and rocuronium simultaneously, or ordinally
arm group label: ordinal administration of propofol and rocuronium
arm group label: simultaneous administration of propofol and rocuronium
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: JH Seo
role: Principal Investigator
affiliation: Seoul National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Jeong-Hwa Seo
investigator title: Professor
mesh term: Propofol
mesh term: Rocuronium