xml: <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/NCT06029049</url>
    </required_header>
    <id_info>
      <org_study_id>HSC-MS-23-0468</org_study_id>
      <nct_id>NCT06029049</nct_id>
    </id_info>
    <brief_title>Comparison of Intubation Conditions During Rapid Sequence Induction Obtained With Modified Time Principal Induction With a Standard Intubation Dose of Rocuronium Versus Succinylcholine</brief_title>
    <official_title>Comparison of Intubation Conditions During Rapid Sequence Induction Obtained With Modified Time Principal Induction With a Standard Intubation Dose of Rocuronium Versus Succinylcholine : A Prospective Non-inferiority Randomized and Blind Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The University of Texas Health Science Center, Houston</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>The University of Texas Health Science Center, Houston</source>
    <oversight_info>
      <has_dmc>No</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>
        The purpose of this study is to assess and compare conditions for tracheal intubation&#xD;
        obtained with modified time principal induction with 0.6 mg/kg rocuronium and 1 mg/kg&#xD;
        succinylcholine. Specifically, the investigators will be evaluating ease of laryngoscopy,&#xD;
        vocal cord view, vocal cord opening, and movement of limbs and coughing during tracheal&#xD;
        intubation in order to assess intubation conditions, to compare efficiency and success rate&#xD;
        of tracheal intubation between two induction agents and to determine the rate of patient&#xD;
        awareness during induction and post-operative recall of paralysis.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 5, 2023</start_date>
    <completion_date type="Anticipated">February 14, 2024</completion_date>
    <primary_completion_date type="Anticipated">February 14, 2024</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>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Ease of laryngoscopy</measure>
      <time_frame>During procedure (Between laryngoscope insertion to onset of ventilation (less than 7 minutes))</time_frame>
      <description>Ease of laryngoscopy is scored categorically as easy (Jaw relaxed, no resistance to blade during laryngoscopy) , fair (Jaw not fully relaxed, some resistance to blade) or difficult (Poor jaw relaxation, active resistance by patient to laryngoscopy)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Position of vocal cords</measure>
      <time_frame>During procedure (Between laryngoscope insertion to onset of ventilation (less than 7 minutes))</time_frame>
      <description>Position of vocal cords is scored categorically as abducted, intermediate or closed</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Movement of vocal cords</measure>
      <time_frame>During procedure (Between laryngoscope insertion to onset of ventilation (less than 7 minutes))</time_frame>
      <description>Movement of vocal cords is scored categorically as none , moving or closing</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of participants who moved their limbs during intubation</measure>
      <time_frame>During procedure (Between laryngoscope insertion to onset of ventilation (less than 7 minutes))</time_frame>
      <description>none, slight or vigorous</description>
    </primary_outcome>
    <primary_outcome>
      <measure>number of participants who coughed during tracheal intubation</measure>
      <time_frame>During procedure (Between laryngoscope insertion to onset of ventilation (less than 7 minutes))</time_frame>
      <description>none, diaphragm or sustained (&gt;10s)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of participants for whom tracheal intubations were successful on the first attempt</measure>
      <time_frame>5 minutes after intubation and successful ventilation</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of times tracheal intubations are attempted</measure>
      <time_frame>5 minutes after intubation and successful ventilation</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants for whom tracheal intubations failed</measure>
      <time_frame>After 3 failed intubation attempts (less than 7 minutes from start of intubation)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Airway view at the time of laryngoscopy as categorized by the modified Cormack-Lehane classification (before external manipulation)</measure>
      <time_frame>from start of induction to 5 minutes of successful ventilation</time_frame>
      <description>Data is reported categorically as follows 1(Full view of glottis),2a(Partial view of glottis), 2b(Only posterior extremity of glottis seen or only arytenoid cartilages), 3(Only epiglottis seen, none of glottis seen) and 4(Neither glottis nor epiglottis seen)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Satisfaction of providers with intubating conditions</measure>
      <time_frame>from 5 minutes of successful ventilation</time_frame>
      <description>Providers will answer yes or no for satisfaction</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Heart Rate</measure>
      <time_frame>from the start of induction drug administration to about 5 minutes after successful ventilation</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Diastolic Blood Pressure</measure>
      <time_frame>from the start of induction drug administration to about 5 minutes after successful ventilation</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Systolic Blood Pressure</measure>
      <time_frame>from the start of induction drug administration to about 5 minutes after successful ventilation</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>End-tidal carbon dioxide (CO2)</measure>
      <time_frame>from the start of induction drug administration to about 5 minutes after successful ventilation</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Oxygen saturation (SpO2)</measure>
      <time_frame>from the start of induction drug administration to about 5 minutes after successful ventilation</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants that had injury associated with intubation</measure>
      <time_frame>within 24 hours after surgery</time_frame>
      <description>Injury is defined as injury to dentition, lips, tongue, and pharyngeal bleeding.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with muscle paralysis awareness prior to loss of consciousness as assessed by the Post Anesthesia Care Unit Survey of Modified Time Principle Induction</measure>
      <time_frame>within 24 hours after surgery</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants who had presence of sore throat as assessed by the score on the Post Anesthesia Care Unit Survey of Modified Time Principle Induction</measure>
      <time_frame>within 24 hours after surgery</time_frame>
      <description>This is scored from 0(no pain) to 10(worst pain)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants who had nausea as assessed by the score on the Post Anesthesia Care Unit Survey of Modified Time Principle Induction</measure>
      <time_frame>within 24 hours after surgery</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants who had vomiting as assessed by the score on the Post Anesthesia Care Unit Survey of Modified Time Principle Induction</measure>
      <time_frame>within 24 hours after surgery</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall patient satisfaction as assessed by the score on the Post Anesthesia Care Unit Survey of Modified Time Principle Induction</measure>
      <time_frame>within 24 hours after surgery</time_frame>
      <description>This is scored from 0(not satisfied) to 10(extremely satisfied)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants who had recollection of pain on induction</measure>
      <time_frame>within 24 hours after surgery</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">152</enrollment>
    <condition>Anesthesia</condition>
    <arm_group>
      <arm_group_label>Modified Time Principle Induction (MTPI) with rocuronium</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>RSI with succinylcholine</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Modified Time Principle Induction (MTPI) with rocuronium</intervention_name>
      <description>Participants will be induced using lidocaine 1 mg/kg IV, an opioid such a fentanyl (1-2 mcg/kg) IV, followed by 0.6 mg/kg IV rocuronium, and IV propofol with dosage at the discretion of the care team, administered within 10 seconds of rocuronium and the intubation will be performed with a C-MAC</description>
      <arm_group_label>Modified Time Principle Induction (MTPI) with rocuronium</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>RSI succinylcholine</intervention_name>
      <description>Participants will be induced as per routine care using lidocaine 1 mg/kg IV, an opioid such a fentanyl (1-2 mcg/kg) IV, propofol 1-2 mg/kg IV, and succinylcholine 1mg/kg IV, and the intubation will be performed with a C-MAC</description>
      <arm_group_label>RSI with succinylcholine</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  BMI &gt; 30kg/m2 or Mallampati class III or IV.&#xD;
  &#xD;
            -  Requiring general anesthesia and endotracheal intubation&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Acute and chronic respiratory disorders, including Chronic obstructive pulmonary&#xD;
               disease(COPD) and asthma.&#xD;
  &#xD;
            -  The American Society of Anesthesiologists (ASA) physical status classification &gt; III.&#xD;
  &#xD;
            -  Patients requiring awake intubation.&#xD;
  &#xD;
            -  Pregnant women.&#xD;
  &#xD;
            -  Untreated ischemic heart disease.&#xD;
  &#xD;
            -  Patients requiring an induction dose of propofol &lt; 1 mg/kg.&#xD;
  &#xD;
            -  Allergy to propofol, rocuronium, succinylcholine, or sugammadex.&#xD;
  &#xD;
            -  Patients with renal failure and unknown potassium (K+) level, or patients with K+&#xD;
               level &gt; 5.0&#xD;
  &#xD;
            -  Personal history of malignant hyperthermia (MH), or family history of MH&#xD;
  &#xD;
            -  Patients with suspected or diagnosed neuromuscular disease, patients with burn&#xD;
               injuries&#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>Lauren M Nakazawa, MD,MBA</last_name>
      <role>Principal Investigator</role>
      <affiliation>The University of Texas Health Science Center, Houston</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Lauren M Nakazawa, MD,MBA</last_name>
      <phone>713-500-6775</phone>
      <email>Lauren.M.Nakazawa@uth.tmc.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Ellie Tuchaai</last_name>
      <phone>713.614.9355</phone>
      <email>Ellie.J.Tuchaai@uth.tmc.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>The University of Texas Health Science Center at Houston</name>
        <address>
          <city>Houston</city>
          <state>Texas</state>
          <zip>77030</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Lauren M Nakazawa, MD,MBA</last_name>
        <phone>713-500-6775</phone>
        <email>Lauren.M.Nakazawa@uth.tmc.edu</email>
      </contact>
      <contact_backup>
        <last_name>Ellie Tuchaai</last_name>
        <phone>713.614.9355</phone>
        <email>Ellie.J.Tuchaai@uth.tmc.edu</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>The University of Texas Health Science Center, Houston</investigator_affiliation>
      <investigator_full_name>Lauren Nakazawa</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Rocuronium</mesh_term>
      <mesh_term>Succinylcholine</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06029049
  org study id: HSC-MS-23-0468
  nct id: NCT06029049
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  The purpose of this study is to assess and compare conditions for tracheal intubation
        obtained with modified time principal induction with 0.6 mg/kg rocuronium and 1 mg/kg
        succinylcholine. Specifically, the investigators will be evaluating ease of laryngoscopy,
        vocal cord view, vocal cord opening, and movement of limbs and coughing during tracheal
        intubation in order to assess intubation conditions, to compare efficiency and success rate
        of tracheal intubation between two induction agents and to determine the rate of patient
        awareness during induction and post-operative recall of paralysis.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  measure: Ease of laryngoscopy
  time frame: During procedure (Between laryngoscope insertion to onset of ventilation (less than 7 minutes))
  description: Ease of laryngoscopy is scored categorically as easy (Jaw relaxed, no resistance to blade during laryngoscopy) , fair (Jaw not fully relaxed, some resistance to blade) or difficult (Poor jaw relaxation, active resistance by patient to laryngoscopy)
  measure: Position of vocal cords
  time frame: During procedure (Between laryngoscope insertion to onset of ventilation (less than 7 minutes))
  description: Position of vocal cords is scored categorically as abducted, intermediate or closed
  measure: Movement of vocal cords
  time frame: During procedure (Between laryngoscope insertion to onset of ventilation (less than 7 minutes))
  description: Movement of vocal cords is scored categorically as none , moving or closing
  measure: Number of participants who moved their limbs during intubation
  time frame: During procedure (Between laryngoscope insertion to onset of ventilation (less than 7 minutes))
  description: none, slight or vigorous
  measure: number of participants who coughed during tracheal intubation
  time frame: During procedure (Between laryngoscope insertion to onset of ventilation (less than 7 minutes))
  description: none, diaphragm or sustained (>10s)
  measure: Number of participants for whom tracheal intubations were successful on the first attempt
  time frame: 5 minutes after intubation and successful ventilation
  measure: Number of times tracheal intubations are attempted
  time frame: 5 minutes after intubation and successful ventilation
  measure: Number of participants for whom tracheal intubations failed
  time frame: After 3 failed intubation attempts (less than 7 minutes from start of intubation)
  measure: Airway view at the time of laryngoscopy as categorized by the modified Cormack-Lehane classification (before external manipulation)
  time frame: from start of induction to 5 minutes of successful ventilation
  description: Data is reported categorically as follows 1(Full view of glottis),2a(Partial view of glottis), 2b(Only posterior extremity of glottis seen or only arytenoid cartilages), 3(Only epiglottis seen, none of glottis seen) and 4(Neither glottis nor epiglottis seen)
  measure: Satisfaction of providers with intubating conditions
  time frame: from 5 minutes of successful ventilation
  description: Providers will answer yes or no for satisfaction
  measure: Heart Rate
  time frame: from the start of induction drug administration to about 5 minutes after successful ventilation
  measure: Diastolic Blood Pressure
  time frame: from the start of induction drug administration to about 5 minutes after successful ventilation
  measure: Systolic Blood Pressure
  time frame: from the start of induction drug administration to about 5 minutes after successful ventilation
  measure: End-tidal carbon dioxide (CO2)
  time frame: from the start of induction drug administration to about 5 minutes after successful ventilation
  measure: Oxygen saturation (SpO2)
  time frame: from the start of induction drug administration to about 5 minutes after successful ventilation
  measure: Number of participants that had injury associated with intubation
  time frame: within 24 hours after surgery
  description: Injury is defined as injury to dentition, lips, tongue, and pharyngeal bleeding.
  measure: Number of participants with muscle paralysis awareness prior to loss of consciousness as assessed by the Post Anesthesia Care Unit Survey of Modified Time Principle Induction
  time frame: within 24 hours after surgery
  measure: Number of participants who had presence of sore throat as assessed by the score on the Post Anesthesia Care Unit Survey of Modified Time Principle Induction
  time frame: within 24 hours after surgery
  description: This is scored from 0(no pain) to 10(worst pain)
  measure: Number of participants who had nausea as assessed by the score on the Post Anesthesia Care Unit Survey of Modified Time Principle Induction
  time frame: within 24 hours after surgery
  measure: Number of participants who had vomiting as assessed by the score on the Post Anesthesia Care Unit Survey of Modified Time Principle Induction
  time frame: within 24 hours after surgery
  measure: Overall patient satisfaction as assessed by the score on the Post Anesthesia Care Unit Survey of Modified Time Principle Induction
  time frame: within 24 hours after surgery
  description: This is scored from 0(not satisfied) to 10(extremely satisfied)
  measure: Number of participants who had recollection of pain on induction
  time frame: within 24 hours after surgery
  arm group label: Modified Time Principle Induction (MTPI) with rocuronium
  arm group type: Experimental
  arm group label: RSI with succinylcholine
  arm group type: Active Comparator
  intervention type: Drug
  intervention name: Modified Time Principle Induction (MTPI) with rocuronium
  description: Participants will be induced using lidocaine 1 mg/kg IV, an opioid such a fentanyl (1-2 mcg/kg) IV, followed by 0.6 mg/kg IV rocuronium, and IV propofol with dosage at the discretion of the care team, administered within 10 seconds of rocuronium and the intubation will be performed with a C-MAC
  arm group label: Modified Time Principle Induction (MTPI) with rocuronium
  intervention type: Drug
  intervention name: RSI succinylcholine
  description: Participants will be induced as per routine care using lidocaine 1 mg/kg IV, an opioid such a fentanyl (1-2 mcg/kg) IV, propofol 1-2 mg/kg IV, and succinylcholine 1mg/kg IV, and the intubation will be performed with a C-MAC
  arm group label: RSI with succinylcholine
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Lauren M Nakazawa, MD,MBA
  role: Principal Investigator
  affiliation: The University of Texas Health Science Center, Houston
  last name: Lauren M Nakazawa, MD,MBA
  phone: 713-500-6775
  email: Lauren.M.Nakazawa@uth.tmc.edu
  last name: Ellie Tuchaai
  phone: 713.614.9355
  email: Ellie.J.Tuchaai@uth.tmc.edu
  facility: 
  contact: 
  contact backup: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: The University of Texas Health Science Center, Houston
  investigator full name: Lauren Nakazawa
  investigator title: Assistant Professor
  mesh term: Rocuronium
  mesh term: Succinylcholine
  sharing ipd: No