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/NCT05993390</url>
    </required_header>
    <id_info>
      <org_study_id>H-2306-197-1445</org_study_id>
      <nct_id>NCT05993390</nct_id>
    </id_info>
    <brief_title>Pharmacological Reversal of Neuromuscular Blockade in Critically Ill Patients</brief_title>
    <official_title>Effect of Neuromuscular Reversal Agents on Time for Neurological Assessment After Endotracheal Intubation in Critically Ill Patients</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>
      <has_dmc>Yes</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>
        The goal of this clinical trial is to compare the effect of use of reversal agents for&#xD;
        neuromuscular blockade in critically ill patients on time for neurological assessment after&#xD;
        endotracheal intubation&#xD;
  &#xD;
        The main questions it aims to answer are:&#xD;
  &#xD;
          -  The use of reversal agents for neuromuscular blockade after endotracheal intubation may&#xD;
             reduce the time for neurological assessment.&#xD;
  &#xD;
          -  The types of reversal agents for neuromuscular blockade may affect the time for&#xD;
             neurological assessment.&#xD;
  &#xD;
        Participants will receive different reversal agents or no medications based on the assigned&#xD;
        groups. Thirty minutes after intubation using rocuronium, medication is administered, and the&#xD;
        time of initial confirmation of eye opening and movement is recorded.&#xD;
  &#xD;
        Researchers will compare 3 groups (sugammadex, neostigmine and control(no medication) to see&#xD;
        the difference of time for neurological assessment after endotracheal intubation.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Patients who agree to participate in the study will be randomized to the sugammadex group,&#xD;
        neostigmine group, or control group.&#xD;
  &#xD;
        Randomization will be performed by an independent investigator. Patient, medical staff&#xD;
        performing patient evaluation are masked for the assignment otherwise the medical staff&#xD;
        administering medications to patient is not blinded.&#xD;
  &#xD;
        An independent investigator, who is not included in this study, will provide the assignment&#xD;
        result to the medical staff administering medications to patient.&#xD;
  &#xD;
          1. Neurologic assessment&#xD;
  &#xD;
             The point at which first available neurologic assessment is defined as the point at&#xD;
             which the patient is able to move on command (Motor score of 6 on the GCS), and the GCS&#xD;
             will be assessed until that point.&#xD;
  &#xD;
             Regardless of randomization outcome, all patients will be monitored for GCS and&#xD;
             monitored for processed EEG and cerebral regional oxygen saturation prior to intubation.&#xD;
  &#xD;
             Assessment of GCS before administration of sedatives for endotracheal intubation, every&#xD;
             10 minutes after intubation, before administration of study medications, every 5 minutes&#xD;
             until 30 minutes after administration of study medications, and every 10 minutes after&#xD;
             30 minutes, with additional assessments at that time if spontaneous eye opening occurs.&#xD;
             The GCS will be assessed until directed movement is possible (Motor score of 6 on the&#xD;
             GCS).&#xD;
  &#xD;
             Eye opening response: If there is no response after 2 repetitions of 'OOO, please open&#xD;
             your eyes', the response is evaluated with 2 repetitions of the stimulus of pressing the&#xD;
             thumb nail. If the subject opens his/her eyes spontaneously, skip this assessment.&#xD;
  &#xD;
             Motor response: 'Please make a fist' and 'Please open your fist' are performed twice,&#xD;
             and if there is no response, the stimulus of pressing the thumb nail is performed twice&#xD;
             to assess the response.&#xD;
  &#xD;
          2. Processed EEG and cerebral regional oxygen saturation&#xD;
  &#xD;
             Processed EEG using Masimo's Next Generation SedLine® Brain Function Monitoring, and&#xD;
             cerebral regional oxygen saturation using Masimo's O3® Regional Oximetry is monitored&#xD;
             and recorded.&#xD;
  &#xD;
             Processed EEG and cerebral regional oxygen saturation will be recorded at 10 minute&#xD;
             intervals from before sedation for intubation until neurological function can be&#xD;
             assessed.&#xD;
  &#xD;
          3. Neuromuscular function monitoring&#xD;
  &#xD;
             Utilized by the Philips Intellivue NMT(neuromuscular transmission) monitor. Monitor&#xD;
             every 5 minutes beginning 30 minutes after Rocuronium dosing and discontinue monitoring&#xD;
             if eyes open spontaneously (Eye score of 4 on GCS).&#xD;
  &#xD;
          4. Endotracheal intubation 100% oxygen is delivered via a facial fitting mask. Patients who&#xD;
             have been maintained on oxygen via a high-flow nasal cannula are given 100% oxygen with&#xD;
             a flow rate of 60 L/min.&#xD;
  &#xD;
             Sedation is administered with etomidate 0.1-0.2 mg/kg, and endotracheal intubation is&#xD;
             performed with rocuronium 1 mg/kg once the patient's loss of consciousness is confirmed.&#xD;
  &#xD;
          5. Drug Administration&#xD;
  &#xD;
             Sugammadex treatment group&#xD;
  &#xD;
             Neuromuscular function monitoring is performed every 5 minutes starting 30 minutes after&#xD;
             rocuronium administration.&#xD;
  &#xD;
             Sugammadex 0.2 mg/kg 30 minutes after rocuronium is administered, after GCS assessment&#xD;
             and neuromuscular function monitoring.&#xD;
  &#xD;
             Processed EEG and cerebral regional oxygen saturation levels at the time of sugammadex&#xD;
             administration is recorded.&#xD;
  &#xD;
             Neostigmine group Neuromuscular function monitoring is performed every 5 minutes&#xD;
             starting 30 minutes after rocuronium administration.&#xD;
  &#xD;
             Administer neostigmine 0.05 mg/kg + glycopyrrolate 0.01 mg/kg after rocuronium is&#xD;
             administered, after GCS assessment and neuromuscular function monitoring.&#xD;
  &#xD;
             Processed EEG and cerebral regional oxygen saturation levels at the time of sugammadex&#xD;
             administration is recorded.&#xD;
  &#xD;
             Control group Processed EEG and cerebral regional oxygen saturation levels at the time&#xD;
             of sugammadex administration is recorded.&#xD;
  &#xD;
          6. GCS assessment and neuromuscular function monitoring is performed 30 minutes after&#xD;
             rocuronium administration, and processed EEG and cerebral regional oxygen saturation&#xD;
             levels is recorded.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 11, 2023</start_date>
    <completion_date type="Anticipated">August 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">August 14, 2025</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>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Time from administration of neuromuscular blocker to the first available neurologic assessment (in minutes)</measure>
      <time_frame>Time from administration of neuromuscular blocker to first available neurologic assessment (Motor score 6 on GCS, in minutes), assessed up to 48 hours.</time_frame>
      <description>Time from administration of neuromuscular blocker to the first time the patient is able to make a directed movement (Motor score 6 on GCS), assessed up to 48 hours.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Time from administration of neuromuscular blocker to first available spontaneous eye opening (in minutes)</measure>
      <time_frame>Time from administration of neuromuscular blocker to first time the patient is able to open eyes spontaneously (Eye score 4 on GCS, in minutes), assessed up to 48 hours.</time_frame>
      <description>Time from administration of neuromuscular blocker to first time the patient is able to open eyes spontaneously (Eye score 4 on GCS), assessed up to 48 hours.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes of Patient State index (PSi) values</measure>
      <time_frame>Before intubation (Time 0), Time 10/20/30/35/40/45/50/55/60/70/80/90 minutes</time_frame>
      <description>Changes of Patient State index (PSi) values</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes of regional cerebral oxygen saturation (O3) values</measure>
      <time_frame>Before intubation (Time 0), Time 10/20/30/35/40/45/50/55/60/70/80/90 minutes</time_frame>
      <description>Changes of regional cerebral oxygen saturation (O3) values</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time from intubation to extubation</measure>
      <time_frame>Date of the patient extubated, up to 1 month</time_frame>
      <description>Time from intubation to extubation, up to 1 month</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total length of hospital stay</measure>
      <time_frame>Date of discharge from the hospital, up to 1 month</time_frame>
      <description>Total length of hospital stay, up to 1 month</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total length of intensive care unit(ICU) stay</measure>
      <time_frame>Date of discharge from the ICU, up to 1 month</time_frame>
      <description>Total length of intensive care unit(ICU) stay, up to 1 month</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>In-ICU mortality</measure>
      <time_frame>Date of death from any cause in ICU, up to 1 month</time_frame>
      <description>In-ICU mortality, up to 1 month</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>In-hospital mortality</measure>
      <time_frame>Date of death from any cause in hospital, up to 1 month</time_frame>
      <description>In-hospital mortality, up to 1 month</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Neuromuscular Blockade</condition>
    <condition>Critical Illness</condition>
    <condition>Neurologic Findings</condition>
    <arm_group>
      <arm_group_label>Sugammadex group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patient is intubated with etomidate 0.1~0.2mg/kg and rocuronium 1mg/kg. 30 minutes after rocuronium administration, patient is administered sugammadex 1mg/kg. Glasgow coma scale as neurologic assessment is assessed at 10-minute intervals before intubation, and at 5-minute intervals up to 30 minutes after administration of sugammadex. After 30 minutes, the assessments are conducted at 10-minute intervals. Additionally, if the patient spontaneously opens their eyes, the GCS is assessed at that specific moment. The GCS evaluation continues until the patient reaches a point of responsiveness, indicated by a Motor score of 6 on the GCS.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Neostigmine group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patient is intubated with etomidate 0.1~0.2mg/kg and rocuronium 1mg/kg. 30 minutes after rocuronium administration, patient is administered neostigmine 0.05mg/kg + glycopyrrolate 0.01mg/kg. Glasgow coma scale as neurologic assessment is assessed at 10-minute intervals before intubation, and at 5-minute intervals up to 30 minutes after administration of neostigmine. After 30 minutes, the assessments are conducted at 10-minute intervals. Additionally, if the patient spontaneously opens their eyes, the GCS is assessed at that specific moment. The GCS evaluation continues until the patient reaches a point of responsiveness, indicated by a Motor score of 6 on the GCS.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Patient is intubated with etomidate 0.1~0.2mg/kg and rocuronium 1mg/kg. Glasgow coma scale as neurologic assessment is assessed at 10-minute intervals before intubation, and at 5-minute intervals up to 60 minutes after intubation. After 60 minutes, the assessments are conducted at 10-minute intervals. Additionally, if the patient spontaneously opens their eyes, the GCS is assessed at that specific moment. The GCS evaluation continues until the patient reaches a point of responsiveness, indicated by a Motor score of 6 on the GCS.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Sugammadex</intervention_name>
      <description>Intravenous administration of sugammadex 2mg/kg.</description>
      <arm_group_label>Sugammadex group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Neostigmine</intervention_name>
      <description>Intravenous administration of neostigmine 0.05mg/kg with glycopyrrolate 0.01mg/kg</description>
      <arm_group_label>Neostigmine group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult patients 19 years of age or older who were intubated after admission to the&#xD;
               intensive care unit.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients younger than 19 years of age&#xD;
  &#xD;
            -  Patients who are not neurologically evaluable or have concomitant neurologic&#xD;
               dysfunction&#xD;
  &#xD;
            -  Patients with neuromuscular disorder&#xD;
  &#xD;
            -  Patients with a history of drug allergic reactions to sugammadex or neostigmine&#xD;
  &#xD;
            -  Patients taking or planning to take toremifene, fusidic acid, or hormonal&#xD;
               contraceptives&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>19 Years</minimum_age>
      <maximum_age>90 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ho Geol Ryu, M.D., Ph.D</last_name>
      <role>Study Chair</role>
      <affiliation>Seoul National University Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Leerang Lim, MD</last_name>
      <phone>+82-10-5063-1742</phone>
      <email>erange@snu.ac.kr</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
      <investigator_full_name>Ho Geol Ryu</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>Reversal of neuromuscular blockade</keyword>
    <keyword>Neurologic assessment</keyword>
    <keyword>Endotracheal intubation</keyword>
    <keyword>Critically ill patient</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neurologic Manifestations</mesh_term>
      <mesh_term>Critical Illness</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neostigmine</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/NCT05993390
  org study id: H-2306-197-1445
  nct id: NCT05993390
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to compare the effect of use of reversal agents for
        neuromuscular blockade in critically ill patients on time for neurological assessment after
        endotracheal intubation
  
        The main questions it aims to answer are:
  
          -  The use of reversal agents for neuromuscular blockade after endotracheal intubation may
             reduce the time for neurological assessment.
  
          -  The types of reversal agents for neuromuscular blockade may affect the time for
             neurological assessment.
  
        Participants will receive different reversal agents or no medications based on the assigned
        groups. Thirty minutes after intubation using rocuronium, medication is administered, and the
        time of initial confirmation of eye opening and movement is recorded.
  
        Researchers will compare 3 groups (sugammadex, neostigmine and control(no medication) to see
        the difference of time for neurological assessment after endotracheal intubation.
  Patients who agree to participate in the study will be randomized to the sugammadex group,
        neostigmine group, or control group.
  
        Randomization will be performed by an independent investigator. Patient, medical staff
        performing patient evaluation are masked for the assignment otherwise the medical staff
        administering medications to patient is not blinded.
  
        An independent investigator, who is not included in this study, will provide the assignment
        result to the medical staff administering medications to patient.
  
          1. Neurologic assessment
  
             The point at which first available neurologic assessment is defined as the point at
             which the patient is able to move on command (Motor score of 6 on the GCS), and the GCS
             will be assessed until that point.
  
             Regardless of randomization outcome, all patients will be monitored for GCS and
             monitored for processed EEG and cerebral regional oxygen saturation prior to intubation.
  
             Assessment of GCS before administration of sedatives for endotracheal intubation, every
             10 minutes after intubation, before administration of study medications, every 5 minutes
             until 30 minutes after administration of study medications, and every 10 minutes after
             30 minutes, with additional assessments at that time if spontaneous eye opening occurs.
             The GCS will be assessed until directed movement is possible (Motor score of 6 on the
             GCS).
  
             Eye opening response: If there is no response after 2 repetitions of 'OOO, please open
             your eyes', the response is evaluated with 2 repetitions of the stimulus of pressing the
             thumb nail. If the subject opens his/her eyes spontaneously, skip this assessment.
  
             Motor response: 'Please make a fist' and 'Please open your fist' are performed twice,
             and if there is no response, the stimulus of pressing the thumb nail is performed twice
             to assess the response.
  
          2. Processed EEG and cerebral regional oxygen saturation
  
             Processed EEG using Masimo's Next Generation SedLine® Brain Function Monitoring, and
             cerebral regional oxygen saturation using Masimo's O3® Regional Oximetry is monitored
             and recorded.
  
             Processed EEG and cerebral regional oxygen saturation will be recorded at 10 minute
             intervals from before sedation for intubation until neurological function can be
             assessed.
  
          3. Neuromuscular function monitoring
  
             Utilized by the Philips Intellivue NMT(neuromuscular transmission) monitor. Monitor
             every 5 minutes beginning 30 minutes after Rocuronium dosing and discontinue monitoring
             if eyes open spontaneously (Eye score of 4 on GCS).
  
          4. Endotracheal intubation 100% oxygen is delivered via a facial fitting mask. Patients who
             have been maintained on oxygen via a high-flow nasal cannula are given 100% oxygen with
             a flow rate of 60 L/min.
  
             Sedation is administered with etomidate 0.1-0.2 mg/kg, and endotracheal intubation is
             performed with rocuronium 1 mg/kg once the patient's loss of consciousness is confirmed.
  
          5. Drug Administration
  
             Sugammadex treatment group
  
             Neuromuscular function monitoring is performed every 5 minutes starting 30 minutes after
             rocuronium administration.
  
             Sugammadex 0.2 mg/kg 30 minutes after rocuronium is administered, after GCS assessment
             and neuromuscular function monitoring.
  
             Processed EEG and cerebral regional oxygen saturation levels at the time of sugammadex
             administration is recorded.
  
             Neostigmine group Neuromuscular function monitoring is performed every 5 minutes
             starting 30 minutes after rocuronium administration.
  
             Administer neostigmine 0.05 mg/kg + glycopyrrolate 0.01 mg/kg after rocuronium is
             administered, after GCS assessment and neuromuscular function monitoring.
  
             Processed EEG and cerebral regional oxygen saturation levels at the time of sugammadex
             administration is recorded.
  
             Control group Processed EEG and cerebral regional oxygen saturation levels at the time
             of sugammadex administration is recorded.
  
          6. GCS assessment and neuromuscular function monitoring is performed 30 minutes after
             rocuronium administration, and processed EEG and cerebral regional oxygen saturation
             levels is recorded.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Care Provider, Outcomes Assessor)
  measure: Time from administration of neuromuscular blocker to the first available neurologic assessment (in minutes)
  time frame: Time from administration of neuromuscular blocker to first available neurologic assessment (Motor score 6 on GCS, in minutes), assessed up to 48 hours.
  description: Time from administration of neuromuscular blocker to the first time the patient is able to make a directed movement (Motor score 6 on GCS), assessed up to 48 hours.
  measure: Time from administration of neuromuscular blocker to first available spontaneous eye opening (in minutes)
  time frame: Time from administration of neuromuscular blocker to first time the patient is able to open eyes spontaneously (Eye score 4 on GCS, in minutes), assessed up to 48 hours.
  description: Time from administration of neuromuscular blocker to first time the patient is able to open eyes spontaneously (Eye score 4 on GCS), assessed up to 48 hours.
  measure: Changes of Patient State index (PSi) values
  time frame: Before intubation (Time 0), Time 10/20/30/35/40/45/50/55/60/70/80/90 minutes
  description: Changes of Patient State index (PSi) values
  measure: Changes of regional cerebral oxygen saturation (O3) values
  time frame: Before intubation (Time 0), Time 10/20/30/35/40/45/50/55/60/70/80/90 minutes
  description: Changes of regional cerebral oxygen saturation (O3) values
  measure: Time from intubation to extubation
  time frame: Date of the patient extubated, up to 1 month
  description: Time from intubation to extubation, up to 1 month
  measure: Total length of hospital stay
  time frame: Date of discharge from the hospital, up to 1 month
  description: Total length of hospital stay, up to 1 month
  measure: Total length of intensive care unit(ICU) stay
  time frame: Date of discharge from the ICU, up to 1 month
  description: Total length of intensive care unit(ICU) stay, up to 1 month
  measure: In-ICU mortality
  time frame: Date of death from any cause in ICU, up to 1 month
  description: In-ICU mortality, up to 1 month
  measure: In-hospital mortality
  time frame: Date of death from any cause in hospital, up to 1 month
  description: In-hospital mortality, up to 1 month
  arm group label: Sugammadex group
  arm group type: Experimental
  description: Patient is intubated with etomidate 0.1~0.2mg/kg and rocuronium 1mg/kg. 30 minutes after rocuronium administration, patient is administered sugammadex 1mg/kg. Glasgow coma scale as neurologic assessment is assessed at 10-minute intervals before intubation, and at 5-minute intervals up to 30 minutes after administration of sugammadex. After 30 minutes, the assessments are conducted at 10-minute intervals. Additionally, if the patient spontaneously opens their eyes, the GCS is assessed at that specific moment. The GCS evaluation continues until the patient reaches a point of responsiveness, indicated by a Motor score of 6 on the GCS.
  arm group label: Neostigmine group
  arm group type: Experimental
  description: Patient is intubated with etomidate 0.1~0.2mg/kg and rocuronium 1mg/kg. 30 minutes after rocuronium administration, patient is administered neostigmine 0.05mg/kg + glycopyrrolate 0.01mg/kg. Glasgow coma scale as neurologic assessment is assessed at 10-minute intervals before intubation, and at 5-minute intervals up to 30 minutes after administration of neostigmine. After 30 minutes, the assessments are conducted at 10-minute intervals. Additionally, if the patient spontaneously opens their eyes, the GCS is assessed at that specific moment. The GCS evaluation continues until the patient reaches a point of responsiveness, indicated by a Motor score of 6 on the GCS.
  arm group label: Control group
  arm group type: No Intervention
  description: Patient is intubated with etomidate 0.1~0.2mg/kg and rocuronium 1mg/kg. Glasgow coma scale as neurologic assessment is assessed at 10-minute intervals before intubation, and at 5-minute intervals up to 60 minutes after intubation. After 60 minutes, the assessments are conducted at 10-minute intervals. Additionally, if the patient spontaneously opens their eyes, the GCS is assessed at that specific moment. The GCS evaluation continues until the patient reaches a point of responsiveness, indicated by a Motor score of 6 on the GCS.
  intervention type: Drug
  intervention name: Sugammadex
  description: Intravenous administration of sugammadex 2mg/kg.
  arm group label: Sugammadex group
  intervention type: Drug
  intervention name: Neostigmine
  description: Intravenous administration of neostigmine 0.05mg/kg with glycopyrrolate 0.01mg/kg
  arm group label: Neostigmine group
  criteria: 
  gender: All
  minimum age: 19 Years
  maximum age: 90 Years
  healthy volunteers: No
  last name: Ho Geol Ryu, M.D., Ph.D
  role: Study Chair
  affiliation: Seoul National University Hospital
  last name: Leerang Lim, MD
  phone: +82-10-5063-1742
  email: erange@snu.ac.kr
  responsible party type: Principal Investigator
  investigator affiliation: Seoul National University Hospital
  investigator full name: Ho Geol Ryu
  investigator title: Professor
  mesh term: Neurologic Manifestations
  mesh term: Critical Illness
  mesh term: Neostigmine
  sharing ipd: No