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/NCT05985343</url>
    </required_header>
    <id_info>
      <org_study_id>23-700</org_study_id>
      <nct_id>NCT05985343</nct_id>
    </id_info>
    <brief_title>The Impact of Sugammadex on Ileus After Abdominal Wall Reconstruction</brief_title>
    <official_title>The Impact of Sugammadex on Ileus After Abdominal Wall Reconstruction</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The Cleveland Clinic</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>The Cleveland Clinic</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 aim of the study is to determine if the usage of sugammadex would reduce the time to&#xD;
        return of bowel function when compared to standard of care (neostigmine/glycopyrrolate) when&#xD;
        used for neuromuscular blockade reversal in patients with open abdominal wall reconstruction&#xD;
        (AWR).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The investigators baseline postoperative ileus (POI) rate in the setting of open abdominal&#xD;
        wall reconstruction (AWR) is similar to patients undergoing an open bowel resection and often&#xD;
        prolongs patients' hospital stay. Therefore, the investigators aim to determine whether the&#xD;
        use of sugammadex has a clinically significant impact on return of postoperative bowel&#xD;
        function and prevention of POI in these patients.&#xD;
  &#xD;
        The primary outcome is GI-2: postoperative time until passage of 1st bowel movement and&#xD;
        tolerance of solid food.&#xD;
  &#xD;
        The investigators hypothesize:&#xD;
  &#xD;
          -  postoperative time to return of bowel function (GI-2) after open AWR will be&#xD;
             significantly shorter for patients who receive sugammadex for reversal of neuromuscular&#xD;
             blockade when compared to those receiving standard of care (neostigmine/glycopyrrolate).&#xD;
  &#xD;
          -  patients who receive sugammadex for reversal of neuromuscular blockade will have a&#xD;
             reduced incidence of POI requiring nasogastric tube (NG) placement, and decreased length&#xD;
             of hospital stay when compared to standard of care.&#xD;
  &#xD;
        Specific Aim 1: To determine if the use of sugammadex for neuromuscular blockade reversal&#xD;
        reduces the time to postoperative GI-2 bowel function compared to neostigmine/glycopyrrolate&#xD;
        for neuromuscular blockade reversal.&#xD;
  &#xD;
        Specific Aim 2: To determine if sugammadex reduces the incidence of postoperative NG&#xD;
        placement compared to neostigmine/glycopyrrolate for neuromuscular blockade reversal.&#xD;
  &#xD;
        Specific Aim 3: To determine if sugammadex reduces postoperative length of stay following AWR&#xD;
        compared to neostigmine/glycopyrrolate for neuromuscular blockade reversal.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 1, 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>
      <intervention_model_description>Patients will be assigned to receive sugammadex or neostigmine/glycopyrrolate for reversal of neuromuscular blockade</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>The patient will be blinded as to what medication they receive for reversal of neuromuscular blockade</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Time to GI-2 bowel function after surgery</measure>
      <time_frame>From time of randomization to progression of bowel function, which is an average of 87 hours, or until 1 month after randomization; whichever comes first</time_frame>
      <description>The median time to first postoperative bowel movement and tolerance of solid food (defined as GastroIntestinal-2), as measured in hours, will be recorded for each patient and compared between the two groups.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Length of stay</measure>
      <time_frame>From time of randomization to progression allowing safe discharge home, which is an average of 6 days, or until 1 month after randomization; whichever comes first</time_frame>
      <description>Duration of hospital stay as measured in hours from end of surgery to placement of discharge order will be</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Postoperative nasogastric tube placement rate</measure>
      <time_frame>Up to 1 month after randomization</time_frame>
      <description>Placement of nasogastric tube for nausea/vomiting after surgery will be recorded and compared between the two groups.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Postoperative complications</measure>
      <time_frame>Up to 1 month after randomization</time_frame>
      <description>All postoperative complications will be recorded and compared between the two groups</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Postoperative pain</measure>
      <time_frame>Postop day 1, 2, 3, and 4</time_frame>
      <description>Postop pain will be assessed using the Pain Numeric Rating Scale (NRS-11) where patients will report their pain on a 0-10 scale, where higher scores mean worse pain. Overall scores will be compared between the two groups.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Opioid used in morphine milligram equivalents</measure>
      <time_frame>Postop day 1, 2, 3, and 4</time_frame>
      <description>Total postoperative opioid use will be recorded after converted into morphine milligram equivalents (MMEs) and compared between the two groups.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">184</enrollment>
    <condition>Hernia, Ventral</condition>
    <condition>Ileus</condition>
    <arm_group>
      <arm_group_label>Neostigmine/Glycopyrrolate</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Patients assigned to the control arm receive the standardized reversal neostigmine dose with on-label dosing (0.03-0.07mg/kg) and a fixed ratio of glycopyrrolate</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Sugammadex</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Patients randomized to the experimental arm will receive an IV dose of sugammadex according to the package insert of 2 mg/kg for ≥ 2 twitches, 4 mg/kg for 1-2 post-tetanic twitches</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Neostigmine / Glycopyrrolate</intervention_name>
      <description>Patients will receive standard of care for reversal of neuromuscular blockade</description>
      <arm_group_label>Neostigmine/Glycopyrrolate</arm_group_label>
      <other_name>Control arm</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Sugammadex</intervention_name>
      <description>Patients will receive sugammadex for reversal of neuromuscular blockade</description>
      <arm_group_label>Sugammadex</arm_group_label>
      <other_name>Experimental arm</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adults &gt;18 years old&#xD;
  &#xD;
            -  Patients requiring an open ventral hernia repair with retromuscular mesh placement and&#xD;
               at least one myofascial advancement flap&#xD;
  &#xD;
            -  Hernias with fascial defects &lt; 20cm wide&#xD;
  &#xD;
            -  Non-emergent cases&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Known serious or severe hypersensitivity reaction to sugammadex or any of the&#xD;
               ingredients in sugammadex.&#xD;
  &#xD;
            -  Hernias with fascial defects &gt; 20cm wide&#xD;
  &#xD;
            -  Concomitant treatment with a strong or moderate cytochrome P450 3A4 inhibitor (e.g.,&#xD;
               Ketoconazole and other anti-fungals, Clarithromycin, HIV protease inhibitors,&#xD;
               diltiazem, erythromycin, verapamil) or strong CYP3A4 inducers (e.g., rifampin).&#xD;
  &#xD;
            -  Known small bowel obstruction (SBO) at the time of hernia repair&#xD;
  &#xD;
            -  Suspected SBO or at risk of recurrent SBO at the time of hernia repair - at the&#xD;
               discretion of the staff surgeon.&#xD;
  &#xD;
            -  Nasogastric (NG), orogastric (OG), or gastric (eg. PEG) in place at the time of hernia&#xD;
               repair and left in beyond the morning of the first postoperative day.&#xD;
  &#xD;
            -  Patients with a stoma.&#xD;
  &#xD;
            -  Cancer with increased risk of gastro-duodenal perforation (e.g., infiltrative&#xD;
               gastrointestinal tract malignancy, recent gastrointestinal tract surgery, diverticular&#xD;
               disease including diverticulitis, ischemic colitis, or concomitantly treated with&#xD;
               bevacizumab) - at the discretion of the staff surgeon.&#xD;
  &#xD;
            -  Disorder that could alter the integrity of the gastrointestinal lining (e.g., Crohn's&#xD;
               disease) - at the discretion of the staff surgeon.&#xD;
  &#xD;
            -  Severe hepatic failure (Child-Pugh Class C).&#xD;
  &#xD;
            -  Clinically relevant hepatic failure (e.g. cirrhosis) - at the discretion of the staff&#xD;
               surgeon.&#xD;
  &#xD;
            -  Severe renal failure (GFR&lt;30ml/min, on dialysis, or have an arteriovenous fistula,&#xD;
               indwelling hemodialysis catheter or peritoneal dialysis catheter) - at the discretion&#xD;
               of the staff surgeon.&#xD;
  &#xD;
            -  Pregnant or planning to become pregnant during study period.&#xD;
  &#xD;
            -  Breastfeeding or planning to breastfeed during study period.&#xD;
  &#xD;
            -  Clinically relevant alteration of the blood-brain-barrier - at the discretion of the&#xD;
               staff surgeon.&#xD;
  &#xD;
            -  Other contraindication to sugammadex as documented by a physician.&#xD;
  &#xD;
            -  Unable to give informed consent; vulnerable populations; non-English speaking.&#xD;
  &#xD;
            -  Emergent operation.&#xD;
  &#xD;
            -  Undergoing minimally invasive approaches.&#xD;
  &#xD;
            -  Undergoing repair with mesh placed in a position other than retromuscular.&#xD;
  &#xD;
            -  Chronic opioid users, as defined by the daily use of opioids for at least 90 days&#xD;
               within the past year&#xD;
  &#xD;
            -  Inability to safely extubate the patient at the end of the surgery for any reason, as&#xD;
               determined by the operative team.&#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>Clayton C Petro, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>The Cleveland Clinic</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Clayton C Petro, MD</last_name>
      <phone>216 445-0053</phone>
      <email>petroc@ccf.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Ryan C Ellis, MD</last_name>
      <phone>440 409-3948</phone>
      <email>ellisr2@ccf.org</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Cleveland Clinic Center for Abdominal Core Health</name>
        <address>
          <city>Cleveland</city>
          <state>Ohio</state>
          <zip>44195</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Clayton C Petro, MD</last_name>
        <phone>216-445-0053</phone>
        <email>petroc@ccf.org</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>The Cleveland Clinic</investigator_affiliation>
      <investigator_full_name>Clayton Petro</investigator_full_name>
      <investigator_title>Assistant Professor of Surgery Lerner College of Medicine</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Ileus</mesh_term>
      <mesh_term>Hernia, Ventral</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Glycopyrrolate</mesh_term>
      <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/NCT05985343
  org study id: 23-700
  nct id: NCT05985343
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  The aim of the study is to determine if the usage of sugammadex would reduce the time to
        return of bowel function when compared to standard of care (neostigmine/glycopyrrolate) when
        used for neuromuscular blockade reversal in patients with open abdominal wall reconstruction
        (AWR).
  The investigators baseline postoperative ileus (POI) rate in the setting of open abdominal
        wall reconstruction (AWR) is similar to patients undergoing an open bowel resection and often
        prolongs patients' hospital stay. Therefore, the investigators aim to determine whether the
        use of sugammadex has a clinically significant impact on return of postoperative bowel
        function and prevention of POI in these patients.
  
        The primary outcome is GI-2: postoperative time until passage of 1st bowel movement and
        tolerance of solid food.
  
        The investigators hypothesize:
  
          -  postoperative time to return of bowel function (GI-2) after open AWR will be
             significantly shorter for patients who receive sugammadex for reversal of neuromuscular
             blockade when compared to those receiving standard of care (neostigmine/glycopyrrolate).
  
          -  patients who receive sugammadex for reversal of neuromuscular blockade will have a
             reduced incidence of POI requiring nasogastric tube (NG) placement, and decreased length
             of hospital stay when compared to standard of care.
  
        Specific Aim 1: To determine if the use of sugammadex for neuromuscular blockade reversal
        reduces the time to postoperative GI-2 bowel function compared to neostigmine/glycopyrrolate
        for neuromuscular blockade reversal.
  
        Specific Aim 2: To determine if sugammadex reduces the incidence of postoperative NG
        placement compared to neostigmine/glycopyrrolate for neuromuscular blockade reversal.
  
        Specific Aim 3: To determine if sugammadex reduces postoperative length of stay following AWR
        compared to neostigmine/glycopyrrolate for neuromuscular blockade reversal.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Patients will be assigned to receive sugammadex or neostigmine/glycopyrrolate for reversal of neuromuscular blockade
  primary purpose: Supportive Care
  masking: Single (Participant)
  masking description: The patient will be blinded as to what medication they receive for reversal of neuromuscular blockade
  measure: Time to GI-2 bowel function after surgery
  time frame: From time of randomization to progression of bowel function, which is an average of 87 hours, or until 1 month after randomization; whichever comes first
  description: The median time to first postoperative bowel movement and tolerance of solid food (defined as GastroIntestinal-2), as measured in hours, will be recorded for each patient and compared between the two groups.
  measure: Length of stay
  time frame: From time of randomization to progression allowing safe discharge home, which is an average of 6 days, or until 1 month after randomization; whichever comes first
  description: Duration of hospital stay as measured in hours from end of surgery to placement of discharge order will be
  measure: Postoperative nasogastric tube placement rate
  time frame: Up to 1 month after randomization
  description: Placement of nasogastric tube for nausea/vomiting after surgery will be recorded and compared between the two groups.
  measure: Postoperative complications
  time frame: Up to 1 month after randomization
  description: All postoperative complications will be recorded and compared between the two groups
  measure: Postoperative pain
  time frame: Postop day 1, 2, 3, and 4
  description: Postop pain will be assessed using the Pain Numeric Rating Scale (NRS-11) where patients will report their pain on a 0-10 scale, where higher scores mean worse pain. Overall scores will be compared between the two groups.
  measure: Opioid used in morphine milligram equivalents
  time frame: Postop day 1, 2, 3, and 4
  description: Total postoperative opioid use will be recorded after converted into morphine milligram equivalents (MMEs) and compared between the two groups.
  arm group label: Neostigmine/Glycopyrrolate
  arm group type: Other
  description: Patients assigned to the control arm receive the standardized reversal neostigmine dose with on-label dosing (0.03-0.07mg/kg) and a fixed ratio of glycopyrrolate
  arm group label: Sugammadex
  arm group type: Other
  description: Patients randomized to the experimental arm will receive an IV dose of sugammadex according to the package insert of 2 mg/kg for ≥ 2 twitches, 4 mg/kg for 1-2 post-tetanic twitches
  intervention type: Drug
  intervention name: Neostigmine / Glycopyrrolate
  description: Patients will receive standard of care for reversal of neuromuscular blockade
  arm group label: Neostigmine/Glycopyrrolate
  other name: Control arm
  intervention type: Drug
  intervention name: Sugammadex
  description: Patients will receive sugammadex for reversal of neuromuscular blockade
  arm group label: Sugammadex
  other name: Experimental arm
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Clayton C Petro, MD
  role: Principal Investigator
  affiliation: The Cleveland Clinic
  last name: Clayton C Petro, MD
  phone: 216 445-0053
  email: petroc@ccf.org
  last name: Ryan C Ellis, MD
  phone: 440 409-3948
  email: ellisr2@ccf.org
  facility: 
  contact: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: The Cleveland Clinic
  investigator full name: Clayton Petro
  investigator title: Assistant Professor of Surgery Lerner College of Medicine
  mesh term: Ileus
  mesh term: Hernia, Ventral
  mesh term: Glycopyrrolate
  mesh term: Neostigmine
  sharing ipd: No