<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/NCT03808077</url>
  </required_header>
  <id_info>
    <org_study_id>18-408</org_study_id>
    <nct_id>NCT03808077</nct_id>
  </id_info>
  <brief_title>The Effect of Deep Versus Moderate Muscle Relaxants in Men During and After Robotic Surgery for Prostate Cancer</brief_title>
  <official_title>A Randomized Controlled Trial to Compare the Effectiveness of Deep vs. Moderate Neuromuscular Blockade in Reducing Postoperative Pain and Intra-Abdominal Insufflation Pressure During Minimally Invasive Robotic Prostatectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Memorial Sloan Kettering Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Memorial Sloan Kettering Cancer Center</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if there is a difference in intra-abdominal&#xD;
      pressure which surgeons use during surgery and post-surgery pain in men who undergo robotic&#xD;
      prostate surgery with deep neuromuscular blockade (NMB), compared with moderate NMB.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 14, 2019</start_date>
  <completion_date type="Anticipated">January 2024</completion_date>
  <primary_completion_date type="Anticipated">January 2024</primary_completion_date>
  <phase>Phase 2</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference in levels of Intra-Abdominal Pressure (IAP) when performing robotic prostatectomy in participants under a moderate vs deep Neuromuscular Blockade technique</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Difference in levels of postoperative pain in participants under a moderate vs deep Neuromuscular Blockade technique during robotic prostatectomy using the pain numeric pain scale (NPS).</measure>
    <time_frame>1 year</time_frame>
    <description>Difference in levels of postoperative pain in participants under a moderate vs deep Neuromuscular Blockade technique during robotic prostatectomy using the pain numeric pain scale (NPS). The numeric pain scale (NPS) is a subjective measure which can be used in recovery rooms to assist in the assessment of pain. Individuals rate their pain on an eleven-point scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">130</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Interventional Group: Deep Neuromuscular Blockade</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Deep NMB group (Intervention) will have rocuronium infusion titrated to deep paralysis defined as PTC of 1-2 (infusion start rate 0.025mg/kg/min or 1.5mg/kg/hr).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group: Moderate Neuromuscular Blockade</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The Moderate NMB group (Control ) will have rocuronium infusion titrated to moderate paralysis defined as TOF of 1-2 (infusion start rate 0.005mg/kg/min or 0.3mg/kg/hr).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rocuronium 0.3mg/kg/hr</intervention_name>
    <description>The Moderate NMB group (Control ) will have rocuronium infusion titrated to moderate paralysis defined as TOF of 1-2 (infusion start rate 0.005mg/kg/min or 0.3mg/kg/hr).</description>
    <arm_group_label>Control Group: Moderate Neuromuscular Blockade</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rocuronium 1.5mg/kg/hr</intervention_name>
    <description>The Deep NMB group (Intervention) will have rocuronium infusion titrated to deep paralysis defined as PTC of 1-2 (infusion start rate 0.025mg/kg/min or 1.5mg/kg/hr).</description>
    <arm_group_label>Interventional Group: Deep Neuromuscular Blockade</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients under the age of 80&#xD;
&#xD;
          -  American Society of Anesthesiologists Physical Status 1, 2, 3.&#xD;
&#xD;
          -  Elective Robotic Prostatectomy&#xD;
&#xD;
          -  Patient undergoing surgery at Josie Robertson Surgical Center&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age younger than 18&#xD;
&#xD;
          -  Inability to provide informed consent&#xD;
&#xD;
          -  Allergy to rocuronium, sugammadex, midazolam, propofol, fentanyl, lidocaine, mannitol&#xD;
             (IV Acetaeminophen), IV Acetaminophen, Ketorolac, Morphine, Hydromorphone,&#xD;
             Dexamethasone, Zofran, Benadryl, Compazine&#xD;
&#xD;
          -  Neuromuscular disease&#xD;
&#xD;
          -  Any patient with previous abdominal surgery less than or equal to 20 years prior to&#xD;
             scheduled surgery date&#xD;
&#xD;
          -  Patients with BMI&gt;35&#xD;
&#xD;
          -  Severe renal impairment (Creatinine clearance &lt; 30 ml/min)&#xD;
&#xD;
          -  Patient receiving Toremifene or any history of receiving Toremifene&#xD;
&#xD;
          -  Chronic pain patients&#xD;
&#xD;
          -  Patients receiving suboxone&#xD;
&#xD;
          -  Patients receiving succinylcholine&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elizabeth Rieth, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Memorial Sloan Kettering Cancer Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Elizabeth Rieth, MD</last_name>
    <phone>212-639-5737</phone>
    <email>riethe@mskcc.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Marielle Palop Soeprono, CRNA</last_name>
    <phone>212-639-6840</phone>
    <email>PalopM@mskcc.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elizabeth Rieth, MD</last_name>
      <phone>212-639-5737</phone>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mskcc.org</url>
    <description>Memorial Sloan Kettering Cancer Center</description>
  </link>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>January 16, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <last_update_submitted>March 16, 2023</last_update_submitted>
  <last_update_submitted_qc>March 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 20, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>prostate cancer</keyword>
  <keyword>robotic surgery</keyword>
  <keyword>muscle relaxants</keyword>
  <keyword>neuromuscular blockade</keyword>
  <keyword>18-408</keyword>
  <keyword>Memorial Sloan Kettering Cancer Center</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rocuronium</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.</ipd_description>
  </patient_data>
  <!-- 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/NCT03808077
org study id: 18-408
nct id: NCT03808077
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The purpose of this study is to determine if there is a difference in intra-abdominal
      pressure which surgeons use during surgery and post-surgery pain in men who undergo robotic
      prostate surgery with deep neuromuscular blockade (NMB), compared with moderate NMB.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Difference in levels of Intra-Abdominal Pressure (IAP) when performing robotic prostatectomy in participants under a moderate vs deep Neuromuscular Blockade technique
time frame: 1 year
measure: Difference in levels of postoperative pain in participants under a moderate vs deep Neuromuscular Blockade technique during robotic prostatectomy using the pain numeric pain scale (NPS).
time frame: 1 year
description: Difference in levels of postoperative pain in participants under a moderate vs deep Neuromuscular Blockade technique during robotic prostatectomy using the pain numeric pain scale (NPS). The numeric pain scale (NPS) is a subjective measure which can be used in recovery rooms to assist in the assessment of pain. Individuals rate their pain on an eleven-point scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).
arm group label: Interventional Group: Deep Neuromuscular Blockade
arm group type: Experimental
description: The Deep NMB group (Intervention) will have rocuronium infusion titrated to deep paralysis defined as PTC of 1-2 (infusion start rate 0.025mg/kg/min or 1.5mg/kg/hr).
arm group label: Control Group: Moderate Neuromuscular Blockade
arm group type: Active Comparator
description: The Moderate NMB group (Control ) will have rocuronium infusion titrated to moderate paralysis defined as TOF of 1-2 (infusion start rate 0.005mg/kg/min or 0.3mg/kg/hr).
intervention type: Drug
intervention name: Rocuronium 0.3mg/kg/hr
description: The Moderate NMB group (Control ) will have rocuronium infusion titrated to moderate paralysis defined as TOF of 1-2 (infusion start rate 0.005mg/kg/min or 0.3mg/kg/hr).
arm group label: Control Group: Moderate Neuromuscular Blockade
intervention type: Drug
intervention name: Rocuronium 1.5mg/kg/hr
description: The Deep NMB group (Intervention) will have rocuronium infusion titrated to deep paralysis defined as PTC of 1-2 (infusion start rate 0.025mg/kg/min or 1.5mg/kg/hr).
arm group label: Interventional Group: Deep Neuromuscular Blockade
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Elizabeth Rieth, MD
role: Principal Investigator
affiliation: Memorial Sloan Kettering Cancer Center
last name: Elizabeth Rieth, MD
phone: 212-639-5737
email: riethe@mskcc.org
last name: Marielle Palop Soeprono, CRNA
phone: 212-639-6840
email: PalopM@mskcc.org
facility: 
status: Recruiting
contact: 
country: United States
url: http://www.mskcc.org
description: Memorial Sloan Kettering Cancer Center
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
mesh term: Rocuronium
sharing ipd: Yes
ipd description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.