<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/NCT03762109</url>
  </required_header>
  <id_info>
    <org_study_id>2018P000799</org_study_id>
    <nct_id>NCT03762109</nct_id>
  </id_info>
  <brief_title>The Use of Dantrolene to Improve Analgesia in Posterior Lumbar Surgery</brief_title>
  <official_title>The Use of Dantrolene to Improve Analgesia in Posterior Lumbar Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beth Israel Deaconess Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beth Israel Deaconess Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <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 whether administration of a non-centrally acting&#xD;
      muscle relaxants will improve the Overall Benefit of Analgesia Score (OBAS), and Richmond&#xD;
      Agitation Sedation Scale (RASS) scores in patients undergoing lumbar fusion.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 29, 2019</start_date>
  <completion_date type="Anticipated">March 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2023</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Benefit of Analgesia Score (OBAS)</measure>
    <time_frame>Measured at 24 hours after surgery</time_frame>
    <description>OBAS scores will be recorded on a scale from 0 (best outcome) to 28 (worst outcome).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Benefit of Analgesia Score (OBAS)</measure>
    <time_frame>Measured at 48 hours after surgery</time_frame>
    <description>OBAS scores will be recorded on a scale from 0 (best outcome) to 28 (worst outcome).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Richmond Agitation Sedation Scale (RASS)</measure>
    <time_frame>Measured at 24 and 48 hours after surgery</time_frame>
    <description>The Richmond Agitation and Sedation Scale (RASS) is a validated and reliable method to assess patients' level of sedation in the intensive care unit. Scores range from +4 (combative) to -5 (unarousable). A score of 0 (alert and calm) is considered the best outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Numerical Rating Scale (NRS) for Pain</measure>
    <time_frame>Measured at 0, 1, 2, 3, 24, 48 hours after surgery</time_frame>
    <description>Pain scores will be recorded on a scale from 0 (best outcome) to 10 (worst outcome).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU Length of Stay</measure>
    <time_frame>Until discharge from the hospital, on average 24 hours</time_frame>
    <description>The length of the patients stay in the ICU will be measured in hours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital length of stay</measure>
    <time_frame>Until discharge from the hospital, on average three days</time_frame>
    <description>The length of the patients stay in the hospital will be measured in days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Benzodiazepine use postoperatively</measure>
    <time_frame>Until discharge from the hospital, on average three days</time_frame>
    <description>The number of patients who receive benzodiazepines after surgery will be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Morphine Equivalent Dose</measure>
    <time_frame>Duration of the patient's stay in the hospital, on average three days</time_frame>
    <description>The postoperative analgesia requirement of narcotic medications during the patients recovery will be measured in morphine equivalent dose (miligrams)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU Mobility Score</measure>
    <time_frame>Measured at 24 and 48 hours after surgery</time_frame>
    <description>The patients ability to move will be recorded on a scale from 0 (nothing, lying in bed; worst outcome) to 10 (walking independently without a gait aid; best outcome).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Lumbar Spine Injury</condition>
  <arm_group>
    <arm_group_label>Dantrolene Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive 25 mg of Dantrolene orally at four different time points: immediately before surgery, as well as at 12, 24 and 36 hours after surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Oral Tablet Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients will receive a 25 mg of a placebo pill orally at four different time points: immediately before surgery, as well as at 12, 24 and 36 hours after surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dantrolene</intervention_name>
    <description>muscle relaxant</description>
    <arm_group_label>Dantrolene Group</arm_group_label>
    <other_name>Dantrium</other_name>
    <other_name>Dantrolene Sodium</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Oral Tablet</intervention_name>
    <description>inactive pill</description>
    <arm_group_label>Placebo Oral Tablet Group</arm_group_label>
    <other_name>placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  18 - 80 years of age (inclusive)&#xD;
&#xD;
          -  Presenting to the study hospital for lumbar decompression and/or fusion (instrumented&#xD;
             fusion of the lumbar spine &lt; 4 levels) under general anesthesia, and scheduled for&#xD;
             same-day admission or in-patient admission&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) Category 1, 2 or 3&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Known allergy to Dantrolene, morphine or other opioids, benzodiazepines that causes a&#xD;
             reaction of hives, anaphylaxis, shock, unconsciousness/fainting, rashes/blisters,&#xD;
             irregular heartbeat, fever, swelling, shortness of breath, wheezing, serum sickness,&#xD;
             drug induced anemia, drug reaction with eosinophilia, and systemic symptoms, or&#xD;
             nephritis&#xD;
&#xD;
          -  Oxygen saturation &lt; 94%&#xD;
&#xD;
          -  Patient being treated with any of the following medications:Non-dihydropyridine&#xD;
             Calcium Channel Blockers including verapamil, Estrogen therapy&#xD;
&#xD;
          -  Current or past medical history of any of the following: hepatic impairment (including&#xD;
             history of transplant), renal impairment or chronic renal disease (including history&#xD;
             of transplant), chronic alcohol abuse, chronic respiratory disease (i.e. chronic&#xD;
             hypoxia or hypercapnia, COPD)&#xD;
&#xD;
          -  Recent history of aspiration (within the last 3 months)&#xD;
&#xD;
          -  Patients with any history of neuromuscular dysfunction&#xD;
&#xD;
          -  History of obstructive sleep apnea&#xD;
&#xD;
          -  Weight &gt; 140 kg&#xD;
&#xD;
          -  Currently pregnant&#xD;
&#xD;
          -  Actively breastfeeding&#xD;
&#xD;
          -  Inability to provide written informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard J Pollard, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beth Israel Deaconess Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Richard J Pollard, MD</last_name>
    <phone>704-905-6637</phone>
    <email>rpollard@bidmc.harvard.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Evynne Gartner, BA</last_name>
    <email>egartner@bidmc.harvard.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Beth Israel Deaconess Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Richard Pollard, MD</last_name>
      <phone>704-905-6637</phone>
    </contact>
    <contact_backup>
      <last_name>Thy Nguyen, BS</last_name>
      <phone>617-632-8048</phone>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>November 30, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>March 22, 2023</last_update_submitted>
  <last_update_submitted_qc>March 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beth Israel Deaconess Medical Center</investigator_affiliation>
    <investigator_full_name>Richard J. Pollard</investigator_full_name>
    <investigator_title>Director, Neurosurgical Anesthesia Fellowship</investigator_title>
  </responsible_party>
  <keyword>Surgery</keyword>
  <keyword>Dantrolene</keyword>
  <keyword>Anesthesia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Injuries</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dantrolene</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03762109
org study id: 2018P000799
nct id: NCT03762109
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The purpose of this study is to determine whether administration of a non-centrally acting
      muscle relaxants will improve the Overall Benefit of Analgesia Score (OBAS), and Richmond
      Agitation Sedation Scale (RASS) scores in patients undergoing lumbar fusion.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Overall Benefit of Analgesia Score (OBAS)
time frame: Measured at 24 hours after surgery
description: OBAS scores will be recorded on a scale from 0 (best outcome) to 28 (worst outcome).
measure: Overall Benefit of Analgesia Score (OBAS)
time frame: Measured at 48 hours after surgery
description: OBAS scores will be recorded on a scale from 0 (best outcome) to 28 (worst outcome).
measure: Richmond Agitation Sedation Scale (RASS)
time frame: Measured at 24 and 48 hours after surgery
description: The Richmond Agitation and Sedation Scale (RASS) is a validated and reliable method to assess patients' level of sedation in the intensive care unit. Scores range from +4 (combative) to -5 (unarousable). A score of 0 (alert and calm) is considered the best outcome.
measure: Numerical Rating Scale (NRS) for Pain
time frame: Measured at 0, 1, 2, 3, 24, 48 hours after surgery
description: Pain scores will be recorded on a scale from 0 (best outcome) to 10 (worst outcome).
measure: ICU Length of Stay
time frame: Until discharge from the hospital, on average 24 hours
description: The length of the patients stay in the ICU will be measured in hours
measure: Hospital length of stay
time frame: Until discharge from the hospital, on average three days
description: The length of the patients stay in the hospital will be measured in days
measure: Benzodiazepine use postoperatively
time frame: Until discharge from the hospital, on average three days
description: The number of patients who receive benzodiazepines after surgery will be recorded.
measure: Morphine Equivalent Dose
time frame: Duration of the patient's stay in the hospital, on average three days
description: The postoperative analgesia requirement of narcotic medications during the patients recovery will be measured in morphine equivalent dose (miligrams)
measure: ICU Mobility Score
time frame: Measured at 24 and 48 hours after surgery
description: The patients ability to move will be recorded on a scale from 0 (nothing, lying in bed; worst outcome) to 10 (walking independently without a gait aid; best outcome).
arm group label: Dantrolene Group
arm group type: Experimental
description: Patients will receive 25 mg of Dantrolene orally at four different time points: immediately before surgery, as well as at 12, 24 and 36 hours after surgery.
arm group label: Placebo Oral Tablet Group
arm group type: Placebo Comparator
description: Patients will receive a 25 mg of a placebo pill orally at four different time points: immediately before surgery, as well as at 12, 24 and 36 hours after surgery.
intervention type: Drug
intervention name: Dantrolene
description: muscle relaxant
arm group label: Dantrolene Group
other name: Dantrium
other name: Dantrolene Sodium
intervention type: Drug
intervention name: Placebo Oral Tablet
description: inactive pill
arm group label: Placebo Oral Tablet Group
other name: placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Richard J Pollard, MD
role: Principal Investigator
affiliation: Beth Israel Deaconess Medical Center
last name: Richard J Pollard, MD
phone: 704-905-6637
email: rpollard@bidmc.harvard.edu
last name: Evynne Gartner, BA
email: egartner@bidmc.harvard.edu
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Beth Israel Deaconess Medical Center
investigator full name: Richard J. Pollard
investigator title: Director, Neurosurgical Anesthesia Fellowship
mesh term: Spinal Injuries
mesh term: Dantrolene
sharing ipd: No