<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/NCT03253224</url>
  </required_header>
  <id_info>
    <org_study_id>B-1707/406-006</org_study_id>
    <nct_id>NCT03253224</nct_id>
  </id_info>
  <brief_title>Magnesium and Postoperative Pain</brief_title>
  <official_title>The Influence of Intraoperative Magnesium Sulfate Administration on Postoperative Pain After Total Knee Arthroplasty in Patients Sedated With Dexmedetomidine Under Spinal Anesthesia: A Randomized-controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Seoul National University Bundang Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>No</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>
      With ongoing advancements in healthcare leading to prolonged life expectancy, orthopedic&#xD;
      surgeries are increasingly performed in elderly patients. Total knee arthroplasty, in&#xD;
      particular, has been increasing with the growing demand for improved mobility and quality of&#xD;
      life. Total knee arthroplasty is performed on patients with advanced and painful&#xD;
      osteoarthritis of the knees, but it can result in moderate to severe postoperative pain&#xD;
      during the recovery period.&#xD;
&#xD;
      To relieve anxiety or stress during surgery under regional anesthesia, sedation can be&#xD;
      provided. Dexmedetomidine is a sedative-analgesic agent acting as α2-adrenergic receptor&#xD;
      agonist, and its analgesic effect has been well established in various procedures or&#xD;
      surgeries.&#xD;
&#xD;
      Magnesium has been reported to produce important analgesic effects including the suppression&#xD;
      of neuropathic pain, potentiation of morphine analgesia, and attenuation of morphine&#xD;
      tolerance. Although the exact mechanism is not yet fully understood, the analgesic properties&#xD;
      of magnesium are believed to stem from regulation of calcium influx into the cell and&#xD;
      antagonism of N-methyl-D-aspartate (NMDA) receptors in the central nervous system. In this&#xD;
      study, investigators will evaluate the reducing effect of magnesium on the post-total knee&#xD;
      arthroplasty pain in patients sedated with dexmedetomidine under spinal anesthesia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Because the principle investigator will participate a visiting scholar program for one year in&#xD;
    other country, this study has been terminated.&#xD;
  </why_stopped>
  <start_date type="Actual">September 10, 2017</start_date>
  <completion_date type="Actual">March 29, 2018</completion_date>
  <primary_completion_date type="Actual">March 29, 2018</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>Supportive Care</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient controlled analgesia (PCA)</measure>
    <time_frame>Postoperative 24 hour</time_frame>
    <description>Amounts of PCA consumption</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Numerical rating scale</measure>
    <time_frame>Postoperative 24 hour</time_frame>
    <description>Postoperative pain score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rescue analgesics</measure>
    <time_frame>Postoperative 24 hour</time_frame>
    <description>Amounts of the analgesics administered to mange the postoperative pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nausea</measure>
    <time_frame>Postoperative 24 hour</time_frame>
    <description>Incidence of nausea</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vomiting</measure>
    <time_frame>Postoperative 24 hour</time_frame>
    <description>Incidence of vomiting</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antiemetics</measure>
    <time_frame>Postoperative 24 hour</time_frame>
    <description>Amounts of antiemetics consumption</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Arthritis Knee</condition>
  <condition>Magnesium Sulfate</condition>
  <condition>Dexmedetomidine</condition>
  <arm_group>
    <arm_group_label>Saline</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patient who received normal saline during the operation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Magnesium</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient who received magnesium sulfate during the operation</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Magnesium Sulfate</intervention_name>
    <description>Magnesium group receives magnesium sulfate (50 mg/kg) in 100 mL of normal saline over 15 min during induction of anesthesia, followed by a continuous magnesium sulfate infusion (15 mg/kg/h) until the end of surgery.</description>
    <arm_group_label>Magnesium</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal saline</intervention_name>
    <description>Normal saline group receives the same volume of normal saline, administered according to the same method as in the magnesium group.</description>
    <arm_group_label>Saline</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who undergo total knee arthroplasty under spinal anesthesia&#xD;
&#xD;
          -  Patients who want to sedation during the surgery&#xD;
&#xD;
          -  American Society of Anesthesiologists physical status classification 1 and 2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  General anesthesia&#xD;
&#xD;
          -  Patients who do not want to sedation during the surgery&#xD;
&#xD;
          -  Patients who do not receive patient controlled analgesia postoperatively&#xD;
&#xD;
          -  Muscular disease&#xD;
&#xD;
          -  Hypermagnesemia&#xD;
&#xD;
          -  Atrioventricular block&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hyun-Jung Shin, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Bundang Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam-si</city>
        <zip>13620</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>August 15, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>April 16, 2018</last_update_submitted>
  <last_update_submitted_qc>April 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Hyun-Jung Shin</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Magnesium Sulfate</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/NCT03253224
org study id: B-1707/406-006
nct id: NCT03253224
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
With ongoing advancements in healthcare leading to prolonged life expectancy, orthopedic
      surgeries are increasingly performed in elderly patients. Total knee arthroplasty, in
      particular, has been increasing with the growing demand for improved mobility and quality of
      life. Total knee arthroplasty is performed on patients with advanced and painful
      osteoarthritis of the knees, but it can result in moderate to severe postoperative pain
      during the recovery period.

      To relieve anxiety or stress during surgery under regional anesthesia, sedation can be
      provided. Dexmedetomidine is a sedative-analgesic agent acting as α2-adrenergic receptor
      agonist, and its analgesic effect has been well established in various procedures or
      surgeries.

      Magnesium has been reported to produce important analgesic effects including the suppression
      of neuropathic pain, potentiation of morphine analgesia, and attenuation of morphine
      tolerance. Although the exact mechanism is not yet fully understood, the analgesic properties
      of magnesium are believed to stem from regulation of calcium influx into the cell and
      antagonism of N-methyl-D-aspartate (NMDA) receptors in the central nervous system. In this
      study, investigators will evaluate the reducing effect of magnesium on the post-total knee
      arthroplasty pain in patients sedated with dexmedetomidine under spinal anesthesia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Patient controlled analgesia (PCA)
time frame: Postoperative 24 hour
description: Amounts of PCA consumption
measure: Numerical rating scale
time frame: Postoperative 24 hour
description: Postoperative pain score
measure: Rescue analgesics
time frame: Postoperative 24 hour
description: Amounts of the analgesics administered to mange the postoperative pain
measure: Nausea
time frame: Postoperative 24 hour
description: Incidence of nausea
measure: Vomiting
time frame: Postoperative 24 hour
description: Incidence of vomiting
measure: Antiemetics
time frame: Postoperative 24 hour
description: Amounts of antiemetics consumption
arm group label: Saline
arm group type: Placebo Comparator
description: Patient who received normal saline during the operation
arm group label: Magnesium
arm group type: Experimental
description: Patient who received magnesium sulfate during the operation
intervention type: Drug
intervention name: Magnesium Sulfate
description: Magnesium group receives magnesium sulfate (50 mg/kg) in 100 mL of normal saline over 15 min during induction of anesthesia, followed by a continuous magnesium sulfate infusion (15 mg/kg/h) until the end of surgery.
arm group label: Magnesium
intervention type: Drug
intervention name: Normal saline
description: Normal saline group receives the same volume of normal saline, administered according to the same method as in the magnesium group.
arm group label: Saline
criteria: 
gender: All
minimum age: 50 Years
maximum age: 75 Years
healthy volunteers: No
last name: Hyun-Jung Shin, MD, PhD
role: Principal Investigator
affiliation: Seoul National University Bundang Hospital
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Hyun-Jung Shin
investigator title: Assistant Professor
mesh term: Pain, Postoperative
mesh term: Magnesium Sulfate
sharing ipd: No