<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/NCT02235246</url>
  </required_header>
  <id_info>
    <org_study_id>4-2014-0601</org_study_id>
    <nct_id>NCT02235246</nct_id>
  </id_info>
  <brief_title>The Effect of Perioperative Intravenous Magnesium on Pain After Endoscopic Submucosal Dissection for Gastric Neoplasm: Prospective Randomized Double-blind Placebo Controlled Study</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Endoscopic submucosal dissection (ESD) is an effective treatment for early gastric cancer or&#xD;
      premalignant lesions in the stomach. ESD enables en bloc resection of gastrointestinal&#xD;
      neoplasms, increases the rates of histologically complete resections, and also reduces local&#xD;
      recurrence rates. Despite these advantages, ESD is thought to induce various complications.&#xD;
      Wellknown ESD-related complications include perforation, postoperative bleeding, or&#xD;
      stricture. In addition, minor adverse events after ESD are also commonly noticed. Pain is one&#xD;
      of these frequently noticed minor ESD related complications, is the main reason for&#xD;
      prolongation of the hospital stay, and is related to patients' compliance; however, there is&#xD;
      a tendency to neglect or underestimate post-ESD pain. The causes of pain associated with ESD&#xD;
      are thought to be associated with transmural burn or transmural air leak. Some studies have&#xD;
      tried to control localized pain during and after ESD using local lidocaine, single dose&#xD;
      postoperative intravenous dexamethasone or a transdermal fentanyl patch. Magnesium has been&#xD;
      reported to alter the perception and duration of pain and produce important analgesic&#xD;
      effects. It is included the suppression of neuropathic pain, potentiation of morphine&#xD;
      analgesia, and attenuation of morphine tolerance. Although the exact mechanism is not yet&#xD;
      fully understood, the analgesic properties of magnesium are believed to stem from regulation&#xD;
      of calcium influx into the cell and antagonism of N-methyl-D-aspartate receptors in the&#xD;
      central nervous system. Also, magnesium may prolong neuromuscular blockade after&#xD;
      administration of neuromuscular blocking drugs, increase sedation and contribute to serious&#xD;
      cardiac morbidity. And magnesium as a hypotensive anaesthesia technique supply objectively&#xD;
      better operative field, reduction in the duration of surgery and reduced blood loss. There&#xD;
      have been no previous trials on the use of magnesium specifically for pain control following&#xD;
      ESD. Thus, the purpose of this study was to assess the efficacy of intravenous magnesium for&#xD;
      pain relief after ESD.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</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>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>pain score</measure>
    <time_frame>average 24hours from endoscopic processure</time_frame>
    <description>Pain score related with endoscopic mucosal resection will be evaluated with numerical rating scale (0 ~ 10) at time of 30 min, 1 hr, 6 hr, and 24 hr after procedure end.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Gastric Neoplasm</condition>
  <arm_group>
    <arm_group_label>normal saline</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>magnesium sulfate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Magnesium Sulfate</intervention_name>
    <description>magnesium sulfate 50 mg/kg will be administrated during 10 min before anesthetic induction in patients undergoing endoscopic submucosal dissection.</description>
    <arm_group_label>magnesium sulfate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal saline</intervention_name>
    <description>Normal saline will be administrated during 10 min before anesethetic induction in patients undergoing endoscopic submucosal dissection.</description>
    <arm_group_label>normal saline</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1. ASA 1~2, 2. age of 40- 80 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. patients who cannot read,&#xD;
&#xD;
          2. patients refusing the study&#xD;
&#xD;
          3. allergy to magnesium&#xD;
&#xD;
          4. chronic pain&#xD;
&#xD;
          5. chronic abuse of opioid or NSAID&#xD;
&#xD;
          6. neuromuscular block&#xD;
&#xD;
          7. atrioventricular conductance block&#xD;
&#xD;
          8. liver failure,&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Sevrance hospital</name>
      <address>
        <city>Seoul</city>
        <zip>120-752</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>September 5, 2014</study_first_submitted>
  <study_first_submitted_qc>September 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <last_update_submitted>May 8, 2015</last_update_submitted>
  <last_update_submitted_qc>May 8, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 12, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>perioperative intravenous magnesium</keyword>
  <keyword>endoscopic submucosal dissection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Stomach Neoplasms</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>
  <!-- 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/NCT02235246
org study id: 4-2014-0601
nct id: NCT02235246
lead sponsor: 
has dmc: No
Endoscopic submucosal dissection (ESD) is an effective treatment for early gastric cancer or
      premalignant lesions in the stomach. ESD enables en bloc resection of gastrointestinal
      neoplasms, increases the rates of histologically complete resections, and also reduces local
      recurrence rates. Despite these advantages, ESD is thought to induce various complications.
      Wellknown ESD-related complications include perforation, postoperative bleeding, or
      stricture. In addition, minor adverse events after ESD are also commonly noticed. Pain is one
      of these frequently noticed minor ESD related complications, is the main reason for
      prolongation of the hospital stay, and is related to patients' compliance; however, there is
      a tendency to neglect or underestimate post-ESD pain. The causes of pain associated with ESD
      are thought to be associated with transmural burn or transmural air leak. Some studies have
      tried to control localized pain during and after ESD using local lidocaine, single dose
      postoperative intravenous dexamethasone or a transdermal fentanyl patch. Magnesium has been
      reported to alter the perception and duration of pain and produce important analgesic
      effects. It is included 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 receptors in the
      central nervous system. Also, magnesium may prolong neuromuscular blockade after
      administration of neuromuscular blocking drugs, increase sedation and contribute to serious
      cardiac morbidity. And magnesium as a hypotensive anaesthesia technique supply objectively
      better operative field, reduction in the duration of surgery and reduced blood loss. There
      have been no previous trials on the use of magnesium specifically for pain control following
      ESD. Thus, the purpose of this study was to assess the efficacy of intravenous magnesium for
      pain relief after ESD.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: pain score
time frame: average 24hours from endoscopic processure
description: Pain score related with endoscopic mucosal resection will be evaluated with numerical rating scale (0 ~ 10) at time of 30 min, 1 hr, 6 hr, and 24 hr after procedure end.
arm group label: normal saline
arm group type: Experimental
arm group label: magnesium sulfate
arm group type: Active Comparator
intervention type: Drug
intervention name: Magnesium Sulfate
description: magnesium sulfate 50 mg/kg will be administrated during 10 min before anesthetic induction in patients undergoing endoscopic submucosal dissection.
arm group label: magnesium sulfate
intervention type: Drug
intervention name: Normal saline
description: Normal saline will be administrated during 10 min before anesethetic induction in patients undergoing endoscopic submucosal dissection.
arm group label: normal saline
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Stomach Neoplasms
mesh term: Magnesium Sulfate