<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/NCT03825471</url>
  </required_header>
  <id_info>
    <org_study_id>CES and Postoperative pain</org_study_id>
    <nct_id>NCT03825471</nct_id>
  </id_info>
  <brief_title>Cranial Electrotherapy Stimulation on Anesthetics Consumption and Postoperative Pain</brief_title>
  <official_title>Effects of Cranial Electrotherapy Stimulation on Anesthetics Consumption, Perioperative Cytokines Response, and Postoperative Pain in Patients Undergoing Colonic Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tri-Service General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tri-Service General 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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cranial electrotherapy stimulation (CES) is a non-invasive intervention to treat anxiety,&#xD;
      depression, insomnia, and pain. But clinical studies and applications of CES in relation to&#xD;
      acute postoperative pain are few. tThe investigators investigate a double-blind, randomized&#xD;
      controlled trial to figure out if intraoperative CES could decrease dosage of intraoperative&#xD;
      anesthetics and patient-controlled analgesia (PCA) consumption in patients undergoing colon&#xD;
      cancer surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cranial electrotherapy stimulation (CES) is a non-invasive and safe intervention,&#xD;
      transmitting microcurrents of brain stimulation and releasing various neurotransmitters such&#xD;
      as endorphin and downstream hormones to modulate autonomic nervous system, as a result, for&#xD;
      treating anxiety, depression, insomnia, and pain.&#xD;
&#xD;
      Acute postoperative pain annoys patients receiving surgery. Once acute postoperative pain is&#xD;
      poorly controlled, it may result in adverse acute effects (i.e., physiologic and psychologic&#xD;
      stress), chronic effects (i.e., delayed long-term recovery and chronic pain), and, in&#xD;
      consequence, excess length of hospitalization and extra costs. Besides, inflammatory&#xD;
      reactions mediated by immune system are formed after tissue injury (e.g. trauma, surgery,&#xD;
      etc), release serial inflammatory cytokines and are related to pain signal transmission.&#xD;
      However, clinical studies and applications of CES focus on management of chronic pain,&#xD;
      modulation of mood and insomnia rather than acute postoperative pain in recent years.&#xD;
&#xD;
      The investigators investigate a double-blind, randomized controlled trial to figure out if&#xD;
      intraoperative CES could decrease dosage of intraoperative anesthetics and patient-controlled&#xD;
      analgesia (PCA) consumption in patients undergoing colon cancer surgery. The investigators&#xD;
      also collect blood samples before and after surgery for analysis of serum cytokines.&#xD;
      Meanwhile, Bispectral IndexTM (BISTM) monitoring and Analgesia Nociception Index (ANI) are&#xD;
      prescribed during the surgery not only for measuring of the effects of anesthetics and&#xD;
      sedatives on the brain, but also evaluating perioperative analgesia. Thereby, the&#xD;
      effectiveness of CES for management of acute postoperative pain may introduce clinicians for&#xD;
      alternative application of pain control after surgery in the future.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 14, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</primary_completion_date>
  <phase>N/A</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>dosage of intraoperative anesthetics</measure>
    <time_frame>during surgery</time_frame>
    <description>The consumption of total amount of supplemental analgesics administered during colon cancer surgery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rescue analgesics</measure>
    <time_frame>from the end of the surgery to postoperative 72 hours</time_frame>
    <description>The consumption of total amount of rescue analgesics administered after colon cancer surgery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Differences in Pain Intensity Between CES intervention and the control group</measure>
    <time_frame>from the end of the surgery to postoperative 72 hours</time_frame>
    <description>Pain assessment of NRS pain intensity scores and patient satisfaction assessed by the NRS through end of surgery to postoperative 72 hours</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>dosage of patient-controlled analgesia (PCA) consumption</measure>
    <time_frame>from the end of the surgery to postoperative 72 hours</time_frame>
    <description>postoperative PCA consumption</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>serum concentration of serum cytokine</measure>
    <time_frame>from the beginning of the surgery to postoperative 72 hours</time_frame>
    <description>proinflammatory and antiinflammatory cytokines (IL-1a, IL-2, IL-6, IL-7, TNF-a, IL-4, IL-10, IL-10, IL-1, TGF-b)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with CES and control groups</measure>
    <time_frame>during surgery</time_frame>
    <description>patient characteristics</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Opioid Use</condition>
  <condition>Cytokine</condition>
  <arm_group>
    <arm_group_label>electrotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergoing CES and general anesthesia in colon cancer surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Opioid Anesthetics</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients undergoing general anesthesia in colon cancer surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>electrotherapy</intervention_name>
    <description>Cranial electrotherapy stimulation</description>
    <arm_group_label>Opioid Anesthetics</arm_group_label>
    <arm_group_label>electrotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Opioid Anesthetics</intervention_name>
    <description>consumption of opioids during general anesthesia</description>
    <arm_group_label>Opioid Anesthetics</arm_group_label>
    <arm_group_label>electrotherapy</arm_group_label>
    <other_name>Opioid consumption during general anesthesia</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>colon cancer surgery</intervention_name>
    <description>laparoscopic colon cancer surgery</description>
    <arm_group_label>Opioid Anesthetics</arm_group_label>
    <arm_group_label>electrotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing colon cancer surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  presence of an implantable device (e.g., pacemaker)&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  having a known mental illness (e.g., schizophrenia, mood disorder, bipolar disorder,&#xD;
             etc.&#xD;
&#xD;
          -  cancer of the head and neck or brain tumor or brain metastasis&#xD;
&#xD;
          -  having delirium&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yi-hsuan Huang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>TriService General Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yi-hsuan Huang, MD</last_name>
    <phone>+886-2-87927128</phone>
    <email>yixiun72@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yi-hsuan Huang, MD</last_name>
    <phone>+886-2-87927128</phone>
    <email>yixun72@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>TriService General Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>11490</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yi-hsuan Huang, MD</last_name>
      <phone>+886-2-87927128</phone>
      <email>yixiun72@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <results_reference>
    <citation>Lee SH, Kim WY, Lee CH, Min TJ, Lee YS, Kim JH, Park YC. Effects of cranial electrotherapy stimulation on preoperative anxiety, pain and endocrine response. J Int Med Res. 2013 Dec;41(6):1788-95. doi: 10.1177/0300060513500749.</citation>
    <PMID>24265330</PMID>
  </results_reference>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>March 9, 2020</last_update_submitted>
  <last_update_submitted_qc>March 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tri-Service General Hospital</investigator_affiliation>
    <investigator_full_name>Yi-hsuan Huang</investigator_full_name>
    <investigator_title>Attending Physician</investigator_title>
  </responsible_party>
  <keyword>Cranial electrotherapy stimulation (CES)</keyword>
  <keyword>Autonomic nervous system</keyword>
  <keyword>acute postoperative pain</keyword>
  <keyword>colon cancer surgery</keyword>
  <keyword>patient-controlled analgesia (PCA)</keyword>
  <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>Analgesics, Opioid</mesh_term>
    <mesh_term>Anesthetics</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/NCT03825471
org study id: CES and Postoperative pain
nct id: NCT03825471
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Cranial electrotherapy stimulation (CES) is a non-invasive intervention to treat anxiety,
      depression, insomnia, and pain. But clinical studies and applications of CES in relation to
      acute postoperative pain are few. tThe investigators investigate a double-blind, randomized
      controlled trial to figure out if intraoperative CES could decrease dosage of intraoperative
      anesthetics and patient-controlled analgesia (PCA) consumption in patients undergoing colon
      cancer surgery.
Cranial electrotherapy stimulation (CES) is a non-invasive and safe intervention,
      transmitting microcurrents of brain stimulation and releasing various neurotransmitters such
      as endorphin and downstream hormones to modulate autonomic nervous system, as a result, for
      treating anxiety, depression, insomnia, and pain.

      Acute postoperative pain annoys patients receiving surgery. Once acute postoperative pain is
      poorly controlled, it may result in adverse acute effects (i.e., physiologic and psychologic
      stress), chronic effects (i.e., delayed long-term recovery and chronic pain), and, in
      consequence, excess length of hospitalization and extra costs. Besides, inflammatory
      reactions mediated by immune system are formed after tissue injury (e.g. trauma, surgery,
      etc), release serial inflammatory cytokines and are related to pain signal transmission.
      However, clinical studies and applications of CES focus on management of chronic pain,
      modulation of mood and insomnia rather than acute postoperative pain in recent years.

      The investigators investigate a double-blind, randomized controlled trial to figure out if
      intraoperative CES could decrease dosage of intraoperative anesthetics and patient-controlled
      analgesia (PCA) consumption in patients undergoing colon cancer surgery. The investigators
      also collect blood samples before and after surgery for analysis of serum cytokines.
      Meanwhile, Bispectral IndexTM (BISTM) monitoring and Analgesia Nociception Index (ANI) are
      prescribed during the surgery not only for measuring of the effects of anesthetics and
      sedatives on the brain, but also evaluating perioperative analgesia. Thereby, the
      effectiveness of CES for management of acute postoperative pain may introduce clinicians for
      alternative application of pain control after surgery in the future.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: dosage of intraoperative anesthetics
time frame: during surgery
description: The consumption of total amount of supplemental analgesics administered during colon cancer surgery
measure: Rescue analgesics
time frame: from the end of the surgery to postoperative 72 hours
description: The consumption of total amount of rescue analgesics administered after colon cancer surgery
measure: Differences in Pain Intensity Between CES intervention and the control group
time frame: from the end of the surgery to postoperative 72 hours
description: Pain assessment of NRS pain intensity scores and patient satisfaction assessed by the NRS through end of surgery to postoperative 72 hours
measure: dosage of patient-controlled analgesia (PCA) consumption
time frame: from the end of the surgery to postoperative 72 hours
description: postoperative PCA consumption
measure: serum concentration of serum cytokine
time frame: from the beginning of the surgery to postoperative 72 hours
description: proinflammatory and antiinflammatory cytokines (IL-1a, IL-2, IL-6, IL-7, TNF-a, IL-4, IL-10, IL-10, IL-1, TGF-b)
measure: Number of Participants with CES and control groups
time frame: during surgery
description: patient characteristics
arm group label: electrotherapy
arm group type: Experimental
description: Patients undergoing CES and general anesthesia in colon cancer surgery
arm group label: Opioid Anesthetics
arm group type: Placebo Comparator
description: Patients undergoing general anesthesia in colon cancer surgery
intervention type: Procedure
intervention name: electrotherapy
description: Cranial electrotherapy stimulation
arm group label: Opioid Anesthetics
arm group label: electrotherapy
intervention type: Drug
intervention name: Opioid Anesthetics
description: consumption of opioids during general anesthesia
arm group label: Opioid Anesthetics
arm group label: electrotherapy
other name: Opioid consumption during general anesthesia
intervention type: Procedure
intervention name: colon cancer surgery
description: laparoscopic colon cancer surgery
arm group label: Opioid Anesthetics
arm group label: electrotherapy
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Yi-hsuan Huang, MD
role: Principal Investigator
affiliation: TriService General Hospital
last name: Yi-hsuan Huang, MD
phone: +886-2-87927128
email: yixiun72@gmail.com
last name: Yi-hsuan Huang, MD
phone: +886-2-87927128
email: yixun72@gmail.com
facility: 
status: Recruiting
contact: 
country: Taiwan
citation: Lee SH, Kim WY, Lee CH, Min TJ, Lee YS, Kim JH, Park YC. Effects of cranial electrotherapy stimulation on preoperative anxiety, pain and endocrine response. J Int Med Res. 2013 Dec;41(6):1788-95. doi: 10.1177/0300060513500749.
PMID: 24265330
responsible party type: Principal Investigator
investigator affiliation: Tri-Service General Hospital
investigator full name: Yi-hsuan Huang
investigator title: Attending Physician
mesh term: Pain, Postoperative
mesh term: Analgesics, Opioid
mesh term: Anesthetics
sharing ipd: No