xml: <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/NCT06015711</url>
    </required_header>
    <id_info>
      <org_study_id>AJOUIRB-IV-2023-400</org_study_id>
      <nct_id>NCT06015711</nct_id>
    </id_info>
    <brief_title>The Effect of Preoperative Maxigesic® on Intraoperative Remifentanil Requirement</brief_title>
    <official_title>The Effect of Preoperative Maxigesic® Administration on Analgesic Nociception Index (ANI) Guided Remifentanil Administration</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ajou University School of Medicine</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ajou University School of Medicine</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>
        Maxigesic is combined intravenous analgesic of ibuprofen and acetaminphen. The purpose of&#xD;
        this study is investigate weather preoperative Maxigesic administration can reduce&#xD;
        intraoperative remifentanil requirement.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Remifentanil is an ultra-short-acting opioid that is useful during surgery because of its&#xD;
        fast onset and recovery. However, because of this profile, it is known that the use of high&#xD;
        doses of remifentanil during surgery paradoxically increases postoperative pain. It has been&#xD;
        reported that intraoperative remifentanil use resulted in higher pain scores 2 hours after&#xD;
        surgery compared to intraoperative dexmedetomidine, and that the incidence of hypotension,&#xD;
        tremor, and postoperative nausea and vomiting were higher in the remifentanil group.&#xD;
        Therefore, minimizing the use of remifentanil during surgery is clinically meaningful.&#xD;
  &#xD;
        Nonsteroidal anti-inflammatory drugs (NSAIDs) play an important role in multimodal analgesia,&#xD;
        and are known to reduce the use of opioids when used together with opioids in postoperative&#xD;
        pain [3]. It has also been reported that preoperative administration of ibuprofen reduces&#xD;
        postoperative opioid use. Administration of acetaminophen has also been reported to reduce&#xD;
        opioid usage. However, there is no study on whether the administration of these NSAIDs and&#xD;
        acetaminophen reduces the opioid requirement used during surgery, not after surgery.&#xD;
  &#xD;
        The Analgesia nociception index (ANI, MDoloris medical system, France) was developed to&#xD;
        measure real-time nociception in patients undergoing surgery under general anesthesia. This&#xD;
        index measures parasympathetic nerve activity based on heart rate variability. It is known to&#xD;
        be superior in detecting nociceptive stimuli rather than judging only by existing pulse rate&#xD;
        and blood pressure. In addition, since information is provided as an objectified numerical&#xD;
        value, analgesic drugs can be adjusted during surgery based on this information. This helps&#xD;
        to provide an appropriate amount of opioids during surgery when needed, and can prevent&#xD;
        overdose. A previous study reported that when ANI-guided remifentanil infusion was performed,&#xD;
        the amount of remifentanil used was reduced compared to conventional control of remifentanil&#xD;
        only with blood pressure and pulse rate.&#xD;
  &#xD;
        Maxigesic® is a combination of acetaminophen and ibuprofen, and is a drug that rapidly&#xD;
        relieves various types of pain. It is known to be more effective in relieving postoperative&#xD;
        pain than single acetaminophen or ibuprofen. The hypothesis of this study is that&#xD;
        administration of Maxigesic®, a combination of acetaminophen and NSAIDs, reduces&#xD;
        intraoperative remifentanil requirement. This study aims to investigate whether preoperative&#xD;
        Maxigesic® administration can reduce intraoperative remifentanil requirements by performing&#xD;
        ANI-guided remifentanil infusion for objective control of remifentanil administration.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 30, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 31, 2024</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>Other</primary_purpose>
      <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Remifentanil requirement</measure>
      <time_frame>3 hours, from incision to skin closure</time_frame>
      <description>Intraoperative remifentanil requirement</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>postoperative analgesic requirement</measure>
      <time_frame>1 hour, while in the recovery room</time_frame>
      <description>postoperative fentanyl requirement</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">96</enrollment>
    <condition>Opioid Use</condition>
    <arm_group>
      <arm_group_label>Maxigesic group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Administration of Maxigesic before surgery start.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Administration of normal saline before surgery start.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Maxigesic administration</intervention_name>
      <description>Preoperative Maxigesic IV administration</description>
      <arm_group_label>Maxigesic group</arm_group_label>
      <other_name>Preoperative Maxigesic administration</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult patients (19-60 years old) with ASA physical status 1, 2, 3&#xD;
  &#xD;
            -  Scheduled surgery under general anesthesia&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  The patient does not conset&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  hepatic disorder&#xD;
  &#xD;
            -  Renal disorder&#xD;
  &#xD;
            -  Asthma&#xD;
  &#xD;
            -  Hypersensitivity to the NSAIDs or acetaminophen&#xD;
  &#xD;
            -  Patients receiving chronic pain therapy&#xD;
  &#xD;
            -  Drug dependence&#xD;
  &#xD;
            -  Patients taking psychiatric drugs&#xD;
  &#xD;
            -  Alcoholics&#xD;
  &#xD;
            -  History of gastrointestinal ulcer or bleeding&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>19 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>In Kyong Yi, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Ajou University School of Medicine</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>In Kyong Yi, MD</last_name>
      <phone>+82-31-219-5579</phone>
      <phone_ext>7724</phone_ext>
      <email>lyrin01@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Ajou university school of medicine</name>
        <address>
          <city>Suwon</city>
          <state>Gyeonggi-do</state>
          <zip>16499</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Korea, Republic of</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ajou University School of Medicine</investigator_affiliation>
      <investigator_full_name>In-kyong Yi</investigator_full_name>
      <investigator_title>Assitant professor</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>In case of individual reasonable request to PI</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06015711
  org study id: AJOUIRB-IV-2023-400
  nct id: NCT06015711
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Maxigesic is combined intravenous analgesic of ibuprofen and acetaminphen. The purpose of
        this study is investigate weather preoperative Maxigesic administration can reduce
        intraoperative remifentanil requirement.
  Remifentanil is an ultra-short-acting opioid that is useful during surgery because of its
        fast onset and recovery. However, because of this profile, it is known that the use of high
        doses of remifentanil during surgery paradoxically increases postoperative pain. It has been
        reported that intraoperative remifentanil use resulted in higher pain scores 2 hours after
        surgery compared to intraoperative dexmedetomidine, and that the incidence of hypotension,
        tremor, and postoperative nausea and vomiting were higher in the remifentanil group.
        Therefore, minimizing the use of remifentanil during surgery is clinically meaningful.
  
        Nonsteroidal anti-inflammatory drugs (NSAIDs) play an important role in multimodal analgesia,
        and are known to reduce the use of opioids when used together with opioids in postoperative
        pain [3]. It has also been reported that preoperative administration of ibuprofen reduces
        postoperative opioid use. Administration of acetaminophen has also been reported to reduce
        opioid usage. However, there is no study on whether the administration of these NSAIDs and
        acetaminophen reduces the opioid requirement used during surgery, not after surgery.
  
        The Analgesia nociception index (ANI, MDoloris medical system, France) was developed to
        measure real-time nociception in patients undergoing surgery under general anesthesia. This
        index measures parasympathetic nerve activity based on heart rate variability. It is known to
        be superior in detecting nociceptive stimuli rather than judging only by existing pulse rate
        and blood pressure. In addition, since information is provided as an objectified numerical
        value, analgesic drugs can be adjusted during surgery based on this information. This helps
        to provide an appropriate amount of opioids during surgery when needed, and can prevent
        overdose. A previous study reported that when ANI-guided remifentanil infusion was performed,
        the amount of remifentanil used was reduced compared to conventional control of remifentanil
        only with blood pressure and pulse rate.
  
        Maxigesic® is a combination of acetaminophen and ibuprofen, and is a drug that rapidly
        relieves various types of pain. It is known to be more effective in relieving postoperative
        pain than single acetaminophen or ibuprofen. The hypothesis of this study is that
        administration of Maxigesic®, a combination of acetaminophen and NSAIDs, reduces
        intraoperative remifentanil requirement. This study aims to investigate whether preoperative
        Maxigesic® administration can reduce intraoperative remifentanil requirements by performing
        ANI-guided remifentanil infusion for objective control of remifentanil administration.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: Triple (Participant, Care Provider, Outcomes Assessor)
  measure: Remifentanil requirement
  time frame: 3 hours, from incision to skin closure
  description: Intraoperative remifentanil requirement
  measure: postoperative analgesic requirement
  time frame: 1 hour, while in the recovery room
  description: postoperative fentanyl requirement
  arm group label: Maxigesic group
  arm group type: Experimental
  description: Administration of Maxigesic before surgery start.
  arm group label: Control group
  arm group type: No Intervention
  description: Administration of normal saline before surgery start.
  intervention type: Drug
  intervention name: Maxigesic administration
  description: Preoperative Maxigesic IV administration
  arm group label: Maxigesic group
  other name: Preoperative Maxigesic administration
  criteria: 
  gender: All
  minimum age: 19 Years
  maximum age: 60 Years
  healthy volunteers: No
  last name: In Kyong Yi, MD
  role: Principal Investigator
  affiliation: Ajou University School of Medicine
  last name: In Kyong Yi, MD
  phone: +82-31-219-5579
  phone ext: 7724
  email: lyrin01@gmail.com
  facility: 
  country: Korea, Republic of
  responsible party type: Principal Investigator
  investigator affiliation: Ajou University School of Medicine
  investigator full name: In-kyong Yi
  investigator title: Assitant professor
  sharing ipd: No
  ipd description: In case of individual reasonable request to PI