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/NCT06004687</url>
    </required_header>
    <id_info>
      <org_study_id>zhhszjjh</org_study_id>
      <nct_id>NCT06004687</nct_id>
    </id_info>
    <brief_title>Effect of Acetaminophen Preemptive Analgesia on Postoperative Cognitive Function</brief_title>
    <official_title>Effects of Acetaminophen Preemptive Analgesia on Anesthesia Recovery Time and Postoperative Cognitive Function in Patients Undergoing Gastrointestinal Tumor Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Affiliated Hospital of Nantong University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Affiliated Hospital of Nantong University</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>
        Patients undergoing gastrointestinal tumor surgery are prone to delayed recovery and&#xD;
        postoperative cognitive dysfunction due to greater trauma and longer operation time.&#xD;
        Pre-analgesia can reverse the effects of nociceptive stimulation on recovery from general&#xD;
        anesthesia and postoperative cognitive function. Intravenous injection of non-steroidal drugs&#xD;
        can effectively reduce postoperative pain and the use of opioids. Therefore, This study&#xD;
        selected acetaminophen mannitol injection for preemptive analgesia to observe the effects on&#xD;
        anesthesia recovery time and postoperative cognitive function of patients undergoing&#xD;
        gastrointestinal tumor surgery, providing new ideas for reducing cognitive dysfunction in&#xD;
        patients undergoing gastrointestinal tumor surgery&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        By administering acetaminophen to patients with gastrointestinal tumors before surgery,&#xD;
        recording the time to recovery from anesthesia, and assessing cognitive function status by&#xD;
        CAM on the first, third, and seventh day after surgery&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 26, 2023</start_date>
    <completion_date type="Anticipated">December 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 30, 2024</primary_completion_date>
    <phase>Phase 1/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>Prevention</primary_purpose>
      <masking>Single (Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Postoperative delirium</measure>
      <time_frame>1/3/7 days after the surgery</time_frame>
      <description>The confusion assessment method (CAM) was used to assess postoperative cognitive dysfunction</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Recovery time</measure>
      <time_frame>immediately after the surgery</time_frame>
      <description>The postoperative recovery time was recorded</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Neurotransmitters in the blood</measure>
      <time_frame>1/3/7 days after the surgery</time_frame>
      <description>Neurotransmitters include epinephrine, norepinephrine, and so on</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Cognitive Function</condition>
    <arm_group>
      <arm_group_label>By applying acetaminophen mannitol to patients with gastrointestinal tumors before surgery</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Acetaminophen mannitol injection 50ml(500mg) intravenously pumped 30 minutes before surgery</description>
    </arm_group>
    <arm_group>
      <arm_group_label>By applying normal saline to patients with gastrointestinal tumors before surgery</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Normal saline injection 50ml intravenously pumped 30 minutes before surgery</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>acetaminophen mannitol</intervention_name>
      <description>Intravenous acetaminophen was administered 30 minutes before anesthesia</description>
      <arm_group_label>By applying acetaminophen mannitol to patients with gastrointestinal tumors before surgery</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Normal saline</intervention_name>
      <description>Intravenous acetaminophen was administered 30 minutes before anesthesia</description>
      <arm_group_label>By applying normal saline to patients with gastrointestinal tumors before surgery</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients undergoing gastrointestinal tumor surgery&#xD;
  &#xD;
            -  American Society of Anesthesiologists（ASA）≤Ⅲ&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  History of severe adverse reactions to oral acetaminophen&#xD;
  &#xD;
            -  Dysfunction of heart, liver, kidney and other important organs&#xD;
  &#xD;
            -  History of chronic pain&#xD;
  &#xD;
            -  Oral non-steroidal or opioid drugs&#xD;
  &#xD;
            -  Patients who do not accept clinical trials&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>16 Years</minimum_age>
      <maximum_age>88 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Hongsheng Chen</last_name>
      <role>Study Chair</role>
      <affiliation>Chair</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Hongsheng Chen</last_name>
      <phone>+86 513 81160313</phone>
      <email>chenhongsheng8@163.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Chaochao Zhong</last_name>
      <phone>+86 513 81160313</phone>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Affiliated Hospital of nantong University</name>
        <address>
          <city>Nantong</city>
          <state>Jiangsu</state>
          <zip>226001</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Hongsheng Chen</last_name>
        <phone>+86 513 8116 0313</phone>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 20, 2023</last_update_submitted>
    <last_update_submitted_qc>August 20, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>acetaminophen mannitol</keyword>
    <keyword>cognitive function</keyword>
    <keyword>anesthesia recovery time</keyword>
    <keyword>gastrointestinal tumor surgery</keyword>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Acetaminophen</mesh_term>
      <mesh_term>Mannitol</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT06004687
  org study id: zhhszjjh
  nct id: NCT06004687
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Patients undergoing gastrointestinal tumor surgery are prone to delayed recovery and
        postoperative cognitive dysfunction due to greater trauma and longer operation time.
        Pre-analgesia can reverse the effects of nociceptive stimulation on recovery from general
        anesthesia and postoperative cognitive function. Intravenous injection of non-steroidal drugs
        can effectively reduce postoperative pain and the use of opioids. Therefore, This study
        selected acetaminophen mannitol injection for preemptive analgesia to observe the effects on
        anesthesia recovery time and postoperative cognitive function of patients undergoing
        gastrointestinal tumor surgery, providing new ideas for reducing cognitive dysfunction in
        patients undergoing gastrointestinal tumor surgery
  By administering acetaminophen to patients with gastrointestinal tumors before surgery,
        recording the time to recovery from anesthesia, and assessing cognitive function status by
        CAM on the first, third, and seventh day after surgery
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Single (Investigator)
  measure: Postoperative delirium
  time frame: 1/3/7 days after the surgery
  description: The confusion assessment method (CAM) was used to assess postoperative cognitive dysfunction
  measure: Recovery time
  time frame: immediately after the surgery
  description: The postoperative recovery time was recorded
  measure: Neurotransmitters in the blood
  time frame: 1/3/7 days after the surgery
  description: Neurotransmitters include epinephrine, norepinephrine, and so on
  arm group label: By applying acetaminophen mannitol to patients with gastrointestinal tumors before surgery
  arm group type: Active Comparator
  description: Acetaminophen mannitol injection 50ml(500mg) intravenously pumped 30 minutes before surgery
  arm group label: By applying normal saline to patients with gastrointestinal tumors before surgery
  arm group type: Placebo Comparator
  description: Normal saline injection 50ml intravenously pumped 30 minutes before surgery
  intervention type: Drug
  intervention name: acetaminophen mannitol
  description: Intravenous acetaminophen was administered 30 minutes before anesthesia
  arm group label: By applying acetaminophen mannitol to patients with gastrointestinal tumors before surgery
  intervention type: Drug
  intervention name: Normal saline
  description: Intravenous acetaminophen was administered 30 minutes before anesthesia
  arm group label: By applying normal saline to patients with gastrointestinal tumors before surgery
  criteria: 
  gender: All
  minimum age: 16 Years
  maximum age: 88 Years
  healthy volunteers: No
  last name: Hongsheng Chen
  role: Study Chair
  affiliation: Chair
  last name: Hongsheng Chen
  phone: +86 513 81160313
  email: chenhongsheng8@163.com
  last name: Chaochao Zhong
  phone: +86 513 81160313
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Acetaminophen
  mesh term: Mannitol
  sharing ipd: No