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/NCT06028256</url>
    </required_header>
    <id_info>
      <org_study_id>2023-L-126</org_study_id>
      <nct_id>NCT06028256</nct_id>
    </id_info>
    <brief_title>Norepinephrine Prevent Post-induction Hypotension in High-risk Patients</brief_title>
    <official_title>Continuous Norepinephrine Infusion Before General Anesthesia to Prevent Post-induction Hypotension in High-risk Patients Undergoing Major Noncardiac Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>First Affiliated Hospital of Kunming Medical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>First Affiliated Hospital of Kunming Medical 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>
        The investigators aimed to investigate the effects of continuous infusion of norepinephrine&#xD;
        before and after general anesthesia induction on the occurrence of post-induction&#xD;
        hypotension.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Intraoperative hypotension is common after general anesthesia induction and is associated&#xD;
        with adverse postoperative events. Norepinephrine is one of the most applied vasopressors in&#xD;
        clinical to treat intraoperative hypotension. Due to the absence of effective measures for&#xD;
        predicting intraoperative hypotension, infusing norepinephrine before and during anesthesia&#xD;
        induction may reduce intraoperative hypotension. There is currently a lack of research&#xD;
        regarding whether continuous norepinephrine infusion before and during the induction of&#xD;
        general anesthesia can mitigate or prevent post-induction hypotension. The investigators aim&#xD;
        to investigate the effects of continuous infusion of norepinephrine before and after general&#xD;
        anesthesia induction on the occurrence of post-induction hypotension.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">October 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">April 1, 2024</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>Triple (Participant, Care Provider, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Incidence of post-induction hypotension</measure>
      <time_frame>From induction of general anesthesia to skin incision (up to one hour from induction of general anesthesia)</time_frame>
      <description>Hypotension: mean arterial pressure (MAP) &lt;65 mmHg</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Incidence of the following abnormal vital signs</measure>
      <time_frame>From induction of general anesthesia to skin incision (up to one hours from induction of general anesthesia)</time_frame>
      <description>MAP&lt;65 mmHg, MAP&lt;55 mmHg, MAP decreased over 20% ,30% and 40% from preoperative level; MAP increased over 20%, 30%, and 40% from preoperative level; SAP &lt; 90 mmHg; Systolic arterial pressure (SAP) &gt; 160 mmHg; Heart rate (HR) &lt; 40 bpm, HR &gt; 100 bpm; dosage of norepinephrine given by anesthesiologists; amount of fluid; the time-point of the first events of MAP &lt; 65 mmHg, MAP &lt; 55 mmHg, SAP &lt; 90 mmHg, SAP &gt; 160 mmHg, MAP increased over 20%, 30%, and 40% from preoperative level.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of the following abnormal vital signs</measure>
      <time_frame>From surgical incision to the end of surgery (up to six hours from surgical incision)</time_frame>
      <description>MAP&lt;65 mmHg, MAP&lt;55 mmHg, MAP decreased over 20%, 30%, and 40% from preoperative level; MAP increased over 20%, 30%, and 40% from preoperative level; SAP &lt; 90 mmHg; SAP &gt; 160 mmHg; HR &lt; 40 bpm, HR &gt; 100 bpm. Dosage of norepinephrine given by anesthesiologists; amount of fluid; the time-point of the first events of MAP &lt; 65 mmHg, MAP &lt; 55 mmHg, SAP &lt; 90 mmHg, SAP &gt; 160 mmHg, MAP increased over 20%, 30%, and 40% from preoperative level</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of the following abnormal vital signs</measure>
      <time_frame>from the end of surgery until leaving the post-anesthesia care unit (up to four hours from the end of surgery)</time_frame>
      <description>MAP&lt;65 mmHg, MAP&lt;55 mmHg, MAP decreased over 20%, 30%, and 40% from preoperative level; MAP increased over 20%, 30%, and 40% from preoperative level; SAP &lt; 90 mmHg; SAP &gt; 160 mmHg; HR &lt; 40 bpm, HR &gt; 100 bpm. Dosage of norepinephrine given by anesthesiologists; amount of fluid; the time-point of the first events of MAP &lt; 65 mmHg, MAP &lt; 55 mmHg, SAP &lt; 90 mmHg, SAP &gt; 160 mmHg, MAP increased over 20%, 30%, and 40% from preoperative level</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Postoperative major adverse cardiac events</measure>
      <time_frame>Within 30 days after surgery</time_frame>
      <description>Cardiac death, myocardial infarction, on-fatal cardiac arrest, coronary revascularization</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">180</enrollment>
    <condition>Anesthesia</condition>
    <condition>Blood Pressure</condition>
    <condition>Norepinephrine</condition>
    <arm_group>
      <arm_group_label>Norepinephrine</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The interventional group will receive a continuous infusion of norepinephrine 5 minutes (0.01μg/kg*min) before anesthesia induction until skin incision.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>the placebo group will receive a continuous infusion of normal saline (10 ml/h) 5 minutes before anesthesia induction until skin incision.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Norepinephrine Hydrochloride</intervention_name>
      <description>Both arms of patients will receive standard anesthesia and surgical management. Radial artery cannulation and invasive blood pressure monitoring will be perform.&#xD;
  Norepinephrine will be pumped at a rate of 10 ml/h for 5 minutes before anesthesia induction to skin incision.</description>
      <arm_group_label>Norepinephrine</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Normal saline will be pumped at a rate of 10 ml/h for 5 minutes before anesthesia induction to skin incision.</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients aged above 65 years or those above 45 years with at least one of the&#xD;
               following preoperative cardiovascular diseases: essential hypertension, coronary&#xD;
               artery disease, stroke, or type I/II diabetes mellitus.&#xD;
  &#xD;
            -  Patients who will receive major noncardiac surgery as open or laparoscopic abdominal&#xD;
               surgeries with an anticipated operative duration over two hours, including&#xD;
               gastrointestinal, liver, pancreatic, bladder, and uterine/adnexal surgeries.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who declined to participate in the present study.&#xD;
  &#xD;
            -  Patients enrolled in another ongoing clinical study.&#xD;
  &#xD;
            -  Patients with systolic arterial pressure (SAP) below 90 mmHg or above 160 mmHg, or&#xD;
               heart rate (HR) over 100 beats per minute (bpm) before anesthesia induction.&#xD;
  &#xD;
            -  Patients who have experienced any type of shock within 30 days before surgery.&#xD;
  &#xD;
            -  Patients with circulatory instability require continuous or intermittent positive&#xD;
               inotropic and/or vasopressors within 24 hours before surgery.&#xD;
  &#xD;
            -  Patients receive continuous or intermittent intravenous antihypertensive agents within&#xD;
               24 hours before surgery.&#xD;
  &#xD;
            -  Patients underwent coronary artery bypass grafting, coronary angiography, or coronary&#xD;
               stenting within 180 days before surgery.&#xD;
  &#xD;
            -  Patients who were diagnosed with new-onset tachyarrhythmia within 180 days before&#xD;
               surgery, such as atrial fibrillation, atrial flutter, and premature ventricular&#xD;
               contractions.&#xD;
  &#xD;
            -  Patients with preoperative alanine aminotransferase &gt;80 international units and/or&#xD;
               glomerular filtration rate &lt; 80 ml/min within the 180 days before surgery.&#xD;
  &#xD;
            -  Patients are ineligible for intraoperative invasive radial artery blood pressure&#xD;
               monitoring.&#xD;
  &#xD;
            -  Patients with a known history of allergy to norepinephrine.&#xD;
  &#xD;
            -  Patients who were planned for rapid sequence induction.&#xD;
  &#xD;
            -  Patients who were scheduled for awake tracheal intubation.&#xD;
  &#xD;
            -  Patients who were scheduled for double-lumen endotracheal intubation. Pregnant or&#xD;
               lactating patients.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>45 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Yuan Chang</last_name>
      <phone>+86 0871 65324888</phone>
      <email>changyuan@ydyy.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Jianlin Shao</last_name>
      <email>shaojlL@ydyy.cn</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>First Affiliated Hospital of Kunming Medical University</investigator_affiliation>
      <investigator_full_name>Yuan Chang</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>intraoperative hypotension</keyword>
    <keyword>arterial pressure</keyword>
    <keyword>general surgery</keyword>
    <keyword>general anesthesia</keyword>
    <keyword>noncardiac surgery</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hypotension</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Norepinephrine</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/NCT06028256
  org study id: 2023-L-126
  nct id: NCT06028256
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The investigators aimed to investigate the effects of continuous infusion of norepinephrine
        before and after general anesthesia induction on the occurrence of post-induction
        hypotension.
  Intraoperative hypotension is common after general anesthesia induction and is associated
        with adverse postoperative events. Norepinephrine is one of the most applied vasopressors in
        clinical to treat intraoperative hypotension. Due to the absence of effective measures for
        predicting intraoperative hypotension, infusing norepinephrine before and during anesthesia
        induction may reduce intraoperative hypotension. There is currently a lack of research
        regarding whether continuous norepinephrine infusion before and during the induction of
        general anesthesia can mitigate or prevent post-induction hypotension. The investigators aim
        to investigate the effects of continuous infusion of norepinephrine before and after general
        anesthesia induction on the occurrence of post-induction hypotension.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Triple (Participant, Care Provider, Investigator)
  measure: Incidence of post-induction hypotension
  time frame: From induction of general anesthesia to skin incision (up to one hour from induction of general anesthesia)
  description: Hypotension: mean arterial pressure (MAP) <65 mmHg
  measure: Incidence of the following abnormal vital signs
  time frame: From induction of general anesthesia to skin incision (up to one hours from induction of general anesthesia)
  description: MAP<65 mmHg, MAP<55 mmHg, MAP decreased over 20% ,30% and 40% from preoperative level; MAP increased over 20%, 30%, and 40% from preoperative level; SAP < 90 mmHg; Systolic arterial pressure (SAP) > 160 mmHg; Heart rate (HR) < 40 bpm, HR > 100 bpm; dosage of norepinephrine given by anesthesiologists; amount of fluid; the time-point of the first events of MAP < 65 mmHg, MAP < 55 mmHg, SAP < 90 mmHg, SAP > 160 mmHg, MAP increased over 20%, 30%, and 40% from preoperative level.
  measure: Incidence of the following abnormal vital signs
  time frame: From surgical incision to the end of surgery (up to six hours from surgical incision)
  description: MAP<65 mmHg, MAP<55 mmHg, MAP decreased over 20%, 30%, and 40% from preoperative level; MAP increased over 20%, 30%, and 40% from preoperative level; SAP < 90 mmHg; SAP > 160 mmHg; HR < 40 bpm, HR > 100 bpm. Dosage of norepinephrine given by anesthesiologists; amount of fluid; the time-point of the first events of MAP < 65 mmHg, MAP < 55 mmHg, SAP < 90 mmHg, SAP > 160 mmHg, MAP increased over 20%, 30%, and 40% from preoperative level
  measure: Incidence of the following abnormal vital signs
  time frame: from the end of surgery until leaving the post-anesthesia care unit (up to four hours from the end of surgery)
  description: MAP<65 mmHg, MAP<55 mmHg, MAP decreased over 20%, 30%, and 40% from preoperative level; MAP increased over 20%, 30%, and 40% from preoperative level; SAP < 90 mmHg; SAP > 160 mmHg; HR < 40 bpm, HR > 100 bpm. Dosage of norepinephrine given by anesthesiologists; amount of fluid; the time-point of the first events of MAP < 65 mmHg, MAP < 55 mmHg, SAP < 90 mmHg, SAP > 160 mmHg, MAP increased over 20%, 30%, and 40% from preoperative level
  measure: Postoperative major adverse cardiac events
  time frame: Within 30 days after surgery
  description: Cardiac death, myocardial infarction, on-fatal cardiac arrest, coronary revascularization
  arm group label: Norepinephrine
  arm group type: Experimental
  description: The interventional group will receive a continuous infusion of norepinephrine 5 minutes (0.01μg/kg*min) before anesthesia induction until skin incision.
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: the placebo group will receive a continuous infusion of normal saline (10 ml/h) 5 minutes before anesthesia induction until skin incision.
  intervention type: Drug
  intervention name: Norepinephrine Hydrochloride
  description: Both arms of patients will receive standard anesthesia and surgical management. Radial artery cannulation and invasive blood pressure monitoring will be perform.
  Norepinephrine will be pumped at a rate of 10 ml/h for 5 minutes before anesthesia induction to skin incision.
  arm group label: Norepinephrine
  intervention type: Drug
  intervention name: Placebo
  description: Normal saline will be pumped at a rate of 10 ml/h for 5 minutes before anesthesia induction to skin incision.
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 45 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Yuan Chang
  phone: +86 0871 65324888
  email: changyuan@ydyy.cn
  last name: Jianlin Shao
  email: shaojlL@ydyy.cn
  responsible party type: Principal Investigator
  investigator affiliation: First Affiliated Hospital of Kunming Medical University
  investigator full name: Yuan Chang
  investigator title: Principal Investigator
  mesh term: Hypotension
  mesh term: Norepinephrine
  sharing ipd: No