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/NCT06037135</url>
    </required_header>
    <id_info>
      <org_study_id>4-2012-0577</org_study_id>
      <nct_id>NCT06037135</nct_id>
    </id_info>
    <brief_title>The Effects of Sufentanil-remimazolam vs. Remifentanil-remimazolam Total Intravenous Anesthesia on Postoperative Pain in Laparoscopic-assisted Gastrectomy</brief_title>
    <official_title>The Effects of Sufentanil-remimazolam vs. Remifentanil-remimazolam Total Intravenous Anesthesia on Postoperative Pain in Laparoscopic-assisted Gastrectomy - A Randomized, Controlled Study</official_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>
      <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 planned this study to investigate the effects of dexmedetomidine&#xD;
        administration on intraoperative hemodynamic stability in patients with pheochromocytoma.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">December 3, 2012</start_date>
    <completion_date type="Actual">March 26, 2021</completion_date>
    <primary_completion_date type="Actual">March 26, 2021</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>Supportive Care</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Intraoperative hemodynamic stability ( maximum blood pressure during surgery (systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MBP))</measure>
      <time_frame>during operation</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Intraoperative hemodynamic stability (duration of SBP increase by 30% or more from baseline (in minutes)</measure>
      <time_frame>during operation</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Intraoperative hemodynamic stability (duration of SBP exceeding 200 mmHg)</measure>
      <time_frame>during operation</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Intraoperative hemodynamic stability (maximum HR during surgery)</measure>
      <time_frame>during operation</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Intraoperative hemodynamic stability (duration of HR exceeding 110 beats per minute during surgery)</measure>
      <time_frame>during operation</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Intraoperative hemodynamic stability (comparison of the quantity of vasoactive drugs (nitroprusside, esmolol, norepinephrine) used during surgery)</measure>
      <time_frame>during operation</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>levels of catecholamines</measure>
      <time_frame>immediately after anesthesia induction</time_frame>
      <description>the actual secretion levels of catecholamines, specifically epinephrine and norepinephrine, were measured at different time points</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>levels of catecholamines</measure>
      <time_frame>immediately after removal of the pheochromocytoma</time_frame>
      <description>the actual secretion levels of catecholamines, specifically epinephrine and norepinephrine, were measured at different time points</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>levels of catecholamines</measure>
      <time_frame>immediately after the completion of surgery</time_frame>
      <description>the actual secretion levels of catecholamines, specifically epinephrine and norepinephrine, were measured at different time points</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">40</enrollment>
    <condition>Pheochromocytoma</condition>
    <arm_group>
      <arm_group_label>dexmedetomidine group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In the dexmedetomidine group, dexmedetomidine is administered at a rate of 0.5 μg/kg/h immediately after anesthesia induction and continued until the completion of the surgery.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>In the control group, a 0.9% normal saline infusion is initiated at the same rate immediately after anesthesia induction and continued until the end of the operation.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>dexmedetomidine</intervention_name>
      <description>In the dexmedetomidine group, dexmedetomidine is administered at a rate of 0.5 μg/kg/h immediately after anesthesia induction and continued until the completion of the surgery. The research nurse, who did not participate in the study other than the management and preparation of the study medication, prepared 50mL of 0.9% normal saline for the control group and a mixture of dexmedetomidine 2 mL and 0.9% normal saline 48 mL (at a concentration of 4 μg/mL) for the dexmedetomidine group.</description>
      <arm_group_label>dexmedetomidine group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>0.9% normal saline</intervention_name>
      <description>In the control group, a 0.9% normal saline infusion is initiated at the same rate immediately after anesthesia induction and continued until the end of the operation.</description>
      <arm_group_label>Control group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. ages of 20 and 70&#xD;
  &#xD;
            2. American Society of Anesthesiologists(ASA) physical status classification I to III,&#xD;
  &#xD;
            3. planned laparoscopic adrenalectomy for pheochromocytoma.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. emergency operation,&#xD;
  &#xD;
            2. re-operation,&#xD;
  &#xD;
            3. combined surgery with other departments,&#xD;
  &#xD;
            4. body mass index (BMI) &gt;32 kg/m2,&#xD;
  &#xD;
            5. history of arrhythmias (especially AV nodal block) and ventricular conduction&#xD;
               abnormalities,&#xD;
  &#xD;
            6. uncontrolled hypertension (diastolic blood pressure &gt;110mmHg)&#xD;
  &#xD;
            7. bradycardia (heart rate &lt; 40 beats per minute),&#xD;
  &#xD;
            8. history of heart failure, hepatic and/or renal failure,&#xD;
  &#xD;
            9. history of cerebrovascular disease (cerebral hemorrhage, cerebral ischemia),&#xD;
  &#xD;
           10. history of beta-blocker therapy, 10) history of uncontrolled psychiatric disease.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Young Jun Oh, M.D., Ph.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Severance hospital</name>
        <address>
          <city>Seoul</city>
          <country>Korea, Republic of</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Korea, Republic of</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>September 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pheochromocytoma</mesh_term>
      <mesh_term>Pain, Postoperative</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dexmedetomidine</mesh_term>
    </intervention_browse>
    <!-- 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/NCT06037135
  org study id: 4-2012-0577
  nct id: NCT06037135
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The investigators planned this study to investigate the effects of dexmedetomidine
        administration on intraoperative hemodynamic stability in patients with pheochromocytoma.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Double (Participant, Outcomes Assessor)
  measure: Intraoperative hemodynamic stability ( maximum blood pressure during surgery (systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MBP))
  time frame: during operation
  measure: Intraoperative hemodynamic stability (duration of SBP increase by 30% or more from baseline (in minutes)
  time frame: during operation
  measure: Intraoperative hemodynamic stability (duration of SBP exceeding 200 mmHg)
  time frame: during operation
  measure: Intraoperative hemodynamic stability (maximum HR during surgery)
  time frame: during operation
  measure: Intraoperative hemodynamic stability (duration of HR exceeding 110 beats per minute during surgery)
  time frame: during operation
  measure: Intraoperative hemodynamic stability (comparison of the quantity of vasoactive drugs (nitroprusside, esmolol, norepinephrine) used during surgery)
  time frame: during operation
  measure: levels of catecholamines
  time frame: immediately after anesthesia induction
  description: the actual secretion levels of catecholamines, specifically epinephrine and norepinephrine, were measured at different time points
  measure: levels of catecholamines
  time frame: immediately after removal of the pheochromocytoma
  description: the actual secretion levels of catecholamines, specifically epinephrine and norepinephrine, were measured at different time points
  measure: levels of catecholamines
  time frame: immediately after the completion of surgery
  description: the actual secretion levels of catecholamines, specifically epinephrine and norepinephrine, were measured at different time points
  arm group label: dexmedetomidine group
  arm group type: Experimental
  description: In the dexmedetomidine group, dexmedetomidine is administered at a rate of 0.5 μg/kg/h immediately after anesthesia induction and continued until the completion of the surgery.
  arm group label: Control group
  arm group type: Active Comparator
  description: In the control group, a 0.9% normal saline infusion is initiated at the same rate immediately after anesthesia induction and continued until the end of the operation.
  intervention type: Drug
  intervention name: dexmedetomidine
  description: In the dexmedetomidine group, dexmedetomidine is administered at a rate of 0.5 μg/kg/h immediately after anesthesia induction and continued until the completion of the surgery. The research nurse, who did not participate in the study other than the management and preparation of the study medication, prepared 50mL of 0.9% normal saline for the control group and a mixture of dexmedetomidine 2 mL and 0.9% normal saline 48 mL (at a concentration of 4 μg/mL) for the dexmedetomidine group.
  arm group label: dexmedetomidine group
  intervention type: Drug
  intervention name: 0.9% normal saline
  description: In the control group, a 0.9% normal saline infusion is initiated at the same rate immediately after anesthesia induction and continued until the end of the operation.
  arm group label: Control group
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Young Jun Oh, M.D., Ph.D.
  role: Principal Investigator
  affiliation: Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
  facility: 
  country: Korea, Republic of
  responsible party type: Sponsor
  mesh term: Pheochromocytoma
  mesh term: Pain, Postoperative
  mesh term: Dexmedetomidine