<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/NCT03763305</url>
  </required_header>
  <id_info>
    <org_study_id>SKNA-TURB</org_study_id>
    <nct_id>NCT03763305</nct_id>
  </id_info>
  <brief_title>Comparison of Skin Sympathetic Nerve Activity According to Different Anesthetics</brief_title>
  <official_title>Comparison of Skin Sympathetic Nerve Activity According to Different Anesthetics During Transurethral Procedures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Skin sympathetic nerve activity (SKNA) has recently been discovered from the&#xD;
      electrocardiogram obtained from healthy volunteers. The raw physiologic electric signal from&#xD;
      electrodes placed on the skin was reprocessed through filtering and integration using&#xD;
      software to produce the SKNA signal. However, no study has yet provided knowledge on the&#xD;
      effect of anesthetics on SKNA during general anesthesia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The most commonly used anesthetic techniques during general anesthesia are the total&#xD;
      intravenous anesthesia (TIVA) and anesthesia using inhalants such as sevoflurane or&#xD;
      desflurane. For TIVA, the combination of propofol and remifentanil has been used and&#xD;
      remifentanil is known for increasing vagal tone and inhibiting sympathetic nervous system as&#xD;
      other opioids do. Sevoflurane is presumed to have no effect on parasympathetic or sympathetic&#xD;
      tone. On the other hand, desflurane induces tachycardia and is noted for activating&#xD;
      sympathetic activity. Previous studies on sympathetic nervous activity according to different&#xD;
      anesthetics did not directly measure sympathetic tone but have relied on indirect measures&#xD;
      such as blood pressure, heart rate, and heart rate variability.&#xD;
&#xD;
      In order to evaluate skin sympathetic nerve activity according to different anesthetics, we&#xD;
      will be recruiting patients undergoing transurethral procedures, where the sympathetic tone&#xD;
      is expected to be activated during anesthesia and surgery. The transurethral procedures&#xD;
      consist of transurethral resection of bladder (TURB) and transurethral resection of prostate&#xD;
      (TURP). During transurethral surgery, about 300mL of fluid is used to fill the bladder to&#xD;
      secure surgical view and for irrigation. Bladder expansion causes sympathetic nerve&#xD;
      activation and vasoconstriction, which will also increase SKNA signals. The purpose of this&#xD;
      study is to measure skin sympathetic nerve activity according to different anesthetics during&#xD;
      intraoperative events that stimulate sympathetic tone.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Devices for measuring SKNA are need to be re-constructed, which takes considerable time.&#xD;
  </why_stopped>
  <start_date type="Anticipated">January 1, 2023</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</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, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The skin sympathetic nerve activity (SKNA) presented as uV obtained via skin leads.</measure>
    <time_frame>Intraoperative</time_frame>
    <description>The average intraoperative SKNA divided by average SKNA before induction of general anesthesia (T0)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percent change of SKNA</measure>
    <time_frame>T1: 1.5 minute after use of anesthetics, T2: 1.5 minute after use of muscle relaxant, T3: 30 seconds after intubation, T4: before bladder expansion, T5: 30 seconds after bladder expansion, T6: 30 sec after start of surgery, T7: 30sec after end of surgery</time_frame>
    <description>Percent change of SKNA at different time points (T1-T7) compared to T0</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>SKNA According to Different Anesthetics</condition>
  <arm_group>
    <arm_group_label>Total intravenous anesthesia (TIVA)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Study participants are anesthetized by total intravenous anesthesia (TIVA) using propofol continuous infusion and remifentanil continuous infusion. During induction of general anesthesia, participants receive 3~5mcg/mL Propofol Fresenius and 3~5ng/mL and Remifentanil [Ultiva] as initial effect site concentrations. The effect site concentration is controlled with target-controlled infusion to maintain bispectral index (BIS) values between 40 and 60.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sevoflurane</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Study participants receive fentanyl 1mcg/kg and propofol bolus injection 1.5~2mg/kg for induction of general anesthesia. For maintenance of anesthesia, sevoflurane inhalant solution [Sojourn] is used to maintain 1 age-related minimum alveolar concentration (MAC).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Desflurane</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Study participants receive fentanyl 1mcg/kg and propofol bolus injection 1.5~2mg/kg for induction of general anesthesia. For maintenance of anesthesia, desflurane [Suprane] is used to maintain 1 age-related minimum alveolar concentration (MAC).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Propofol continuous infusion</intervention_name>
    <description>Propofol intravenous continuous infusion for anesthetic induction and maintenance</description>
    <arm_group_label>Total intravenous anesthesia (TIVA)</arm_group_label>
    <other_name>Propofol Fresenius</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Remifentanil</intervention_name>
    <description>Remifentanil intravenous continuous infusion for anesthetic induction and maintenance</description>
    <arm_group_label>Total intravenous anesthesia (TIVA)</arm_group_label>
    <other_name>Ultiva</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sevoflurane</intervention_name>
    <description>Study participants receive fentanyl 1mcg/kg and propofol 1.5~2mg/kg for induction of general anesthesia. For maintenance of anesthesia, desflurane is used to maintain 1 age-related minimum alveolar concentration (MAC).</description>
    <arm_group_label>Sevoflurane</arm_group_label>
    <other_name>Sevoflurane Inhalant Solution [Sojourn]</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Desflurane</intervention_name>
    <description>1 age-related minimum alveolar concentration (MAC) of desflurane inhalation for anesthetic maintenance</description>
    <arm_group_label>Desflurane</arm_group_label>
    <other_name>Desflurane Inhalation Solution [Suprane]</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Propofol bolus injection</intervention_name>
    <description>Propofol intravenous injection for anesthetic induction</description>
    <arm_group_label>Desflurane</arm_group_label>
    <arm_group_label>Sevoflurane</arm_group_label>
    <other_name>Anepol</other_name>
    <other_name>Pofol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fentanyl</intervention_name>
    <description>Fentanyl intravenous injection for anesthetic induction</description>
    <arm_group_label>Desflurane</arm_group_label>
    <arm_group_label>Sevoflurane</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Scheduled to undergo elective transurethral procedures under general anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with autonomic dysfunction&#xD;
&#xD;
          -  Current use of beta blockers&#xD;
&#xD;
          -  Cardiac arrhythmia&#xD;
&#xD;
          -  Absolute indication for either TIVA or inhalants, absolute contraindication for either&#xD;
             TIVA or inhalants (adverse effects on either propofol or remifentanil, risk of&#xD;
             malignant hyperthermia)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yunseok Jeon, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>November 25, 2018</study_first_submitted>
  <study_first_submitted_qc>December 1, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>May 5, 2022</last_update_submitted>
  <last_update_submitted_qc>May 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Yunseok Jeon</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>skin sympathetic nerve activity, anesthetics</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fentanyl</mesh_term>
    <mesh_term>Remifentanil</mesh_term>
    <mesh_term>Propofol</mesh_term>
    <mesh_term>Sevoflurane</mesh_term>
    <mesh_term>Desflurane</mesh_term>
    <mesh_term>Pharmaceutical Solutions</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03763305
org study id: SKNA-TURB
nct id: NCT03763305
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Skin sympathetic nerve activity (SKNA) has recently been discovered from the
      electrocardiogram obtained from healthy volunteers. The raw physiologic electric signal from
      electrodes placed on the skin was reprocessed through filtering and integration using
      software to produce the SKNA signal. However, no study has yet provided knowledge on the
      effect of anesthetics on SKNA during general anesthesia.
The most commonly used anesthetic techniques during general anesthesia are the total
      intravenous anesthesia (TIVA) and anesthesia using inhalants such as sevoflurane or
      desflurane. For TIVA, the combination of propofol and remifentanil has been used and
      remifentanil is known for increasing vagal tone and inhibiting sympathetic nervous system as
      other opioids do. Sevoflurane is presumed to have no effect on parasympathetic or sympathetic
      tone. On the other hand, desflurane induces tachycardia and is noted for activating
      sympathetic activity. Previous studies on sympathetic nervous activity according to different
      anesthetics did not directly measure sympathetic tone but have relied on indirect measures
      such as blood pressure, heart rate, and heart rate variability.

      In order to evaluate skin sympathetic nerve activity according to different anesthetics, we
      will be recruiting patients undergoing transurethral procedures, where the sympathetic tone
      is expected to be activated during anesthesia and surgery. The transurethral procedures
      consist of transurethral resection of bladder (TURB) and transurethral resection of prostate
      (TURP). During transurethral surgery, about 300mL of fluid is used to fill the bladder to
      secure surgical view and for irrigation. Bladder expansion causes sympathetic nerve
      activation and vasoconstriction, which will also increase SKNA signals. The purpose of this
      study is to measure skin sympathetic nerve activity according to different anesthetics during
      intraoperative events that stimulate sympathetic tone.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: The skin sympathetic nerve activity (SKNA) presented as uV obtained via skin leads.
time frame: Intraoperative
description: The average intraoperative SKNA divided by average SKNA before induction of general anesthesia (T0)
measure: Percent change of SKNA
time frame: T1: 1.5 minute after use of anesthetics, T2: 1.5 minute after use of muscle relaxant, T3: 30 seconds after intubation, T4: before bladder expansion, T5: 30 seconds after bladder expansion, T6: 30 sec after start of surgery, T7: 30sec after end of surgery
description: Percent change of SKNA at different time points (T1-T7) compared to T0
arm group label: Total intravenous anesthesia (TIVA)
arm group type: Experimental
description: Study participants are anesthetized by total intravenous anesthesia (TIVA) using propofol continuous infusion and remifentanil continuous infusion. During induction of general anesthesia, participants receive 3~5mcg/mL Propofol Fresenius and 3~5ng/mL and Remifentanil [Ultiva] as initial effect site concentrations. The effect site concentration is controlled with target-controlled infusion to maintain bispectral index (BIS) values between 40 and 60.
arm group label: Sevoflurane
arm group type: Experimental
description: Study participants receive fentanyl 1mcg/kg and propofol bolus injection 1.5~2mg/kg for induction of general anesthesia. For maintenance of anesthesia, sevoflurane inhalant solution [Sojourn] is used to maintain 1 age-related minimum alveolar concentration (MAC).
arm group label: Desflurane
arm group type: Experimental
description: Study participants receive fentanyl 1mcg/kg and propofol bolus injection 1.5~2mg/kg for induction of general anesthesia. For maintenance of anesthesia, desflurane [Suprane] is used to maintain 1 age-related minimum alveolar concentration (MAC).
intervention type: Drug
intervention name: Propofol continuous infusion
description: Propofol intravenous continuous infusion for anesthetic induction and maintenance
arm group label: Total intravenous anesthesia (TIVA)
other name: Propofol Fresenius
intervention type: Drug
intervention name: Remifentanil
description: Remifentanil intravenous continuous infusion for anesthetic induction and maintenance
arm group label: Total intravenous anesthesia (TIVA)
other name: Ultiva
intervention type: Drug
intervention name: Sevoflurane
description: Study participants receive fentanyl 1mcg/kg and propofol 1.5~2mg/kg for induction of general anesthesia. For maintenance of anesthesia, desflurane is used to maintain 1 age-related minimum alveolar concentration (MAC).
arm group label: Sevoflurane
other name: Sevoflurane Inhalant Solution [Sojourn]
intervention type: Drug
intervention name: Desflurane
description: 1 age-related minimum alveolar concentration (MAC) of desflurane inhalation for anesthetic maintenance
arm group label: Desflurane
other name: Desflurane Inhalation Solution [Suprane]
intervention type: Drug
intervention name: Propofol bolus injection
description: Propofol intravenous injection for anesthetic induction
arm group label: Desflurane
arm group label: Sevoflurane
other name: Anepol
other name: Pofol
intervention type: Drug
intervention name: Fentanyl
description: Fentanyl intravenous injection for anesthetic induction
arm group label: Desflurane
arm group label: Sevoflurane
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Yunseok Jeon, MD, PhD
role: Study Director
affiliation: Seoul National University Hospital
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Yunseok Jeon
investigator title: Professor
mesh term: Fentanyl
mesh term: Remifentanil
mesh term: Propofol
mesh term: Sevoflurane
mesh term: Desflurane
mesh term: Pharmaceutical Solutions