<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/NCT03302221</url>
  </required_header>
  <id_info>
    <org_study_id>20170711-01</org_study_id>
    <nct_id>NCT03302221</nct_id>
  </id_info>
  <brief_title>Regional Haemodynamic Changes in Radial Artery Assessment With Continuous Pulsed-wave Doppler Ultrasound</brief_title>
  <official_title>Regional Haemodynamic Changes in Radial Artery Assessment With Continuous Pulsed-wave Doppler Ultrasound in Patients Undergoing Video-assisted Thoracic Surgery With Different Kinds of Anaesthesia Management</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>China Medical University, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>China Medical University, China</source>
  <oversight_info>
    <has_dmc>Yes</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 objective of the trial was to evaluate velocity-associated parameters of pulsed-wave&#xD;
      Doppler ultrasound at induction, discharge from the post-anaesthesia care unit and during&#xD;
      inspiratory cough in addition to the consumption of phenylephrine during the operation in&#xD;
      patients undergoing video-assisted thoracic surgery with three types of anaesthesia&#xD;
      management.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of the trial was to evaluate velocity-associated parameters of pulsed-wave&#xD;
      Doppler ultrasound at induction, discharge from the post-anaesthesia care unit and during&#xD;
      inspiratory cough in addition to the consumption of phenylephrine during the operation in&#xD;
      patients undergoing video-assisted thoracic surgery with three types of anaesthesia&#xD;
      management. The patients in this trial were visited during the entire operation and just&#xD;
      before leaving the post-anaesthesia care unit. Velocity-associated data related to&#xD;
      pulsed-wave Doppler ultrasound and the consumption of phenylephrine were collected.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    No participants enrolled&#xD;
  </why_stopped>
  <start_date type="Actual">October 15, 2017</start_date>
  <completion_date type="Anticipated">September 20, 2020</completion_date>
  <primary_completion_date type="Anticipated">August 20, 2020</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>
    <intervention_model_description>Doppler Ultrasonography Assessed Vascular Changes</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Change of end-diastolic velocity</measure>
    <time_frame>baseline and 10 minutes after induction</time_frame>
    <description>The primary outcome was the end-diastolic velocity at 12 time points of anaesthesia induction among the three groups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>pulsed-wave Doppler ultrasound</measure>
    <time_frame>before leaving the PACU, up to 5 minutes</time_frame>
    <description>other data related to pulsed-wave Doppler ultrasound and acquired during anaesthesia induction, before leaving the PACU and during inspiratory cough</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>intraoperative consumption of phenylephrine</measure>
    <time_frame>through study completion, an average of 3 hours</time_frame>
    <description>intraoperative consumption of phenylephrine</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Group control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>In the control group, local anaesthesia at the incision was induced by 0.5% ropivacaine by the surgeon just before the surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Paravertebral Block Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In Group Paravertebral Block, patients received standardized general anaesthesia supplemented by paravertebral Block. The USG approach for TPVB was used with the patient in the lateral position at the T4-T6 level according to the incision protocol in our centre.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Epidural Block Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The investigators designed a study to assess whether there were any blood flow indexes change during induction with doppler ultrasonography ;general anesthesia combined with epidural block</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>0.5% ropivacaine paravertebral block</intervention_name>
    <description>The investigators designed a study to assess whether there were any blood flow indexes change during induction with doppler ultrasonography after 0.5% ropivacaine paravertebral block</description>
    <arm_group_label>Paravertebral Block Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>0.25% ropivacaine epidural block</intervention_name>
    <description>A 4-5 ml bolus of 0.25% ropivacaine was administered 1 h after the initiation of TEB.</description>
    <arm_group_label>Epidural Block Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>0.5% ropivacaine local anaesthesia</intervention_name>
    <description>local anaesthesia at the incision was induced by 0.5% ropivacaine by the surgeon just before the surgery.</description>
    <arm_group_label>Group control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. ethnic Chinese;&#xD;
&#xD;
          2. age, 18 to 65 years old;&#xD;
&#xD;
          3. American Society of Anaesthesiologists (ASA) physical status I or II;&#xD;
&#xD;
          4. required VATS for lung surgery and one lung ventilation .&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        body mass index exceeding 30 kg/m2; Patients with a history of hypertension, diabetes&#xD;
        mellitus or arteriosclerosis; and any allergy to drugs used in the study.&#xD;
&#xD;
        Patients with arrhythmias or implanted cardiac pacemakers were excluded. Patients with&#xD;
        diseases of the central or peripheral nervous system were excluded.&#xD;
&#xD;
        Patients taking medications affecting the autonomic nervous system, such as b-blockers and&#xD;
        calcium channel blockers&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hong Ma, MD,PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Anesthesiology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>the First Hospital of China Medical University</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <zip>110001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>October 1, 2017</study_first_submitted>
  <study_first_submitted_qc>October 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 5, 2017</study_first_posted>
  <last_update_submitted>March 6, 2020</last_update_submitted>
  <last_update_submitted_qc>March 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>China Medical University, China</investigator_affiliation>
    <investigator_full_name>Wen-fei Tan</investigator_full_name>
    <investigator_title>Associate proffesor</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ropivacaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03302221
org study id: 20170711-01
nct id: NCT03302221
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The objective of the trial was to evaluate velocity-associated parameters of pulsed-wave
      Doppler ultrasound at induction, discharge from the post-anaesthesia care unit and during
      inspiratory cough in addition to the consumption of phenylephrine during the operation in
      patients undergoing video-assisted thoracic surgery with three types of anaesthesia
      management.
The objective of the trial was to evaluate velocity-associated parameters of pulsed-wave
      Doppler ultrasound at induction, discharge from the post-anaesthesia care unit and during
      inspiratory cough in addition to the consumption of phenylephrine during the operation in
      patients undergoing video-assisted thoracic surgery with three types of anaesthesia
      management. The patients in this trial were visited during the entire operation and just
      before leaving the post-anaesthesia care unit. Velocity-associated data related to
      pulsed-wave Doppler ultrasound and the consumption of phenylephrine were collected.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Doppler Ultrasonography Assessed Vascular Changes
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: The Change of end-diastolic velocity
time frame: baseline and 10 minutes after induction
description: The primary outcome was the end-diastolic velocity at 12 time points of anaesthesia induction among the three groups.
measure: pulsed-wave Doppler ultrasound
time frame: before leaving the PACU, up to 5 minutes
description: other data related to pulsed-wave Doppler ultrasound and acquired during anaesthesia induction, before leaving the PACU and during inspiratory cough
measure: intraoperative consumption of phenylephrine
time frame: through study completion, an average of 3 hours
description: intraoperative consumption of phenylephrine
arm group label: Group control
arm group type: Other
description: In the control group, local anaesthesia at the incision was induced by 0.5% ropivacaine by the surgeon just before the surgery.
arm group label: Paravertebral Block Group
arm group type: Experimental
description: In Group Paravertebral Block, patients received standardized general anaesthesia supplemented by paravertebral Block. The USG approach for TPVB was used with the patient in the lateral position at the T4-T6 level according to the incision protocol in our centre.
arm group label: Epidural Block Group
arm group type: Experimental
description: The investigators designed a study to assess whether there were any blood flow indexes change during induction with doppler ultrasonography ;general anesthesia combined with epidural block
intervention type: Drug
intervention name: 0.5% ropivacaine paravertebral block
description: The investigators designed a study to assess whether there were any blood flow indexes change during induction with doppler ultrasonography after 0.5% ropivacaine paravertebral block
arm group label: Paravertebral Block Group
intervention type: Drug
intervention name: 0.25% ropivacaine epidural block
description: A 4-5 ml bolus of 0.25% ropivacaine was administered 1 h after the initiation of TEB.
arm group label: Epidural Block Group
intervention type: Drug
intervention name: 0.5% ropivacaine local anaesthesia
description: local anaesthesia at the incision was induced by 0.5% ropivacaine by the surgeon just before the surgery.
arm group label: Group control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Hong Ma, MD,PhD
role: Study Chair
affiliation: Department of Anesthesiology
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: China Medical University, China
investigator full name: Wen-fei Tan
investigator title: Associate proffesor
mesh term: Ropivacaine
sharing ipd: Undecided