<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/NCT04426097</url>
  </required_header>
  <id_info>
    <org_study_id>TMU-JIRB N201803027</org_study_id>
    <nct_id>NCT04426097</nct_id>
  </id_info>
  <brief_title>Effect of Cervical Vagal Blockade on Cough Incidence in Non-intubated Uniportal Video-assisted Thoracic Surgery</brief_title>
  <official_title>Effect of Cervical Vagal Blockade on Cough Incidence in Non-intubated Uniportal Video-assisted Thoracoscopic Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taipei Medical University WanFang Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taipei Medical University WanFang Hospital</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>
      Currently, there is a trend toward non-intubated anesthesia methods for video-assisted&#xD;
      thoracic surgery in our hospital. During the surgery, intrathoracic vagus nerve blockade is&#xD;
      suggested for inhibit cough reflex in previous paper. However, right and left side of vagus&#xD;
      nerves both deep near the aorta or trachea respectively. To achieving the procedure may&#xD;
      induce cough reflex by lobar traction even result vital organ damage. This study aims to&#xD;
      apply alternative vagus nerve blockade at neck level via ultrasound guidance and test if the&#xD;
      procedure real reduce cough reflex then previous method. We also follow up the patient's&#xD;
      vital sign, vocal cord and diaphragm movement, horner syndrome and hoarseness to evaluating&#xD;
      if cervical vagal blockade has the potential risk involve other surrounding nerves&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 1, 2020</start_date>
  <completion_date type="Anticipated">July 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">July 1, 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>Treatment</primary_purpose>
    <masking>Double (Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Effect of Cervical Vagal Blockade on Cough Incidence</measure>
    <time_frame>During the VATS procedure</time_frame>
    <description>number of coughing episodes</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Video-assisted Thoracoscopic Surgery</condition>
  <arm_group>
    <arm_group_label>Cervical Vagal Blockade</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Without Blockade</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cervical Vagal Blockade</intervention_name>
    <description>Cervical Vagal Blockade with 0.5 % ropivacaine 2.5 ml and 2% xylocaine 2.5 ml</description>
    <arm_group_label>Cervical Vagal Blockade</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Without Blockade</intervention_name>
    <description>Without Blockade</description>
    <arm_group_label>Without Blockade</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults younger than 80 years old are scheduled for one-port video assisted thoracic&#xD;
             surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Anticipated difficult airway, Respiratory insufficiency,Vocal cord palsy,diaphragm&#xD;
             palsy parkinsonism,previous stroke,tachycardia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Lin Jui An, PhD</last_name>
    <phone>+886-66382736,</phone>
    <phone_ext>1728</phone_ext>
    <email>greenscatter1031@gmail.com</email>
  </overall_contact>
  <reference>
    <citation>Katlic MR, Facktor MA. Video-assisted thoracic surgery utilizing local anesthesia and sedation: 384 consecutive cases. Ann Thorac Surg. 2010 Jul;90(1):240-5. doi: 10.1016/j.athoracsur.2010.02.113.</citation>
    <PMID>20609784</PMID>
  </reference>
  <reference>
    <citation>Chen KC, Cheng YJ, Hung MH, Tseng YD, Chen JS. Nonintubated thoracoscopic surgery using regional anesthesia and vagal block and targeted sedation. J Thorac Dis. 2014 Jan;6(1):31-6. doi: 10.3978/j.issn.2072-1439.2014.01.01.</citation>
    <PMID>24455173</PMID>
  </reference>
  <reference>
    <citation>Chen JS, Cheng YJ, Hung MH, Tseng YD, Chen KC, Lee YC. Nonintubated thoracoscopic lobectomy for lung cancer. Ann Surg. 2011 Dec;254(6):1038-43. doi: 10.1097/SLA.0b013e31822ed19b.</citation>
    <PMID>21869676</PMID>
  </reference>
  <reference>
    <citation>Lee YJ, Chung CC, Chou HC, Lin JA. Block for uniportal video-assisted thoracoscopic surgery: an ultrasound-guided, single-penetration, double-injection approach. Br J Anaesth. 2015 Nov;115(5):792-4. doi: 10.1093/bja/aev327. No abstract available.</citation>
    <PMID>26475808</PMID>
  </reference>
  <reference>
    <citation>Dong Q, Liang L, Li Y, Liu J, Yin W, Chen H, Xu X, Shao W, He J. Anesthesia with nontracheal intubation in thoracic surgery. J Thorac Dis. 2012 Apr 1;4(2):126-30. doi: 10.3978/j.issn.2072-1439.2012.03.10.</citation>
    <PMID>22833817</PMID>
  </reference>
  <reference>
    <citation>Giovagnorio F, Martinoli C. Sonography of the cervical vagus nerve: normal appearance and abnormal findings. AJR Am J Roentgenol. 2001 Mar;176(3):745-9. doi: 10.2214/ajr.176.3.1760745.</citation>
    <PMID>11222217</PMID>
  </reference>
  <reference>
    <citation>Arsanious D, Khoury S, Martinez E, Nawras A, Filatoff G, Ajabnoor H, Darr U, Atallah J. Ultrasound-Guided Phrenic Nerve Block for Intractable Hiccups following Placement of Esophageal Stent for Esophageal Squamous Cell Carcinoma. Pain Physician. 2016 May;19(4):E653-6.</citation>
    <PMID>27228533</PMID>
  </reference>
  <reference>
    <citation>Elias M. Cervical sympathetic and stellate ganglion blocks. Pain Physician. 2000 Jul;3(3):294-304.</citation>
    <PMID>16906187</PMID>
  </reference>
  <reference>
    <citation>Polverino M, Polverino F, Fasolino M, Ando F, Alfieri A, De Blasio F. Anatomy and neuro-pathophysiology of the cough reflex arc. Multidiscip Respir Med. 2012 Jun 18;7(1):5. doi: 10.1186/2049-6958-7-5.</citation>
    <PMID>22958367</PMID>
  </reference>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>March 31, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 9, 2020</last_update_submitted>
  <last_update_submitted_qc>June 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>vagus nerve block</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Iodine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04426097
org study id: TMU-JIRB N201803027
nct id: NCT04426097
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Currently, there is a trend toward non-intubated anesthesia methods for video-assisted
      thoracic surgery in our hospital. During the surgery, intrathoracic vagus nerve blockade is
      suggested for inhibit cough reflex in previous paper. However, right and left side of vagus
      nerves both deep near the aorta or trachea respectively. To achieving the procedure may
      induce cough reflex by lobar traction even result vital organ damage. This study aims to
      apply alternative vagus nerve blockade at neck level via ultrasound guidance and test if the
      procedure real reduce cough reflex then previous method. We also follow up the patient's
      vital sign, vocal cord and diaphragm movement, horner syndrome and hoarseness to evaluating
      if cervical vagal blockade has the potential risk involve other surrounding nerves
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Care Provider, Outcomes Assessor)
measure: Effect of Cervical Vagal Blockade on Cough Incidence
time frame: During the VATS procedure
description: number of coughing episodes
arm group label: Cervical Vagal Blockade
arm group type: Experimental
arm group label: Without Blockade
arm group type: Placebo Comparator
intervention type: Procedure
intervention name: Cervical Vagal Blockade
description: Cervical Vagal Blockade with 0.5 % ropivacaine 2.5 ml and 2% xylocaine 2.5 ml
arm group label: Cervical Vagal Blockade
intervention type: Procedure
intervention name: Without Blockade
description: Without Blockade
arm group label: Without Blockade
criteria: 
gender: All
minimum age: 20 Years
maximum age: 79 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Lin Jui An, PhD
phone: +886-66382736,
phone ext: 1728
email: greenscatter1031@gmail.com
citation: Katlic MR, Facktor MA. Video-assisted thoracic surgery utilizing local anesthesia and sedation: 384 consecutive cases. Ann Thorac Surg. 2010 Jul;90(1):240-5. doi: 10.1016/j.athoracsur.2010.02.113.
PMID: 20609784
citation: Chen KC, Cheng YJ, Hung MH, Tseng YD, Chen JS. Nonintubated thoracoscopic surgery using regional anesthesia and vagal block and targeted sedation. J Thorac Dis. 2014 Jan;6(1):31-6. doi: 10.3978/j.issn.2072-1439.2014.01.01.
PMID: 24455173
citation: Chen JS, Cheng YJ, Hung MH, Tseng YD, Chen KC, Lee YC. Nonintubated thoracoscopic lobectomy for lung cancer. Ann Surg. 2011 Dec;254(6):1038-43. doi: 10.1097/SLA.0b013e31822ed19b.
PMID: 21869676
citation: Lee YJ, Chung CC, Chou HC, Lin JA. Block for uniportal video-assisted thoracoscopic surgery: an ultrasound-guided, single-penetration, double-injection approach. Br J Anaesth. 2015 Nov;115(5):792-4. doi: 10.1093/bja/aev327. No abstract available.
PMID: 26475808
citation: Dong Q, Liang L, Li Y, Liu J, Yin W, Chen H, Xu X, Shao W, He J. Anesthesia with nontracheal intubation in thoracic surgery. J Thorac Dis. 2012 Apr 1;4(2):126-30. doi: 10.3978/j.issn.2072-1439.2012.03.10.
PMID: 22833817
citation: Giovagnorio F, Martinoli C. Sonography of the cervical vagus nerve: normal appearance and abnormal findings. AJR Am J Roentgenol. 2001 Mar;176(3):745-9. doi: 10.2214/ajr.176.3.1760745.
PMID: 11222217
citation: Arsanious D, Khoury S, Martinez E, Nawras A, Filatoff G, Ajabnoor H, Darr U, Atallah J. Ultrasound-Guided Phrenic Nerve Block for Intractable Hiccups following Placement of Esophageal Stent for Esophageal Squamous Cell Carcinoma. Pain Physician. 2016 May;19(4):E653-6.
PMID: 27228533
citation: Elias M. Cervical sympathetic and stellate ganglion blocks. Pain Physician. 2000 Jul;3(3):294-304.
PMID: 16906187
citation: Polverino M, Polverino F, Fasolino M, Ando F, Alfieri A, De Blasio F. Anatomy and neuro-pathophysiology of the cough reflex arc. Multidiscip Respir Med. 2012 Jun 18;7(1):5. doi: 10.1186/2049-6958-7-5.
PMID: 22958367
responsible party type: Sponsor
mesh term: Iodine
sharing ipd: No