<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/NCT04500249</url>
  </required_header>
  <id_info>
    <org_study_id>SilesianMUKOAiIT4</org_study_id>
    <nct_id>NCT04500249</nct_id>
  </id_info>
  <brief_title>SPI-guided Analgesia During CEA Under RA</brief_title>
  <acronym>CEA</acronym>
  <official_title>SPI-guided Analgesia in Patients Undergoing Carotid Endarterectomy Under Cervical Plexus Block</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Silesia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Silesian University of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Medical University of Silesia</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 aim of this randomized prospective trial is to assess the utility of Adequacy of&#xD;
      Anaesthesia technique (Response Entropy and Surgical Pleth Index) for monitoring pain&#xD;
      perception intraoperatively, maintainance of hemodynamic stability during anesthesia and its&#xD;
      influence on postoperative outcomes, in patients undergoing carotid endarterectomy under&#xD;
      cervical plexus block.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Carotid artery stenosis constitutes a major risk factor for ischemic stroke so carotid&#xD;
      endarterectomy is performed to protects patients with severe atherosclerotic carotid artery&#xD;
      stenosis against stroke.&#xD;
&#xD;
      Surgical Pleth Index (SPI) is reported to properly reflect nociception-antinociception&#xD;
      balance in patients undergoing surgical procedures, where a value of 100 corresponds to a&#xD;
      high stress level and a value of 0 to a low stress level; values near 50 or increase in value&#xD;
      &gt; delta 10 correspond to the stress level which is known to reflect requirement for rescue&#xD;
      analgesia.&#xD;
&#xD;
      A randomized interventional trial to evaluate the effects of SPI-guided rescue analgesia on&#xD;
      hemodynamic stability during anesthesia in patients undergoing carotid endarterectomy under&#xD;
      cervical plexus block.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 1, 2015</start_date>
  <completion_date type="Anticipated">October 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2020</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>Single (Participant)</masking>
    <masking_description>neither participant nor operator is aware of rescue analgesia protocol</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>haemodynamic stability</measure>
    <time_frame>intraoperatively</time_frame>
    <description>variations of haemodynamic parametres will be analysed</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>pain perception using SPI value variations</measure>
    <time_frame>intraoperatively</time_frame>
    <description>pain perception using SPI value variations will be analysed</description>
  </secondary_outcome>
  <other_outcome>
    <measure>ischaemic stroke</measure>
    <time_frame>from beginning of operation till discharge from hospital</time_frame>
    <description>presence of ischaemic stroke will be observed</description>
  </other_outcome>
  <other_outcome>
    <measure>dysarthria</measure>
    <time_frame>from beginning of operation till discharge from hospital, approximately 2 - 14 days</time_frame>
    <description>presence of dysarthria will be observed</description>
  </other_outcome>
  <other_outcome>
    <measure>limb paresis</measure>
    <time_frame>from beginning of operation till discharge from hospital, approximately 2 - 14 days</time_frame>
    <description>presence of limb paresis will be observed</description>
  </other_outcome>
  <other_outcome>
    <measure>hoarseness</measure>
    <time_frame>from beginning of operation till discharge from hospital, approximately 2 - 14 days</time_frame>
    <description>presence of hoarseness will be observed</description>
  </other_outcome>
  <other_outcome>
    <measure>face semiparesis</measure>
    <time_frame>from beginning of operation till discharge from hospital, approximately 2 - 14 days</time_frame>
    <description>presence of semiparesis will be observed</description>
  </other_outcome>
  <other_outcome>
    <measure>postoperative nausea and vomitting</measure>
    <time_frame>from beginning of operation till discharge from hospital, approximately 2 - 14 days</time_frame>
    <description>presence of postoperative nausea and vomitting will be observed</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">105</enrollment>
  <condition>Carotid Artery Stenoses</condition>
  <arm_group>
    <arm_group_label>CPB</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>cervical plexus block was performed with 0,5% bupivacaine using Moore's technique</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CPB with SPI guided analgesia</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>cervical plexus block was performed with 0,5% bupivacaine using Moore's technique alongside with SPI-guided rescue analgesia using 1% lidokaine and intravenous fentanyl</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CPB plus SPI guided analgesia plus carotid artery block</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>cervical plexus block was performed with 0,5% bupivacaine using Moore's technique combined ith US-guided carotid artery block alongside with SPI-guided rescue analgesia using 1% lidokaine and intravenous fentanyl</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>infiltration rescue intraoperative analgesia</intervention_name>
    <description>in the case of intraoperative pain perception, rescue infiltration analgesia using 1 % lidocaine administered by the operator into the operation field.</description>
    <arm_group_label>CPB</arm_group_label>
    <arm_group_label>CPB plus SPI guided analgesia plus carotid artery block</arm_group_label>
    <arm_group_label>CPB with SPI guided analgesia</arm_group_label>
    <other_name>rescue LA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>rescue IA</intervention_name>
    <description>in the case of intraoperative pain perception, rescue intravenous analgesia using 50 mcg of fentanyl will be administered by anaesthesiologist</description>
    <arm_group_label>CPB</arm_group_label>
    <arm_group_label>CPB plus SPI guided analgesia plus carotid artery block</arm_group_label>
    <arm_group_label>CPB with SPI guided analgesia</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>rescue antyhypertensive medication</intervention_name>
    <description>in the case of intraoperative hypertension reluctant to rescue analgesia, rescue intravenous antihypertensive medication using 10 mcg of urapidil will be administered by anaesthesiologist</description>
    <arm_group_label>CPB</arm_group_label>
    <arm_group_label>CPB plus SPI guided analgesia plus carotid artery block</arm_group_label>
    <arm_group_label>CPB with SPI guided analgesia</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>rescue antyemetic medication</intervention_name>
    <description>in the case of postoperative nausea and vomitting, rescue intravenous antiemetic medication using 4 mg of ondansetron will be administered by anaesthesiologist</description>
    <arm_group_label>CPB</arm_group_label>
    <arm_group_label>CPB plus SPI guided analgesia plus carotid artery block</arm_group_label>
    <arm_group_label>CPB with SPI guided analgesia</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>rescue antyhypotensive medication</intervention_name>
    <description>in the case of intraoperative hypotension, rescue intravenous antihypotensive medication using 10 mg of ephedrine will be administered by anaesthesiologist</description>
    <arm_group_label>CPB</arm_group_label>
    <arm_group_label>CPB plus SPI guided analgesia plus carotid artery block</arm_group_label>
    <arm_group_label>CPB with SPI guided analgesia</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>rescue antyhypotensive medication</intervention_name>
    <description>in the case of intraoperative bradycardia, rescue intravenous antihypotensive medication using 500 mcg of atropine will be administered by anaesthesiologist</description>
    <arm_group_label>CPB</arm_group_label>
    <arm_group_label>CPB plus SPI guided analgesia plus carotid artery block</arm_group_label>
    <arm_group_label>CPB with SPI guided analgesia</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        clinical diagnosis of stenosis of carotid artery written consent to participate in the&#xD;
        study written consent to undergo carotid endarterectomy under regional anaesthesia of&#xD;
        cervical plexus using Moore's technique general heath condition I-III of American Society&#xD;
        of Anaesthesiology&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  necessity of administration of vasoactive drugs influencing SPI monitoring pregnancy&#xD;
&#xD;
          -  anatomical malformation that make monitoring using SE sensor impossible&#xD;
&#xD;
          -  general atherosclerosis and heart rhythm disturbances impairing SPI monitoring&#xD;
&#xD;
          -  chronic medication using opioid drugs leading to resistancy to opioids.&#xD;
&#xD;
          -  farmacotherapy with anticoagulants&#xD;
&#xD;
          -  allergy to local anaesthetics&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michał J Stasiowski, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of Silesia</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Michał J Stasiowski, M.D</last_name>
    <phone>696797922</phone>
    <phone_ext>0048</phone_ext>
    <email>mstasiowski.anest@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Lech Krawczyk, Ph. Dr</last_name>
    <phone>32-3682341</phone>
    <phone_ext>0048</phone_ext>
    <email>lech.kraw@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Medical University of Silesia</name>
      <address>
        <city>Sosnowiec</city>
        <state>Silesia</state>
        <zip>41-200</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michał J. Stasiowski</last_name>
      <phone>696797922</phone>
      <phone_ext>0048</phone_ext>
      <email>mstasiowski.anest@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Lech Krawczyk, Ph. Dr.</last_name>
      <phone>323682341</phone>
      <phone_ext>0048</phone_ext>
      <email>lech.kraw@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <results_reference>
    <citation>Gruenewald M, Herz J, Schoenherr T, Thee C, Steinfath M, Bein B. Measurement of the nociceptive balance by Analgesia Nociception Index and Surgical Pleth Index during sevoflurane-remifentanil anesthesia. Minerva Anestesiol. 2015 May;81(5):480-9. Epub 2014 Jul 17.</citation>
    <PMID>25032676</PMID>
  </results_reference>
  <results_reference>
    <citation>Gruenewald M, Ilies C, Herz J, Schoenherr T, Fudickar A, Hocker J, Bein B. Influence of nociceptive stimulation on analgesia nociception index (ANI) during propofol-remifentanil anaesthesia. Br J Anaesth. 2013 Jun;110(6):1024-30. doi: 10.1093/bja/aet019. Epub 2013 Mar 6.</citation>
    <PMID>23471754</PMID>
  </results_reference>
  <results_reference>
    <citation>Gruenewald M, Ilies C. Monitoring the nociception-anti-nociception balance. Best Pract Res Clin Anaesthesiol. 2013 Jun;27(2):235-47. doi: 10.1016/j.bpa.2013.06.007.</citation>
    <PMID>24012235</PMID>
  </results_reference>
  <results_reference>
    <citation>Gruenewald M, Willms S, Broch O, Kott M, Steinfath M, Bein B. Sufentanil administration guided by surgical pleth index vs standard practice during sevoflurane anaesthesia: a randomized controlled pilot study. Br J Anaesth. 2014 May;112(5):898-905. doi: 10.1093/bja/aet485. Epub 2014 Feb 16.</citation>
    <PMID>24535604</PMID>
  </results_reference>
  <results_reference>
    <citation>Won YJ, Lim BG, Lee SH, Park S, Kim H, Lee IO, Kong MH. Comparison of relative oxycodone consumption in surgical pleth index-guided analgesia versus conventional analgesia during sevoflurane anesthesia: A randomized controlled trial. Medicine (Baltimore). 2016 Aug;95(35):e4743. doi: 10.1097/MD.0000000000004743.</citation>
    <PMID>27583920</PMID>
  </results_reference>
  <results_reference>
    <citation>Calderon AL, Zetlaoui P, Benatir F, Davidson J, Desebbe O, Rahali N, Truc C, Feugier P, Lermusiaux P, Allaouchiche B, Boselli E. Ultrasound-guided intermediate cervical plexus block for carotid endarterectomy using a new anterior approach: a two-centre prospective observational study. Anaesthesia. 2015 Apr;70(4):445-51. doi: 10.1111/anae.12960. Epub 2014 Dec 1.</citation>
    <PMID>25440694</PMID>
  </results_reference>
  <results_reference>
    <citation>Tsujikawa S, Ikeshita K. Low-dose dexmedetomidine provides hemodynamics stabilization during emergence and recovery from general anesthesia in patients undergoing carotid endarterectomy: a randomized double-blind, placebo-controlled trial. J Anesth. 2019 Apr;33(2):266-272. doi: 10.1007/s00540-019-02612-w. Epub 2019 Jan 17.</citation>
    <PMID>30656404</PMID>
  </results_reference>
  <results_reference>
    <citation>Zdrehus C. Anaesthesia for carotid endarterectomy - general or loco-regional? Rom J Anaesth Intensive Care. 2015 Apr;22(1):17-24.</citation>
    <PMID>28913451</PMID>
  </results_reference>
  <results_reference>
    <citation>Ishiguro T, Yoneyama T, Ishikawa T, Yamaguchi K, Kawashima A, Kawamata T, Okada Y. Perioperative and Long-term Outcomes of Carotid Endarterectomy for Japanese Asymptomatic Cervical Carotid Artery Stenosis: A Single Institution Study. Neurol Med Chir (Tokyo). 2015;55(11):830-7. doi: 10.2176/nmc.oa.2014-0398. Epub 2015 Oct 9.</citation>
    <PMID>26458845</PMID>
  </results_reference>
  <results_reference>
    <citation>Lee J, Huh U, Song S, Chung SW, Sung SM, Cho HJ. Regional Anesthesia with Dexmedetomidine Infusion: A Feasible Method for the Awake Test during Carotid Endarterectomy. Ann Vasc Dis. 2016;9(4):295-299. doi: 10.3400/avd.oa.16-00049. Epub 2016 Oct 11.</citation>
    <PMID>28018501</PMID>
  </results_reference>
  <results_reference>
    <citation>Scimia P, Giordano C, Basso Ricci E, Petrucci E, Fusco P. The ultrasound-guided C2-C4 compartment block combined to dexmedetomidine sedation: an ideal approach for carotid endarterectomy in awake patients. Minerva Anestesiol. 2018 Oct;84(10):1226-1227. doi: 10.23736/S0375-9393.18.12780-5. Epub 2018 Apr 5. No abstract available.</citation>
    <PMID>29624030</PMID>
  </results_reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>April 14, 2019</study_first_submitted>
  <study_first_submitted_qc>July 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>July 31, 2020</last_update_submitted>
  <last_update_submitted_qc>July 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Silesia</investigator_affiliation>
    <investigator_full_name>Michał Stasiowski</investigator_full_name>
    <investigator_title>Principal Investigator, 2Department of Anaesthesiology and Intensive Therapy</investigator_title>
  </responsible_party>
  <keyword>Surgical Pleth Index (SPI)</keyword>
  <keyword>Cervical plexus block</keyword>
  <keyword>Adequacy of Anaesthesia (AoA</keyword>
  <keyword>State Entropy</keyword>
  <keyword>Stroke</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carotid Stenosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>publication in AiIT</ipd_description>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>within a year</ipd_time_frame>
    <ipd_access_criteria>on a reasonable request</ipd_access_criteria>
  </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/NCT04500249
org study id: SilesianMUKOAiIT4
nct id: NCT04500249
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of this randomized prospective trial is to assess the utility of Adequacy of
      Anaesthesia technique (Response Entropy and Surgical Pleth Index) for monitoring pain
      perception intraoperatively, maintainance of hemodynamic stability during anesthesia and its
      influence on postoperative outcomes, in patients undergoing carotid endarterectomy under
      cervical plexus block.
Carotid artery stenosis constitutes a major risk factor for ischemic stroke so carotid
      endarterectomy is performed to protects patients with severe atherosclerotic carotid artery
      stenosis against stroke.

      Surgical Pleth Index (SPI) is reported to properly reflect nociception-antinociception
      balance in patients undergoing surgical procedures, where a value of 100 corresponds to a
      high stress level and a value of 0 to a low stress level; values near 50 or increase in value
      > delta 10 correspond to the stress level which is known to reflect requirement for rescue
      analgesia.

      A randomized interventional trial to evaluate the effects of SPI-guided rescue analgesia on
      hemodynamic stability during anesthesia in patients undergoing carotid endarterectomy under
      cervical plexus block.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
masking description: neither participant nor operator is aware of rescue analgesia protocol
measure: haemodynamic stability
time frame: intraoperatively
description: variations of haemodynamic parametres will be analysed
measure: pain perception using SPI value variations
time frame: intraoperatively
description: pain perception using SPI value variations will be analysed
measure: ischaemic stroke
time frame: from beginning of operation till discharge from hospital
description: presence of ischaemic stroke will be observed
measure: dysarthria
time frame: from beginning of operation till discharge from hospital, approximately 2 - 14 days
description: presence of dysarthria will be observed
measure: limb paresis
time frame: from beginning of operation till discharge from hospital, approximately 2 - 14 days
description: presence of limb paresis will be observed
measure: hoarseness
time frame: from beginning of operation till discharge from hospital, approximately 2 - 14 days
description: presence of hoarseness will be observed
measure: face semiparesis
time frame: from beginning of operation till discharge from hospital, approximately 2 - 14 days
description: presence of semiparesis will be observed
measure: postoperative nausea and vomitting
time frame: from beginning of operation till discharge from hospital, approximately 2 - 14 days
description: presence of postoperative nausea and vomitting will be observed
arm group label: CPB
arm group type: Experimental
description: cervical plexus block was performed with 0,5% bupivacaine using Moore's technique
arm group label: CPB with SPI guided analgesia
arm group type: Experimental
description: cervical plexus block was performed with 0,5% bupivacaine using Moore's technique alongside with SPI-guided rescue analgesia using 1% lidokaine and intravenous fentanyl
arm group label: CPB plus SPI guided analgesia plus carotid artery block
arm group type: Experimental
description: cervical plexus block was performed with 0,5% bupivacaine using Moore's technique combined ith US-guided carotid artery block alongside with SPI-guided rescue analgesia using 1% lidokaine and intravenous fentanyl
intervention type: Drug
intervention name: infiltration rescue intraoperative analgesia
description: in the case of intraoperative pain perception, rescue infiltration analgesia using 1 % lidocaine administered by the operator into the operation field.
arm group label: CPB
arm group label: CPB plus SPI guided analgesia plus carotid artery block
arm group label: CPB with SPI guided analgesia
other name: rescue LA
intervention type: Drug
intervention name: rescue IA
description: in the case of intraoperative pain perception, rescue intravenous analgesia using 50 mcg of fentanyl will be administered by anaesthesiologist
arm group label: CPB
arm group label: CPB plus SPI guided analgesia plus carotid artery block
arm group label: CPB with SPI guided analgesia
intervention type: Drug
intervention name: rescue antyhypertensive medication
description: in the case of intraoperative hypertension reluctant to rescue analgesia, rescue intravenous antihypertensive medication using 10 mcg of urapidil will be administered by anaesthesiologist
arm group label: CPB
arm group label: CPB plus SPI guided analgesia plus carotid artery block
arm group label: CPB with SPI guided analgesia
intervention type: Drug
intervention name: rescue antyemetic medication
description: in the case of postoperative nausea and vomitting, rescue intravenous antiemetic medication using 4 mg of ondansetron will be administered by anaesthesiologist
arm group label: CPB
arm group label: CPB plus SPI guided analgesia plus carotid artery block
arm group label: CPB with SPI guided analgesia
intervention type: Drug
intervention name: rescue antyhypotensive medication
description: in the case of intraoperative hypotension, rescue intravenous antihypotensive medication using 10 mg of ephedrine will be administered by anaesthesiologist
arm group label: CPB
arm group label: CPB plus SPI guided analgesia plus carotid artery block
arm group label: CPB with SPI guided analgesia
intervention type: Drug
intervention name: rescue antyhypotensive medication
description: in the case of intraoperative bradycardia, rescue intravenous antihypotensive medication using 500 mcg of atropine will be administered by anaesthesiologist
arm group label: CPB
arm group label: CPB plus SPI guided analgesia plus carotid artery block
arm group label: CPB with SPI guided analgesia
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Michał J Stasiowski, M.D
role: Principal Investigator
affiliation: Medical University of Silesia
last name: Michał J Stasiowski, M.D
phone: 696797922
phone ext: 0048
email: mstasiowski.anest@gmail.com
last name: Lech Krawczyk, Ph. Dr
phone: 32-3682341
phone ext: 0048
email: lech.kraw@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Poland
citation: Gruenewald M, Herz J, Schoenherr T, Thee C, Steinfath M, Bein B. Measurement of the nociceptive balance by Analgesia Nociception Index and Surgical Pleth Index during sevoflurane-remifentanil anesthesia. Minerva Anestesiol. 2015 May;81(5):480-9. Epub 2014 Jul 17.
PMID: 25032676
citation: Gruenewald M, Ilies C, Herz J, Schoenherr T, Fudickar A, Hocker J, Bein B. Influence of nociceptive stimulation on analgesia nociception index (ANI) during propofol-remifentanil anaesthesia. Br J Anaesth. 2013 Jun;110(6):1024-30. doi: 10.1093/bja/aet019. Epub 2013 Mar 6.
PMID: 23471754
citation: Gruenewald M, Ilies C. Monitoring the nociception-anti-nociception balance. Best Pract Res Clin Anaesthesiol. 2013 Jun;27(2):235-47. doi: 10.1016/j.bpa.2013.06.007.
PMID: 24012235
citation: Gruenewald M, Willms S, Broch O, Kott M, Steinfath M, Bein B. Sufentanil administration guided by surgical pleth index vs standard practice during sevoflurane anaesthesia: a randomized controlled pilot study. Br J Anaesth. 2014 May;112(5):898-905. doi: 10.1093/bja/aet485. Epub 2014 Feb 16.
PMID: 24535604
citation: Won YJ, Lim BG, Lee SH, Park S, Kim H, Lee IO, Kong MH. Comparison of relative oxycodone consumption in surgical pleth index-guided analgesia versus conventional analgesia during sevoflurane anesthesia: A randomized controlled trial. Medicine (Baltimore). 2016 Aug;95(35):e4743. doi: 10.1097/MD.0000000000004743.
PMID: 27583920
citation: Calderon AL, Zetlaoui P, Benatir F, Davidson J, Desebbe O, Rahali N, Truc C, Feugier P, Lermusiaux P, Allaouchiche B, Boselli E. Ultrasound-guided intermediate cervical plexus block for carotid endarterectomy using a new anterior approach: a two-centre prospective observational study. Anaesthesia. 2015 Apr;70(4):445-51. doi: 10.1111/anae.12960. Epub 2014 Dec 1.
PMID: 25440694
citation: Tsujikawa S, Ikeshita K. Low-dose dexmedetomidine provides hemodynamics stabilization during emergence and recovery from general anesthesia in patients undergoing carotid endarterectomy: a randomized double-blind, placebo-controlled trial. J Anesth. 2019 Apr;33(2):266-272. doi: 10.1007/s00540-019-02612-w. Epub 2019 Jan 17.
PMID: 30656404
citation: Zdrehus C. Anaesthesia for carotid endarterectomy - general or loco-regional? Rom J Anaesth Intensive Care. 2015 Apr;22(1):17-24.
PMID: 28913451
citation: Ishiguro T, Yoneyama T, Ishikawa T, Yamaguchi K, Kawashima A, Kawamata T, Okada Y. Perioperative and Long-term Outcomes of Carotid Endarterectomy for Japanese Asymptomatic Cervical Carotid Artery Stenosis: A Single Institution Study. Neurol Med Chir (Tokyo). 2015;55(11):830-7. doi: 10.2176/nmc.oa.2014-0398. Epub 2015 Oct 9.
PMID: 26458845
citation: Lee J, Huh U, Song S, Chung SW, Sung SM, Cho HJ. Regional Anesthesia with Dexmedetomidine Infusion: A Feasible Method for the Awake Test during Carotid Endarterectomy. Ann Vasc Dis. 2016;9(4):295-299. doi: 10.3400/avd.oa.16-00049. Epub 2016 Oct 11.
PMID: 28018501
citation: Scimia P, Giordano C, Basso Ricci E, Petrucci E, Fusco P. The ultrasound-guided C2-C4 compartment block combined to dexmedetomidine sedation: an ideal approach for carotid endarterectomy in awake patients. Minerva Anestesiol. 2018 Oct;84(10):1226-1227. doi: 10.23736/S0375-9393.18.12780-5. Epub 2018 Apr 5. No abstract available.
PMID: 29624030
responsible party type: Principal Investigator
investigator affiliation: Medical University of Silesia
investigator full name: Michał Stasiowski
investigator title: Principal Investigator, 2Department of Anaesthesiology and Intensive Therapy
mesh term: Carotid Stenosis
sharing ipd: Yes
ipd description: publication in AiIT
ipd info type: Informed Consent Form (ICF)
ipd time frame: within a year
ipd access criteria: on a reasonable request