<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/NCT04423146</url>
  </required_header>
  <id_info>
    <org_study_id>SCOL 2020</org_study_id>
    <nct_id>NCT04423146</nct_id>
  </id_info>
  <brief_title>Anesthesiologic Management Effect on Perioperative Outcome in Scoliosis Surgery</brief_title>
  <acronym>SCOL</acronym>
  <official_title>Advanced Methods for Improving Anesthesiologic Management and Their Effect on Perioperative Outcome in Scoliosis Surgery, Especially in Childhood (SCOL Study): a Prospective Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brno University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Brno University Hospital</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>
      Alteration of evoked potentials is described in cases with using inhalation anaesthetics.&#xD;
      Muscle relaxants are contraindicated in case of motor evoked potentials except for initial&#xD;
      dose for intubation of the patient. Dominant anaesthetic method for procedures with measuring&#xD;
      motor evoked potentials is total intravenous anaesthesia (TIVA). Bispectral index (BIS)&#xD;
      monitoring is one of the possible options for comprehensive monitoring of the depth of&#xD;
      general anaesthesia. It helps to optimize the management of anaesthesia, so it reduces the&#xD;
      risk of perioperative awakenings due to shallow anaesthesia or inadequate depth of&#xD;
      anaesthesia associated with the risk of cognitive dysfunction, as well as investigators&#xD;
      expect worse interpretation of motor evoked potentials. At the same time, it shortens the&#xD;
      time to wake up from general anaesthesia after hours-long surgery. BIS monitoring allows&#xD;
      optimizing the depth of anaesthesia and leads to improve quality and interpretation of motor&#xD;
      evoked potentials. The depth of TIVA managed by BIS affects the reproducibility of motor&#xD;
      evoked potentials.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      SCOL study is designed as a prospective observational study. We will monitor patients with&#xD;
      scoliosis suitable for TIVA with BIS monitoring after the approval by the ethical committee&#xD;
      of the University Hospital Brno and the Faculty of Medicine of Masaryk University in Brno,&#xD;
      Czech Republic. The study period is planned from 1st September 2020 to 31st December 2024.&#xD;
      Anaesthesia will be maintained following standardized local protocol for scoliosis surgery,&#xD;
      include preoperative preparation and premedication. General anaesthesia will be performed in&#xD;
      TIVA mode,combining propofol and remifentanil with titration to the target BIS value. Motor&#xD;
      evoked potentials will be measured and evaluated by members of operating team&#xD;
      perioperatively. The evocation of reproducible motor evoked potential and the actual value of&#xD;
      amplitude and latency at different BIS levels (40 - 60) will be monitored. Motor evoked&#xD;
      potentials (MEP) reproducibility will be based on standardized orthopaedic practice,&#xD;
      according to the amplitude, latency of the MEP. The reproducibility will be monitored in&#xD;
      defined surgery phases: before skin incision at the different BIS levels, next after screw&#xD;
      application, rod applications, after distraction and the last one before wound suturing. At&#xD;
      the same time, the BIS value is recorded.&#xD;
&#xD;
      In addition to the MEP reproducibility, investigators will measure the amplitude and latency&#xD;
      value. These parameters and actual BIS value will be monitored in each patient after the&#xD;
      recovery from neuromuscular blockade (TOF ratio value above 90%) to eliminate the influence&#xD;
      of neuromuscular blockade on neurophysiology monitoring. Due to individual variability in the&#xD;
      MEP latency and amplitude in these patients, the initial MEP value will be set as the default&#xD;
      (100%), and other values will be expressed as a percentage.&#xD;
&#xD;
      Other monitored parameters in this study will be blood loss, blood derivates and transfusion&#xD;
      products administered to the patient in first 24 hours after surgery, the time between the&#xD;
      end of the surgery and extubation, neurological complications, number of surgical revisions&#xD;
      and a total length of hospitalization.&#xD;
&#xD;
      The annual number of scoliosis operations at the University hospital Brno is around 130&#xD;
      patients. It is the largest surgery centre in Central Europe.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Anticipated">January 1, 2025</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The evocation of reproducible motor evoked potentials at different BIS levels (40 - 60)</measure>
    <time_frame>During the scoliosis surgery</time_frame>
    <description>The evocation of reproducible motor evoked potentials at different BIS levels (40 - 60) will be monitored according to standardized orthopaedic practise for evaluation of MEP.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>MEP parameters</measure>
    <time_frame>During the scoliosis surgery</time_frame>
    <description>MEP parameters (latency and amplitude) parameters will be monitored in defined surgery phases with recording the actual MEP values and BIS value after recovery from neuromuscular blockade. The initial MEP value will be set as the default (100%), and other values will be expressed as a percentage. We will analyze scoliosis subgroups, the idiopathic and neuromuscular scoliosis.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Perioperative blood management</measure>
    <time_frame>24 hours postoperatively</time_frame>
    <description>blood loss, blood derivates and transfusion products administered to the patient in first 24 hours after surgery</description>
  </other_outcome>
  <other_outcome>
    <measure>Surgical complications</measure>
    <time_frame>30 days postoperatively</time_frame>
    <description>Neurological complications and number of surgical revisions within 30 days and length of days of hospitalization will be recorded.</description>
  </other_outcome>
  <other_outcome>
    <measure>Anaesthesiology management data</measure>
    <time_frame>Intraoperative period until extubation</time_frame>
    <description>Surgery length, the interval between the end of surgery to extubation.</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Scoliosis</condition>
  <arm_group>
    <arm_group_label>Patients scheduled for elective scoliosis surgery</arm_group_label>
    <description>Patients scheduled for elective scoliosis surgery will be anesthetized in TIVA mode,combining propofol and remifentanil with titration to the target BIS value. Motor evoked potentials will be measured and evaluated by members of operating team perioperatively. The quality of evoked potentials (poor vs good quality) and the actual value of amplitude and latency at different BIS levels (40 - 60) will be monitored.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>The evocation of reproducible motor evoked potential according to the different BIS levels</intervention_name>
    <description>The evocation of reproducible motor evoked potential and the actual value of amplitude and latency at different BIS levels (40 - 60) will be monitored.</description>
    <arm_group_label>Patients scheduled for elective scoliosis surgery</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients indicated for elective scoliosis surgery with perioperative MEP monitoring&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients indicated for scoliosis surgery with perioperative MEP monitoring&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Scoliosis surgery without perioperative MEP monitoring&#xD;
&#xD;
          -  Contraindication for perioperative MEP monitoring&#xD;
&#xD;
          -  Contraindication of using propofol (soy, egg lecithin or peanuts allergy,...) or other&#xD;
             drugs used for anaesthesia&#xD;
&#xD;
          -  The inability of attachment of BIS electrodes to the standard position&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Repko Martin, prof. MD., Ph.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Faculty of medicince Masaryk University and University Hospital Brno</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Martina Kosinova, MD., Ph.D</last_name>
    <phone>532234692</phone>
    <phone_ext>00420</phone_ext>
    <email>kosinova.martina@fnbrno.cz</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jan Hudec, MD.</last_name>
    <phone>532233852</phone>
    <phone_ext>00420</phone_ext>
    <email>hudec.jan@fnbrno.cz</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Faculty hospital Brno</name>
      <address>
        <city>Brno</city>
        <state>Jihomoravský Kraj</state>
        <zip>62500</zip>
        <country>Czechia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Martina Kosinova, MD., Ph.D.</last_name>
      <phone>532234692</phone>
      <phone_ext>00420</phone_ext>
      <email>kosinova.martina@fnbrno.cz</email>
    </contact>
    <contact_backup>
      <last_name>Jan Hudec, MD.</last_name>
      <phone>532233852</phone>
      <phone_ext>00420</phone_ext>
      <email>hudec.jan@fnbrno.cz</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Czechia</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>March 23, 2023</last_update_submitted>
  <last_update_submitted_qc>March 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brno University Hospital</investigator_affiliation>
    <investigator_full_name>Petr Štourač, MD</investigator_full_name>
    <investigator_title>assoc.prof.MD,Ph.D</investigator_title>
  </responsible_party>
  <keyword>scoliosis</keyword>
  <keyword>surgery</keyword>
  <keyword>scoliosis surgery</keyword>
  <keyword>Motor evoked potentials</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Scoliosis</mesh_term>
  </condition_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/NCT04423146
org study id: SCOL 2020
nct id: NCT04423146
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Alteration of evoked potentials is described in cases with using inhalation anaesthetics.
      Muscle relaxants are contraindicated in case of motor evoked potentials except for initial
      dose for intubation of the patient. Dominant anaesthetic method for procedures with measuring
      motor evoked potentials is total intravenous anaesthesia (TIVA). Bispectral index (BIS)
      monitoring is one of the possible options for comprehensive monitoring of the depth of
      general anaesthesia. It helps to optimize the management of anaesthesia, so it reduces the
      risk of perioperative awakenings due to shallow anaesthesia or inadequate depth of
      anaesthesia associated with the risk of cognitive dysfunction, as well as investigators
      expect worse interpretation of motor evoked potentials. At the same time, it shortens the
      time to wake up from general anaesthesia after hours-long surgery. BIS monitoring allows
      optimizing the depth of anaesthesia and leads to improve quality and interpretation of motor
      evoked potentials. The depth of TIVA managed by BIS affects the reproducibility of motor
      evoked potentials.
SCOL study is designed as a prospective observational study. We will monitor patients with
      scoliosis suitable for TIVA with BIS monitoring after the approval by the ethical committee
      of the University Hospital Brno and the Faculty of Medicine of Masaryk University in Brno,
      Czech Republic. The study period is planned from 1st September 2020 to 31st December 2024.
      Anaesthesia will be maintained following standardized local protocol for scoliosis surgery,
      include preoperative preparation and premedication. General anaesthesia will be performed in
      TIVA mode,combining propofol and remifentanil with titration to the target BIS value. Motor
      evoked potentials will be measured and evaluated by members of operating team
      perioperatively. The evocation of reproducible motor evoked potential and the actual value of
      amplitude and latency at different BIS levels (40 - 60) will be monitored. Motor evoked
      potentials (MEP) reproducibility will be based on standardized orthopaedic practice,
      according to the amplitude, latency of the MEP. The reproducibility will be monitored in
      defined surgery phases: before skin incision at the different BIS levels, next after screw
      application, rod applications, after distraction and the last one before wound suturing. At
      the same time, the BIS value is recorded.

      In addition to the MEP reproducibility, investigators will measure the amplitude and latency
      value. These parameters and actual BIS value will be monitored in each patient after the
      recovery from neuromuscular blockade (TOF ratio value above 90%) to eliminate the influence
      of neuromuscular blockade on neurophysiology monitoring. Due to individual variability in the
      MEP latency and amplitude in these patients, the initial MEP value will be set as the default
      (100%), and other values will be expressed as a percentage.

      Other monitored parameters in this study will be blood loss, blood derivates and transfusion
      products administered to the patient in first 24 hours after surgery, the time between the
      end of the surgery and extubation, neurological complications, number of surgical revisions
      and a total length of hospitalization.

      The annual number of scoliosis operations at the University hospital Brno is around 130
      patients. It is the largest surgery centre in Central Europe.
observational model: Cohort
time perspective: Prospective
measure: The evocation of reproducible motor evoked potentials at different BIS levels (40 - 60)
time frame: During the scoliosis surgery
description: The evocation of reproducible motor evoked potentials at different BIS levels (40 - 60) will be monitored according to standardized orthopaedic practise for evaluation of MEP.
measure: MEP parameters
time frame: During the scoliosis surgery
description: MEP parameters (latency and amplitude) parameters will be monitored in defined surgery phases with recording the actual MEP values and BIS value after recovery from neuromuscular blockade. The initial MEP value will be set as the default (100%), and other values will be expressed as a percentage. We will analyze scoliosis subgroups, the idiopathic and neuromuscular scoliosis.
measure: Perioperative blood management
time frame: 24 hours postoperatively
description: blood loss, blood derivates and transfusion products administered to the patient in first 24 hours after surgery
measure: Surgical complications
time frame: 30 days postoperatively
description: Neurological complications and number of surgical revisions within 30 days and length of days of hospitalization will be recorded.
measure: Anaesthesiology management data
time frame: Intraoperative period until extubation
description: Surgery length, the interval between the end of surgery to extubation.
arm group label: Patients scheduled for elective scoliosis surgery
description: Patients scheduled for elective scoliosis surgery will be anesthetized in TIVA mode,combining propofol and remifentanil with titration to the target BIS value. Motor evoked potentials will be measured and evaluated by members of operating team perioperatively. The quality of evoked potentials (poor vs good quality) and the actual value of amplitude and latency at different BIS levels (40 - 60) will be monitored.
intervention type: Other
intervention name: The evocation of reproducible motor evoked potential according to the different BIS levels
description: The evocation of reproducible motor evoked potential and the actual value of amplitude and latency at different BIS levels (40 - 60) will be monitored.
arm group label: Patients scheduled for elective scoliosis surgery
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 2 Years
maximum age: 75 Years
healthy volunteers: No
last name: Repko Martin, prof. MD., Ph.D.
role: Study Chair
affiliation: Faculty of medicince Masaryk University and University Hospital Brno
last name: Martina Kosinova, MD., Ph.D
phone: 532234692
phone ext: 00420
email: kosinova.martina@fnbrno.cz
last name: Jan Hudec, MD.
phone: 532233852
phone ext: 00420
email: hudec.jan@fnbrno.cz
facility: 
status: Recruiting
contact: 
contact backup: 
country: Czechia
responsible party type: Principal Investigator
investigator affiliation: Brno University Hospital
investigator full name: Petr Štourač, MD
investigator title: assoc.prof.MD,Ph.D
mesh term: Scoliosis
sharing ipd: Undecided