<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/NCT03767296</url>
  </required_header>
  <id_info>
    <org_study_id>2016/0644</org_study_id>
    <nct_id>NCT03767296</nct_id>
  </id_info>
  <brief_title>Influence of a Bolus Administration of Ephedrine and Phenylephrine on the Spinal Oxygen Saturation, Measured With NIRS.</brief_title>
  <acronym>NIRS BOLUS</acronym>
  <official_title>Influence of a Bolus Administration of Ephedrine and Phenylephrine on the Spinal Oxygen Saturation, Measured With NIRS.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Ghent</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Ghent</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the influence of vasoactive medication on the spinal vasculature, we have chosen&#xD;
      patients scheduled for arterial dilation of the lower limb as our study population. In these&#xD;
      patients the spinal cord perfusion is not compromised. However, most patients will suffer&#xD;
      from hypotension during surgery, due to the non-invasive type of surgery and the vasodilating&#xD;
      effects of the anesthetics. Therefore, bolus administration of vasoactive medication&#xD;
      (ephedrine, phenylephrine) is routinely required in order to increase the blood pressure.&#xD;
&#xD;
      The aim of the study is to observe the influence of a bolus administration of ephedrine and&#xD;
      phenylephrine on the spinal vasculature, measured by NIRS.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      During the preoperative visit, baseline MAP (mean arterial blood pressure) will be defined.&#xD;
&#xD;
      All patients receive standard anesthesia care during the surgical procedure. Before induction&#xD;
      of anesthesia, 6 additional sensors (stickers) are applied to the back of the patient (at&#xD;
      three levels: 2 at the upper thoracic level, 2 at the lower thoracic level and 2 at the&#xD;
      lumbar region). 2 sensors are routinely applied to the forehead to measure the cerebral&#xD;
      oxygenation and a BIS sensor is applied to measure the depth of anesthesia. Through an&#xD;
      intravenous line anesthetics will be administered. Vasopressor agents will be administered&#xD;
      through a second intravenous line. After induction of anesthesia, an endotracheal tube is&#xD;
      placed. According to the estimated duration of surgery a bladder catheter is placed.&#xD;
&#xD;
      If - after induction of anesthesia- MAP has decreased more than 20%, a vasopressor agent will&#xD;
      be administered in order to increase the blood pressure to normal (preoperative) values.&#xD;
      According to the MAP, several bolus administrations and incremental bolus dosages might be&#xD;
      needed to reach the target blood pressure range (MAP decrease less than 20%). According to&#xD;
      the group to which the patient has been randomized, a bolus of ephedrine and/or phenylephrine&#xD;
      will be administered.&#xD;
&#xD;
      The study will be completed when MAP decreases more than 20% from baseline for the 4th time.&#xD;
&#xD;
      A total amount of Ephedrine and Phenylephrine resp. of 140 mg and 1500 μg will not be&#xD;
      exceeded.&#xD;
&#xD;
      If the administration of the vasopressor study medication does not achieve the desired&#xD;
      result, the patient will receive an appropriate treatment.&#xD;
&#xD;
      The endovascular surgical procedure can start without delay and the duration of surgery will&#xD;
      not be prolonged because of the measurements and blood pressure management.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 6, 2017</start_date>
  <completion_date type="Actual">December 4, 2018</completion_date>
  <primary_completion_date type="Actual">September 9, 2017</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Spinal oxygen saturation measured by NIRS</measure>
    <time_frame>from first till 4th MAP decrease &gt; 20 % from baseline</time_frame>
    <description>Spinal oxygen saturation measured by NIRS</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Heart rate</measure>
    <time_frame>from first till 4th MAP decrease &gt; 20 % from baseline</time_frame>
    <description>Heart rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>from first till 4th MAP decrease &gt; 20 % from baseline</time_frame>
    <description>Blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cerebral oxygenation (NIRS)</measure>
    <time_frame>from first till 4th MAP decrease &gt; 20 % from baseline</time_frame>
    <description>Cerebral oxygenation (NIRS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total amount of vasoactive medication used</measure>
    <time_frame>from first till 4th MAP decrease &gt; 20 % from baseline</time_frame>
    <description>Total amount of vasoactive medication used</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">33</enrollment>
  <condition>Influence of Vasoactive Medication on Spinal Oxygenation</condition>
  <arm_group>
    <arm_group_label>Dose Bolus of E-P-E</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ephedrine Hydrochloride 3 MG/ML- Phenylephrine - Ephedrine Hydrochloride 3 MG/ML</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Bolus P-E-P</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Phenylephrine- Ephedrine Hydrochloride 3 MG/ML - Phenylephrine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Bolus E-E-E</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ephedrine Hydrochloride 3 MG/ML- Ephedrine Hydrochloride 3 MG/ML - Ephedrine Hydrochloride 3 MG/ML</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Bolus P-P-P</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Phenylephrine-Phenylephrine-Phenylephrine</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ephedrine Hydrochloride 3 MG/ML</intervention_name>
    <description>Bolus group, according to the randomization. Multiple boluses with incremental doses might be needed, according to the MAP ('effect titration')&#xD;
Incremental doses if needed:&#xD;
Ephedrine (E): 6 mg, 6mg, 9 mg, 9 mg, 12 mg, …..(max 24mg/bolus) A total amount of 140 mg Ephedrine will not be exceeded.&#xD;
Titrated according to the desired effect (= MAP decrease &lt; 20%)</description>
    <arm_group_label>Dose Bolus E-E-E</arm_group_label>
    <arm_group_label>Dose Bolus P-E-P</arm_group_label>
    <arm_group_label>Dose Bolus of E-P-E</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Phenylephrine</intervention_name>
    <description>Bolus group, according to the randomization. Multiple boluses with incremental doses might be needed, according to the MAP ('effect titration')&#xD;
Incremental doses if needed:&#xD;
Phenylephrine (PE): 50μg, 50μg, 100μg, 100μg, 150μg, 150μg,…(max 500µg/bolus) A total amount of 1500 μg will not be exceeded. Titrated according to the desired effect (= MAP decrease &lt; 20%)</description>
    <arm_group_label>Dose Bolus P-E-P</arm_group_label>
    <arm_group_label>Dose Bolus P-P-P</arm_group_label>
    <arm_group_label>Dose Bolus of E-P-E</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients &gt; 18y&#xD;
&#xD;
          -  scheduled for dilation of arterial blood vessels of the lower limb&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18y&#xD;
&#xD;
          -  BMI &gt; 30&#xD;
&#xD;
          -  severe valvular disease&#xD;
&#xD;
          -  previous aortic surgery&#xD;
&#xD;
          -  paraplegia/ paraparesis&#xD;
&#xD;
          -  renal replacement therapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Caroline Vanpeteghem</last_name>
    <role>Principal Investigator</role>
    <affiliation>UZ Ghent</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Ghent</name>
      <address>
        <city>Gent</city>
        <state>Oost-Vlaanderen</state>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>May 10, 2017</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <last_update_submitted>December 6, 2018</last_update_submitted>
  <last_update_submitted_qc>December 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>spinal oxygenation</keyword>
  <keyword>NIRS</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Phenylephrine</mesh_term>
    <mesh_term>Oxymetazoline</mesh_term>
    <mesh_term>Ephedrine</mesh_term>
    <mesh_term>Pseudoephedrine</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/NCT03767296
org study id: 2016/0644
nct id: NCT03767296
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
To evaluate the influence of vasoactive medication on the spinal vasculature, we have chosen
      patients scheduled for arterial dilation of the lower limb as our study population. In these
      patients the spinal cord perfusion is not compromised. However, most patients will suffer
      from hypotension during surgery, due to the non-invasive type of surgery and the vasodilating
      effects of the anesthetics. Therefore, bolus administration of vasoactive medication
      (ephedrine, phenylephrine) is routinely required in order to increase the blood pressure.

      The aim of the study is to observe the influence of a bolus administration of ephedrine and
      phenylephrine on the spinal vasculature, measured by NIRS.
During the preoperative visit, baseline MAP (mean arterial blood pressure) will be defined.

      All patients receive standard anesthesia care during the surgical procedure. Before induction
      of anesthesia, 6 additional sensors (stickers) are applied to the back of the patient (at
      three levels: 2 at the upper thoracic level, 2 at the lower thoracic level and 2 at the
      lumbar region). 2 sensors are routinely applied to the forehead to measure the cerebral
      oxygenation and a BIS sensor is applied to measure the depth of anesthesia. Through an
      intravenous line anesthetics will be administered. Vasopressor agents will be administered
      through a second intravenous line. After induction of anesthesia, an endotracheal tube is
      placed. According to the estimated duration of surgery a bladder catheter is placed.

      If - after induction of anesthesia- MAP has decreased more than 20%, a vasopressor agent will
      be administered in order to increase the blood pressure to normal (preoperative) values.
      According to the MAP, several bolus administrations and incremental bolus dosages might be
      needed to reach the target blood pressure range (MAP decrease less than 20%). According to
      the group to which the patient has been randomized, a bolus of ephedrine and/or phenylephrine
      will be administered.

      The study will be completed when MAP decreases more than 20% from baseline for the 4th time.

      A total amount of Ephedrine and Phenylephrine resp. of 140 mg and 1500 μg will not be
      exceeded.

      If the administration of the vasopressor study medication does not achieve the desired
      result, the patient will receive an appropriate treatment.

      The endovascular surgical procedure can start without delay and the duration of surgery will
      not be prolonged because of the measurements and blood pressure management.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Spinal oxygen saturation measured by NIRS
time frame: from first till 4th MAP decrease > 20 % from baseline
description: Spinal oxygen saturation measured by NIRS
measure: Heart rate
time frame: from first till 4th MAP decrease > 20 % from baseline
description: Heart rate
measure: Blood pressure
time frame: from first till 4th MAP decrease > 20 % from baseline
description: Blood pressure
measure: Cerebral oxygenation (NIRS)
time frame: from first till 4th MAP decrease > 20 % from baseline
description: Cerebral oxygenation (NIRS)
measure: Total amount of vasoactive medication used
time frame: from first till 4th MAP decrease > 20 % from baseline
description: Total amount of vasoactive medication used
arm group label: Dose Bolus of E-P-E
arm group type: Experimental
description: Ephedrine Hydrochloride 3 MG/ML- Phenylephrine - Ephedrine Hydrochloride 3 MG/ML
arm group label: Dose Bolus P-E-P
arm group type: Experimental
description: Phenylephrine- Ephedrine Hydrochloride 3 MG/ML - Phenylephrine
arm group label: Dose Bolus E-E-E
arm group type: Experimental
description: Ephedrine Hydrochloride 3 MG/ML- Ephedrine Hydrochloride 3 MG/ML - Ephedrine Hydrochloride 3 MG/ML
arm group label: Dose Bolus P-P-P
arm group type: Experimental
description: Phenylephrine-Phenylephrine-Phenylephrine
intervention type: Drug
intervention name: Ephedrine Hydrochloride 3 MG/ML
description: Bolus group, according to the randomization. Multiple boluses with incremental doses might be needed, according to the MAP ('effect titration')
Incremental doses if needed:
Ephedrine (E): 6 mg, 6mg, 9 mg, 9 mg, 12 mg, …..(max 24mg/bolus) A total amount of 140 mg Ephedrine will not be exceeded.
Titrated according to the desired effect (= MAP decrease < 20%)
arm group label: Dose Bolus E-E-E
arm group label: Dose Bolus P-E-P
arm group label: Dose Bolus of E-P-E
intervention type: Drug
intervention name: Phenylephrine
description: Bolus group, according to the randomization. Multiple boluses with incremental doses might be needed, according to the MAP ('effect titration')
Incremental doses if needed:
Phenylephrine (PE): 50μg, 50μg, 100μg, 100μg, 150μg, 150μg,…(max 500µg/bolus) A total amount of 1500 μg will not be exceeded. Titrated according to the desired effect (= MAP decrease < 20%)
arm group label: Dose Bolus P-E-P
arm group label: Dose Bolus P-P-P
arm group label: Dose Bolus of E-P-E
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Caroline Vanpeteghem
role: Principal Investigator
affiliation: UZ Ghent
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: Phenylephrine
mesh term: Oxymetazoline
mesh term: Ephedrine
mesh term: Pseudoephedrine
sharing ipd: No