<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/NCT04486612</url>
  </required_header>
  <id_info>
    <org_study_id>10.12.19/43</org_study_id>
    <nct_id>NCT04486612</nct_id>
  </id_info>
  <brief_title>Ultrasonographic Measurement of Internal Jugular Vein as a Predictor of Hypotension Following Spinal Anesthesia</brief_title>
  <acronym>IJV</acronym>
  <official_title>Department of Anesthesiology and Reanimation, Faculty of Medicine, Osmangazi University, Eskişehir, Turkey</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eskisehir Osmangazi University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eskisehir Osmangazi University</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>
      Hypotension after spinal anesthesia is associated with significant perioperative morbidity&#xD;
      and mortality, especially in hypovolemic patients. Ultrasonographic measurement of internal&#xD;
      jugular vein (IJV) has been recently shown as effective in predicting the intravascular&#xD;
      volume status. The aim was to investigate the reliability of preanesthetic ultrasound&#xD;
      measurements of IJV in predicting hypotension after spinal anesthesia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hypotension after spinal anesthesia is associated with significant perioperative morbidity&#xD;
      and mortality, especially in hypovolemic patients. Ultrasonographic measurement of internal&#xD;
      jugular vein (IJV) has been recently shown as effective in predicting the intravascular&#xD;
      volume status. The aim was to investigate the reliability of preanesthetic ultrasound&#xD;
      measurements of IJV in predicting hypotension after spinal anesthesia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2020</start_date>
  <completion_date type="Actual">September 24, 2020</completion_date>
  <primary_completion_date type="Actual">September 24, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The association between sonographic measurements and postspinal hypotension</measure>
    <time_frame>first 30 minute</time_frame>
    <description>The aim of the study is to evaluate the association between sonographic measurements and postinduction hypotension.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">47</enrollment>
  <condition>Spinal Anesthetics Causing Adverse Effects in Therapeutic Use</condition>
  <condition>Hypotension Postprocedural</condition>
  <arm_group>
    <arm_group_label>hypotension</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>non-hypotension</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>spinal anesthesia</intervention_name>
    <description>prospective observational study</description>
    <arm_group_label>hypotension</arm_group_label>
    <arm_group_label>non-hypotension</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients between the ages of 18-65&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients between the ages of 18-65 Patients who read and accept the consent form of&#xD;
             the study Patients undergoing elective surgery under spinal anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  under 18 years old, ASA scores 3-4, presence of any significant hepatic, renal,&#xD;
             cardiavasculary, or respiratory disease, having left ventricular ejection fraction&#xD;
             less than 40%, and allergy to study medications.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>yeliz kılıç, Ass. Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Eskişehir Osmangazi Univercity</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Eskişehir Osmangazi Univercity</name>
      <address>
        <city>Eskişehir</city>
        <zip>26040</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>February 1, 2021</last_update_submitted>
  <last_update_submitted_qc>February 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Eskisehir Osmangazi University</investigator_affiliation>
    <investigator_full_name>Yeliz KILIÇ</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>spinal anesthesia</keyword>
  <keyword>internal jugular vein</keyword>
  <keyword>hypotension</keyword>
  <keyword>ultrasonography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypotension</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</mesh_term>
  </intervention_browse>
  <!-- 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/NCT04486612
org study id: 10.12.19/43
nct id: NCT04486612
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Hypotension after spinal anesthesia is associated with significant perioperative morbidity
      and mortality, especially in hypovolemic patients. Ultrasonographic measurement of internal
      jugular vein (IJV) has been recently shown as effective in predicting the intravascular
      volume status. The aim was to investigate the reliability of preanesthetic ultrasound
      measurements of IJV in predicting hypotension after spinal anesthesia.
Hypotension after spinal anesthesia is associated with significant perioperative morbidity
      and mortality, especially in hypovolemic patients. Ultrasonographic measurement of internal
      jugular vein (IJV) has been recently shown as effective in predicting the intravascular
      volume status. The aim was to investigate the reliability of preanesthetic ultrasound
      measurements of IJV in predicting hypotension after spinal anesthesia.
observational model: Case-Control
time perspective: Prospective
measure: The association between sonographic measurements and postspinal hypotension
time frame: first 30 minute
description: The aim of the study is to evaluate the association between sonographic measurements and postinduction hypotension.
arm group label: hypotension
arm group label: non-hypotension
intervention type: Other
intervention name: spinal anesthesia
description: prospective observational study
arm group label: hypotension
arm group label: non-hypotension
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
last name: yeliz kılıç, Ass. Prof
role: Principal Investigator
affiliation: Eskişehir Osmangazi Univercity
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Eskisehir Osmangazi University
investigator full name: Yeliz KILIÇ
investigator title: Assistant Professor
mesh term: Hypotension
mesh term: Anesthetics