<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/NCT01714362</url>
  </required_header>
  <id_info>
    <org_study_id>GUMed-Ow-003</org_study_id>
    <nct_id>NCT01714362</nct_id>
  </id_info>
  <brief_title>Autonomic Nervous System Activity and Oculocardiac Reflex.</brief_title>
  <official_title>Prediction of Oculocardiac Reflex in Relationship to Autonomic Nervous System Activity, Mesured With the Use of ECG HRV Analysis.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Gdansk</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Gdansk</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pulling the eyeball during ophthalmic surgery provokes decrease in heart rate. This&#xD;
      phenomenon is called oculocardiac reflex. In some patients asystole may occur. Other cardiac&#xD;
      features of this reflex include hypotension, dysrhythmias, atrioventricular block. These&#xD;
      cardiovascular disturbances may lead to decreased perfusion and ischemia of vital organs.&#xD;
      Patients with existing cardiovascular disease are in risk of complications. Cardiovascular&#xD;
      system is mainly innervated with autonomic nervous system (ANS). Sympathetic/parasympathetic&#xD;
      activity may be determined by Heart Rate Variability (HRV). HRV analysis based on short 5&#xD;
      minutes electrocardiography has been found useful for prediction of hypotension and&#xD;
      bradycardia during induction of general anaesthesia and during spinal block. The aim of this&#xD;
      study is to verify whether it is possible to predict oculocardiac reflex with the use of HRV&#xD;
      analysis for ANS activity assessment, measured prior to the ophthalmic surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2009</start_date>
  <completion_date type="Actual">October 2018</completion_date>
  <primary_completion_date type="Actual">October 2018</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>oculocardiac reflex occurence in relation to autonomic system activity</measure>
    <time_frame>perioperatively - about 2 hours</time_frame>
  </primary_outcome>
  <enrollment type="Actual">52</enrollment>
  <condition>Bradycardia During Pulling of Eyeball</condition>
  <eligibility>
    <study_pop>
      <textblock>
        patients operated bacause of retinal pathology&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  planned surgery&#xD;
&#xD;
          -  over 18 years of age&#xD;
&#xD;
          -  surgery under general anaesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  urgent surgery&#xD;
&#xD;
          -  under 18 years of age and over 65&#xD;
&#xD;
          -  patients with generalised, nontreated disease&#xD;
&#xD;
          -  patients receiving beta blockers or calcium channel blocker&#xD;
&#xD;
          -  diabetic patients&#xD;
&#xD;
          -  patients operated under peri or retrobulbar anaesthesia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Magdalena A Wujtewicz, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Ophthalmology, Mediacal University of Gdansk, Gdansk, Poland</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical University of Gdansk</name>
      <address>
        <city>Gdansk</city>
        <zip>80-211</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>October 23, 2012</study_first_submitted>
  <study_first_submitted_qc>October 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 25, 2012</study_first_posted>
  <last_update_submitted>April 26, 2022</last_update_submitted>
  <last_update_submitted_qc>April 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Gdansk</investigator_affiliation>
    <investigator_full_name>Magdalena Wujtewicz</investigator_full_name>
    <investigator_title>assistant professor</investigator_title>
  </responsible_party>
  <keyword>oculocardiac effect</keyword>
  <keyword>bradycardia</keyword>
  <keyword>HRV</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bradycardia</mesh_term>
  </condition_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/NCT01714362
org study id: GUMed-Ow-003
nct id: NCT01714362
lead sponsor: 
has dmc: No
Pulling the eyeball during ophthalmic surgery provokes decrease in heart rate. This
      phenomenon is called oculocardiac reflex. In some patients asystole may occur. Other cardiac
      features of this reflex include hypotension, dysrhythmias, atrioventricular block. These
      cardiovascular disturbances may lead to decreased perfusion and ischemia of vital organs.
      Patients with existing cardiovascular disease are in risk of complications. Cardiovascular
      system is mainly innervated with autonomic nervous system (ANS). Sympathetic/parasympathetic
      activity may be determined by Heart Rate Variability (HRV). HRV analysis based on short 5
      minutes electrocardiography has been found useful for prediction of hypotension and
      bradycardia during induction of general anaesthesia and during spinal block. The aim of this
      study is to verify whether it is possible to predict oculocardiac reflex with the use of HRV
      analysis for ANS activity assessment, measured prior to the ophthalmic surgery.
observational model: Cohort
time perspective: Prospective
measure: oculocardiac reflex occurence in relation to autonomic system activity
time frame: perioperatively - about 2 hours
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Magdalena A Wujtewicz, MD PhD
role: Principal Investigator
affiliation: Department of Ophthalmology, Mediacal University of Gdansk, Gdansk, Poland
facility: 
country: Poland
responsible party type: Principal Investigator
investigator affiliation: Medical University of Gdansk
investigator full name: Magdalena Wujtewicz
investigator title: assistant professor
mesh term: Bradycardia