<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/NCT01714388</url>
  </required_header>
  <id_info>
    <org_study_id>GUMed-Ow-004</org_study_id>
    <nct_id>NCT01714388</nct_id>
  </id_info>
  <brief_title>Vagotonic Effect of Remifentanil and Autonomic Nervous System Activity.</brief_title>
  <official_title>Vagotonic Effect of Remifentanil in Reference to Sympathetic or Parasympathetic Predominance of Autonomic Nervous System.</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>
      Remifentanil (RMFNT) is a very short active opioid, used for analgesia during general&#xD;
      anaesthesia and for analgesic and sedative effect in intensive care units (ICU) patients.&#xD;
      Registration for anesthesia includes bolus dose and continuous infusion, in ICU only infusion&#xD;
      regimen is allowed. Pharmacokinetic/pharmacodynamic parameters of RMFNT results in rapid&#xD;
      onset and offset of clinical effect, which makes this drug almost ideal in many situations.&#xD;
      Unfortunately, its vagomimetic influence on cardiac activity may result in decrease of heart&#xD;
      rate. It may be hypothesized that patients with parasympathetic predominance may be prone to&#xD;
      more intense parasympathomimetic effect of this opioid. An optimal method for assessment of&#xD;
      autonomic nervous system activity and assessment of influence of RMFNT on that activity is&#xD;
      Heart Rate Variability (HRV) analysis. Parasympathetic predominance is expressed as high&#xD;
      frequency (HF) power and HF/(LF+HF) (LF-low frequency) ratio in frequency domain and Root&#xD;
      Mean Square of the Successive Difference (RMSSD), the number of pairs of successive NNs that&#xD;
      differ by more than 50 ms (NN50), the proportion of NN50 divided by total number of NNs&#xD;
      (pNN50) in time domain. The aim of this study is to verify the hypothesis that patients with&#xD;
      predominance of parasympathetic activity are more subject to vagomimetic effect of RMFNT. HRV&#xD;
      based on 5 minutes electrocardiogram (ECG) recorded before and after bolus dose of RMFNT will&#xD;
      be analyzed. The occurrence of heart rate decrease will be than compared between patients&#xD;
      with sympathetic and parasympathetic predominance measured prior to drug injection.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2010</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Vagomimetic effect of RMFNT in reference to autonomic nervous system activity</measure>
    <time_frame>before and after drug injection</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Autonomic Nervous System Activity</condition>
  <arm_group>
    <arm_group_label>Remifentanil, Vagotonic response</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1 microgram/kg remifentanil given iv over at least 30 sec. at the beginning of induction of general anaesthesia</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Remifentanil</intervention_name>
    <description>1mcg/kg iv dose, followed by 5 minutes ECG recording</description>
    <arm_group_label>Remifentanil, Vagotonic response</arm_group_label>
    <other_name>Ultiva</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients assessed with American Society of Anesthesiologists' Physical Status&#xD;
             Classification System as 1-2 status&#xD;
&#xD;
          -  planned surgery under general anaesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  known sensitivity to remifentanil&#xD;
&#xD;
          -  anticipated problems with tracheal intubation&#xD;
&#xD;
          -  increased risk of aspiration&#xD;
&#xD;
          -  diabetic patients&#xD;
&#xD;
          -  patients taking medications with known influence on autonomic nervous system&#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 Wujtewicz</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Ophthalmology, Medical University of Gdańsk</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>September 2015</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>September 30, 2015</last_update_submitted>
  <last_update_submitted_qc>September 30, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 2, 2015</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>remifentanil</keyword>
  <keyword>heart rate</keyword>
  <keyword>autonomic nervous system</keyword>
  <keyword>heart rate variability</keyword>
  <keyword>autonomic nervous activity</keyword>
  <keyword>vagotonic effect</keyword>
  <keyword>single dose</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Remifentanil</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/NCT01714388
org study id: GUMed-Ow-004
nct id: NCT01714388
lead sponsor: 
has dmc: No
Remifentanil (RMFNT) is a very short active opioid, used for analgesia during general
      anaesthesia and for analgesic and sedative effect in intensive care units (ICU) patients.
      Registration for anesthesia includes bolus dose and continuous infusion, in ICU only infusion
      regimen is allowed. Pharmacokinetic/pharmacodynamic parameters of RMFNT results in rapid
      onset and offset of clinical effect, which makes this drug almost ideal in many situations.
      Unfortunately, its vagomimetic influence on cardiac activity may result in decrease of heart
      rate. It may be hypothesized that patients with parasympathetic predominance may be prone to
      more intense parasympathomimetic effect of this opioid. An optimal method for assessment of
      autonomic nervous system activity and assessment of influence of RMFNT on that activity is
      Heart Rate Variability (HRV) analysis. Parasympathetic predominance is expressed as high
      frequency (HF) power and HF/(LF+HF) (LF-low frequency) ratio in frequency domain and Root
      Mean Square of the Successive Difference (RMSSD), the number of pairs of successive NNs that
      differ by more than 50 ms (NN50), the proportion of NN50 divided by total number of NNs
      (pNN50) in time domain. The aim of this study is to verify the hypothesis that patients with
      predominance of parasympathetic activity are more subject to vagomimetic effect of RMFNT. HRV
      based on 5 minutes electrocardiogram (ECG) recorded before and after bolus dose of RMFNT will
      be analyzed. The occurrence of heart rate decrease will be than compared between patients
      with sympathetic and parasympathetic predominance measured prior to drug injection.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Vagomimetic effect of RMFNT in reference to autonomic nervous system activity
time frame: before and after drug injection
arm group label: Remifentanil, Vagotonic response
arm group type: Experimental
description: 1 microgram/kg remifentanil given iv over at least 30 sec. at the beginning of induction of general anaesthesia
intervention type: Drug
intervention name: Remifentanil
description: 1mcg/kg iv dose, followed by 5 minutes ECG recording
arm group label: Remifentanil, Vagotonic response
other name: Ultiva
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Magdalena Wujtewicz
role: Principal Investigator
affiliation: Department of Ophthalmology, Medical University of Gdańsk
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: Remifentanil