<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/NCT03816592</url>
  </required_header>
  <id_info>
    <org_study_id>GUINOT 2019</org_study_id>
    <nct_id>NCT03816592</nct_id>
  </id_info>
  <brief_title>Opioid Free Anaesthesia in Cardiac Surgery With Cardiopulmonary Bypass</brief_title>
  <acronym>OFACAR 1</acronym>
  <official_title>Opioid Free Anaesthesia in Cardiac Surgery With Cardiopulmonary Bypas</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire Dijon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire Dijon</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Since the 1990s, the concept of anesthesia without morphine (OFA) has been developed. The&#xD;
      principle is based on the fact that in a sleeping patient a sympathetic reaction marked by&#xD;
      hemodynamic changes does not reflect a painful phenomenon, that a painful phenomenon in a&#xD;
      sleeping patient is not memorized, that hormonal stress, sympathetic reaction and&#xD;
      inflammatory reaction can be controlled by therapeutic classes other than a morphine agent.&#xD;
      This therapeutic management would avoid the side effects associated with the use of morphine.&#xD;
      In cardiac surgery, no studies have evaluated the effect of an OFA on morphine consumption&#xD;
      and on a post-operative composite endpoint. Lidocaine was only studied in the context of&#xD;
      cardioprotection and neuroprotection. Studies found a cardioprotective effect with a decrease&#xD;
      in episodes of rhythmic disorders, and neuroprotective with a non-constant improvement in&#xD;
      postoperative cognitive functions, but all these studies were performed during opioid&#xD;
      anaesthesia (opioid agent use)/ The purpose of our study is to demonstrate that general&#xD;
      anesthesia without opioid (OFA) is associated with a decrease in post-operative morphine&#xD;
      consumption and an improvement in the patient's post-operative well-being (complications,&#xD;
      confusion, vigilance, length of stay).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">March 31, 2019</completion_date>
  <primary_completion_date type="Actual">March 31, 2019</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Morphine consumption</measure>
    <time_frame>Day 2</time_frame>
    <description>Total morphine consumption over the first 48 post operative hours in milligrammes</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Complications</measure>
    <time_frame>Day 7</time_frame>
    <description>composite end point of post operative complications (cardiac, neurological, renal, respiratory)</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">110</enrollment>
  <condition>Opioid Free Anaesthesia</condition>
  <condition>Opioid Anaesthesia</condition>
  <arm_group>
    <arm_group_label>Opioid free anaesthesia</arm_group_label>
    <description>patient anesthtesized with lidocaine, ketamine and dexamethasone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Opioid anaesthesia</arm_group_label>
    <description>patients anesthetized with sufentanil ketamine and dexamethasone</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Opioid free anaesthesia</intervention_name>
    <description>patient anesthtesized with lidocaine, ketamine and dexamethasone</description>
    <arm_group_label>Opioid free anaesthesia</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Opioid anaesthesia</intervention_name>
    <description>patients anesthetized with sufentanil ketamine and dexamethasone</description>
    <arm_group_label>Opioid anaesthesia</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Cardiac surgical&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age over 18 years&#xD;
&#xD;
          -  cardiac surgery with cardiopulmonary bypass&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patient with chronic analgesia treatment&#xD;
&#xD;
          -  patient on antidepressive therapy&#xD;
&#xD;
          -  gabapentin use&#xD;
&#xD;
          -  preoperative cognitive dysfunction&#xD;
&#xD;
          -  patient treated with zyvoxid&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Chu Dijon Bourogne</name>
      <address>
        <city>Dijon</city>
        <zip>21000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 22, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>May 17, 2019</last_update_submitted>
  <last_update_submitted_qc>May 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 21, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Analgesics, Opioid</mesh_term>
    <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/NCT03816592
org study id: GUINOT 2019
nct id: NCT03816592
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Since the 1990s, the concept of anesthesia without morphine (OFA) has been developed. The
      principle is based on the fact that in a sleeping patient a sympathetic reaction marked by
      hemodynamic changes does not reflect a painful phenomenon, that a painful phenomenon in a
      sleeping patient is not memorized, that hormonal stress, sympathetic reaction and
      inflammatory reaction can be controlled by therapeutic classes other than a morphine agent.
      This therapeutic management would avoid the side effects associated with the use of morphine.
      In cardiac surgery, no studies have evaluated the effect of an OFA on morphine consumption
      and on a post-operative composite endpoint. Lidocaine was only studied in the context of
      cardioprotection and neuroprotection. Studies found a cardioprotective effect with a decrease
      in episodes of rhythmic disorders, and neuroprotective with a non-constant improvement in
      postoperative cognitive functions, but all these studies were performed during opioid
      anaesthesia (opioid agent use)/ The purpose of our study is to demonstrate that general
      anesthesia without opioid (OFA) is associated with a decrease in post-operative morphine
      consumption and an improvement in the patient's post-operative well-being (complications,
      confusion, vigilance, length of stay).
observational model: Case-Control
time perspective: Retrospective
measure: Morphine consumption
time frame: Day 2
description: Total morphine consumption over the first 48 post operative hours in milligrammes
measure: Complications
time frame: Day 7
description: composite end point of post operative complications (cardiac, neurological, renal, respiratory)
arm group label: Opioid free anaesthesia
description: patient anesthtesized with lidocaine, ketamine and dexamethasone
arm group label: Opioid anaesthesia
description: patients anesthetized with sufentanil ketamine and dexamethasone
intervention type: Procedure
intervention name: Opioid free anaesthesia
description: patient anesthtesized with lidocaine, ketamine and dexamethasone
arm group label: Opioid free anaesthesia
intervention type: Procedure
intervention name: Opioid anaesthesia
description: patients anesthetized with sufentanil ketamine and dexamethasone
arm group label: Opioid anaesthesia
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Analgesics, Opioid
mesh term: Anesthetics