<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/NCT04492813</url>
  </required_header>
  <id_info>
    <org_study_id>COCOPOPONO</org_study_id>
    <nct_id>NCT04492813</nct_id>
  </id_info>
  <brief_title>Plasmatic Concentrations of Propofol and Remifentanil in Obese and Non Obese Patients.</brief_title>
  <acronym>COCOPOPONO</acronym>
  <official_title>Comparison of Plasmatic Concentrations of Propofol and Remifentanil During Monitored Anesthesia in Obese and Non Obese Patients.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Clermont-Ferrand</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Clermont-Ferrand</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>
      This prospective monocentric phamacokinetics study aims to compare plasmatic concentrations&#xD;
      of Propofol and Remifentanil required to target a specific range of monitored anesthesia and&#xD;
      analgesia during sus-mesocolic surgery in obese and non obese patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Remifentanil and Propofol are administered intravenously as an opioid pain reliever and&#xD;
      hypnotic pain reliever during anesthesia. Their advantages are numerous: short half-life&#xD;
      allowing anesthesia and rapid awakening, little accumulation, allowing to adapt the level of&#xD;
      anesthesia or sedation to each patient, few side effects.&#xD;
&#xD;
      Entropy° is an index derived from the electroencephalographic signal of patients, validated&#xD;
      for the evaluation of the level of narcosis during general anesthesia.&#xD;
&#xD;
      ANI ° (nociception index analgesia) is an index using the ventilatory physiological&#xD;
      variability of the sinus rhythm validated to monitor patient's analgesia during general&#xD;
      anesthesia.&#xD;
&#xD;
      These non-invasive means of analgesia and sedation monitoring allows the clinician to ensure&#xD;
      satisfactory levels of anesthesia by administering products at minimum effective doses.&#xD;
&#xD;
      The authors propose to determine whether, for a comparable target effect (analgesia and&#xD;
      monitored sedation), plasmatic concentrations and administration rates of propofol and&#xD;
      remifentanil necessary during general anesthesia for a comparable surgical stimulus are the&#xD;
      same in populations of obese and non obese patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 20, 2018</start_date>
  <completion_date type="Actual">May 25, 2021</completion_date>
  <primary_completion_date type="Actual">January 25, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Each obese patient is matched with a non-obese patient by considering a pairing according to age (more or less 5 years), gender and renal function (more or less 10ml / min / 1.73m² creatinine clearance).</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Plasma concentration of Propofol</measure>
    <time_frame>5 minutes after the insufflation of the pneumoperitoneum</time_frame>
    <description>Plasma concentration of Propofol at different times during the maintenance phase of general anesthesia</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma concentration of Propofol</measure>
    <time_frame>5 minutes after completion of the gastric slice or ligation of the bile ducts</time_frame>
    <description>Plasma concentration of Propofol at different times during the maintenance phase of general anesthesia</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma concentration of Propofol</measure>
    <time_frame>At time of removing surgical specimen from the abdomen</time_frame>
    <description>Plasma concentration of Propofol at different times during the maintenance phase of general anesthesia</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma concentration of Propofol</measure>
    <time_frame>At the exsufflation of the pneumoperitoneum</time_frame>
    <description>Plasma concentration of Propofol at different times during the maintenance phase of general anesthesia</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma concentration of Remifentanil</measure>
    <time_frame>5 minutes after the insufflation of the pneumoperitoneum</time_frame>
    <description>Plasma concentration of Remifentanil at different times during the maintenance phase of general anesthesia</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma concentration of Remifentanil</measure>
    <time_frame>5 minutes after completion of the gastric slice or ligation of the bile ducts</time_frame>
    <description>Plasma concentration of Remifentanil at different times during the maintenance phase of general anesthesia</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma concentration of Remifentanil</measure>
    <time_frame>At time of removing surgical specimen from the abdomen</time_frame>
    <description>Plasma concentration of Remifentanil at different times during the maintenance phase of general anesthesia</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma concentration of Remifentanil</measure>
    <time_frame>At the exsufflation of the pneumoperitoneum</time_frame>
    <description>Plasma concentration of Remifentanil at different times during the maintenance phase of general anesthesia</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>General Anesthesia</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Obese patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Severe and morbidly obese patients (35²≤BMI &lt;55)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non Obese patients</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients with normal weight or slightly overweight (19 &lt;BMI &lt;30).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pharmacokinetic of propofol and remifentanil</intervention_name>
    <description>Pharmacokinetic of propofol and remifentanil in both population: Obese and non Obese patients</description>
    <arm_group_label>Non Obese patients</arm_group_label>
    <arm_group_label>Obese patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Obese patients group:&#xD;
&#xD;
          -  Age ≥ 18 years old&#xD;
&#xD;
          -  Severe and morbidly obese patients (35kg / m2≤IMC &lt;55kg / m2).&#xD;
&#xD;
          -  Patients undergoing general anesthesia for laparoscopic susmesocolic surgery&#xD;
             (bariatric surgery or cholecystectomy).&#xD;
&#xD;
          -  Patients who have given their consent in the manner described by the public health law&#xD;
             of August 9, 2004.&#xD;
&#xD;
          -  Patients benefiting from a Social Security scheme.&#xD;
&#xD;
        Group of non-obese patients:&#xD;
&#xD;
          -  Age ≥ 18 years old&#xD;
&#xD;
          -  Patients with normal weight or slightly overweight (19 &lt;BMI &lt;30).&#xD;
&#xD;
          -  Patients receiving general anesthesia for laparoscopic susmesocolic surgery&#xD;
             (cholecystectomy).&#xD;
&#xD;
          -  Patients who have given their consent in the manner described by the public health law&#xD;
             of August 9, 2004.&#xD;
&#xD;
          -  Patients benefiting from a Social Security scheme.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient refusal&#xD;
&#xD;
          -  Age &lt;18 years old&#xD;
&#xD;
          -  Protected adults and vulnerable persons&#xD;
&#xD;
          -  Pace maker&#xD;
&#xD;
          -  General anesthesia in the 24 hours preceding this surgery&#xD;
&#xD;
          -  Proven or suspected dysautonomia&#xD;
&#xD;
          -  Premedication by gabapentin Neurontin °&#xD;
&#xD;
          -  Locoregional peri-medullary analgesia technique used concomitantly during the pre- and&#xD;
             intraoperative period.&#xD;
&#xD;
          -  Unbalanced dysrhythmic heart disease (AC / FA; extrasystoles; non-sinus rhythm)&#xD;
&#xD;
          -  Pregnant or breastfeeding woman&#xD;
&#xD;
          -  Intubation impossible planned&#xD;
&#xD;
          -  Hypersensitivity to the products used&#xD;
&#xD;
          -  Allergy to peanut or soy&#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>Jean-Etienne Bazin, Pr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Service d'Anesthésie-Réanimation, Pôle Médecine Périopératoire - Hôpital Estaing, CHU de Clermont-Ferrand</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Service d'Anesthésie-Réanimation, Pôle Médecine Périopératoire - Hôpital Estaing, CHU de Clermont-Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <state>Puy De Dôme</state>
        <zip>63000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>July 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>August 24, 2021</last_update_submitted>
  <last_update_submitted_qc>August 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>General anesthesia</keyword>
  <keyword>Obesity</keyword>
  <keyword>Propofol pharmacokinetic</keyword>
  <keyword>Remifentanyl pharmacokinetic</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Remifentanil</mesh_term>
    <mesh_term>Propofol</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/NCT04492813
org study id: COCOPOPONO
nct id: NCT04492813
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This prospective monocentric phamacokinetics study aims to compare plasmatic concentrations
      of Propofol and Remifentanil required to target a specific range of monitored anesthesia and
      analgesia during sus-mesocolic surgery in obese and non obese patients.
Remifentanil and Propofol are administered intravenously as an opioid pain reliever and
      hypnotic pain reliever during anesthesia. Their advantages are numerous: short half-life
      allowing anesthesia and rapid awakening, little accumulation, allowing to adapt the level of
      anesthesia or sedation to each patient, few side effects.

      Entropy° is an index derived from the electroencephalographic signal of patients, validated
      for the evaluation of the level of narcosis during general anesthesia.

      ANI ° (nociception index analgesia) is an index using the ventilatory physiological
      variability of the sinus rhythm validated to monitor patient's analgesia during general
      anesthesia.

      These non-invasive means of analgesia and sedation monitoring allows the clinician to ensure
      satisfactory levels of anesthesia by administering products at minimum effective doses.

      The authors propose to determine whether, for a comparable target effect (analgesia and
      monitored sedation), plasmatic concentrations and administration rates of propofol and
      remifentanil necessary during general anesthesia for a comparable surgical stimulus are the
      same in populations of obese and non obese patients.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Each obese patient is matched with a non-obese patient by considering a pairing according to age (more or less 5 years), gender and renal function (more or less 10ml / min / 1.73m² creatinine clearance).
primary purpose: Basic Science
masking: Single (Outcomes Assessor)
measure: Plasma concentration of Propofol
time frame: 5 minutes after the insufflation of the pneumoperitoneum
description: Plasma concentration of Propofol at different times during the maintenance phase of general anesthesia
measure: Plasma concentration of Propofol
time frame: 5 minutes after completion of the gastric slice or ligation of the bile ducts
description: Plasma concentration of Propofol at different times during the maintenance phase of general anesthesia
measure: Plasma concentration of Propofol
time frame: At time of removing surgical specimen from the abdomen
description: Plasma concentration of Propofol at different times during the maintenance phase of general anesthesia
measure: Plasma concentration of Propofol
time frame: At the exsufflation of the pneumoperitoneum
description: Plasma concentration of Propofol at different times during the maintenance phase of general anesthesia
measure: Plasma concentration of Remifentanil
time frame: 5 minutes after the insufflation of the pneumoperitoneum
description: Plasma concentration of Remifentanil at different times during the maintenance phase of general anesthesia
measure: Plasma concentration of Remifentanil
time frame: 5 minutes after completion of the gastric slice or ligation of the bile ducts
description: Plasma concentration of Remifentanil at different times during the maintenance phase of general anesthesia
measure: Plasma concentration of Remifentanil
time frame: At time of removing surgical specimen from the abdomen
description: Plasma concentration of Remifentanil at different times during the maintenance phase of general anesthesia
measure: Plasma concentration of Remifentanil
time frame: At the exsufflation of the pneumoperitoneum
description: Plasma concentration of Remifentanil at different times during the maintenance phase of general anesthesia
arm group label: Obese patients
arm group type: Experimental
description: Severe and morbidly obese patients (35²≤BMI <55)
arm group label: Non Obese patients
arm group type: Active Comparator
description: Patients with normal weight or slightly overweight (19 <BMI <30).
intervention type: Drug
intervention name: Pharmacokinetic of propofol and remifentanil
description: Pharmacokinetic of propofol and remifentanil in both population: Obese and non Obese patients
arm group label: Non Obese patients
arm group label: Obese patients
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jean-Etienne Bazin, Pr
role: Principal Investigator
affiliation: Service d'Anesthésie-Réanimation, Pôle Médecine Périopératoire - Hôpital Estaing, CHU de Clermont-Ferrand
facility: 
country: France
responsible party type: Sponsor
mesh term: Obesity
mesh term: Remifentanil
mesh term: Propofol