xml: <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/NCT06026033</url>
    </required_header>
    <id_info>
      <org_study_id>2022/11</org_study_id>
      <nct_id>NCT06026033</nct_id>
    </id_info>
    <brief_title>The Effect of Anthropometrics on Desflurane Rise Time</brief_title>
    <official_title>Does Desflurane Take Longer to Reach Target Endtidal Concentration in Patients With Higher Body Muscle Content: a Pragmatic Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Rize Üniversitesi</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Recep Tayyip Erdogan University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Rize Üniversitesi</source>
    <oversight_info>
      <has_dmc>Yes</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>
        Desflurane is increasingly used in general anesthesia. Its pharmacokinetic properties are&#xD;
        known and its distribution is easily modeled. Yet these models fail in practice. In order to&#xD;
        increase accuracy, any model should include cardiac output, alveolar ventilation and alveolar&#xD;
        dead space, all of which are either hard to measure or impractical, at least.&#xD;
  &#xD;
        A previous study performed by the same investigator showed that time to target endtidal&#xD;
        concentration of sevoflurane is prolonged with increased cardiac output, but only if the&#xD;
        patient has increased muscle mass. Although desflurane has lower muscle and fat sloubility,&#xD;
        our observations suggest a similar prolongation in case of increased muscle mass.&#xD;
  &#xD;
        The investigators aim to investigate if patient characteristics such as gender, age, height,&#xD;
        weight, body type prolongs time to reach target endtidal desflurane concentration in low flow&#xD;
        anesthesia.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Low flow anesthesia is a frequently used application in anesthesiology practice. With the&#xD;
        widespread use of modern anesthesia devices, the implementation of this application has&#xD;
        become easier and its complications have been greatly reduced. It is routinely applied in our&#xD;
        clinic, accompanied by both the protocols in the literature and the protocols the&#xD;
        investigators have created.&#xD;
  &#xD;
        Desflurane is the most recently developed inhaler anesthetic agent, and it has advantages&#xD;
        such as faster recovery from anesthesia and less metabolism compared to sevoflurane. Although&#xD;
        the physicochemical properties of desflurane are known, computer models for its use with&#xD;
        low-flow anesthesia are based on desflurane's physicocemical protperties, and not on the&#xD;
        pharmacokinetic properties of patients. The inhaled induction times obtained with these&#xD;
        models do not agree with our observations in practice.&#xD;
  &#xD;
        In a study conducted in 2021, it was shown that parameters such as cardiac output and&#xD;
        alveolar ventilation can increase the accuracy of these models. Among these models, the most&#xD;
        frequently used one in the literature is included in the Gas Man simulator, which is also&#xD;
        used in anesthesia specialty training. It allows one to perform studies that compare&#xD;
        simulation-based and in vivo values are carried out.&#xD;
  &#xD;
        A similar study was conducted by us with sevoflurane in 2018; A significant difference was&#xD;
        found in the rate of increase in alveolar sevoflurane concentration according to cardiac&#xD;
        output and muscle mass. Based on this study, the investigators aimed to investigate the&#xD;
        effect of the patient's muscle mass evaluated by pragmatic measures such as height, body&#xD;
        weight and body type on the rate of increase in the alveolar concentration of desflurane.&#xD;
  &#xD;
        For this purpose, the investigators aimed to investigate the relationship between the time to&#xD;
        reach the targeted alveolar desflurane gas concentration and patient characteristics. The&#xD;
        investigators believe that the results of the study will be useful in explaining the factors&#xD;
        affecting the induction of general anesthesia with desflurane.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">February 1, 2022</start_date>
    <completion_date type="Actual">September 1, 2023</completion_date>
    <primary_completion_date type="Actual">August 30, 2023</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>Rate of rise in expiratory desflurane concentration</measure>
      <time_frame>intraoperative</time_frame>
      <description>Correlataion between the time required for the endtidal expiratory desflurane concentration to reach 8% and patient characteristics</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Rate of rise in inspiratory desflurane concentration</measure>
      <time_frame>intraoperative</time_frame>
      <description>Correlataion between the time required for the endtidal inspiratory desflurane concentration to reach 6% and patient characteristics</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Correlation of expiratory target time with GasMan simulation</measure>
      <time_frame>intraoperative</time_frame>
      <description>Correlation of the time required for the endtidal expiratory desflurane concentration to reach 8% and result of GasMan simulation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation of inspiratory target time with GasMan simulation</measure>
      <time_frame>intraoperative</time_frame>
      <description>Correlation of the time required for the endtidal inspiratory desflurane concentration to reach 8% and result of GasMan simulation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation between occurrence of hypertension and patient characteristics</measure>
      <time_frame>intraoperative</time_frame>
      <description>Correlation between occurrence of hypertension defined as any measurement of systolic arterial blood pressure &gt; 160 mmHg and patient characteristics</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation between occurrence of tachycardia and patient characteristics</measure>
      <time_frame>intraoperative</time_frame>
      <description>Correlation between occurrence of tachycardia defined as any measurement of heart rate &gt; 100/minute and patient characteristics</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Actual">361</enrollment>
    <condition>Desflurane</condition>
    <condition>Anesthesia, General</condition>
    <arm_group>
      <arm_group_label>Patients scheduled for general anesthesia</arm_group_label>
      <description>Patients scheduled for elective general anesthesia will be included, if accepts and signs the informed consent. The inhalational anesthetic should be desflurane. No other inhalational agent should be used during the induction of anesthesia. The inspiratory and expiratory concentration of any inhalational agent should be zero before the induction of anesthesia.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Desflurane induction</intervention_name>
      <description>Following tracheal intubation, the fresh gas flow will be set to 1 liters/minute, desflurane vaporizer will be set to maximum.</description>
      <arm_group_label>Patients scheduled for general anesthesia</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Adult patients, who are scheduled for elective general anesthesia. Maintenance of&#xD;
          anesthesia with desflurane should be included in the routine anesthesia plan.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  age &gt; 18 years&#xD;
  &#xD;
            -  planned elective surgery&#xD;
  &#xD;
            -  planned inhalational anesthesia&#xD;
  &#xD;
            -  planned use of desflurane&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  emergency surgery&#xD;
  &#xD;
            -  use of other inhalational anesthetic agent (sevoflurane, isoflurane, nitrous oxide)&#xD;
  &#xD;
            -  disclosed or recognized pregnancy&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Başar Erdivanlı, Assoc. Prof.</last_name>
      <role>Study Director</role>
      <affiliation>Recep Tayyip Erdogan University Medical Faculty, Department of Anesthesiology and Reanimation</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Alihan Madran, M.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Recep Tayyip Erdogan University Medical Faculty, Department of Anesthesiology and Reanimation</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Recep Tayyip Erdogan University Medical Faculty, Department of Anesthesiology and Reanimation</name>
        <address>
          <city>Rize</city>
          <zip>53100</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <results_reference>
      <citation>Weber J, Missbach C, Schmidt J, Wenzel C, Schumann S, Philip JH, Wirth S. Prediction of expiratory desflurane and sevoflurane concentrations in lung-healthy patients utilizing cardiac output and alveolar ventilation matched pharmacokinetic models: A comparative observational study. Medicine (Baltimore). 2021 Feb 12;100(6):e23570. doi: 10.1097/MD.0000000000023570.</citation>
      <PMID>33578509</PMID>
    </results_reference>
    <results_reference>
      <citation>Athiraman U, Ravishankar M, Jahagirdhar S. Performance of computer simulated inhalational anesthetic uptake model in comparison with real time isoflurane concentration. J Clin Monit Comput. 2016 Dec;30(6):791-796. doi: 10.1007/s10877-015-9776-6. Epub 2015 Sep 19.</citation>
      <PMID>26386708</PMID>
    </results_reference>
    <results_reference>
      <citation>Philip JH. Using screen-based simulation of inhaled anaesthetic delivery to improve patient care. Br J Anaesth. 2015 Dec;115 Suppl 2:ii89-94. doi: 10.1093/bja/aev370.</citation>
      <PMID>26658205</PMID>
    </results_reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>March 31, 2023</study_first_submitted>
    <study_first_submitted_qc>September 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>September 3, 2023</last_update_submitted>
    <last_update_submitted_qc>September 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Recep Tayyip Erdogan University</investigator_affiliation>
      <investigator_full_name>Başar Erdivanlı</investigator_full_name>
      <investigator_title>Assoc Prof</investigator_title>
    </responsible_party>
    <keyword>Anesthetics, Inhalation</keyword>
    <keyword>Anesthesia, General</keyword>
    <keyword>Desflurane</keyword>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Desflurane</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06026033
  org study id: 2022/11
  nct id: NCT06026033
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Desflurane is increasingly used in general anesthesia. Its pharmacokinetic properties are
        known and its distribution is easily modeled. Yet these models fail in practice. In order to
        increase accuracy, any model should include cardiac output, alveolar ventilation and alveolar
        dead space, all of which are either hard to measure or impractical, at least.
  
        A previous study performed by the same investigator showed that time to target endtidal
        concentration of sevoflurane is prolonged with increased cardiac output, but only if the
        patient has increased muscle mass. Although desflurane has lower muscle and fat sloubility,
        our observations suggest a similar prolongation in case of increased muscle mass.
  
        The investigators aim to investigate if patient characteristics such as gender, age, height,
        weight, body type prolongs time to reach target endtidal desflurane concentration in low flow
        anesthesia.
  Low flow anesthesia is a frequently used application in anesthesiology practice. With the
        widespread use of modern anesthesia devices, the implementation of this application has
        become easier and its complications have been greatly reduced. It is routinely applied in our
        clinic, accompanied by both the protocols in the literature and the protocols the
        investigators have created.
  
        Desflurane is the most recently developed inhaler anesthetic agent, and it has advantages
        such as faster recovery from anesthesia and less metabolism compared to sevoflurane. Although
        the physicochemical properties of desflurane are known, computer models for its use with
        low-flow anesthesia are based on desflurane's physicocemical protperties, and not on the
        pharmacokinetic properties of patients. The inhaled induction times obtained with these
        models do not agree with our observations in practice.
  
        In a study conducted in 2021, it was shown that parameters such as cardiac output and
        alveolar ventilation can increase the accuracy of these models. Among these models, the most
        frequently used one in the literature is included in the Gas Man simulator, which is also
        used in anesthesia specialty training. It allows one to perform studies that compare
        simulation-based and in vivo values are carried out.
  
        A similar study was conducted by us with sevoflurane in 2018; A significant difference was
        found in the rate of increase in alveolar sevoflurane concentration according to cardiac
        output and muscle mass. Based on this study, the investigators aimed to investigate the
        effect of the patient's muscle mass evaluated by pragmatic measures such as height, body
        weight and body type on the rate of increase in the alveolar concentration of desflurane.
  
        For this purpose, the investigators aimed to investigate the relationship between the time to
        reach the targeted alveolar desflurane gas concentration and patient characteristics. The
        investigators believe that the results of the study will be useful in explaining the factors
        affecting the induction of general anesthesia with desflurane.
  observational model: Cohort
  time perspective: Prospective
  measure: Rate of rise in expiratory desflurane concentration
  time frame: intraoperative
  description: Correlataion between the time required for the endtidal expiratory desflurane concentration to reach 8% and patient characteristics
  measure: Rate of rise in inspiratory desflurane concentration
  time frame: intraoperative
  description: Correlataion between the time required for the endtidal inspiratory desflurane concentration to reach 6% and patient characteristics
  measure: Correlation of expiratory target time with GasMan simulation
  time frame: intraoperative
  description: Correlation of the time required for the endtidal expiratory desflurane concentration to reach 8% and result of GasMan simulation
  measure: Correlation of inspiratory target time with GasMan simulation
  time frame: intraoperative
  description: Correlation of the time required for the endtidal inspiratory desflurane concentration to reach 8% and result of GasMan simulation
  measure: Correlation between occurrence of hypertension and patient characteristics
  time frame: intraoperative
  description: Correlation between occurrence of hypertension defined as any measurement of systolic arterial blood pressure > 160 mmHg and patient characteristics
  measure: Correlation between occurrence of tachycardia and patient characteristics
  time frame: intraoperative
  description: Correlation between occurrence of tachycardia defined as any measurement of heart rate > 100/minute and patient characteristics
  arm group label: Patients scheduled for general anesthesia
  description: Patients scheduled for elective general anesthesia will be included, if accepts and signs the informed consent. The inhalational anesthetic should be desflurane. No other inhalational agent should be used during the induction of anesthesia. The inspiratory and expiratory concentration of any inhalational agent should be zero before the induction of anesthesia.
  intervention type: Drug
  intervention name: Desflurane induction
  description: Following tracheal intubation, the fresh gas flow will be set to 1 liters/minute, desflurane vaporizer will be set to maximum.
  arm group label: Patients scheduled for general anesthesia
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Başar Erdivanlı, Assoc. Prof.
  role: Study Director
  affiliation: Recep Tayyip Erdogan University Medical Faculty, Department of Anesthesiology and Reanimation
  last name: Alihan Madran, M.D.
  role: Principal Investigator
  affiliation: Recep Tayyip Erdogan University Medical Faculty, Department of Anesthesiology and Reanimation
  facility: 
  country: Turkey
  citation: Weber J, Missbach C, Schmidt J, Wenzel C, Schumann S, Philip JH, Wirth S. Prediction of expiratory desflurane and sevoflurane concentrations in lung-healthy patients utilizing cardiac output and alveolar ventilation matched pharmacokinetic models: A comparative observational study. Medicine (Baltimore). 2021 Feb 12;100(6):e23570. doi: 10.1097/MD.0000000000023570.
  PMID: 33578509
  citation: Athiraman U, Ravishankar M, Jahagirdhar S. Performance of computer simulated inhalational anesthetic uptake model in comparison with real time isoflurane concentration. J Clin Monit Comput. 2016 Dec;30(6):791-796. doi: 10.1007/s10877-015-9776-6. Epub 2015 Sep 19.
  PMID: 26386708
  citation: Philip JH. Using screen-based simulation of inhaled anaesthetic delivery to improve patient care. Br J Anaesth. 2015 Dec;115 Suppl 2:ii89-94. doi: 10.1093/bja/aev370.
  PMID: 26658205
  responsible party type: Principal Investigator
  investigator affiliation: Recep Tayyip Erdogan University
  investigator full name: Başar Erdivanlı
  investigator title: Assoc Prof
  mesh term: Desflurane
  sharing ipd: No