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/NCT06018597</url>
    </required_header>
    <id_info>
      <org_study_id>Inonu 2022/92</org_study_id>
      <nct_id>NCT06018597</nct_id>
    </id_info>
    <brief_title>The Relationship of Sevoflurane Consumption With Metabolic Age</brief_title>
    <official_title>The Relationship of Sevoflurane Consumption With Metabolic Age</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Inonu University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Inonu University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of this clinical study is to determine the consumption of sevoflurane, which is one&#xD;
        of the inhalation anesthetics, with metabolic age and basal metabolic rate. The basal&#xD;
        metabolic rates and metabolic ages of the patients who will be given sevoflurane- maintained&#xD;
        general anesthesia were measured preoperatively. The relationship between the amount of&#xD;
        sevoflurane consumption and the measured data of the patients in the postoperative period was&#xD;
        examined.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Standard monitoring, BIS, TOF (train of four) were performed from the premedication&#xD;
        application. Aspect A 2000 (Aspect Medical Systems, Newton) monitor and single-chip BIS&#xD;
        electrodes will be used for BIS. The total amount of sevoflurane consumed and MAK values of&#xD;
        these components will be recorded. Chronological age, metabolic age, BMR, height, weight,&#xD;
        ideal body weight, BMI, body adiposity, body fluid ratio, body fluid care, fat mass, lean&#xD;
        body weight, muscle registered, visceral adiposity, obesity degree in the preoperative period&#xD;
        of the patients. Values, ASA scores and demographic data will be recorded for the operation&#xD;
        process, cutting time, anesthesia time, extubation time, total sevoflurane consumption&#xD;
        throughout the case, and the relationship with basal metabolism and metabolic age will be&#xD;
        evaluated.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">September 9, 2022</start_date>
    <completion_date type="Actual">March 3, 2023</completion_date>
    <primary_completion_date type="Actual">March 1, 2023</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>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>consumption of sevoflurane</measure>
      <time_frame>patients during surgery</time_frame>
      <description>Reducing patients' consumption of sevoflurane according to metabolic law</description>
    </primary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Actual">79</enrollment>
    <condition>Sevoflurane</condition>
    <arm_group>
      <arm_group_label>percent age difference &lt; -6.6%</arm_group_label>
      <description>The percentage age difference in the negative direction represents patients whose metabolic age is greater than their chronological age.&#xD;
  When we analyze the ROC analysis in the negative direction,between Percent Age Difference and Sevoflurane Consumption Amount Calculated According to Metabolic Age, the cut-off value of the percentage age difference is -6,6%.&#xD;
  This group refers to those whose percentage age difference is less than -6.6%</description>
    </arm_group>
    <arm_group>
      <arm_group_label>percent age difference -6.6% to 11.7% those between</arm_group_label>
      <description>When we analyze the ROC analysis in the negative direction,between Percent Age Difference and Sevoflurane Consumption Amount Calculated According to Metabolic Age, the cut-off value of the percentage age difference is -6,6%. When we analyze the ROC analysis in the positive direction, the cut-off value of the percent age difference is 11.7%.&#xD;
  This group refers to those whose percentage age difference between -6.6% and 11.7%</description>
    </arm_group>
    <arm_group>
      <arm_group_label>percent age difference &gt; 11.7%</arm_group_label>
      <description>the percent age difference in the positive direction represents patients whose metabolic age is less than their chronological age.&#xD;
  When we analyze the ROC analysis in the positive direction,between Percent Age Difference and Sevoflurane Consumption Amount Calculated According to Metabolic Age, the cut-off value of the percent age difference is 11.7%.&#xD;
  This group refers to those whose percentage age difference is more than 11.7%</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Sevoflurane Baxter, 100%, Inhalation Vapour, Liquid 250 mL</intervention_name>
      <description>No procedure was performed on the patient other than routine anesthesia management.We compared sevoflurane consumption amount in the patient undergoing general anesthesia with sevoflurane according to their metabolic age.</description>
      <arm_group_label>percent age difference -6.6% to 11.7% those between</arm_group_label>
      <arm_group_label>percent age difference &lt; -6.6%</arm_group_label>
      <arm_group_label>percent age difference &gt; 11.7%</arm_group_label>
      <other_name>No procedure was performed on the patient other than routine anesthesia management.</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          18-65 AGE&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Between the ages of 18-65 who are scheduled for rhinoplasty or septoplasty with ASA I-II&#xD;
          Cases lasting 1 to 3 hours&#xD;
  &#xD;
          Exclude Criteria:&#xD;
  &#xD;
          Patients at high risk of malignant hyperthermia, with a history of allergy to general&#xD;
          anesthesia or any of the drugs to be used in the study, accepted as ASA III- ASA IV&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <gender_based>Yes</gender_based>
      <gender_description>ALL CENDER</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Inonu universitesi</name>
        <address>
          <city>Malatya</city>
          <zip>44050</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>St-Onge MP, Gallagher D. Body composition changes with aging: the cause or the result of alterations in metabolic rate and macronutrient oxidation? Nutrition. 2010 Feb;26(2):152-5. doi: 10.1016/j.nut.2009.07.004. Epub 2009 Dec 8.</citation>
      <PMID>20004080</PMID>
    </reference>
    <reference>
      <citation>Ng JCM, Schooling CM. Effect of Basal Metabolic Rate on Cancer: A Mendelian Randomization Study. Front Genet. 2021 Sep 9;12:735541. doi: 10.3389/fgene.2021.735541. eCollection 2021.</citation>
      <PMID>34567085</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Inonu University</investigator_affiliation>
      <investigator_full_name>DUYGU DEMİROZ</investigator_full_name>
      <investigator_title>associate professor</investigator_title>
    </responsible_party>
    <keyword>Sevoflurane Consumption, Metabolic Age, Tanita</keyword>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Sevoflurane</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/NCT06018597
  org study id: Inonu 2022/92
  nct id: NCT06018597
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: Yes
  The aim of this clinical study is to determine the consumption of sevoflurane, which is one
        of the inhalation anesthetics, with metabolic age and basal metabolic rate. The basal
        metabolic rates and metabolic ages of the patients who will be given sevoflurane- maintained
        general anesthesia were measured preoperatively. The relationship between the amount of
        sevoflurane consumption and the measured data of the patients in the postoperative period was
        examined.
  Standard monitoring, BIS, TOF (train of four) were performed from the premedication
        application. Aspect A 2000 (Aspect Medical Systems, Newton) monitor and single-chip BIS
        electrodes will be used for BIS. The total amount of sevoflurane consumed and MAK values of
        these components will be recorded. Chronological age, metabolic age, BMR, height, weight,
        ideal body weight, BMI, body adiposity, body fluid ratio, body fluid care, fat mass, lean
        body weight, muscle registered, visceral adiposity, obesity degree in the preoperative period
        of the patients. Values, ASA scores and demographic data will be recorded for the operation
        process, cutting time, anesthesia time, extubation time, total sevoflurane consumption
        throughout the case, and the relationship with basal metabolism and metabolic age will be
        evaluated.
  observational model: Case-Control
  time perspective: Prospective
  measure: consumption of sevoflurane
  time frame: patients during surgery
  description: Reducing patients' consumption of sevoflurane according to metabolic law
  arm group label: percent age difference < -6.6%
  description: The percentage age difference in the negative direction represents patients whose metabolic age is greater than their chronological age.
  When we analyze the ROC analysis in the negative direction,between Percent Age Difference and Sevoflurane Consumption Amount Calculated According to Metabolic Age, the cut-off value of the percentage age difference is -6,6%.
  This group refers to those whose percentage age difference is less than -6.6%
  arm group label: percent age difference -6.6% to 11.7% those between
  description: When we analyze the ROC analysis in the negative direction,between Percent Age Difference and Sevoflurane Consumption Amount Calculated According to Metabolic Age, the cut-off value of the percentage age difference is -6,6%. When we analyze the ROC analysis in the positive direction, the cut-off value of the percent age difference is 11.7%.
  This group refers to those whose percentage age difference between -6.6% and 11.7%
  arm group label: percent age difference > 11.7%
  description: the percent age difference in the positive direction represents patients whose metabolic age is less than their chronological age.
  When we analyze the ROC analysis in the positive direction,between Percent Age Difference and Sevoflurane Consumption Amount Calculated According to Metabolic Age, the cut-off value of the percent age difference is 11.7%.
  This group refers to those whose percentage age difference is more than 11.7%
  intervention type: Drug
  intervention name: Sevoflurane Baxter, 100%, Inhalation Vapour, Liquid 250 mL
  description: No procedure was performed on the patient other than routine anesthesia management.We compared sevoflurane consumption amount in the patient undergoing general anesthesia with sevoflurane according to their metabolic age.
  arm group label: percent age difference -6.6% to 11.7% those between
  arm group label: percent age difference < -6.6%
  arm group label: percent age difference > 11.7%
  other name: No procedure was performed on the patient other than routine anesthesia management.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  gender based: Yes
  gender description: ALL CENDER
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  facility: 
  country: Turkey
  citation: St-Onge MP, Gallagher D. Body composition changes with aging: the cause or the result of alterations in metabolic rate and macronutrient oxidation? Nutrition. 2010 Feb;26(2):152-5. doi: 10.1016/j.nut.2009.07.004. Epub 2009 Dec 8.
  PMID: 20004080
  citation: Ng JCM, Schooling CM. Effect of Basal Metabolic Rate on Cancer: A Mendelian Randomization Study. Front Genet. 2021 Sep 9;12:735541. doi: 10.3389/fgene.2021.735541. eCollection 2021.
  PMID: 34567085
  responsible party type: Principal Investigator
  investigator affiliation: Inonu University
  investigator full name: DUYGU DEMİROZ
  investigator title: associate professor
  mesh term: Sevoflurane
  sharing ipd: No