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/NCT06018623</url>
    </required_header>
    <id_info>
      <org_study_id>TOTM</org_study_id>
      <nct_id>NCT06018623</nct_id>
    </id_info>
    <brief_title>Dosage of Propofol Based on Lean Body Weight</brief_title>
    <official_title>Lean Body Weight Scalar for the Anesthetic Induction Dose of Propofol</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>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Patients who will be induction of anesthesia with propofol will have a body analysis with&#xD;
        Tanita before the operation. Patients' height, weight, age, gender and other general&#xD;
        information will be recorded. Total body weight (TBW), ideal body weight (IBW) and lean body&#xD;
        weight (LBW) of the patients will be calculated. Patients over the age of 18 who will be&#xD;
        operated under general anesthesia for 2-6 hours will be included. Patients with propofol&#xD;
        allergy or contraindicated to propofol are included in the study. In order to decide and try&#xD;
        the most appropriate weight-based scalar for propofol dosing for anesthesia induction to be&#xD;
        evaluated by specifying patients who need additional propofol during intubation in the study,&#xD;
        Ingrande et al. 80 patients with a mean body mass index [BMI] between 18-35 and Bispectoral&#xD;
        index (BIS). ) monitorization, propofol infusion (100 mg/kg/hour) will be started according&#xD;
        to total body weight, and the infusion will be stopped with a BIS value between 50 and 40,&#xD;
        and the elapsed time will be recorded. Routine anesthesia applications will be performed with&#xD;
        neuromuscular blocker applied. The total dose of Propofol given; the dose applied to&#xD;
        kilograms will be calculated according to TBW, IBW and LBW. And the relationship between the&#xD;
        given doses and the body mass index will be evaluated.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Patients who will be induction of anesthesia with propofol will have a body analysis with&#xD;
        Tanita before the operation. Patients' height, weight, age, gender and other general&#xD;
        information will be recorded. Total body weight (TBW), ideal body weight (IBW) and lean body&#xD;
        weight (LBW) of the patients will be calculated. Patients over the age of 18 who will be&#xD;
        operated under general anesthesia for 2-6 hours will be included. Patients with propofol&#xD;
        allergy or contraindicated to propofol are included in the study. In order to decide and try&#xD;
        the most appropriate weight-based scalar for propofol dosing for anesthesia induction to be&#xD;
        evaluated by specifying patients who need additional propofol during intubation in the study,&#xD;
        Ingrande et al. 80 patients with a mean body mass index [BMI] between 18-35 and Bispectoral&#xD;
        index (BIS). ) monitorization, propofol infusion (100 mg/kg/hour) will be started according&#xD;
        to total body weight, and the infusion will be stopped with a BIS value between 50 and 40,&#xD;
        and the elapsed time will be recorded. Routine anesthesia applications will be performed with&#xD;
        neuromuscular blocker applied. The total dose of Propofol given; the dose applied to&#xD;
        kilograms will be calculated according to TBW, IBW and LBW. And the relationship between the&#xD;
        doses given and the body mass index will be evaluated. In our study, we aimed to evaluate the&#xD;
        effects of Propofol dose according to lean body weight by evaluating patients with bodymass&#xD;
        index below 35.Patients who will be induction of anesthesia with propofol will have a body&#xD;
        analysis with Tanita before the operation. Patients' height, weight, age, gender and other&#xD;
        general information will be recorded. Total body weight (TBW), ideal body weight (IBW) and&#xD;
        lean body weight (LBW) of the patients will be calculated. Patients over the age of 18 who&#xD;
        will be operated under general anesthesia for 2-6 hours will be included. Patients with&#xD;
        propofol allergy or contraindicated to propofol are included in the study. In order to decide&#xD;
        and try the most appropriate weight-based scalar for propofol dosing for anesthesia induction&#xD;
        to be evaluated by specifying patients who need additional propofol during intubation in the&#xD;
        study, Ingrande et al. 80 patients with a mean body mass index [BMI] between 18-35 and&#xD;
        Bispectoral index (BIS). ) monitorization, propofol infusion (100 mg/kg/hour) will be started&#xD;
        according to total body weight, and the infusion will be stopped with a BIS value between 50&#xD;
        and 40, and the elapsed time will be recorded. Routine anesthesia applications will be&#xD;
        performed with neuromuscular blocker applied. The total dose of Propofol given; the dose&#xD;
        applied to kilograms will be calculated according to TBW, IBW and LBW. And the relationship&#xD;
        between the doses given and the body mass index will be evaluated. In our study, we aimed to&#xD;
        evaluate the effects of Propofol dose according to lean body weight by evaluating patients&#xD;
        with bodymass index below 35.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">January 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 15, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>PROPOFOL DOSE</measure>
      <time_frame>2</time_frame>
      <description>THE RATIO OF PROPOFOL DOSE WITH SUFFICIENT DEPTH OF ANESTHESIA ACCORDING TO TOTAL AND LEATHER BODY WEIGHT</description>
    </primary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Anticipated">90</enrollment>
    <condition>Gender</condition>
    <condition>Anesthesia</condition>
    <arm_group>
      <arm_group_label>grup1</arm_group_label>
      <description>Group 1 BMI = 18.5-24.9,</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 2 BMI = 25-29.9</arm_group_label>
      <description>BMI = 25-29.9,</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 3</arm_group_label>
      <description>BMI=30-34.9</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>It is an observational study and no non-routine procedures will be performed on patients. Routine anesthesia procedure will be applied to the patients</intervention_name>
      <description>It is an observational study and no non-routine procedures will be performed on patients.&#xD;
  Routine anesthesia procedure will be applied to the patients</description>
      <arm_group_label>Group 2 BMI = 25-29.9</arm_group_label>
      <arm_group_label>Group 3</arm_group_label>
      <arm_group_label>grup1</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          VOLUNTARY PATIENTS BETWEEN 18-65 YEARS WITH NO ADDITIONAL DISEASES&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria: BMI 18-35 will be included. over 18 years old It will take 2-6 hours&#xD;
          Patients who will be operated under general anesthesia will be included.&#xD;
  &#xD;
          -&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          PATIENT DOESN'T WANT CONTRAINDICATION OF PROPOFOL Propofol allergy&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>duygu demiroz, dr</last_name>
      <phone>905319504421</phone>
      <email>drduygudemiroz@hotmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>yusuf ziya colak, dr</last_name>
    </overall_contact_backup>
    <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>
    <link>
      <url>https://doi.org/10.1016/j.vas.2020.100131</url>
      <description>Drug dosing in obese adults</description>
    </link>
    <link>
      <url>https://doi.org/10.1093/bja/aes368</url>
      <description>In non-obese patients, duration of action of rocuronium is directly correlated with body mass index.</description>
    </link>
    <reference>
      <citation>Barras M, Legg A. Drug dosing in obese adults. Aust Prescr. 2017 Oct;40(5):189-193. doi: 10.18773/austprescr.2017.053. Epub 2017 Oct 3. No abstract available.</citation>
      <PMID>29109603</PMID>
    </reference>
    <reference>
      <citation>Fujimoto M, Tanahira C, Nishi M, Yamamoto T. In non-obese patients, duration of action of rocuronium is directly correlated with body mass index. Can J Anaesth. 2013 Jun;60(6):552-6. doi: 10.1007/s12630-013-9914-x. Epub 2013 Mar 6.</citation>
      <PMID>23463483</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>dr</investigator_title>
    </responsible_party>
    <keyword>the lean body weight, propofol intubation conditions</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Body Weight</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Anesthetics</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT06018623
  org study id: TOTM
  nct id: NCT06018623
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Patients who will be induction of anesthesia with propofol will have a body analysis with
        Tanita before the operation. Patients' height, weight, age, gender and other general
        information will be recorded. Total body weight (TBW), ideal body weight (IBW) and lean body
        weight (LBW) of the patients will be calculated. Patients over the age of 18 who will be
        operated under general anesthesia for 2-6 hours will be included. Patients with propofol
        allergy or contraindicated to propofol are included in the study. In order to decide and try
        the most appropriate weight-based scalar for propofol dosing for anesthesia induction to be
        evaluated by specifying patients who need additional propofol during intubation in the study,
        Ingrande et al. 80 patients with a mean body mass index [BMI] between 18-35 and Bispectoral
        index (BIS). ) monitorization, propofol infusion (100 mg/kg/hour) will be started according
        to total body weight, and the infusion will be stopped with a BIS value between 50 and 40,
        and the elapsed time will be recorded. Routine anesthesia applications will be performed with
        neuromuscular blocker applied. The total dose of Propofol given; the dose applied to
        kilograms will be calculated according to TBW, IBW and LBW. And the relationship between the
        given doses and the body mass index will be evaluated.
  Patients who will be induction of anesthesia with propofol will have a body analysis with
        Tanita before the operation. Patients' height, weight, age, gender and other general
        information will be recorded. Total body weight (TBW), ideal body weight (IBW) and lean body
        weight (LBW) of the patients will be calculated. Patients over the age of 18 who will be
        operated under general anesthesia for 2-6 hours will be included. Patients with propofol
        allergy or contraindicated to propofol are included in the study. In order to decide and try
        the most appropriate weight-based scalar for propofol dosing for anesthesia induction to be
        evaluated by specifying patients who need additional propofol during intubation in the study,
        Ingrande et al. 80 patients with a mean body mass index [BMI] between 18-35 and Bispectoral
        index (BIS). ) monitorization, propofol infusion (100 mg/kg/hour) will be started according
        to total body weight, and the infusion will be stopped with a BIS value between 50 and 40,
        and the elapsed time will be recorded. Routine anesthesia applications will be performed with
        neuromuscular blocker applied. The total dose of Propofol given; the dose applied to
        kilograms will be calculated according to TBW, IBW and LBW. And the relationship between the
        doses given and the body mass index will be evaluated. In our study, we aimed to evaluate the
        effects of Propofol dose according to lean body weight by evaluating patients with bodymass
        index below 35.Patients who will be induction of anesthesia with propofol will have a body
        analysis with Tanita before the operation. Patients' height, weight, age, gender and other
        general information will be recorded. Total body weight (TBW), ideal body weight (IBW) and
        lean body weight (LBW) of the patients will be calculated. Patients over the age of 18 who
        will be operated under general anesthesia for 2-6 hours will be included. Patients with
        propofol allergy or contraindicated to propofol are included in the study. In order to decide
        and try the most appropriate weight-based scalar for propofol dosing for anesthesia induction
        to be evaluated by specifying patients who need additional propofol during intubation in the
        study, Ingrande et al. 80 patients with a mean body mass index [BMI] between 18-35 and
        Bispectoral index (BIS). ) monitorization, propofol infusion (100 mg/kg/hour) will be started
        according to total body weight, and the infusion will be stopped with a BIS value between 50
        and 40, and the elapsed time will be recorded. Routine anesthesia applications will be
        performed with neuromuscular blocker applied. The total dose of Propofol given; the dose
        applied to kilograms will be calculated according to TBW, IBW and LBW. And the relationship
        between the doses given and the body mass index will be evaluated. In our study, we aimed to
        evaluate the effects of Propofol dose according to lean body weight by evaluating patients
        with bodymass index below 35.
  observational model: Other
  time perspective: Prospective
  measure: PROPOFOL DOSE
  time frame: 2
  description: THE RATIO OF PROPOFOL DOSE WITH SUFFICIENT DEPTH OF ANESTHESIA ACCORDING TO TOTAL AND LEATHER BODY WEIGHT
  arm group label: grup1
  description: Group 1 BMI = 18.5-24.9,
  arm group label: Group 2 BMI = 25-29.9
  description: BMI = 25-29.9,
  arm group label: Group 3
  description: BMI=30-34.9
  intervention type: Other
  intervention name: It is an observational study and no non-routine procedures will be performed on patients. Routine anesthesia procedure will be applied to the patients
  description: It is an observational study and no non-routine procedures will be performed on patients.
  Routine anesthesia procedure will be applied to the patients
  arm group label: Group 2 BMI = 25-29.9
  arm group label: Group 3
  arm group label: grup1
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: duygu demiroz, dr
  phone: 905319504421
  email: drduygudemiroz@hotmail.com
  last name: yusuf ziya colak, dr
  facility: 
  country: Turkey
  url: https://doi.org/10.1016/j.vas.2020.100131
  description: Drug dosing in obese adults
  url: https://doi.org/10.1093/bja/aes368
  description: In non-obese patients, duration of action of rocuronium is directly correlated with body mass index.
  citation: Barras M, Legg A. Drug dosing in obese adults. Aust Prescr. 2017 Oct;40(5):189-193. doi: 10.18773/austprescr.2017.053. Epub 2017 Oct 3. No abstract available.
  PMID: 29109603
  citation: Fujimoto M, Tanahira C, Nishi M, Yamamoto T. In non-obese patients, duration of action of rocuronium is directly correlated with body mass index. Can J Anaesth. 2013 Jun;60(6):552-6. doi: 10.1007/s12630-013-9914-x. Epub 2013 Mar 6.
  PMID: 23463483
  responsible party type: Principal Investigator
  investigator affiliation: Inonu University
  investigator full name: DUYGU DEMİROZ
  investigator title: dr
  mesh term: Body Weight
  mesh term: Anesthetics
  sharing ipd: Undecided