<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/NCT03756909</url>
  </required_header>
  <id_info>
    <org_study_id>NLOPEDİ</org_study_id>
    <nct_id>NCT03756909</nct_id>
  </id_info>
  <brief_title>Effect of Neutrophil Lymphocyte-platelet Lymphocyte Ratio on Complications in Pediatric Patients</brief_title>
  <acronym>NLOPEDI</acronym>
  <official_title>The Effect of Neutrophil Lymphocyte Ratio and Platelet Lymphocyte Ratio on Intraoperative and Postoperative Complications in Pediatric Patients Undergoing Otolaryngology</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aydin Adnan Menderes University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aydin Adnan Menderes University</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>
      The aim of this study was to investigate the relationship between NLR, PLR and postoperative&#xD;
      complications in children undergoing adenotonsillectomy and adenoidectomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Between the dates of February 1, 2018 and June 30, 2018, patients between 2-10 years of age,&#xD;
      ASA I-II, elective adenotonsillectomy and adenoidectomy under general anesthesia were planned&#xD;
      to be included in the study. The number of neutrophils, lymphocytes and platelets will be&#xD;
      taken from the hospital registry system taken preoperatively and the NLR and PLR ratios will&#xD;
      be calculated.&#xD;
&#xD;
      All patients in the operating room will be started with routine monitoring and anesthesia.&#xD;
      Hemodynamic data during surgery will be recorded. The entrance to the operating room (T1), 5&#xD;
      minutes after the start of anesthesia (T5), 15 minutes (T15), 30 minutes (T30) and 45 minutes&#xD;
      (T45) will be recorded in the follow-up form of the anesthesia. The fasting period of the&#xD;
      patients and the drugs and fluids applied during surgery will be recorded from the anesthesia&#xD;
      form. At the end of the operation, the patients who were taken to the recovery room at the&#xD;
      end of the surgery will be evaluated with 1 point, 15 minutes, 30 minutes, 1 hour and 4 hours&#xD;
      and 6 hours vomiting using the 4 point nausea scale.&#xD;
&#xD;
      Introduction to recovery room using Modified Eastern Ontario Children's Hospital Pain Scale&#xD;
      (mCHEOPS), postoperative pain at 15 min, 30 min, 1 hr and 4 hr. Analgesic requirement will be&#xD;
      recorded. Bronchospasm, agitation, etc. will be recorded by evaluating whether there are&#xD;
      complications.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2018</start_date>
  <completion_date type="Actual">November 1, 2018</completion_date>
  <primary_completion_date type="Actual">June 30, 2018</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The effect on postoperative complications of neutrophil lymphocyte ratio in adenotonsillectomy and adenoidectomy PAIN</measure>
    <time_frame>Postoperative 6 hours</time_frame>
    <description>Pain level will be evaluated by using CHEOPS (Children's Hospital of Eastern Ontario Pain Scale ) pain score. The scale includes six categories of pain behavior (Cry, facial, verbal, torso, touch, and legs). A score ranging from 0 to 2 or 1 to 3 is assigned to each activity and the total score ranges between 4 and 13.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The effect on postoperative complications of neutrophil lymphocyte ratio in adenotonsillectomy and/or adenoidectomy POVN</measure>
    <time_frame>Postoperative 6 hours</time_frame>
    <description>Pain level will be evaluated by using POVN score. Evaluation of nausea and vomiting was performed by a four-point scale; 0: No nausea and/or vomiting, 1: mild nausea and/or vomiting which does not require treatment, 2: nausea and/or vomiting requiring treatment and 3: vomiting resistant to antiemetic treatment</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">127</enrollment>
  <condition>Anesthesia</condition>
  <condition>Complication</condition>
  <arm_group>
    <arm_group_label>adenoidectomy group</arm_group_label>
    <description>Operations of adenoidectomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>adenotonsillectomy group</arm_group_label>
    <description>Operations of adenotonsillectomy</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        2-10 years&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing elective adenotonsillectomy and adenoidectomy under general&#xD;
             anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Immunodeficiency&#xD;
&#xD;
          -  Children of parents who do not want to participate in the study&#xD;
&#xD;
          -  Use of anticoagulants&#xD;
&#xD;
          -  Children with hematological disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Adnan Menderes University Training and Research Hospital</name>
      <address>
        <city>Aydın</city>
        <zip>09100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>November 28, 2018</last_update_submitted>
  <last_update_submitted_qc>November 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 29, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aydin Adnan Menderes University</investigator_affiliation>
    <investigator_full_name>SİNAN YILMAZ</investigator_full_name>
    <investigator_title>Asist.Prof. MD</investigator_title>
  </responsible_party>
  <!-- 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/NCT03756909
org study id: NLOPEDİ
nct id: NCT03756909
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of this study was to investigate the relationship between NLR, PLR and postoperative
      complications in children undergoing adenotonsillectomy and adenoidectomy.
Between the dates of February 1, 2018 and June 30, 2018, patients between 2-10 years of age,
      ASA I-II, elective adenotonsillectomy and adenoidectomy under general anesthesia were planned
      to be included in the study. The number of neutrophils, lymphocytes and platelets will be
      taken from the hospital registry system taken preoperatively and the NLR and PLR ratios will
      be calculated.

      All patients in the operating room will be started with routine monitoring and anesthesia.
      Hemodynamic data during surgery will be recorded. The entrance to the operating room (T1), 5
      minutes after the start of anesthesia (T5), 15 minutes (T15), 30 minutes (T30) and 45 minutes
      (T45) will be recorded in the follow-up form of the anesthesia. The fasting period of the
      patients and the drugs and fluids applied during surgery will be recorded from the anesthesia
      form. At the end of the operation, the patients who were taken to the recovery room at the
      end of the surgery will be evaluated with 1 point, 15 minutes, 30 minutes, 1 hour and 4 hours
      and 6 hours vomiting using the 4 point nausea scale.

      Introduction to recovery room using Modified Eastern Ontario Children's Hospital Pain Scale
      (mCHEOPS), postoperative pain at 15 min, 30 min, 1 hr and 4 hr. Analgesic requirement will be
      recorded. Bronchospasm, agitation, etc. will be recorded by evaluating whether there are
      complications.
observational model: Cohort
time perspective: Cross-Sectional
measure: The effect on postoperative complications of neutrophil lymphocyte ratio in adenotonsillectomy and adenoidectomy PAIN
time frame: Postoperative 6 hours
description: Pain level will be evaluated by using CHEOPS (Children's Hospital of Eastern Ontario Pain Scale ) pain score. The scale includes six categories of pain behavior (Cry, facial, verbal, torso, touch, and legs). A score ranging from 0 to 2 or 1 to 3 is assigned to each activity and the total score ranges between 4 and 13.
measure: The effect on postoperative complications of neutrophil lymphocyte ratio in adenotonsillectomy and/or adenoidectomy POVN
time frame: Postoperative 6 hours
description: Pain level will be evaluated by using POVN score. Evaluation of nausea and vomiting was performed by a four-point scale; 0: No nausea and/or vomiting, 1: mild nausea and/or vomiting which does not require treatment, 2: nausea and/or vomiting requiring treatment and 3: vomiting resistant to antiemetic treatment
arm group label: adenoidectomy group
description: Operations of adenoidectomy
arm group label: adenotonsillectomy group
description: Operations of adenotonsillectomy
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 2 Years
maximum age: 10 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Aydin Adnan Menderes University
investigator full name: SİNAN YILMAZ
investigator title: Asist.Prof. MD