<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20200730048255N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-09-05</date_registration>
      <primary_sponsor>Ardabil University of Medical Sciences</primary_sponsor>
      <public_title>Effect of intravenous Dexamethasone on prevention of complications of laryngeal mask airway in inguinal region surgeries</public_title>
      <acronym>LMA=Laryngeal Mask Airway, ASA=American Society of Anesthesiologists</acronym>
      <scientific_title>Effect of intravenous Dexamethasone on prevention of complications of laryngeal mask airway (LMA) in inguinal region surgeries</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-08-24</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>140</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50074</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: . In terms of random allocation, patients will be assigned between two groups using a random quadruple blocks method. Thus, we will create blocks A, B, C and D and it will be randomly assigned to the relevant groups (Dexamethasone group and control group). The blocks are pre-prepared and randomly assigned to the control group and the Dexamethasone group.
Except for the executor of the project, the rest, including patients and clinical caregivers and evaluators and analyzers, will be unaware of the type and amount of medicine, Blinding description: In terms of blinding, Dexamethasone and Normal Saline will be given to the anesthesia technician in ready-made syringes and will be injected in order of quadruple blocks.In terms of outcomes measurement, the assessor will measure the studied variables and he will be unaware of the classification of the group receiving Dexamethasone or Normal Saline.
Except for the executor of the project, the rest, including patients and clinical caregivers and evaluators and analyzers, will be unaware of the type and amount of medicine.</study_design>
      <phase>3</phase>
      <hc_freetext>Inguinal region surgeries.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group (70 patients): This group will have general anesthesia with LMA. After establishing the airway, Dexamethasone 8 mg / IV / stat will be injected. Intervention 2: Control group (70 patients): This group will have general anesthesia with LMA. After establishing the airway, Normal Saline 2cc / IV / stat will be injected.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Arezoo Fekrat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Malata Restaurant, the beginning of the lane of Karshenasan, Keshavarzi Square</address>
        <city>Ardabil</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5615861364</zip>
        <telephone>+98 45 3371 0774</telephone>
        <email>arezoo.fekrat@gmail.com</email>
        <affiliation>Ardabil University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ahmad Ghazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Reza Hospital,</address>
        <city>Ardabil</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5615731567</zip>
        <telephone>+98 45 3373 3086</telephone>
        <email>dr.ghaziahmad@gmail.com</email>
        <affiliation>Ardabil University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients who are candidate for inguinal region surgery (hernia and unilateral varicocele repair) and undergo general anesthesia using classical LMA is selected.</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Dissatisfaction of eligible patients to participate in the study
American Society of Anesthesiologists ≥ 3</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group (70 patients): This group will have general anesthesia with LMA. After establishing the airway, Dexamethasone 8 mg / IV / stat will be injected.</i_keyword>
      <i_keyword>Control group (70 patients): This group will have general anesthesia with LMA. After establishing the airway, Normal Saline 2cc / IV / stat will be injected.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Nausea and vomiting. Timepoint: After extubation, postoperative recovery, 2 and 4 hours after surgery. Method of measurement: Nausea and Vomiting score: score 1: no nausea and vomiting; score 2: nausea; score 3: 1 or 2 times nausea and vomiting; score 4: nausea and vomiting more than 2 times.</prim_outcome>
      <prim_outcome>Cough. Timepoint: Postoperative recovery, 2 and 4 hours after surgery. Method of measurement: Asking the patient.</prim_outcome>
      <prim_outcome>Sore throat. Timepoint: Postoperative recovery, 2 and 4 hours after surgery. Method of measurement: Asking the patient.</prim_outcome>
      <prim_outcome>Chills. Timepoint: Postoperative recovery, 2 and 4 hours after surgery. Method of measurement: Chills score: score 0: No chills; score 1: peripheral vasoconstriction and peripheral cyanosis without specific cause but without visible muscle contraction; score 2: visible contraction limited to one muscle group; score 3: visible contraction in more than one muscle group; score 4: Clear muscle activity throughout the body.</prim_outcome>
      <prim_outcome>Odynophagia. Timepoint: Postoperative recovery, 2 and 4 hours after surgery. Method of measurement: Asking the patient.</prim_outcome>
      <prim_outcome>Dyspnea. Timepoint: Postoperative recovery, 2 and 4 hours after surgery. Method of measurement: Asking the patient.</prim_outcome>
      <prim_outcome>Epigastric pain. Timepoint: Postoperative recovery, 2 and 4 hours after surgery. Method of measurement: Asking the patient.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Ardabil University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-07-11</approval_date>
        <contact_name>Ethics Committee of Ardabil University of Medical Sciences</contact_name>
        <contact_address>Ardabil University of Medical Sciences, Dadghostari square Ardabil Ardabil Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
