<?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>IRCT2016052712123N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-06-18</date_registration>
      <primary_sponsor>Deputy of research, Shahroud University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of cardiovascular response to laryngeal mask airway versus tracheal intubation</public_title>
      <acronym></acronym>
      <scientific_title>Comparative evaluation of Laryngeal mask insertion with conventional tracheal intubation on cardiovascular response during general anesthesia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-06-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>82</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/12245</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Humerus fracture. Condition 2: Fracture of both ulna and radius. Condition 3: Fracture at wrist and hand level. Condition 4: Leg fracture. Condition 5: Appendectomy. Condition 6: Inguinal hernia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: After induction of anesthesia and muscle relaxation size 3 unique singe use LMA for women and size 4 for men will be inserted cuff pressure adjusts by cuff pressure manometer. Intervention 2: Control group: After induction of anesthesia and muscle relaxation laryngoscopy and intubation with size 7.5 cuffed tracheal tube for women and size 8.0 for men will be done and cuff pressure adjusts by cuff pressure manometer.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Javad Nourian MD</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Operating room Imam Hossein Hospital, End of Towhidi avenue  Shahroud</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3616911151</zip>
        <telephone>+98 23 3234 2001</telephone>
        <email>javadnourian@shmu.ac.ir</email>
        <affiliation>Imam Hossein Hospital, Shahroud University of Medical Sciences, Shahroud, Iran</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Javad Nourian MD</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Operating room, Imam Hossein Hospital, End of Towhidi avenue  Shahroud</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3616911151</zip>
        <telephone>+98 23 3234 2001</telephone>
        <email>javadnourian@shmu.ac.ir</email>
        <affiliation>Imam Hossein Hospital, Shahroud University of Medical Sciences, Shahroud, Iran</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: male or female; 20-45 years old; ASA class 1 or 2 (anesthesia risk ); elective limbs open surgery; hernia; appendectomy.&#13;
&#13;
Exclusion criteria: Patient's refusal; hypertension; antihypertensive medication; opiate and analgesic drug abuse; every anesthesia or surgical complication.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S42.3, S42</hc_code>
      <hc_code>S52.6, S52</hc_code>
      <hc_code>S62.0, S62</hc_code>
      <hc_code>S82.0, S82</hc_code>
      <hc_code>K35.3</hc_code>
      <hc_code>K40</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Fracture of shaft of humerus, Fracture of lower end of humerus</hc_keyword>
      <hc_keyword>Fracture of lower end of both ulna and radius, Multiple fractures of forearm, Fracture of other parts of forearm</hc_keyword>
      <hc_keyword>Fracture of navicular [scaphoid] bone of hand, Fracture of other carpal bone(s), Fracture of first metacarpal bone, Fracture of other metacarpal bone, Multiple fractures of metacarpal bones, Fracture of thumb, Fracture of other finger, Multiple fractures </hc_keyword>
      <hc_keyword>Fracture of lower leg, including ankle</hc_keyword>
      <hc_keyword>Acute appendicitis</hc_keyword>
      <hc_keyword>Inguinal hernia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: After induction of anesthesia and muscle relaxation size 3 unique singe use LMA for women and size 4 for men will be inserted cuff pressure adjusts by cuff pressure manometer.</i_keyword>
      <i_keyword>Control group: After induction of anesthesia and muscle relaxation laryngoscopy and intubation with size 7.5 cuffed tracheal tube for women and size 8.0 for men will be done and cuff pressure adjusts by cuff pressure manometer</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Systolic blood pressure. Timepoint: before anesthesia, after induction, during airway control(laryngoscopy and intubation in control group and LMA insertion in intervention group), every five minutes during operation. Method of measurement: mmHg by Novin saadat's monitoring.</prim_outcome>
      <prim_outcome>Pulse rate. Timepoint: before anesthesia, after induction, during airway control(laryngoscopy and intubation in control group and LMA insertion in intervention group), every five minutes during operation. Method of measurement: Beat per minutes by Novin saadat's monitoring.</prim_outcome>
      <prim_outcome>Diastolic blood pressure. Timepoint: before anesthesia, after induction, during airway control(laryngoscopy and intubation in control group and LMA insertion in intervention group), every five minutes during operation. Method of measurement: mmHg by Novin saadat's monitoring.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Postoperative sore throat. Timepoint: At the end of recovery and 4 hours after in ward. Method of measurement: 0-3 scoring system 0-none 1- mild 2-moderate 3- severe.</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>Deputy of research, Shahroud University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-01-21</approval_date>
        <contact_name>Ethics committee, Deputy of research, Shahroud University of Medical Sciences</contact_name>
        <contact_address>Deputy of research, Shahroud University of Medical Sciences, 7th of Tir square Shahroud  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
