<?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>IRCT2016081310765N10</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-12-21</date_registration>
      <primary_sponsor>Reserch center, Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Hemodynamic changes during tracheal intubation</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of intubating conditions and hemodynamic changes using propofol-succinyl choline with remifentanil-propofol for tracheal intubation in patients under General Anesthesia for upper Extremity surgeries</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-09-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/11180</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>1-2</phase>
      <hc_freetext>Failed or difficult intubation.</hc_freetext>
      <i_freetext>Intervention 1: Remifentanil will be IV injected through 5-10 seconds, then propofol    2.5 mg/kg administered through 30 seconds. After 60 seconds mask ventilation with oxygen 100% they will be intubated with suitable number of Macintosh laryngoscope (no 3) and tracheal tube laryngoscopy and endotracheal intubation was performed by another anesthesiologist. The cuff was inflated with pressure of 20-25 cmH2O. Intervention 2: Fentanil 50 µg will be IV injected  then propofol    2.5 mg/kg administered through 30 seconds.  Then sucsynilcoline 1 mg/kg  IV will be administered  after 60 seconds mask ventilation with oxygen 100% they will be intubated.</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>Sousan Rasouli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shohada Hospital, Golshahr Ave, Ilgoli</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 41 3338 9336</telephone>
        <email>Rasooli_s@yahoo.com</email>
        <affiliation>Reaserch center, Tabriz University of Medical Scienses</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sousan Rasooli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Il goli,  Golshahr Hospital, Shohada Hospital</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 41 3338 9336</telephone>
        <email>Rasooli_s@yahoo.com</email>
        <affiliation>Reaserch Center, Tabriz University of Medical Scienses</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Patients candidates to upper limb surgeries under general anesthesia; patients with ASA class I and II; patients with Mallampaty grade 1 or 2; requested to contribute on study&#13;
Exclusion criteria: patients with ASA class III or higher; cardiovascular or respiratory patients; brain vascular diseases; intramuscular diseases; patients with Mallampaty grade 3 or higher; obese patients; patients with romanticismal disease; laryngeal or vocal cords disease; preoperative horsness</inclusion_criteria>
      <agemin>18 days</agemin>
      <agemax>7 days</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T88.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Failed or difficult intubation</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Remifentanil will be IV injected through 5-10 seconds, then propofol    2.5 mg/kg administered through 30 seconds. After 60 seconds mask ventilation with oxygen 100% they will be intubated with suitable number of Macintosh laryngoscope (no 3) and tracheal tube laryngoscopy and endotracheal intubation was performed by another anesthesiologist. The cuff was inflated with pressure of 20-25 cmH2O.</i_keyword>
      <i_keyword>Fentanil 50 µg will be IV injected  then propofol    2.5 mg/kg administered through 30 seconds.  Then sucsynilcoline 1 mg/kg  IV will be administered  after 60 seconds mask ventilation with oxygen 100% they will be intubated.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Blood Pressure. Timepoint: Imediatly after induction of anesthesia, 3 and 5 minute after induction. Method of measurement: Non invasive BP.</prim_outcome>
      <prim_outcome>Heart rate. Timepoint: Imediatly after induction of anesthesia, 3 and 5 minute after induction. Method of measurement: With electrocardiography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Heart rate. Timepoint: Imediatly after induction of anesthesia, 3 and 5 minute after induction. Method of measurement: With Elecrocardiogram.</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>Reserch center, Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>1995-05-04</approval_date>
        <contact_name>Vice chancellor for research, Tabriz University of Medical Sciences</contact_name>
        <contact_address>Golgasht Ave, Tabriz University of Medical Scienses, Tabriz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
