<?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>IRCT2012101011067N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-05-12</date_registration>
      <primary_sponsor>Research Vice-Chancellor of Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>comparison of three drugs to prevent hemodynamic response of orothracheal intubation</public_title>
      <acronym></acronym>
      <scientific_title>Comparison Effect of Fentanyl, Sufentanil and Alfentanil on Hemodynamic at Rapid Sequence Intubation in the Emergency Department</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-09-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/11415</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Randomization was performed by providing the intubating physician, without informing him about the name of the medication, the different opiates labeled 1, 2 and 3 which were placed in the syringes containing similar amount of medication in each milliliter. When the patient entered the room, a ball was drawn from a bag containing 90 balls (30 balls labeled as 1, 30 as 2 and 30 as 3). Later, based on the number of the ball, the syringe with the similar number was used for the patient throughout the intubation. Neither the patient nor the physician was aware of the name of the opiate used in the intubation as the syringes were placed on the intubation tray by the project executor.</study_design>
      <phase>2</phase>
      <hc_freetext>accidents.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: 30 accidental patients with normal blood pressure that will require intubation with rapid sequence method, alfentanil, single dose intravenous administration 20 micrograms per kilogram (1 cc :500micrograms, Janssen Pharmaceutical Company, Beerse, Belgium) has been used for intubation. Intervention 2: Intervention group 1: 30 accidental patients with normal blood pressure that will require intubation with rapid sequence method, sufentanil, single dose intravenous administration 0.2 micrograms per kilogram (1 cc :5 micrograms, Mylan Pharmaceutical Company, Saint Priest, France) has been used for intubation. Intervention 3: Control group: 30 accidental patients with normal blood pressure that will require intubation with rapid sequence method, fentanyl, single dose intravenous administration 2 micrograms per kilogram (1 cc :50 micrograms, Mylan Pharmaceutical Company, Saint Priest, France) has been used for intubation.</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></firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address></address>
        <city></city>
        <country1></country1>
        <zip></zip>
        <telephone></telephone>
        <email></email>
        <affiliation></affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahboob Pouraghaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golgasht Street, Imam Reza (AS) Medical Research and Training Hospital, Emergency Department</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 41 1335 2078</telephone>
        <email>pouraghaeim@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria include all traumatic patients with normal blood pressure that require intubation in the Emergency Department of Imam Reza (AS) Medical Research and Training Hospital.&#13;
Exclusion criteria:Crush intubation, Asthma, Chronic Obstructive Pulmonary Disease, Porphyry, Allergy to lidocaine,difficult intubation based on physician's clinical judgment.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>V01-X59</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Accidents</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: 30 accidental patients with normal blood pressure that will require intubation with rapid sequence method, alfentanil, single dose intravenous administration 20 micrograms per kilogram (1 cc :500micrograms, Janssen Pharmaceutical Company, Beerse, Belgium) has been used for intubation.</i_keyword>
      <i_keyword>Intervention group 1: 30 accidental patients with normal blood pressure that will require intubation with rapid sequence method, sufentanil, single dose intravenous administration 0.2 micrograms per kilogram (1 cc :5 micrograms, Mylan Pharmaceutical Company, Saint Priest, France) has been used for intubation.</i_keyword>
      <i_keyword>Control group: 30 accidental patients with normal blood pressure that will require intubation with rapid sequence method, fentanyl, single dose intravenous administration 2 micrograms per kilogram (1 cc :50 micrograms, Mylan Pharmaceutical Company, Saint Priest, France) has been used for intubation.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Heart Rate. Timepoint: 5 minute before intubation, 3 minute after intubation, 5 minute after intubation, 10 minute after intubation and. Method of measurement: SAADAT Monitoring Device (Model Number: Novin S1800, Pooyandegan Rah Saadat Incorporation, Tehran, Iran).</prim_outcome>
      <prim_outcome>Blood Pressure. Timepoint: 5 minute before intubation, 3 minute after intubation, 5 minute after intubation, 10 minute after intubation and. Method of measurement: SAADAT Monitoring Device (Model Number: Novin S1800, Pooyandegan Rah Saadat Incorporation, Tehran, Iran.</prim_outcome>
      <prim_outcome>Cardiac Output. Timepoint: 5 minute before intubation, 3 minute after intubation, 5 minute after intubation, 10 minute after intubation and. Method of measurement: NICO Monitoring Device (Model Number:7300, Novametrix Incorporation, Wallingford, United States of America).</prim_outcome>
      <prim_outcome>Pressure of End Tidal Carbon Dioxide. Timepoint: 5 minute before intubation, 3 minute after intubation, 5 minute after intubation, 10 minute after intubation and. Method of measurement: NICO Monitoring Device (Model Number:7300, Novametrix Incorporation, Wallingford, United States of America.</prim_outcome>
      <prim_outcome>Arterial Oxygen Saturation. Timepoint: 5 minute before intubation, 3 minute after intubation, 5 minute after intubation, 10 minute after intubation and. Method of measurement: SAADAT Monitoring Device (Model Number: Novin S1800, Pooyandegan Rah Saadat Corporation, Tehran, Iran).</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>Research Vice-Chancellor of Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-06-12</approval_date>
        <contact_name>Ethic Committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Golgasht Street, Tabriz University of Medical Sciences Tabriz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
