<?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>IRCT2015060520024N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-07-06</date_registration>
      <primary_sponsor>Vice chancellor for research, Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The  effect  of  Dextromethorphan  premedication  on  cough,  pain,  anxiety,  procedure  duration  and  sedation  during  fiber  optic  bronchoscopy.</public_title>
      <acronym></acronym>
      <scientific_title>The  effect  of  Dextromethorphan premedication  on  cough,  pain,  anxiety,  procedure  duration  and  sedation  during  fiber  optic  bronchoscopy:  a randomized, double-blind, placebo-controlled trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-06-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>66</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/17768</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Diagnostic, Other design features: Sixty-six patients scheduled for FOB in Imamkhomeini hospital complex will be randomly allocated into two groups according to four blocks (AABB) randomization system. Six states of AABB, ABAB, ABBA, BBAA, BABA, and BAAB will be recorded in six different cards, and then these cards will be mixed together. Consequently, the cars will be selected for 18 times and the order of letters will be registered. The A and B label will be sealed to the researcher and the patients.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Respiratory disorder, unspecified.</hc_freetext>
      <i_freetext>Intervention 1: Ninety minutes before FOB, 90 mg (30 cc) of syrup Dextromethorphan, manufactured by kharazmi pharmaceutical co, code:IRC-1228087158,. Intervention 2: Ninety minutes before FOB, 30cc sucrose syrup.</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>Dr. Soheil Peiman</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dr Nafissi's Building, Imamkhomeini hospital complex, Keshavarz blvd.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6693 9922</telephone>
        <email>s-peiman@tums.ac.ir</email>
        <affiliation>Department of Internal medicine, Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Besharat Rahimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Advanced Thoracic Research Cente, Imamkhomeini medical complex, Keshavarz blvd.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6658 1594</telephone>
        <email>besharatrahimi@yahoo.com</email>
        <affiliation>Advanced Thoracic Research Center, Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:&#13;
1- Any documented indication for diagnostic Fiber  Optic  Bronchoscopy;&#13;
2- Age&gt;18;&#13;
&#13;
Exclusion criteria:&#13;
1.	Allergy to opioid drugs;&#13;
2.	Taking sedative drugs during last 48 hours;&#13;
3.	Pregnant woman;&#13;
4.	Breastfeeding;&#13;
5.	Patients with central nervous system diseases;&#13;
6.	Patients with unstable medical condition;&#13;
7.	Emergent Fiber  Optic  Bronchoscopy;&#13;
8.	Impaired level of consciousness;&#13;
9.	Intubated patients.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J98.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Respiratory disease (chronic) NOS</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Ninety minutes before FOB, 90 mg (30 cc) of syrup Dextromethorphan, manufactured by kharazmi pharmaceutical co, code:IRC-1228087158,</i_keyword>
      <i_keyword>Ninety minutes before FOB, 30cc sucrose syrup</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cough intensity. Timepoint: during FOB. Method of measurement: Physicians' self assessment score.</prim_outcome>
      <prim_outcome>Anxiety intensity. Timepoint: during FOB. Method of measurement: Patients' self assessment score.</prim_outcome>
      <prim_outcome>Lidocaine requirement. Timepoint: during FOB. Method of measurement: Dose of drug recorded by Physician.</prim_outcome>
      <prim_outcome>Midazolam requirement. Timepoint: during FOB. Method of measurement: Dose of drug recorded by Physician.</prim_outcome>
      <prim_outcome>Fentanyl requirement. Timepoint: during FOB. Method of measurement: Dose of drug recorded by Physician.</prim_outcome>
      <prim_outcome>General perception about procedure. Timepoint: during FOB. Method of measurement: Patients' self assessment score.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>General perception about procedure. Timepoint: 2 hours after FOB. Method of measurement: patients' self-assessment score.</sec_outcome>
      <sec_outcome>Duration of FOB. Timepoint: at the end of FOB. Method of measurement: time in minutes.</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>Vice chancellor for research, Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-12-31</approval_date>
        <contact_name>Ethics committe of Tehran University of Medical Sciences</contact_name>
        <contact_address>6th floor,Vice Chancellor for Research, Tehran University of Medical Sciences central building, Keshavarz blvd. Ghods street. Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
