<?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>IRCT2015101224493N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-01-25</date_registration>
      <primary_sponsor>Clinical Research Developmental Unit, Imam Hossein Medical and educational Hospital, Shahid Behesht</primary_sponsor>
      <public_title>Local dexmedetomidine in awake fiberoptic intubation</public_title>
      <acronym>-</acronym>
      <scientific_title>Studying the effect of Dexmedetomidine as local anesthetic adjuvant on sedation and hemodynami status  of patients during fiberoptic nasotracheal intubation</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>96</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/20660</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Other, Purpose: Treatment, Other design features: Random Number Table.</study_design>
      <phase>N/A</phase>
      <hc_freetext>the quality of awake fiberoptic intubation.</hc_freetext>
      <i_freetext>Intervention 1: Control group:airway nerve blocks  by lidocaine (5 milligram  per kilogram of body weight) and  infusion of 20 cc normal saline over 10 minutes before the blocks. Intervention 2: DEX LOCAL group: infusion of 20 cc normal saline over 10 minutes before the above procedures, and 1 microgram per kilgram of body weight dexmedetomidine (Hospira, USA) added to the total volume of lidocaine (5 miligram per kilogram of body weight) used in blocks as an adjuvant . Intervention 3: DEX IV group: intravenous infusion of 1 microgram per kilogram of body weight dexmedetomidine (Hospira, USA) in a 20 cc syringe over 10 minutes before blocks,  airway nerve blocks  by lidocaine (5 milligram per kilogram of body weight).</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>Parisa Sezari MD</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 2, 10th floor, 8th tower block, Hormozan avenue, Shahrake gharbsquare, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 912 219 4036</telephone>
        <email>psezari@sbmu.ac.ir; parissasezari@yahoo.com</email>
        <affiliation>Shahid Beheshti University of MedicalSciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Alireza Mirkheshti , MD</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pasdaran street, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 912 343 5962</telephone>
        <email>a_mirkheshti@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:&#13;
18-66 year old; ASA class 1 or 2; elective surgery; probable difficult airway; probable injury to cervical spine&#13;
&#13;
Exclusion criteria:&#13;
ASA &gt;3; history of any cardiac disease; history of hypertension; history of renal function impairment; history of liver function impairment; history of opiod/recreational drug abuse; using anti hypertension drugs; usig alpha adrenergic agonists or antagonists; history of any psychological disorders; pregnancy; NPO time less than 8 hours for solid food and less than 3 hours for clear fluids; baseline heart rate less than 60 beats per minute; emergent/urgent surgeries; overt coagulopathy or impaired coagulation tests; history of diabetes mellitus</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>66 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></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>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group:airway nerve blocks  by lidocaine (5 milligram  per kilogram of body weight) and  infusion of 20 cc normal saline over 10 minutes before the blocks</i_keyword>
      <i_keyword>DEX LOCAL group: infusion of 20 cc normal saline over 10 minutes before the above procedures, and 1 microgram per kilgram of body weight dexmedetomidine (Hospira, USA) added to the total volume of lidocaine (5 miligram per kilogram of body weight) used in blocks as an adjuvant .</i_keyword>
      <i_keyword>DEX IV group: intravenous infusion of 1 microgram per kilogram of body weight dexmedetomidine (Hospira, USA) in a 20 cc syringe over 10 minutes before blocks,  airway nerve blocks  by lidocaine (5 milligram per kilogram of body weight)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Propofol consumption (milligrams per kilogram of body weight). Timepoint: at the time of reaching CSI score=75. Method of measurement: observation.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Intubation scores. Timepoint: at the time of bronchoscopy and intubation. Method of measurement: observation.</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>Clinical Research Developmental Unit, Imam Hossein Medical and educational Hospital, Shahid Behesht</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-09-22</approval_date>
        <contact_name>Ethics committee of Sِhahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Koudakyar steet, Daneshgah square, Velenjak, Tehran, Iran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
