<?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>IRCT20201207049639N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-01-06</date_registration>
      <primary_sponsor>Oroumia University of Medical Sciences</primary_sponsor>
      <public_title>Effect of fentanyl with and without topical lidocaine on hemodynamic responses to tracheal intubation</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of intravenous fentanyl with and without topical lidocaine on hemodynamic responses to tracheal intubation; a double-blinded clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-06-26</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53334</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: At www.random.org website, in the "Enter List Items" section, the names of the study groups were written in equal numbers. That is, 50 number of "fentanyl with topical lidocainegroup" and 50 number of "fentanyl without topical lidocainegroup". Then the "Ranomize" option was clicked. In this case, a list was presented that randomly and in different order had an equal number of groups and the patients were entered to the study in order of referral, Blinding description: Patients were unaware of their allocation into the intervention groups and the statistical analyzer received the data as codes, not the actual grouping.</study_design>
      <phase>3</phase>
      <hc_freetext>Hemodynamic response to endotracheal intubation.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The first group received 2μg / kg intravenous fentanyl (Caspian product) and 10 puffs of lidocaine spray 10% (equivalent to 100 mg) (Iran Daru product) about one minute before endotracheal intubation for oropharyngeal and epiglottal anesthesia. Intervention 2: Intervention group: The second group just received only 2μg / kg intravenous fentanyl (Caspian product) about one minute before endotracheal 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Patients data will be shared based on codes assigned to patients

When:
6 months after the publication of the article

To whom:
Faculty Members

Conditions:
Just research

Where to obtain:
Email to Dr.Hoshyar

How to obtain:
One week after sending the email and checking the purpose of the request

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Hadi Hooshyar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Motahhari Hospital; Kashani street; Urmia; Iran.</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5714783734</zip>
        <telephone>+98 44 3198 8293</telephone>
        <email>hooshyar.h@umsu.ac.ir</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Hadi Hooshyar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Motahhari Hospital; Kashani street; Urmia; Iran.</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5714783734</zip>
        <telephone>+98 44 3198 8293</telephone>
        <email>hooshyar.h@umsu.ac.ir</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age over 20 years and under 60 years
American Society of Anesthesiologists (ASA) I and II
patients who are candidates for elective surgery under general anesthesia and endotracheal intubation with cuffed tube</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Morbid obesity (BMI above 40)
History of any disease or abnormality that adversely affects anesthesia and surgery
History of any drug use that adversely affects anesthesia and surgery</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The first group received 2μg / kg intravenous fentanyl (Caspian product) and 10 puffs of lidocaine spray 10% (equivalent to 100 mg) (Iran Daru product) about one minute before endotracheal intubation for oropharyngeal and epiglottal anesthesia</i_keyword>
      <i_keyword>Intervention group: The second group just received only 2μg / kg intravenous fentanyl (Caspian product) about one minute before endotracheal intubation</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Heart rate. Timepoint: Before intubation, immediately after intubation, 1, 3 and 5 minutes after intubation. Method of measurement: Pulsoximeter.</prim_outcome>
      <prim_outcome>Systolic blood pressure. Timepoint: Before intubation, immediately after intubation, 1, 3 and 5 minutes after intubation. Method of measurement: Cardiovascular monitoring device.</prim_outcome>
      <prim_outcome>Diastolic blood pressure. Timepoint: Before intubation, immediately after intubation, 1, 3 and 5 minutes after intubation. Method of measurement: Cardiovascular monitoring device.</prim_outcome>
      <prim_outcome>Mean atrial pressure. Timepoint: Before intubation, immediately after intubation, 1, 3 and 5 minutes after intubation. Method of measurement: Cardiovascular monitoring device.</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>Oroumia University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-06-19</approval_date>
        <contact_name>Ethics Committee of Urmia University of Medical Sciences</contact_name>
        <contact_address>Urmia University of Medical Sciences, Resalat Street, Jahad Ave., Urmia, Iran Urmia West Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
