<?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>IRCT20191110045388N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-04-29</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of different doses of bolus dexmedetomidine to create controlled hypotension and the incidence of bradycardia in rhinoplasty surgery.</public_title>
      <acronym></acronym>
      <scientific_title>The effect of different doses of bolus dexmedetomidine to create controlled hypotension and the incidence of bradycardia in rhinoplasty surgery.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-09-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/47388</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Balanced block randomization.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Rhinoplasty.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the first group, dexmedetomidine is injected at a dose of 1 µ/kg  within 10 minutes after induction of anesthesia according to the required standards.  Dexmedetomidine infusion (µ/kg/h 6/0-3/0) is then used to control blood pressure during surgery.  The drug is injected slowly for ten minutes once in the first stage and is used in the second stage during surgery with continuous infusion. Dexmedetomidine is manufactured by Exir Iran Pharmaceutical Company and Vial 200 micrograms per 2 ml is used. Intervention 2: Intervention group:In the second group, dexmedetomidine is injected at a dose of 9/0 µ/kg within 10 minutes after induction of anesthesia according to the required standards.  Dexmedetomidine infusion (µ/kg/h 6/0-3/0) is then used to control blood pressure during surgery.  The drug is injected slowly for ten minutes once in the first stage and is used in the second stage during surgery with continuous infusion. Dexmedetomidine is manufactured by Exir Iran Pharmaceutical Company and Vial 200 micrograms per 2 ml is used. Intervention 3: Intervention group: In the third group, dexmedetomidine is injected at a dose of 8/0 µ/kg  within 10 minutes after induction of anesthesia according to the required standards.  Dexmedetomidine infusion (µ/kg/h 6/0-3/0) is then used to control blood pressure during surgery.  The drug is injected slowly for ten minutes once in the first stage and is used in the second stage during surgery with continuous infusion. Dexmedetomidine is manufactured by Exir Iran Pharmaceutical Company and Vial 200 micrograms per 2 ml is used.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Soudabeh Djalali Motlagh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit G3, No.1 South 2nd St. Saadat Abad Ave</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1433933111</zip>
        <telephone>+98 21 8214 1360</telephone>
        <email>djalalimotlagh@icloud.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sara Saadat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit G3, No.1 South 2nd St. Saadat Abad Ave.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1433933111</zip>
        <telephone>+98 21 8214 1360</telephone>
        <email>Sara_saadat_8@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with ASA1 and ASA2 Anesthesia score.
The average age  between 18 and 50 years.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patient dissatisfaction with participating in the study
Not having blood pressure</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J34</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other and unspecified disorders of nose and nasal sinuses</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: In the first group, dexmedetomidine is injected at a dose of 1 µ/kg  within 10 minutes after induction of anesthesia according to the required standards.  Dexmedetomidine infusion (µ/kg/h 6/0-3/0) is then used to control blood pressure during surgery.  The drug is injected slowly for ten minutes once in the first stage and is used in the second stage during surgery with continuous infusion. Dexmedetomidine is manufactured by Exir Iran Pharmaceutical Company and Vial 200 micrograms per 2 ml is used.</i_keyword>
      <i_keyword>Intervention group:In the second group, dexmedetomidine is injected at a dose of 9/0 µ/kg within 10 minutes after induction of anesthesia according to the required standards.  Dexmedetomidine infusion (µ/kg/h 6/0-3/0) is then used to control blood pressure during surgery.  The drug is injected slowly for ten minutes once in the first stage and is used in the second stage during surgery with continuous infusion. Dexmedetomidine is manufactured by Exir Iran Pharmaceutical Company and Vial 200 micrograms per 2 ml is used.</i_keyword>
      <i_keyword>Intervention group: In the third group, dexmedetomidine is injected at a dose of 8/0 µ/kg  within 10 minutes after induction of anesthesia according to the required standards.  Dexmedetomidine infusion (µ/kg/h 6/0-3/0) is then used to control blood pressure during surgery.  The drug is injected slowly for ten minutes once in the first stage and is used in the second stage during surgery with continuous infusion. Dexmedetomidine is manufactured by Exir Iran Pharmaceutical Company and Vial 200 micrograms per 2 ml is used.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Blood pressure. Timepoint: During Surgery. Method of measurement: Barometer.</prim_outcome>
      <prim_outcome>Heart Rate. Timepoint: During Surgery. Method of measurement: Pulse Oximeter.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Bleeding during surgery. Timepoint: During Surgery. Method of measurement: Blood volume measurement.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-09-09</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Iran University of Medical Sciences., Hemmat Highway., Next to Milad Tower., Tehran Town Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
