<?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>IRCT20180903040936N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-09-02</date_registration>
      <primary_sponsor>Arak University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the Effect of Dexmedetomidine, Remifentanil and Metoral on Reducing Bleeding and Surgery Satisfaction During Rhinoplasty</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effect of Dexmedetomidine, Remifentanil and Metoral on Reducing Bleeding and Surgery Satisfaction During Rhinoplasty</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-08-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>75</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40751</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: This study is a double-blind randomized clinical trial of patients undergoing rhinoplasty in the Amir Kabir hospital of Arak. A sample of 75 patients with a candidate rhinoplasty that has been studied by a cardiologist and selected by a cardiologist is selected and divided into three randomly assigned randomized complete sets randomly divided into three groups: Remifentanil, Metoral, and Dexmedetomidine, Blinding description: The drugs required for infusion are prepared for anesthetist by the anesthetist and in each of the 3 groups 50 cc syringes are provided with a similar appearance to the partner in order to provide infusion to the patients. also intern responsible for the plan who is responsible for completing the questionnaire, is not aware of the type of study group. Syringes containing infusion solutions are placed on the A, B, and C adhesives for the patients, provided with a syringe A, B and C.</study_design>
      <phase>3</phase>
      <hc_freetext>Comparison of the Effect of Dexmedetomidine, Remifentanil and Metoral on Reducing Bleeding and Surgery Satisfaction During Rhinoplasty.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: After the anesthetic induction, the patients are examined and placed under the ventilator, then they are done and ready for rhinoplasty. Then, for patients in the first group, 0.5 mg / kg / h will be dosed as Dexmedetomidin infusion. Intervention 2: Intervention group: Intervention group: After the anesthetic induction, the patients are examined and placed under the ventilator, then they are done and ready for rhinoplasty. Then, for patients in the first group, 50-100µ / kg /h  will be dosed as Remifentanil infusion. Intervention 3: Intervention group:  Intervention group: After the anesthetic induction, the patients are examined and placed under the ventilator, then they are done and ready for rhinoplasty. Then, for patients in the first group, 50 mg will be dosed as Metoral infusion.</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Narges Anousheh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ashrafi Esfahani Highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1476985574</zip>
        <telephone>+98 21444976300</telephone>
        <email>www.nargesanousheh1994@gmail.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Narges Anousheh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ashrafi Esfahani Highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1476985574</zip>
        <telephone>+98 21444976300</telephone>
        <email>www.nargesanousheh1994@gmail.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All patients with Rhinoplasty who referred to Amir Kabir Hospital in Arak
Patients aged 18 to 50 years</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients who have had a specific heart attack or even a heart attack during the operation
Patients who are unable to get metroral due to early bradycardia.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I95.2:</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Hypotension due to drugs</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: After the anesthetic induction, the patients are examined and placed under the ventilator, then they are done and ready for rhinoplasty. Then, for patients in the first group, 0.5 mg / kg / h will be dosed as Dexmedetomidin infusion.</i_keyword>
      <i_keyword>Intervention group: Intervention group: After the anesthetic induction, the patients are examined and placed under the ventilator, then they are done and ready for rhinoplasty. Then, for patients in the first group, 50-100µ / kg /h  will be dosed as Remifentanil infusion</i_keyword>
      <i_keyword>Intervention group:  Intervention group: After the anesthetic induction, the patients are examined and placed under the ventilator, then they are done and ready for rhinoplasty. Then, for patients in the first group, 50 mg will be dosed as Metoral infusion.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Average MAP of patients. Timepoint: Immediately, 5 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 75 minutes, 90 minutes and 2 hours after anesthesia. Method of measurement: Mercury and digital pressure gauge device.</prim_outcome>
      <prim_outcome>Average heart rate of patients. Timepoint: Immediately, 5 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 75 minutes, 90 minutes and 2 hours after anesthesia. Method of measurement: Cardiac monitoring.</prim_outcome>
      <prim_outcome>Average scour of bleeding during surgery. Timepoint: During surgery. Method of measurement: By check list and according to the amount of gas used to prevent bleeding.</prim_outcome>
      <prim_outcome>Surgeon Satisfaction. Timepoint: After the completion of surgery. Method of measurement: Based on checklist.</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>Arak University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-05-05</approval_date>
        <contact_name>Ethics committee of Arak University of Medical Sciences</contact_name>
        <contact_address>Arak University of Medical Sciences,next to Amiralmomenin Hospital, Basij Square,Sardasht Arak Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
