<?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>IRCT20230816059159N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-10-01</date_registration>
      <primary_sponsor>Hamedan University of Medical Sciences</primary_sponsor>
      <public_title>combined effect of dexmedetomidine and tranexamic acid  in nasal surgery.</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the combined effect of dexmedetomidine and tranexamic acid on bleeding and surgeon satisfaction in nasal surgery.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>102</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72099</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: The people under study will be assigned to three intervention groups using the random number generation software. In this way, first, a random table is designed using Microsoft Excel software for the number of samples (102 samples). Numbers 1 to 34 are assigned to the tranexamic acid group, numbers 35 to 68 to the dexmethomedin group, and numbers 69 to 102 to the combined group. Patients are divided into groups in the order they enter the study using a random table. study, Blinding description: Medications are prepared in uniform syringes by the researcher and provided to the clinical caregiver. The clinical caregiver does not know which patient is receiving which drug. The evaluator also does not know which insurance company received which medicine.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Bleeding rate in nasal candidate patients.</hc_freetext>
      <i_freetext>Intervention 1: Combined injection of dexmethomadine (Made by Arang drug therapy Pharmaceutical Company) and ternaxamic acid (Made by Caspian Pharmaceutical Company) in the prevention of bleeding in patients who are candidates for nose surgery. after the start of general anesthesia, tranexamic acid will prescribe at a dose of 10 mg per kilogram of body weight at a rate of 100 mg per minute. prevention of bleeding in patients who are candidates for nose surgery, dexmedetomidine will prescribe 0.1 micrograms per kilogram of body weight within 10 minutes and then 0.5 micrograms per kilogram of body weight is prescribed within an hour. These drugs are prescribed intravenously. Intervention 2: Injection of dexmedetomidine (Made by Arang drug therapy Pharmaceutical Company) in the prevention of bleeding in patients who are candidates for nose surgery, dexmedetomidine will prescribe 0.1 micrograms per kilogram of body weight within 10 minutes and then 0.5 micrograms per kilogram of body weight is prescribed within an hour. and during the surgery, this drug is injected intravenously.  the patient's bleeding rate and the surgeon's satisfaction are checked. Intervention 3: Injection of ternaxamic acid (Made by Caspian Pharmaceutical Company) in the prevention of bleeding in patients who are candidates for nose surgery. At the beginning of the surgery, this drug is injected intravenously to the patient in one step, after the start of general anesthesia, tranexamic acid will prescribe at a dose of 10 mg per kilogram of body weight at a rate of 100 mg per minute. and during the surgery, the patient's bleeding rate and the surgeon's satisfaction are checked.</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:
This information is made available after de-identifying individuals and includes information that reports the main outcomes of the plan.

When:
Access starts from 2031

To whom:
The access of anesthesia department instructors is allowed

Conditions:
The use of data in the way of patient control is unimpeded, its use in the context of review studies is allowed. The data can be used in review studies. In this field, university professors and educational researchers can receive documents by presenting them.

Where to obtain:
You can access the data by referring to Hamedan University of Medical Sciences, Faculty of Paramedicine, Department of Intelligence, Room 4 or by sending an email to the mentioned address. 
bk13472000@yahoo.com

How to obtain:
By sending an email to Behrouz karkhanei and stating the reason for the request, he can use or access the data with an acceptable and effective reason for the education and care of patients.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Behroz Karkhanei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Fahmida St, Hamadan University of Medical Sciences</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517838667</zip>
        <telephone>008138381014</telephone>
        <email>bk13472000@yahoo.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Behroz Karkhanei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Fahmida St, Hamadan University of Medical Sciences</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517838765</zip>
        <telephone>+98 81 3838 1014</telephone>
        <email>bk13472000@yahoo.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The patient is a candidate for nasal surgery
The patient must be at least 18 years old
The patient has informed consent</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The patient has a history of heart disease
The patient has a history of seizures
The patient has a history of hypertension</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>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Combined injection of dexmethomadine (Made by Arang drug therapy Pharmaceutical Company) and ternaxamic acid (Made by Caspian Pharmaceutical Company) in the prevention of bleeding in patients who are candidates for nose surgery. after the start of general anesthesia, tranexamic acid will prescribe at a dose of 10 mg per kilogram of body weight at a rate of 100 mg per minute. prevention of bleeding in patients who are candidates for nose surgery, dexmedetomidine will prescribe 0.1 micrograms per kilogram of body weight within 10 minutes and then 0.5 micrograms per kilogram of body weight is prescribed within an hour. These drugs are prescribed intravenously.</i_keyword>
      <i_keyword>Injection of dexmedetomidine (Made by Arang drug therapy Pharmaceutical Company) in the prevention of bleeding in patients who are candidates for nose surgery, dexmedetomidine will prescribe 0.1 micrograms per kilogram of body weight within 10 minutes and then 0.5 micrograms per kilogram of body weight is prescribed within an hour. and during the surgery, this drug is injected intravenously.  the patient's bleeding rate and the surgeon's satisfaction are checked.</i_keyword>
      <i_keyword>Injection of ternaxamic acid (Made by Caspian Pharmaceutical Company) in the prevention of bleeding in patients who are candidates for nose surgery. At the beginning of the surgery, this drug is injected intravenously to the patient in one step, after the start of general anesthesia, tranexamic acid will prescribe at a dose of 10 mg per kilogram of body weight at a rate of 100 mg per minute. and during the surgery, the patient's bleeding rate and the surgeon's satisfaction are checked.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Surgery bleeding. Timepoint: Bleeding measurement time: before drug injection, after drug injection every 15 minutes until the end of surgery. Method of measurement: Volume of blood suctioned in cubic centimeters.</prim_outcome>
      <prim_outcome>Surgeon satisfaction. Timepoint: before drug injection, after drug injection every 15 minutes until the end of surgery. Method of measurement: The surgeon's satisfaction is evaluated based on a four-point classification.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The patient's blood pressure. Timepoint: Every 15 minutes after drug injection until the end of surgery. Method of measurement: sphygmomanometer.</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>Hamedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-05-24</approval_date>
        <contact_name>Ethics committee of Hamedan University of Medical Sciences</contact_name>
        <contact_address>Hamedan University of Medical Sciences, Shahid Fahmideh St, Hamedan Hamedan Hamadan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
