<?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>IRCT2016011225982N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-01-25</date_registration>
      <primary_sponsor>Ahvaz Jundishapur University of Medical Sciences</primary_sponsor>
      <public_title>Comparison between clonidine and  Dexmedetomidine as premedication on hemodynamic changes and intraoperative bleeding</public_title>
      <acronym></acronym>
      <scientific_title>Comparison between clonidine and  Dexmedetomidine as premedication on hemodynamic changes and intraoperative bleeding in spine surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/21661</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Bleeding. Condition 2: Hemodynamic Changes.</hc_freetext>
      <i_freetext>Intervention 1: The first group intervention: clonidine 0.2 mg tablets 45 minutes before induction of anesthesia and saline infusion as a placebo to 100 ml 15 minutes before induction of anesthesia. Intervention 2: The second group intervention: placebo tablets and infusion Dexmedetomidine 0.5 micrograms per kg in 100 mL normal saline 15 minutes before induction of anesthesia to continue the infusion of 0.25 mg per kg per hour, pump the syringe 20 mL with a concentration of 5 mg/ cc. Intervention 3: Control group: placebo tablets with 100 mL of normal saline infusion took 15 minutes before induction of anesthesia.</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>Mahshid Vaziri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan Blvd., Ahvaz Golestan hospita-Generall operating room</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 61 3221 6504</telephone>
        <email>vaziri.m@ajums.ac.ir</email>
        <affiliation>Ahvaz Jundishapur University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farahzad Janatmakan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan Blvd., Ahvaz Golestan hospital-General operating room</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>00</telephone>
        <email>Fjanatmakan@yahoo.com</email>
        <affiliation>Ahvaz Jundishapur University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria were as follows: age range of 20 to 50 years, ASA class 1 or 2 and spine surgery candidates. Exclusion criteria included patients with hypertension, diabetes, clotting problems, ischemic heart disease, drug or alcohol abuse, pregnancy, taking beta blockers or calcium channels blockers drugs and operating time of over 120 minutes.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T81</hc_code>
      <hc_code>R00.0, R00</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Complications of procedures, not elsewhere classified</hc_keyword>
      <hc_keyword>Tachycardia (unspecified), Bradycardia (unspecified), Palpitations</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The first group intervention: clonidine 0.2 mg tablets 45 minutes before induction of anesthesia and saline infusion as a placebo to 100 ml 15 minutes before induction of anesthesia</i_keyword>
      <i_keyword>The second group intervention: placebo tablets and infusion Dexmedetomidine 0.5 micrograms per kg in 100 mL normal saline 15 minutes before induction of anesthesia to continue the infusion of 0.25 mg per kg per hour, pump the syringe 20 mL with a concentration of 5 mg/ cc</i_keyword>
      <i_keyword>Control group: placebo tablets with 100 mL of normal saline infusion took 15 minutes before induction of anesthesia</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Intraoperative bleeding. Timepoint: Ending surgery. Method of measurement: Including suction bottle and blood gauzes.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Heart Rate. Timepoint: One minute after intubation, 10, 20, 30 minutes after induction of anesthesia and after extubation. Method of measurement: ECG Monitoring.</sec_outcome>
      <sec_outcome>Blood Pressure. Timepoint: One minute after intubation, 10, 20, 30 minutes after induction of anesthesia and after extubation. Method of measurement: Invasive blood pressure monitoring.</sec_outcome>
      <sec_outcome>Mean Arterial Pressure. Timepoint: One minute after intubation, 10, 20, 30 minutes after induction of anesthesia and after extubation. Method of measurement: Invasive blood pressure monitoring.</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>Ahvaz Jundishapur University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-11-21</approval_date>
        <contact_name>Ahvaz Jundishapur University of Medical Sciences</contact_name>
        <contact_address>Golestan Blvd., Ahvaz, Khuzestan Ahvaz University of Medical Sciences Ethics Committee Ahvaz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
