<?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>IRCT2014121020272N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-08-24</date_registration>
      <primary_sponsor>Deputy for research Zahedan University of Medical Sciences</primary_sponsor>
      <public_title>Effect of pregabalin on hemodynamic on pain</public_title>
      <acronym></acronym>
      <scientific_title>Effect of a single dose of Pregabalin on intraoperative hemodynamic  changes  and duration of  analgesia in spinal anesthesia  for tibial bone fracture orthopedic surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-03-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/18012</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>4</phase>
      <hc_freetext>Spinal anesthesia.</hc_freetext>
      <i_freetext>Intervention 1: pregabalin group (150 mg capsule): because of 150 mg capsules it's not available on the market of Iran that is given  two 75 mg capsules instead. A hour before spinal anesthesia is used by nurses in the orthopedic unite, who was not aware of drugs the patient is given effect by comparison with the placebo group on the dependent variables arterial medium voltage, pulse duration of analgesia after spinal anesthesia are considered. Intervention 2: placebo  group (Appearance, but no active ingredient drug capsules ). A hour before spinal anesthesia is used by nurses in the orthopedic unite, who was not aware of drugs the patient is given effect by comparison with the placebo group on the dependent variables arterial medium voltage, pulse duration of analgesia after spinal anesthesia are considered.</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>Amir Moosavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Khatam Hospital, Jame Jam Boulevard</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9815733169</zip>
        <telephone>+98 54 3322 0501</telephone>
        <email>amir.moosavi@zaums.ac.ir</email>
        <affiliation>Zahedan  University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Alireza Rahat Dahmardeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Khatam Hospital, Jame Jam Boulevard</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9815733169</zip>
        <telephone>+98 915 542 0911</telephone>
        <email>Dr.dahmardeh@gmail.com</email>
        <affiliation>Zahedan Medical Science Univesity</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:&#13;
 The non-emergency patients ASA class 1;  Age 20 to 70 years;  candidates for orthopedic surgery tibia fracture; the prior written consent from patient; social class and level of consciousness  that  patient is able to cooperate ;&#13;
   Exclusion criteria were the beginning of the study:&#13;
 hemodynamic status is affected with diseases or conditions such as heart disease, diabetes, renal ;The history of allergy to gabapentin or Pregabalin,  drug use, regular use of alcohol or smoking more than 5 years,  the diseases of the brain and nerves ;  spinal anesthesia during surgery after more than ninety minutes  ; patients who require drugs that affect hemodynamic  ; pregnancy ; refusal of doing research and refusal of  spinal anesthesia patients ;  patients with coagulopathy ;  infection in site of the spinal anesthesia  ; any interference with the absorption of oral drugs that can cause digestive disorders  ; The disease affects the feeling of pain, such as diabetes, drug addiction  ; Monitor the patient is indicative of Abnormal pulse , mean arteria  presure  ; The need for analgesics for pain relief&#13;
     Exclusion criteria during the study:&#13;
  Abnormal bleeding during surgery ;  Intraoperative cardiovascular and brain complications ;  Monitor the patient is indicative of abnormal pulse,  mean arterial pressure.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T88.7</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Unspecified adverse effect of drug or medicament</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>pregabalin group (150 mg capsule): because of 150 mg capsules it's not available on the market of Iran that is given  two 75 mg capsules instead. A hour before spinal anesthesia is used by nurses in the orthopedic unite, who was not aware of drugs the patient is given effect by comparison with the placebo group on the dependent variables arterial medium voltage, pulse duration of analgesia after spinal anesthesia are considered.</i_keyword>
      <i_keyword>placebo  group (Appearance, but no active ingredient drug capsules ). A hour before spinal anesthesia is used by nurses in the orthopedic unite, who was not aware of drugs the patient is given effect by comparison with the placebo group on the dependent variables arterial medium voltage, pulse duration of analgesia after spinal anesthesia are considered.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mean arterial pressure؛ pulse. Timepoint: Thirty minutes before feeding capsules every ten minutes. Every ten minutes after spinal anesthesia to complete the surgery. Method of measurement: Monitoring of vital signs.</prim_outcome>
      <prim_outcome>Duration of analgesia in spinal anesthesia. Timepoint: After the onset of anelgesia by spinal anesthesia Until the onset of pain. Method of measurement: Timer(minute).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>No exist. Timepoint: No exist. Method of measurement: No exist.</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>Deputy for research Zahedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-09-28</approval_date>
        <contact_name>Zahedan University of Medical Sciences</contact_name>
        <contact_address>Doctor Hesab square Zahedan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
