<?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>IRCT2016101630327N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-11-30</date_registration>
      <primary_sponsor>Kermanshah University of Medical Sciences</primary_sponsor>
      <public_title>The effect of an anesthetic combination drug containing Propofol-Remifentanil-Daxmedetomidine on blood pressure and heart rate and postoperative complications in spine and spinal cord surgery.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison the effect of combination of Propofol-Remifentanil-Dexmedetomidine on hemodynamic parameters and postoperative complications in spine  and spinal cord surgery.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-03-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/24131</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>effect of drug.</hc_freetext>
      <i_freetext>Intervention 1: 15 minutes before time of induction, Daxmedetomidine 0.6mic / kg / h and remifentanil 1mic/Kg/min are infused, at the time of induction Propofol 1-2.5 mg/Kg and neuromuscular blocking drug (Cisatracurium) 0.15 mg/Kg are injected and patient are intubated. Intervention 2: 15 minutes before time of induction, Remifentanil 1mic/Kg/min is infused, at the time of induction Propofol 1-2.5 mg/Kg and neuromuscular blocking drug (Cisatracurium) 0.15 mg/Kg are injected and patient are intubated.</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>Mohammad Javad Moradi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Beheshti Blvd., Kermanshah University of Medical Sciences headquarters</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6714415333</zip>
        <telephone>+98 83 3427 6308</telephone>
        <email>m_javad1550@yahoo.com</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Khosro Farhadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kermanshah University of Medical Sciences</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6714415333</zip>
        <telephone>+98 83 3427 6308</telephone>
        <email>kh_farhady@yahoo.com</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: patients undergoing spine surgery and spinal referring to Imam Reza Kermanshah American Society of Anesthesiologists class (I-II). Exclusion criteria: patients with a history of severe systemic disease; body mass index greater than 30; patients with a history of high blood pressure (Blood Pressure greater than 140/90); severe respiratory diseases does not control; symptomatic heart disease; diabetic patients; consumers beta-blocker drugs; drug-addicted patients; patients with more than one laryngoscopy; the extreme sensitivity to drugs personality disorder; patients with more than 750 cc of blood during surgery.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 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>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>15 minutes before time of induction, Daxmedetomidine 0.6mic / kg / h and remifentanil 1mic/Kg/min are infused, at the time of induction Propofol 1-2.5 mg/Kg and neuromuscular blocking drug (Cisatracurium) 0.15 mg/Kg are injected and patient are intubated.</i_keyword>
      <i_keyword>15 minutes before time of induction, Remifentanil 1mic/Kg/min is infused, at the time of induction Propofol 1-2.5 mg/Kg and neuromuscular blocking drug (Cisatracurium) 0.15 mg/Kg are injected and patient are intubated.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Blood Pressure. Timepoint: 15 minutes before induction, intubation time, two minutes afte intubation, time of change position, and two minutes after the change of position, intraoperative period in minutes of 15,30,45,90, time of repositioning, two minutes after switching position. and before extubation, two, thirty and sixty minutes after extubation. Method of measurement: in mmHg using mercuric manometer.</prim_outcome>
      <prim_outcome>Heart Rate. Timepoint: 15 minutes before induction, intubation time, two minutes afte intubation, time of change position, and two minutes after the change of position, intraoperative period in minutes of 15,30,45,90, time of repositioning, two minutes after switching position. and before extubation, two, thirty and sixty minutes after extubation. Method of measurement: number of heart rate in one minute.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Shivering. Timepoint: Postoperative. Method of measurement: Standard questionnaire.</sec_outcome>
      <sec_outcome>Nausea. Timepoint: Postoperative. Method of measurement: VAS.</sec_outcome>
      <sec_outcome>Vomiting. Timepoint: Postoperative. Method of measurement: VAS.</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>Kermanshah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-06-08</approval_date>
        <contact_name>Kermanshah University of Medical Sciences Ethics Committee</contact_name>
        <contact_address>Beheshti Blvd., Kermanshah University of Medical Sciences headquarters Kermanshah  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
