<?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>IRCT20230805059046N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-09-03</date_registration>
      <primary_sponsor>Qazvin University of Medical Sciences</primary_sponsor>
      <public_title>"Comparison of the effect of Dexmedetomidine + Marcaine with Fentanyl + Marcaine in femur fracture surgery"</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the analgesia effect of Dexmedetomidine with Fentanyl, in combination with Marcaine in femoral neck fracture surgery with spinal anesthesia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>75</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71829</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Blinding description: This is a double-blind type of experiment, which will be blind for the people participating in the study and evaluating the outcome. In the consent form to participate in the study, it is written for the patient that his presence does not necessarily mean intervention but may be included in the control group.</study_design>
      <phase>3</phase>
      <hc_freetext>Femoral neck fracture surgery.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group A: (25 μg/kg Fentanyl from Caspian Tamin Pharmaceutical Company and 2.5 mg/kg Marcaine from Adorateb Pharmaceutical Company). After patients enter the operating room, anesthesia is started with spinal anesthesia, and the anesthesiologist starts prescribing Marcaine-Fentanyl. Intervention 2: Intervention group B: (5μg/kg Dexmedetomidine from Exir Pharmaceutical Company and 2.5mg/kg Marcaine from Adorateb Pharmaceutical Company). After patients enter the operating room, anesthesia is started with spinal anesthesia and the anesthesiologist prescribes Markain-Dexmedetomidine. Intervention 3: Control group: Routine hospital anesthesia method (2.5mg/kg Marcaine from Adorateb Pharmaceutical Company). After patients enter the operating room, anesthesia is started with spinal anesthesia and the anesthesiologist prescribes Markain.</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 Satisfaction of participants</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Paria Talebnezhad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bahonar street</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>34197-58911</zip>
        <telephone>+98 28 3333 6001</telephone>
        <email>Paria.Talebnezhad8898@gmail.com</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>PariaTalebnezhad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University campus building, Bahonar Blvd</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>34197-58911</zip>
        <telephone>+98 28 3333 6001</telephone>
        <email>Paria.Talebnezhad8898@gmail.com</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Willingness to participate in research with informed consent after giving necessary and sufficient explanations about the study
The person's age should be between 45 and 75 years
No history of surgery
No history of smoking, alcohol and drugs
Not having chronic physical or mental illness (schizophrenia, diabetes, etc.)
Not having vision and hearing problems and other disabilities
Not using corticosteroids, antihistamines, narcotics and painkillers for a long time
Lack of allergy to marcaine, fentanyl and dexmedomidine
Absence of pregnancy, breastfeeding and abortion less than 3 months</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Unwillingness to cooperate in the study
Occurrence of any problems and complications during the study
The diagnosis of the surgeon or other specialists to withdraw from the study
Heart diseases and HTN
Liver diseases (cirrhosis, hepatitis, etc.)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S72.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Fracture of head and neck of femur</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 A: (25 μg/kg Fentanyl from Caspian Tamin Pharmaceutical Company and 2.5 mg/kg Marcaine from Adorateb Pharmaceutical Company). After patients enter the operating room, anesthesia is started with spinal anesthesia, and the anesthesiologist starts prescribing Marcaine-Fentanyl.</i_keyword>
      <i_keyword>Intervention group B: (5μg/kg Dexmedetomidine from Exir Pharmaceutical Company and 2.5mg/kg Marcaine from Adorateb Pharmaceutical Company). After patients enter the operating room, anesthesia is started with spinal anesthesia and the anesthesiologist prescribes Markain-Dexmedetomidine.</i_keyword>
      <i_keyword>Control group: Routine hospital anesthesia method (2.5mg/kg Marcaine from Adorateb Pharmaceutical Company). After patients enter the operating room, anesthesia is started with spinal anesthesia and the anesthesiologist prescribes Markain</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The amount and intensity of pain. Timepoint: 3, 6 and 12 hours after the operation. Method of measurement: Using a ruler-like grading system (Visual Analog Scale) from 0 (no pain) to 10 (the most severe pain imaginable).</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>Qazvin University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-03-12</approval_date>
        <contact_name>Ethics committee of qazvin University of Medical Sciences</contact_name>
        <contact_address>Research and Technology deputy ,Mavaddat Alley,Shahid Beheshti Blvd,Qazvin Qazvin Qazvin Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
