<?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>IRCT20221218056854N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-01-23</date_registration>
      <primary_sponsor>Ilam University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the mean effect of Remifentanil, Methadone, and Sufentanil on Pain and Delirium in Patients with spinal surgery</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the mean effect of Remifentanil, Methadone, and Sufentanil on Pain and Delirium in Patients with spinal surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67506</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Blinding description: The Patients with Spinal Surgery whom are entering the study are divided to three groups and receive Remifentanil, Sufentanil and Methadone randomly and they aren't aware of which kind of drugs they receive and the other Patients Information(are blinded).</study_design>
      <phase>3</phase>
      <hc_freetext>multiple fractures of spine, level unspecified.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: patients with spinal surgery whom received Remifentanil Infusion as Remifentanil Hydrochloride I.V. 1mg, sold under the brand name EPAXIR, Exir Pharmaceutical Co. with Dosage: 0.05 to 2 μg/kg Injected at the surgery time and 30 minutes after anesthesia. Intervention 2: Intervention group: patients with spinal surgery whom received Sufentanil Infusion as Sufentanil Citrate I.V. 50μg sold under the brand name SUFIJECT, Aburaihan Pharmaceutical Co. with Dosage: 2.5 to 15 μg/kg Injected at the surgery time and 30 minutes after anesthesia. Intervention 3: Intervention group: patients with spinal surgery whom received Methadone Infusion as Methadone Hydrochloride I.V. 5mg/ml sold under the brand name Methadone, Darou Pakhsh Pharmaceutical Co. with Dosage: 20mg Injected at the surgery time and 30 minutes after 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>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 No Further Information Available</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hamidreza Zanji</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 1,Yas Building 4th Floor, Golha Sq, Ilam</address>
        <city>Ilam</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6931371549</zip>
        <telephone>+98 84 3422 4443</telephone>
        <email>hamidzanji1997@gmail.com</email>
        <affiliation>Ilam University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Lida Nouri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 13, Modares St, Modares Blvd, Ilam, IR</address>
        <city>Ilam</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6931975397</zip>
        <telephone>+98 84 3333 1933</telephone>
        <email>nouri-l@medilam.ac.ir</email>
        <affiliation>Ilam University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with spinal surgery taking Remifentanil
Patients with spinal surgery taking Sufentanil
Patients with spinal surgery taking Methadone</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with Psychological History
Patients with History of Drug Addiction
Patients with History of Allergic Reaction to Drugs
Patients with History of Diabetes
Patients with History of Kidney Disease</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T08</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Fracture of spine, level unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: patients with spinal surgery whom received Remifentanil Infusion as Remifentanil Hydrochloride I.V. 1mg, sold under the brand name EPAXIR, Exir Pharmaceutical Co. with Dosage: 0.05 to 2 μg/kg Injected at the surgery time and 30 minutes after anesthesia</i_keyword>
      <i_keyword>Intervention group: patients with spinal surgery whom received Sufentanil Infusion as Sufentanil Citrate I.V. 50μg sold under the brand name SUFIJECT, Aburaihan Pharmaceutical Co. with Dosage: 2.5 to 15 μg/kg Injected at the surgery time and 30 minutes after anesthesia</i_keyword>
      <i_keyword>Intervention group: patients with spinal surgery whom received Methadone Infusion as Methadone Hydrochloride I.V. 5mg/ml sold under the brand name Methadone, Darou Pakhsh Pharmaceutical Co. with Dosage: 20mg Injected at the surgery time and 30 minutes after anesthesia</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Delirium Severity and Duration. Timepoint: After Spinal Surgery, 6, 12, and 24 Hours After Surgery. Method of measurement: Physical Examination.</prim_outcome>
      <prim_outcome>Four Main Delirium Features. Timepoint: After Spinal Surgery, 6, 12 and 24 Hours After Surgery. Method of measurement: CAM-ICU(Confusion Assessment Method for the Intensive Care Unit) Questionnaire.</prim_outcome>
      <prim_outcome>Pain Intensity Score. Timepoint: After Spinal Surgery, 6, 12 and 24 Hours After Surgery. Method of measurement: Visual Analog Scale.</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>Ilam University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-11-14</approval_date>
        <contact_name>Ethics committee of Ilam University of Medical Sciences</contact_name>
        <contact_address>Yas building 4th floor. Golha Sq. Ilam. IR Iran Ilam Ilam Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
