<?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>IRCT20210928052617N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-11-07</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Evaluation of the effect of fentanyl and morphine on hemodynamic changes during abdominal surgery</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effect of fentanyl and morphine on hemodynamic changes during abdominal surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/59016</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: 36 patients who are candidates for abdominal surgery referred to Amir Al-Momenin Hospital in Tehran during the years 1399-1400 are available to study
 Each person is randomly assigned to one of two groups
The randomization method is simple and individual randomization unit
The tool used in randomization is Excel software, Blinding description: Both groups participating in the clinical trial (morphine group and fentanyl group) enter the trial randomly.
The drugs are taken in two syringes and equal volumes, and in the form of a score of 1, 2, or a and b, which the collector does not know, as well as the surgeon and the patient, so he is both blind.</study_design>
      <phase>3</phase>
      <hc_freetext>Condition 1: pulse rate changes. Condition 2: respiratory rate changes. Condition 3: blood pressure changes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: After establishing a proper venous route and complete monitoring, anesthesia is induced by injection of 2 mimidazolam, 3 cc of fentanyl, thiopental and atracurium, and then 1 cc of fentanyl is injected every hour and hemodynamic changes are measured.Community Verified icon. Intervention 2: Control group: After establishing a proper venous route and complete monitoring, anesthesia is induced by injection of 2 mimidazolam, 3 cc of fentanyl, thiopental and atracurium, and then 2 mg of morphine is injected every hour and hemodynamic changes are measured.Community Verified icon.</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 more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahtab Barkhabeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No4, 6 west boostan,35 laleh Ave,Marzdaran blvd,Tehran town</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1461776195</zip>
        <telephone>+98 21 4426 4451</telephone>
        <email>mahtabbarkhabeh@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahtab Barkhabeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No4, 6west boostan,35 laleh,Marzdaran blvd,Tehran town</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1461776195</zip>
        <telephone>+98 21 4426 4451</telephone>
        <email>mahtabbarkhabeh@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>complete identity profile
age 18 years and higher
candidates for abdominal surgery</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>psychiatric drug users
opioid drug addict
cardio vascular disease, hypertension</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R00</hc_code>
      <hc_code>R09</hc_code>
      <hc_code>R03</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Abnormalities of heart beat</hc_keyword>
      <hc_keyword>Other symptoms and signs involving the circulatory and respiratory system</hc_keyword>
      <hc_keyword>Abnormal blood-pressure reading, without diagnosis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: After establishing a proper venous route and complete monitoring, anesthesia is induced by injection of 2 mimidazolam, 3 cc of fentanyl, thiopental and atracurium, and then 1 cc of fentanyl is injected every hour and hemodynamic changes are measured.Community Verified icon</i_keyword>
      <i_keyword>Control group: After establishing a proper venous route and complete monitoring, anesthesia is induced by injection of 2 mimidazolam, 3 cc of fentanyl, thiopental and atracurium, and then 2 mg of morphine is injected every hour and hemodynamic changes are measured.Community Verified icon</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Blood pressure changes. Timepoint: Evaluation of blood pressure changes in the first 10 minutes after induction of anesthesia and then the average changes per hour of operation and recoveryCommunity Verified icon. Method of measurement: vital sign monitoring.</prim_outcome>
      <prim_outcome>Pulse rate. Timepoint: Evaluation of pulse rate changes in the first 10 minutes after induction of anesthesia and then the average changes per hour of operation and recoveryCommunity Verified icon. Method of measurement: vital sign monitoring.</prim_outcome>
      <prim_outcome>Respiratory rate. Timepoint: Evaluation of respiratory rate changes in the first 10 minutes after induction of anesthesia and then the average changes per hour of operation and recoveryCommunity Verified icon. Method of measurement: vital sign monitoring.</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>Islamic Azad University of Tehran, Medical branch</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-04-27</approval_date>
        <contact_name>Research Ethics Committees of Tehran Islamic Azad University Of Medical Sciences</contact_name>
        <contact_address>No4, 6 west boostan alley, 35 lale Ave, Marzdaran Blvd, Tehran town Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
