<?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>IRCT20240207060924N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-02-17</date_registration>
      <primary_sponsor>Arak University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Propofol in coronary bypass surgery</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of outcomes between Propofol and Dexmedetomidine on extubation time and vital signs in patients with post- coronary artery bypass grafting in Open heart Intensive Care Unit</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>92</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/75364</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, we will randomly divide 92 patients into two equal groups (P) and (D) using random block method.
The randomization unit will be done individually and we will use statistical software as a tool.
All statistical combinations that these two groups can have will be written. These combinations will include PPDD, PDDP, PDPD, DDPP, DPDP, DPPD. Now, using these combinations, the observations are placed into two intervention groups.
Note that the intervention groups are chosen blindly, Blinding description: The aforementioned study is a double-blind study in which patients who meet the inclusion criteria and provide informed consent are assigned to one of two groups receiving Propofol (P) or Dexmedetomidine (D).
Patients are randomized into groups (P) and (D) by the anesthesiologist and are unaware of which group they are in.
In addition, the intern in charge of the project does not know the names of the groups.
After the patients wake up and become conscious and are extubated while the sedative infusion is stopped, the student in charge of the project will be present in the ward to fill in the questionnaires, so he will not know about the studied groups and will be blinded.</study_design>
      <phase>3</phase>
      <hc_freetext>Comparison of Outcomes Between Propofol and Dexmedetomidine in Post-Coronary Artery Bypass Graft Patients.</hc_freetext>
      <i_freetext>Intervention 1: First intervention group: (P) that we infuse 10 cc per hour (10 cc/hr) for 4 to 6 hours from a vial of propofol 10% (manufactured by B. Braun, Germany). Intervention 2: Second intervention group: (D) In the Dexmedetomidine group, the syringe pump is filled to a volume of 50 cc and Dexmedetomidine is infused at a dose of 20 µ/hour (manufactured by Elixir Lorestan, Iran) for 4 to 6 hours.</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 I have not decided yet</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Taha Rafiei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of medicine, Basij square, Sardasht</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3819693345</zip>
        <telephone>+98 86 3313 3147</telephone>
        <email>taharafiei@yahoo.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Alireza Kamali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of medicine, Basij square, Sardasht</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3819693345</zip>
        <telephone>+98 86 3313 6055</telephone>
        <email>alikamaliir@yahoo.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having informed consent
Patients must meet inclusion criteria, i.e. be elective and referred for open heart surgery only
Age should be between 35 and 80 years old
Performed by the same surgeon
The maximum duration of the surgery must be 6 hours
All were operated with a cardiopulmonary pump
Valve surgery should not be performed at the same time as CABG</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patient is not a candidate for elective CABG surgery
Duration of surgery is more than 6 hours
Patients have not had surgery outside of the cardiopulmonary pump
Patients outside the 35-80 age range
The patient has the right to withdraw at any stage of the research</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></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>First intervention group: (P) that we infuse 10 cc per hour (10 cc/hr) for 4 to 6 hours from a vial of propofol 10% (manufactured by B. Braun, Germany).</i_keyword>
      <i_keyword>Second intervention group: (D) In the Dexmedetomidine group, the syringe pump is filled to a volume of 50 cc and Dexmedetomidine is infused at a dose of 20 µ/hour (manufactured by Elixir Lorestan, Iran) for 4 to 6 hours.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mean arterial blood pressure. Timepoint: Measurement of mean arterial blood pressure at 5, 15, 30, 45, 60, 90, 120, 150 minutes after entering the ward. Method of measurement: Pulse Oximeter.</prim_outcome>
      <prim_outcome>Pulse rate. Timepoint: Measurement of pulse rate at 5, 15, 30, 45, 60, 90, 120, 150 minutes after entering the ward. Method of measurement: Pulse Oximeter.</prim_outcome>
      <prim_outcome>Oxygen saturation. Timepoint: Measurement of Oxygen saturation at 5, 15, 30, 45, 60, 90, 120, 150 minutes after entering the ward. Method of measurement: Pulse Oximeter.</prim_outcome>
      <prim_outcome>Extubation time. Timepoint: The duration of extubation from the time of admission to the Open Heart Intensive Care Unit. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Length of stay in the Unit. Timepoint: The duration of the stay in the Intensive Care Unit of the Open Heart surgery after the operation. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Length of hospitalization. Timepoint: The duration of the stay in the hospital. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Ramsay Score. Timepoint: Measurement of Ramsay score at 5, 15, 30, 45, 60, 90, 120, 150 minutes after admission to the unit. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Mortality. Timepoint: Measurement of the number of mortality events in the study population. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Age. Timepoint: Registration of patient age. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Sex. Timepoint: Registration of patient sex. Method of measurement: Questionnaire.</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>Arak University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-02-07</approval_date>
        <contact_name>Ethics committee of Arak University of Medical Sciences</contact_name>
        <contact_address>Basij square, sardasht, Arak university of medical science Arak Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
