<?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>IRCT20200822048478N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-10-04</date_registration>
      <primary_sponsor>Kashan University of Medical Sciences</primary_sponsor>
      <public_title>Continuous infusion of Esmolol in patients undergoing CABG surgery</public_title>
      <acronym></acronym>
      <scientific_title>Comparison study of continuous infusion and bolus of Esmolol on hemodynamic response to laryngoscopy and endotracheal intubation in coronary artery bypass graft patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>66</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/51295</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: We are going to randomize based on Permuted block randomization method. In this way, all 6 groups of 3 groups (20 blocks) are determined and using the random number table, the number of blocks is selected and a sequence of groups A, B and c is determined and each patient is based on the entry number. The plot is placed in one of the groups, Blinding description: After consciously agreeing to participate in the study, patients are randomly assigned to one of three study groups. researchers, evaluators of the outcome, and data Analyzer don't know about which patient is in which One of the treatment groups.</study_design>
      <phase>3</phase>
      <hc_freetext>Coronary artery disease.</hc_freetext>
      <i_freetext>Intervention 1: Infusion group: 0.5 mg/kg Esmolol is injected within 4 minutes and then the infusion is started at 200 μg/kg/min and continues until endotracheal intubation. 0.9% Nacl is administered 2 minutes before endotracheal intubation. Esmolol is manufactured by Claris company, India. Intervention 2: Bolus group: 1.5mg/kg Esmolol is administered as a venous bolus 2 minutes before intubation and 0.9 Nacl% is administered 10 minutes before endotracheal intubation until it. Esmolol is manufactured by Claris company, India. Intervention 3: Control group: 0.9% Nacl infusion and bolus of normal saline are given instead of Esmolol.</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>Hosein Akbari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>5th of Qotb –e Ravandi Blvd. P.O.Box: 8715973449, Kashan, IRAN</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8715973449</zip>
        <telephone>+98 31 5554 0021</telephone>
        <email>akbari1350_h@yahoo.com</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hosein Akbari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>5th of Qotb –e Ravandi Blvd. P.O.Box: 8715973449, Kashan, IRAN</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8715973449</zip>
        <telephone>+98 31 5554 0021</telephone>
        <email>akbari1350_h@yahoo.com</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with ASA 2-4 undergoing elective CABG surgery
EF&gt;40%</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>AV conduction block greater than grade 1
asthma
acute MI
HR&lt;50
Mallampati score greater than 2
Kidney or liver failure
History of allergy or Idiosyncratic reaction to β-blockers
Systolic blood pressure less than 100 mmHg
Diastolic blood pressure less than 50 mmHg</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I25.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Atherosclerotic heart disease of native coronary artery</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>Infusion group: 0.5 mg/kg Esmolol is injected within 4 minutes and then the infusion is started at 200 μg/kg/min and continues until endotracheal intubation. 0.9% Nacl is administered 2 minutes before endotracheal intubation. Esmolol is manufactured by Claris company, India.</i_keyword>
      <i_keyword>Bolus group: 1.5mg/kg Esmolol is administered as a venous bolus 2 minutes before intubation and 0.9 Nacl% is administered 10 minutes before endotracheal intubation until it. Esmolol is manufactured by Claris company, India.</i_keyword>
      <i_keyword>Control group: 0.9% Nacl infusion and bolus of normal saline are given instead of Esmolol.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Heart rate. Timepoint: HR and systolic blood pressure and diastolic blood pressure and mean blood pressure before infusion to induction, during and after induction of anesthesia, at laryngoscopy and endotracheal intubation and every minute for 10 minutes after endotracheal intubation are recorded. Method of measurement: After entering the operating room, patients are monitored by pulse oximeter, electrocardiogram and non-invasive blood pressure.To monitor blood pressure invasively, an intra-arterial catheter is inserted into the left radial artery after local injection of Lidocaine.</prim_outcome>
      <prim_outcome>Systolic blood pressure. Timepoint: HR and systolic blood pressure and diastolic blood pressure and mean blood pressure before infusion to induction, during and after induction of anesthesia, at laryngoscopy and endotracheal intubation and every minute for 10 minutes after endotracheal intubation are recorded. Method of measurement: After entering the operating room, patients are monitored by pulse oximeter, electrocardiogram and non-invasive blood pressure.To monitor blood pressure invasively, an intra-arterial catheter is inserted into the left radial artery after local injection of Lidocaine.</prim_outcome>
      <prim_outcome>Diastolic blood pressure. Timepoint: HR and systolic blood pressure and diastolic blood pressure and mean blood pressure before infusion to induction, during and after induction of anesthesia, at laryngoscopy and endotracheal intubation and every minute for 10 minutes after endotracheal intubation are recorded. Method of measurement: After entering the operating room, patients are monitored by pulse oximeter, electrocardiogram and non-invasive blood pressure.To monitor blood pressure invasively, an intra-arterial catheter is inserted into the left radial artery after local injection of Lidocaine.</prim_outcome>
      <prim_outcome>Mean blood pressure. Timepoint: HR and systolic blood pressure and diastolic blood pressure and mean blood pressure before infusion to induction, during and after induction of anesthesia, at laryngoscopy and endotracheal intubation and every minute for 10 minutes after endotracheal intubation are recorded. Method of measurement: After entering the operating room, patients are monitored by pulse oximeter, electrocardiogram and non-invasive blood pressure.To monitor blood pressure invasively, an intra-arterial catheter is inserted into the left radial artery after local injection of Lidocaine.</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>Kashan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-05-24</approval_date>
        <contact_name>Ethics committee of Kashan University of Medical Sciences</contact_name>
        <contact_address>5th of Qotb –e Ravandi Blvd. P.O.Box: 8715988141, Kashan, IRAN Kashan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
