<?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>IRCT20191229045935N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-03-04</date_registration>
      <primary_sponsor>Kashan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of two different doses of the drug on hemodynamic responses in patients undergoing  laparoscopic cholecystectomy</public_title>
      <acronym></acronym>
      <scientific_title>Comparison study of two doses of magnesium sulfate on hemodynamic response to endotracheal intubation in laparoscopic cholecystectomy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-02-27</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/44676</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients III-IASA were candidates for elective laparoscopic elective cholecystectomy at Shahid Beheshti Hospital in Kashan after obtaining written consent random blocks with 6 blocks are divided into 3 groups. In the case of central hiding randomization, in this method, the random sequence is assigned to a particular person or center and sampling is performed at one or more centers simultaneously. Based on the order of the participants' entry into the study, the researcher communicates with the relevant center and asks about the random assignment of the participant to a specific group, Blinding description: Patients from two different doses of magnesium sulfate are completely blind to their hemodynamic responses.</study_design>
      <phase>0 (exploratory trials)</phase>
      <hc_freetext>Patients undergoing CABG.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Magnesium sulfate 30mg / kg infusion within 5 minutes which continues before induction. The studied drugs were manufactured by Judge Tabriz Company from Alborz Broadcasting Company and recorded at the time of tracheal intubation, 2, 4, 6 and 10 minutes after tracheal intubation.nd 10 minutes after tracheal intubation. Intervention 2: Intervention group: Magnesium sulfate 40mg / kg is infused for 5 minutes and continues until induction. The studied drugs were manufactured by Judge Tabriz Company from Alborz Broadcasting Company and recorded at the time of tracheal intubation, 2, 4, 6 and 10 minutes after tracheal intubation. Intervention 3: Control group: Normal saline equal to the intervention group as placebo, which is infused like the other two groups within 5 minutes and will continue until induction.The studied drugs were manufactured by Judge Tabriz Company from Alborz Broadcasting Company and recorded at the time of tracheal intubation, 2, 4, 6 and 10 minutes after tracheal intubation.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Some portion of the dose information can be shared.

When:
Starting access after printing the article.

To whom:
All researchers

Conditions:
For use in surgeries

Where to obtain:
Author corresponding

How to obtain:
An in-person or written request by email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Jafar Kazemeini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kashan university of medical sciences, Qotbe Ravandi Blvd, Kashan</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8711111111</zip>
        <telephone>+98 31 5550 0111</telephone>
        <email>kazemeini-j@mail.kaums.ac.ir</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Jafar Kazemaini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kashan university of medical sciences, Qotbe Ravandi Blvd, Kashan</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8711111111</zip>
        <telephone>+98 31 5550 0111</telephone>
        <email>kazemeini-j@mail.kaums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>ASA II-III Patients Candidate for Laparoscopic Elective Cholecystectomy</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Emergency Surgery
Probability of intubation problem
Sensitivity to magnesium sulfate
Cardiac arrhythmia
Serum creatinine above 2 mg / dl
pregnant women
Patients with severe heart valve disorders Patients with aortic stenosis</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>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Magnesium sulfate 30mg / kg infusion within 5 minutes which continues before induction. The studied drugs were manufactured by Judge Tabriz Company from Alborz Broadcasting Company and recorded at the time of tracheal intubation, 2, 4, 6 and 10 minutes after tracheal intubation.nd 10 minutes after tracheal intubation.</i_keyword>
      <i_keyword>Intervention group: Magnesium sulfate 40mg / kg is infused for 5 minutes and continues until induction. The studied drugs were manufactured by Judge Tabriz Company from Alborz Broadcasting Company and recorded at the time of tracheal intubation, 2, 4, 6 and 10 minutes after tracheal intubation.</i_keyword>
      <i_keyword>Control group: Normal saline equal to the intervention group as placebo, which is infused like the other two groups within 5 minutes and will continue until induction.The studied drugs were manufactured by Judge Tabriz Company from Alborz Broadcasting Company and recorded at the time of tracheal intubation, 2, 4, 6 and 10 minutes after tracheal intubation.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Heart rate. Timepoint: At the time of tracheal, and 2, 4, 6, and 10 minutes after tracheal intubation. Method of measurement: Digital barometer.</prim_outcome>
      <prim_outcome>Systolic blood pressure, diastolic blood pressure, and mean blood pressure. Timepoint: systolic blood pressure, diastolic blood pressure, and mean blood pressure before infusion to induction were recorded at different time points, including anesthesia induction, at the time of tracheal, and 2, 4, 6, and 10 minutes after tracheal intubation. Method of measurement: Mercury barometer.</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>2019-02-12</approval_date>
        <contact_name>Kashan university of medical sciences, Qotbe Ravandi Blvd, Kashan</contact_name>
        <contact_address>Kashan university of medical sciences, Qotbe Ravandi Blvd, Kashan Kashan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
