<?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>IRCT20191220045829N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-09-27</date_registration>
      <primary_sponsor>Kashan University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of dexmedetomidine and magnesium sulfate in patients undergoing laparoscopic cholecystectomy</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of dexmedetomidine and magnesium sulfate in controlling hemodynamic changes in patients undergoing laparoscopic cholecystectomy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>75</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/44391</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization was used to randomly assign people to three groups and to ensure that the number of people in groups is balanced. Participants randomly had been divided into three groups: dexmedomidine, magnesium sulfate, and control. One envelope was opened for each patient, each envelope had a random number. It had been predetermined that each random number belongs to one of the three groups mentioned, Blinding description: Participants consented to participate in the study but were unaware of which group they were in. The clinical caregiver recording the data was not aware of the type of patient group.</study_design>
      <phase>3</phase>
      <hc_freetext>Laparoscopic cholecystectomy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Dexmedetomidine 1µg/kg was injected intravenously in 20 ml normal saline for ten minutes before induction of anesthesia, and dexmedetomidine 0.5µg/kg per hour after induction of it. Intervention 2: Intervention group: Before induction of anesthesia, 4ml magnesium sulfate 50% (2gr) was infused in 20 ml normal saline for ten minutes and after induction of it, magnesium sulfate 50% (0.9mg/kg) was infused intravenously per hour. Intervention 3: Control group: Normal saline was injected intravenously in 20 ml volume for ten minutes before and after induction of 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 There is not more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Emad Khan ahmad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ghotbe Ravandi Boulevard, Kashan</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8715988141</zip>
        <telephone>+98 31 5554 0026</telephone>
        <email>reza.2240power@gmail.com</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mehdi Rajabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ghotbe Ravandi Boulevard, Kashan</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8715988141</zip>
        <telephone>+98 31 5554 0026</telephone>
        <email>Rajabi_mahdi@kaums.ac.ir</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients Candidate for Laparoscopic Cholecystectomy Surgery in Kashan Shahid Beheshti Hospital
Patients 18-65 years
Level one and two class A.S.A (American society of anesthesiologists)
Blood pressure less than or equal to 140/190</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K80.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Calculus of gallbladder without cholecystitis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Dexmedetomidine 1µg/kg was injected intravenously in 20 ml normal saline for ten minutes before induction of anesthesia, and dexmedetomidine 0.5µg/kg per hour after induction of it.</i_keyword>
      <i_keyword>Intervention group: Before induction of anesthesia, 4ml magnesium sulfate 50% (2gr) was infused in 20 ml normal saline for ten minutes and after induction of it, magnesium sulfate 50% (0.9mg/kg) was infused intravenously per hour.</i_keyword>
      <i_keyword>Control group: Normal saline was injected intravenously in 20 ml volume for ten minutes before and after induction of anesthesia.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Systolic blood pressure. Timepoint: Before and after pre-drug injection, after induction, after intubation, after blowing gas, every 10 minutes up to 40 minutes  and after extubation. Method of measurement: It was recorded by a monitor device attached to the patient.</prim_outcome>
      <prim_outcome>Diastolic blood pressure. Timepoint: Before and after pre-drug injection, after induction, after intubation, after blowing gas, every 10 minutes up to 40 minutes  and after extubation. Method of measurement: It was recorded by a monitor device attached to the patient.</prim_outcome>
      <prim_outcome>Mean arterial blood pressure. Timepoint: Before and after pre-drug injection, after induction, after intubation, after blowing gas, every 10 minutes up to 40 minutes  and after extubation. Method of measurement: It was recorded by a monitor device attached to the patient.</prim_outcome>
      <prim_outcome>Heart Rate. Timepoint: Before and after pre-drug injection, after induction, after intubation, after blowing gas, every 10 minutes up to 40 minutes  and after extubation. Method of measurement: It was recorded by a monitor device attached to the patient.</prim_outcome>
      <prim_outcome>O2 saturation. Timepoint: Before and after pre-drug injection, after induction, after intubation, after blowing gas, every 10 minutes up to 40 minutes  and after extubation. Method of measurement: Pulse oximtery.</prim_outcome>
      <prim_outcome>Intra-abdominal pressure. Timepoint: every 10 minutes up to 40 minutes. Method of measurement: Manometer.</prim_outcome>
      <prim_outcome>End-Tidal CO2. Timepoint: Before and after pre-drug injection, after induction, after intubation, after blowing gas, every 10 minutes up to 40 minutes  and after extubation. Method of measurement: Capnograph device.</prim_outcome>
      <prim_outcome>Bispectral index. Timepoint: Before and after pre-drug injection, after induction, after intubation, after blowing gas, every 10 minutes up to 40 minutes  and after extubation. Method of measurement: It was recorded by a monitor device attached to the patient.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Recovery time. Timepoint: From the the rejection of patient's endotracheal intubation to the number 9 of the Aldrete criteria. Method of measurement: Aldrete criteria.</sec_outcome>
      <sec_outcome>Rate of usage of Propofol. Timepoint: One time at the end of surgery. Method of measurement: The mean dose per kilogram of body weight per minute.</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>2016-11-16</approval_date>
        <contact_name>Ethics committee of Kashan University of Medical Sciences</contact_name>
        <contact_address>Ghotbe Ravandi Boulevard, Kashan Kashan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
