<?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>IRCT138812013376N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2011-02-16</date_registration>
      <primary_sponsor>Vice Chancellor for Research of Shiraz University of Medical Science,Anesthesia department</primary_sponsor>
      <public_title>The effect of Magnesium sulphate on increased intra ocular pressure due to general anesthesia</public_title>
      <acronym></acronym>
      <scientific_title>The effect of intravenous magnesium sulfate on intraocular pressure changes following tracheal intubation in adults in Shiraz University affiliated hospital</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2007-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>180</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/3451</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>3</phase>
      <hc_freetext>Persons encountering health services for specific procedures and health care.</hc_freetext>
      <i_freetext>Intervention 1: administration of magnesium sulphate once 30mg/kg IV before induction of Anesthesia. Intervention 2: administration of normal saline once 30mg/kg IV before 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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Sina Ghaffari pour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shiraz, Shahid Faghihi Hospital, Department of Anesthesia</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7134844119</zip>
        <telephone>+98 71 1233 7636</telephone>
        <email>sina50@gmail.com</email>
        <affiliation>Shiraz Universityof Medical Science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Sina Ghaffari poor</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shiraz, Shahid Faghihi Hospital ,Anesthesia Department</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7134844119</zip>
        <telephone>+98 71 1233 7636</telephone>
        <email>sina50@gmail.com</email>
        <affiliation>Shiraz University of Medical of Science Department of Anesthesia</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: 180 patients (ASA I) healthy adult, (18 to 38years old, both man and woman) that were scheduled for elective non ocular surgery (ENT and ambulatory surgery that needed tracheal intubation), were selected. exclusion criteria: The patients with specific major hepatic, renal and cardio-vascular disease as well as those known to have allergic reaction to magnesium sulphate or other drugs on basis of the history of patients, and hypermagnesemia, hypocalcemia on the basis on lab data, anuria, heart block (ECG), pregnancy, any degree of renal insufficiency, digitalised patients, positive history of glaucoma, or intra ocular hypertension, and patients who refused to participate in this study, were excluded.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>38 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z40 - Z41 </hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Persons encountering health services for specific procedures and health care</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>administration of magnesium sulphate once 30mg/kg IV before induction of Anesthesia</i_keyword>
      <i_keyword>administration of normal saline once 30mg/kg IV before induction of Anesthesia</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Iop (Intra ocular pressure). Timepoint: In 4 stage (T1:Before induction of anesthesia ,T2 :Just before intubation , T3:1 minute after intubation ,T4:5 minute after intubation. Method of measurement: TONOPEN Instrument.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Systolic BP. Timepoint: 4 stages ; T1 :Before Induction of anesthesia , T2 : just before intubation ,T3 : 1 minute after intubation, T4 :5 minute after intubation. Method of measurement: NIBP monitoring.</sec_outcome>
      <sec_outcome>Diastolic BP. Timepoint: 4 stages ; T1 :Before Induction of anesthesia , T2 : just before intubation ,T3 : 1 minute after intubation, T4 :5 minute after intubation. Method of measurement: NIBP monitoring.</sec_outcome>
      <sec_outcome>Mean Arterial Pressure. Timepoint: 4 stages ; T1 :Before Induction of anesthesia , T2 : just before intubation ,T3 : 1 minute after intubation, T4 :5 minute after intubation. Method of measurement: NIBP monitoring.</sec_outcome>
      <sec_outcome>Heart Rate. Timepoint: 4 stages ; T1 :Before Induction of anesthesia , T2 : just before intubation ,T3 : 1 minute after intubation, T4 :5 minute after intubation. Method of measurement: EKG monitoring.</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>Vice Chancellor for Research of Shiraz University of Medical Science,Anesthesia department</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2008-03-16</approval_date>
        <contact_name>Shiraz University of Medical Science</contact_name>
        <contact_address>Shiraz, Zand avenue, Central building of Shiraz University of Medical Science Shiraz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
