<?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>IRCT20230307057651N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-05-03</date_registration>
      <primary_sponsor>Ardabil University of Medical Sciences</primary_sponsor>
      <public_title>Determining the effect of venous magnesium on improving the quality of anesthesia</public_title>
      <acronym></acronym>
      <scientific_title>Determining the effect of venous magnesium on improving the quality of anesthesia in patients undergoing appendectomy under spinal anesthesia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-04-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>84</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69180</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: After entering the study, patients are randomly assigned to two experimental groups (study intervention) and control based on codes A and B.The method of randomly assigning patients to two groups will be in the form of blocks, for the 84 patients studied previously, four blocks of different sequences A, B have been prepared with the help of statistical software, and the random sequences obtained in the form of envelopes containing codes A and B in the package are given to a person who does not know about the drugs used, and after each person enters the study, the corresponding envelope is opened and the person's code is determined, and the corresponding intervention is performed by the anesthesia resident who is not part of the study, Blinding description: Patients and the operator will be unaware of the type of medicine.</study_design>
      <phase>0 (exploratory trials)</phase>
      <hc_freetext>Condition 1: Appendicitis. Condition 2: pain. Condition 3: nausea and vomiting.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  Patients in the intervention group in the study will receive magnesium sulfate at the rate of 50 mg per kilogram of body weight intravenously before the operation and 8 mg per kilogram during the operation. Intervention 2: Control group: Patients in the control group will receive distilled water at the rate of 50 mg per kilogram of body weight intravenously before the operation and 8 mg per kilogram during the operation.</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 no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mina Deldadeh Moghaddam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 1, Molavi St., 8 Molvi</address>
        <city>Ardabil</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5614733775</zip>
        <telephone>+98 45 3325 7086</telephone>
        <email>d.mina15@yahoo.com</email>
        <affiliation>Ardabil University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahzad yosefiyan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ardabil, Jhanbazan Square, the end of University Street, above University Square , Faculty of Medicine and Paramedicine</address>
        <city>Ardabil</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5614733775</zip>
        <telephone>+98 45 3323 2520</telephone>
        <email>d.mina15@yahoo.com</email>
        <affiliation>Ardabil University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 18 to 50 years, acute appendicitis patients</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of drug abuse, alcohol consumption, recent use of tranquilizers, stimulants and antipsychotics, antihypertensive drugs, calcium channel blockers, and history of neuromuscular diseases, thyroid disorders, history of any type of kidney and heart disease.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K35</hc_code>
      <hc_code>R52</hc_code>
      <hc_code>R11</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute appendicitis</hc_keyword>
      <hc_keyword>Pain, unspecified</hc_keyword>
      <hc_keyword>Nausea and vomiting</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>Intervention group:  Patients in the intervention group in the study will receive magnesium sulfate at the rate of 50 mg per kilogram of body weight intravenously before the operation and 8 mg per kilogram during the operation.</i_keyword>
      <i_keyword>Control group: Patients in the control group will receive distilled water at the rate of 50 mg per kilogram of body weight intravenously before the operation and 8 mg per kilogram during the operation.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Pain measurement at 1, 3, 6, 12 and 18 hours after surgery. Method of measurement: The measurement of patients' pain will be based on the criteria for measuring patients pain with 'Visual Analogue Scale.Zero point is equal to not having any pain and 10 is the most severe possible pain.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Nausea and vomiting. Timepoint: 3 and 12 hours after surgery. Method of measurement: Based on a qualitative review by the following method:1- No nausea and vomiting 2- Nausea 3- Nausea and vomiting one to two times 4- Nausea and vomiting more than 2 times.</sec_outcome>
      <sec_outcome>Anxiety and restlessness. Timepoint: 3, 6, 12, 18 hours after surgery. Method of measurement: According to Ramsey scale (0 to 5): 0 (restless), 1 (calm and alert), 2 (sleepy), 3 (confused but responding to verbal commands), 4 (no response to verbal commands), 5 (absence) response to provocations)).</sec_outcome>
      <sec_outcome>Consent of the surgeon. Timepoint: During surgery. Method of measurement: has / does not have.</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>Ardabil University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-03-03</approval_date>
        <contact_name>Ethics committee of Ardabil University of Medical Sciences</contact_name>
        <contact_address>At the end of University Street, Ardabil University of Medical Sciences administrative complex َArdabil Ardabil Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
