<?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>IRCT20160307026950N16</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-03-11</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Evaluating Midazolam effect on post ECT complications in teenagers</public_title>
      <acronym></acronym>
      <scientific_title>Comparative evaluation of midazolam effects before and after seizure occurrence on post ECT complications in teenagers</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-02-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>69</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/44382</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Individuals will be randomly divided into three groups by using computer software and closed envelope technique. The intervention groups will receive midazolam before and after ECT and and the group receiving the routine treatments and placebo without midazolam will be considered as the control group, Blinding description: Patients will be randomly divided into 3 groups by using computer software and each one of the groups will be receiving one of the 3 drug packages (package A &amp; B &amp; C (placebo)). drugs of three packages are prepared by the researcher using syringes of the same form and size, and the person who 
prescribes the drug and the person who registers the vital signs are different and are unaware of the contents of the packages finally the investigator deciphers the codes after dara analysis.</study_design>
      <phase>3</phase>
      <hc_freetext>electroconvulsive therapy complications.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: group A which receives package A consisted of routine anesthesia medications ( sodium thiopental with a dose of 2 mg/kg and 0.5 mg/kg of succinyl choline) plus 1 mg of midazolam before inducing the seizure and administration of anesthesia drugs and 1 cc of N/S after ECT is done. Intervention 2: Intervention group: group B which receives package B consisted of the routine anesthesua medication mentioned above and 1 cc of N/S before inducing seizures and 1 mg of midazolam after the ECT is done and the seizure are completely over. Intervention 3: Control group: group C which receives 1 cc of N/S before inducing seizures and after the ECT is done as a placebo in addition to the routine anesthesia medications mentioned above.</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 more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Raisi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Amirieh town 7th ST</address>
        <city>isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174949351</zip>
        <telephone>+98 913 596 7320</telephone>
        <email>maryamraisi1995@yahoo.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>behzad nazemroaya</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Medical Center Al-Zahra, Blvd Sofeh, Shahid Keshvari Highway</address>
        <city>isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174675731</zip>
        <telephone>+98 31 3620 2020</telephone>
        <email>behzad_nazem@med.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>13 to 18 years of age
ASA I&amp;II
Having indications for ECT
Written consent from parents
NPO regimen</inclusion_criteria>
      <agemin>13 years</agemin>
      <agemax>18 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients who do not have a stable Hemodynamic status
Patients with major diseases like asthma, drug allergy, neuromuscular diseases ,epilepsy, hypertension and cardiovascular diseases</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: group A which receives package A consisted of routine anesthesia medications ( sodium thiopental with a dose of 2 mg/kg and 0.5 mg/kg of succinyl choline) plus 1 mg of midazolam before inducing the seizure and administration of anesthesia drugs and 1 cc of N/S after ECT is done.</i_keyword>
      <i_keyword>Intervention group: group B which receives package B consisted of the routine anesthesua medication mentioned above and 1 cc of N/S before inducing seizures and 1 mg of midazolam after the ECT is done and the seizure are completely over.</i_keyword>
      <i_keyword>Control group: group C which receives 1 cc of N/S before inducing seizures and after the ECT is done as a placebo in addition to the routine anesthesia medications mentioned above.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Tachycardia -  bradycardia. Timepoint: 0 , 5 , 10 , 15  minutes after ECT. Method of measurement: heart monitoring device.</prim_outcome>
      <prim_outcome>Headache. Timepoint: immediately after full consciousness , every 15 minutes in first hour then every 2 hours until 6 hours. Method of measurement: questionnaire.</prim_outcome>
      <prim_outcome>Myalgia. Timepoint: immediately after full consciousness , every 15 minutes in first hour then every 2 hours to 6 hour. Method of measurement: questionnaire.</prim_outcome>
      <prim_outcome>Nausea. Timepoint: immediately after full consciousness , every 15 minutes in first hour then every 2 hours to 6 hour. Method of measurement: questionnaire.</prim_outcome>
      <prim_outcome>O2 saturation. Timepoint: before injection of drug , during seizure and 5, 10 , 15 minutes after ECT. Method of measurement: pulse oxymetery.</prim_outcome>
      <prim_outcome>Systolic and diastolic blood pressure. Timepoint: before drug injection, during seizures and after seizures. Method of measurement: Non invasive blood pressure monitor.</prim_outcome>
      <prim_outcome>Mean blood pressure. Timepoint: before drug injection, during seizures and after seizures. Method of measurement: Non invasive blood pressure monitor.</prim_outcome>
      <prim_outcome>Recovery time. Timepoint: From the end of seizure to full consciousness. Method of measurement: in minutes using a chornometer.</prim_outcome>
      <prim_outcome>Specific complications such as hypoxia and respiratory depression. Timepoint: From the end of seizure to full consciousness. Method of measurement: observation.</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-02-15</approval_date>
        <contact_name>Ethics committee of Isfahan University of medical sciences</contact_name>
        <contact_address>Hezar jarib street Esfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
