<?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>IRCT20100527004041N22</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-06-10</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Investigation of hemodynamic changes between general anesthesia and general caudal anesthesia in children.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of hemodynamic changes during general anesthesia in children with or without caudal anesthesia using rupivacaine.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-06-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/48675</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random assignment of the patients to intervention and control groups will be performed using the random numbered table technique via Randlist online software, individually for patients. In this study, patients were randomly divided into two groups via simple randomization, Blinding description: Two anesthesiologists will be involved in the study An anesthesiologist No. 1 has induced anesthesia,that it will be applied as general anesthesia for one group and caudal for another.Then anesthesiologist No. 1 who is aware of patients codes and injections leave the operation room and anesthesiologist NO.2 and The anesthesia nurse, who is responsible for collecting information and variables from the patient and is unaware of the type of prescribed drug, fills in the checklist during surgery and recovery section .The patient is also unaware of the type of Injecting drug.</study_design>
      <phase>3</phase>
      <hc_freetext>Hemodynamic changes after general anesthesia and caudal anesthesia..</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:In this group, the patient was anesthetized with 1 mg / kg lidocaine and 3.5 to 4.5 mg / kg propofol and after induction of anesthesia,before the start of surgery,caudal anesthesia with 0.2% rupivacaine, 1 micro-gram per kilogram will be performed. Intervention 2: Control group:In this group, anesthesia will be inducted  with 1 mg / kg lidocaine and 3.5 to 4.5 mg / kg propofol.</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:
All potential data can be shared after making peoples unrecognizable.

When:
Starting 6 months after publication

To whom:
Documents will be available for people working in academic institutions and also people working in businesses.

Conditions:
There will be no specific limitations to the utilization of the data

Where to obtain:
Dr .Mahin Seyedhejazi, Department of Anesthesiology, Faculty of Medicine, Golgasht Street, Tabriz East Azarbaijan Islamic Republic of Iran ,Phone+98 413 3341994, Fax+98 41 33341994 , seidhejazie@tbzmed.ac.ir

How to obtain:
Applicants will access the data from the present study by sending an email to the responsible author for a maximum of one week.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Mahin Seyedhejazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tabriz pediatric hospital,sheshgelan street,Tabriz</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5136735886</zip>
        <telephone>+98 41 3526 2255</telephone>
        <email>seidhejazie@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mahin Seyedhejazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tabriz pediatric hospital,sheshgelan street,Tabriz</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5136735886</zip>
        <telephone>+98 41 3526 2255</telephone>
        <email>seidhejazie@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All children from 6 months to 7 years
ASA grade With class I&amp;II
Candidate for lower abdominal surgery</inclusion_criteria>
      <agemin>6 months</agemin>
      <agemax>7 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having any neuropathy
History of allergy to anesthetics</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T88.59</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other complications of anesthesia</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:In this group, the patient was anesthetized with 1 mg / kg lidocaine and 3.5 to 4.5 mg / kg propofol and after induction of anesthesia,before the start of surgery,caudal anesthesia with 0.2% rupivacaine, 1 micro-gram per kilogram will be performed.</i_keyword>
      <i_keyword>Control group:In this group, anesthesia will be inducted  with 1 mg / kg lidocaine and 3.5 to 4.5 mg / kg propofol.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Systolic and diastolic blood pressure. Timepoint: From the beginning of anesthesia to 30th minute,every 5 minutes and after that every 15minutes and in recovery section until discharging,every 10 minutes. Method of measurement: Mercury barometer.</prim_outcome>
      <prim_outcome>Mean arterial pressure(MAP). Timepoint: From the beginning of anesthesia to 30th minute,every 5 minutes and after that every 15minutes and in recovery section until discharging,every 10 minutes. Method of measurement: Mercury barometer.</prim_outcome>
      <prim_outcome>Heart rate. Timepoint: From the beginning of anesthesia to 30th minute,every 5 minutes and after that every 15minutes and in recovery section until discharging,every 10 minutes. Method of measurement: Counting in each minutes.</prim_outcome>
      <prim_outcome>Saturation of peripheral oxygen. Timepoint: From the beginning of anesthesia to 30th minute,every 5 minutes and after that every 15minutes and in recovery section until discharging,every 10 minutes. Method of measurement: Via the Pulse Oximeter.</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-06-07</approval_date>
        <contact_name>Ethic Committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Vice chancellor for research, Golgasht Street Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
