<?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>IRCT2017021430855N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-02-14</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences, The Vice-Chancellery for Research</primary_sponsor>
      <public_title>The Effect of Intravenous Propofol on Local Anesthesia</public_title>
      <acronym></acronym>
      <scientific_title>Studying the effect of intravenous Propofol used with two different volumes of local anesthetic(Bupivacaine) on sensory and motor blockade in patients undergoing upper limb surgery by sonographic supraclavicular brachial plexus block approach</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-01-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/24398</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Supraclavicular Blochade of the  Brachial Plexus.</hc_freetext>
      <i_freetext>Intervention 1: Supraclavicular injection of 30ml Bupivacaine 0.5% + Administration of 25mcg/kg/min  IV Propofol. Intervention 2: Supraclavicular injection of 20ml Bupivacaine 0.5% + Administration of 25mcg/kg/min IV Propofol. Intervention 3: Supraclavicular injection of 30ml Bupivacaine 0.5% + Administration of 25mcg/kg/min IV normal saline as placebo.</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>Mehrdad Sadri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dormitory of Tehran University of Medical Sciences, 16th St, Kargar Shomali St</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>008337249292</telephone>
        <email>m.sadri71@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences, School of Medicine</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Reza Atef Yekta</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shariati Hospital, Jalal Al Ahmad crossroad, Kargar Shomali St, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+218 4901</telephone>
        <email>rezaatefyekta@yshoo.com</email>
        <affiliation>Shariati Hospital</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion Criteria: Ages between 20 and 50; ASA classes: I,II,III; BMI under 35; Absence of the history of drug induced hypersensitivity; Taking of informed consent&#13;
Exclusion Criteria: Failure of supraclavicular blockade; Need to General Anesthesia</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></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>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Supraclavicular injection of 30ml Bupivacaine 0.5% + Administration of 25mcg/kg/min  IV Propofol</i_keyword>
      <i_keyword>Supraclavicular injection of 20ml Bupivacaine 0.5% + Administration of 25mcg/kg/min IV Propofol</i_keyword>
      <i_keyword>Supraclavicular injection of 30ml Bupivacaine 0.5% + Administration of 25mcg/kg/min IV normal saline as placebo</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Duration of Motor Blockage. Timepoint: During and after the intervention. Method of measurement: Physical examination by the physician.</prim_outcome>
      <prim_outcome>Duration of Sensory Blockage. Timepoint: During and after the intervention. Method of measurement: Physical examination by the physician.</prim_outcome>
      <prim_outcome>Onset of the Motor Blockage. Timepoint: During the intervention. Method of measurement: Physical examination by the physician.</prim_outcome>
      <prim_outcome>Onset of the Sensory Blockage. Timepoint: During the intervention. Method of measurement: Physical examination by the physician.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Patient's feeling of pain. Timepoint: After the intervention in the same admission. Method of measurement: Visual Analogue Scale (VAS).</sec_outcome>
      <sec_outcome>The measure of motor blockade. Timepoint: During and after the intervention. Method of measurement: Lovett Rating Scale.</sec_outcome>
      <sec_outcome>The time of the first opioid request by the patient. Timepoint: After the intervention in the same admission. Method of measurement: By using PCA(Patient Controlled Anaesthesia).</sec_outcome>
      <sec_outcome>Administered opioid dosage in 24 hours. Timepoint: After the intervention in the same admission. Method of measurement: Patient Medical Document.</sec_outcome>
      <sec_outcome>Duration of the surgery. Timepoint: During the intervention. Method of measurement: Patient Medical Document.</sec_outcome>
      <sec_outcome>Nausea and vomiting after the surgery. Timepoint: After the intervention in the same admission. Method of measurement: Asking the patient.</sec_outcome>
      <sec_outcome>Mean arterial blood pressure 1 minute after the blockade. Timepoint: 1 minute after the blockade. Method of measurement: Non-invasive automatic manometer.</sec_outcome>
      <sec_outcome>Mean arterial blood pressure 3 minutes after the blockade. Timepoint: 3 minutes after the blockade. Method of measurement: Non-invasive automatic manometer.</sec_outcome>
      <sec_outcome>Mean arterial blood pressure 5 minutes after the blockade. Timepoint: 5 minutes after the blockade. Method of measurement: Non-invasive automatic manometer.</sec_outcome>
      <sec_outcome>Mean arterial blood pressure 1 minute after the recovery. Timepoint: 1 minute after recovery admission. Method of measurement: Non-invasive automatic manometer.</sec_outcome>
      <sec_outcome>Mean arterial blood pressure 3 minutes after the recovery. Timepoint: 3 minutes after the recovery admission. Method of measurement: Non-invasive automatic manometer.</sec_outcome>
      <sec_outcome>Mean arterial blood pressure 5 minutes after the recovery. Timepoint: 5 minutes after the recovery admission. Method of measurement: Non-invasive automatic manometer.</sec_outcome>
      <sec_outcome>Heart rate 1 minute after the blockade. Timepoint: 1 minute after the blockade. Method of measurement: Pulse Oxymetery.</sec_outcome>
      <sec_outcome>Heart rate 3 minutes after the blockade. Timepoint: 3 minutes after the blockade. Method of measurement: Pulse Oxymetery.</sec_outcome>
      <sec_outcome>Heart rate 5 minutes after the blockade. Timepoint: 5 minutes after the blockade. Method of measurement: Pulse Oxymetery.</sec_outcome>
      <sec_outcome>Heart rate 1 minute after the recovery. Timepoint: 1 minute after the recovery admission. Method of measurement: Pulse Oxymetery.</sec_outcome>
      <sec_outcome>Heart rate 3 minutes after the recovery. Timepoint: 3 minutes after the recovery admission. Method of measurement: Pulse Oxymetery.</sec_outcome>
      <sec_outcome>Heart rate 5 minutes after the recovery. Timepoint: 5 minutes after the recovery admission. Method of measurement: Pulse Oxymetery.</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>Tehran University of Medical Sciences, The Vice-Chancellery for Research</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-11-22</approval_date>
        <contact_name>Research Ethics Committee of Tehran University of Medical Sciences, School of Medicine</contact_name>
        <contact_address>Plate 23, 16th of Azar St, Keshavarz Blvd Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
