<?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>IRCT2016112631107N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-05-24</date_registration>
      <primary_sponsor>Tehran University Of Medical Sciences Vice Chancellor Of Research</primary_sponsor>
      <public_title>evaluating the effect of an anesthetic agent on the duration of anesthesia and analgesia among chronic opium abusers</public_title>
      <acronym></acronym>
      <scientific_title>studying the effects of adding dexmedetomidine to bupivacaine on supraclavicular nerve block in upper limb orthopedic surgery among chronic opium abusers compared with non users.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>84</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/24536</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>Regional anesthesia.</hc_freetext>
      <i_freetext>Intervention 1: second intervention group receives 30 ml hyperbaric bupivacaine along with 20 micro gram dexmedetomidine to perform regional anesthesia. Intervention 2: first intervention group receives  30 ml hyperbaric bupivacaine along with 2 ml saline as placebo to perform regional anesthesia. Intervention 3: second control group receives 30 ml hyperbaric bupivacaine along with 20 micro gram dexmedetomidine to perform regional anesthesia. Intervention 4: first control group receives 30 ml hyperbaric bupivacaine along with 2 ml saline as placebo to perform regional 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 Maryam Taheri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shariati Hospital, Jalal-e-Al-e-Ahmad High Way, District 6, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411713135</zip>
        <telephone>+98 21 84901</telephone>
        <email>Aug.taheri@gmail.com</email>
        <affiliation>Shariati Hospital, Anesthesilogy Department</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Reza Atef Yekta</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Anesthesiology Unit, Surgery Room, Shariati Hospital, Jalal-Ae-Al-e-Ahmad High Way,District 6, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411713135</zip>
        <telephone>+98 21 84901</telephone>
        <email>rezaatefyekta@yahoo.com</email>
        <affiliation>Shariati Hospital, Anesthesiology Department</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>inclusion criteria: (ASA) physical status class I and II; male; current smokers; aged between 18-60; scheduled for elective upper limb orthopedic surgery under supraclavicular nerve block.&#13;
exclusion criteria: Patients with any contraindications to supraclavicular nerve block; patients with addiction to any substance other than opium and cigarettes;  patients with known history of cardiac, respiratory, or psychological diseases; block failure of any nerve distributions (i.e. if the patient feel pain in those regions), the patient will be excluded from the study, even when the block is adequate to perform the operation.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T41.3, Y48</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Local anaesthetics</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>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>second intervention group receives 30 ml hyperbaric bupivacaine along with 20 micro gram dexmedetomidine to perform regional anesthesia</i_keyword>
      <i_keyword>first intervention group receives  30 ml hyperbaric bupivacaine along with 2 ml saline as placebo to perform regional anesthesia</i_keyword>
      <i_keyword>second control group receives 30 ml hyperbaric bupivacaine along with 20 micro gram dexmedetomidine to perform regional anesthesia</i_keyword>
      <i_keyword>first control group receives 30 ml hyperbaric bupivacaine along with 2 ml saline as placebo to perform regional anesthesia</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sensory block onset. Timepoint: sensory block will be checked continuously after completion of injection until complete sensory and motor block. Method of measurement: pinprick test and a verbal rating scale from 100% (normal sensation) to 0 (no sensation).</prim_outcome>
      <prim_outcome>Sensory block duration. Timepoint: after complete sensory block and every 15 minutes following the end of operation. Method of measurement: pinprick test and a verbal rating scale from 100% (normal sensation) to 0 (no sensation).</prim_outcome>
      <prim_outcome>Motor block onset. Timepoint: motor block will be checked continuously after completion of injection until complete motor block. Method of measurement: Lovett rating scale.</prim_outcome>
      <prim_outcome>Motor block duration. Timepoint: after complete motor block and every 15 minutes following the end of operation. Method of measurement: the Lovett rating scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Systolic blood pressure. Timepoint: continuously monitoring while the surgery is performing. Method of measurement: manometer.</sec_outcome>
      <sec_outcome>Diastolic blood pressure. Timepoint: continuously monitoring while the surgery is performing. Method of measurement: manometer.</sec_outcome>
      <sec_outcome>Heart rate. Timepoint: continuously monitoring while the surgery is performing. Method of measurement: Monitoring.</sec_outcome>
      <sec_outcome>Respiratory depression. Timepoint: continuously monitoring while the surgery is performing. Method of measurement: O2 saturation &amp; Respiratory Rate.</sec_outcome>
      <sec_outcome>Drug consumption in the 24 hours after surgery. Timepoint: patient need. Method of measurement: Medical records.</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 Vice Chancellor Of Research</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-10-05</approval_date>
        <contact_name>Research Ethics Committee of the Medical Faculty of Tehran University of Medical Sciences</contact_name>
        <contact_address>Professional Doctoral Theses Unite, Ground Floor, Education Building, Faculty of Tehran University of Medical Sciences Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
