<?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>IRCT20181011041308N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-12-11</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>To asses the effects of adding Dexmedetomidine to Ropivacaine in interscallen block.</public_title>
      <acronym></acronym>
      <scientific_title>To Asses the Effects of Adding Dexmedetomidine to Ropivacaine in Interscalen Block with Ultrasound Guide prior to Arthroscopically Repairing the Ruptured Shoulder Tendon Surgery in need of Amount of Anesthetic Drugs during Surgery and Post Operation Analgesia.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>42</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60187</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: In this study, participants were blinded by a clinical observer, caregiver, and outcome assessor.</study_design>
      <phase>2</phase>
      <hc_freetext>Rupture of shoulder rotator cuff.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The first group receives 20 cc of Rupivacaine 0.25% plus 2 cc of normal saline under the interscallen block of the brachial plexus with ultrasound guide.  . Intervention 2: Intervention group: The second group receives 20 cc of Rupivacaine 0.25% plus 1.5 µ / kg dexmethomidine under interscallen block of the brachial plexus with ultrasound guide.</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:
Only part of the data containing information about the main outcome can be shared.

When:
Access period starts 3 months after the results are published.

To whom:
The data will be available only to researchers working in academic and scientific institutions.

Conditions:
It is necessary to send a request for access to data or documents.

Where to obtain:
Refer to Dr. Mahmoud Reza Alebouyeh.
Phone: 00989121253698

How to obtain:
After submitting the request, if approved by the committee and during the legal process, the documents will be sent.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shirin Zarandouz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran, Hemmat Highway next to Milad Tower</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1449614535</zip>
        <telephone>+98 912 285 8544</telephone>
        <email>shirin_zarandouz@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahmoud Reza Alebouyeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 2, baharan street, Est 1 street, Saadat Abad 24 metri Blvd</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1449614535</zip>
        <telephone>+98 21 2213 6136</telephone>
        <email>alebuieh.mr@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients who are satisfied with their participation in the research project.
Patients undergoing elective surgery.
Patients aged between 18 and 60 years.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnant patients.
Patients with ASA 4 and ASA 5.
Patients with asthma and copd
BMI&gt;35
Opioid addiction and use of NSAID or opium in last 3-5 days before
Diabetic patients.
Patients with coagulopathy disorder
any AV Block changes in the ECG.
Head Trauma
Any Abnormality in arm and forearm
Any contraindications of interscalen block such as diaphragmatic paralysis in the other side</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M75.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Rotator cuff tear or rupture, not specified as traumatic</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: The first group receives 20 cc of Rupivacaine 0.25% plus 2 cc of normal saline under the interscallen block of the brachial plexus with ultrasound guide.  .</i_keyword>
      <i_keyword>Intervention group: The second group receives 20 cc of Rupivacaine 0.25% plus 1.5 µ / kg dexmethomidine under interscallen block of the brachial plexus with ultrasound guide</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>1- Investigating the difference between NRS in the hours after surgery in the two groups. Timepoint: during the surgery ,2 hours, 6 hours, 18 hours and 24 hours after surgery. Method of measurement: Anesthetic recording papers,Bispectral index monitoring,ask patients.</prim_outcome>
      <prim_outcome>Frequency of using the Autofuser pump in the two groups -The first hour of using the Autofuser pump in the two groups - The amount of pethidine consumption in the two groups   - The first hour of using the pethidine in the two groups  -Propofol consumption in both groups - Atracurium consumption in two groups - Remifentanil consumption in both groups. Timepoint: during the surgery ,2 hours, 6 hours, 18 hours and 24 hours after surgery. Method of measurement: Anesthetic recording papers,Bispectral index monitoring,ask patients.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Range of  motion and frozen shoulder after 3 months and 6 months of surgery. Timepoint: 3months and 6 months after surgery. Method of measurement: physical examination.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-06-23</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Tehran Hemat Highway next to Milad Tower Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
