<?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>IRCT20110313006044N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-03-10</date_registration>
      <primary_sponsor>Bandare-abbas University of Medical Sciences</primary_sponsor>
      <public_title>The effect of sufentanil on intravenous anesthesia in orthopedic patients</public_title>
      <acronym></acronym>
      <scientific_title>The Efficacy of Sufentanil-Lidocaine Compound as the Intravenous Regional Anesthetic in Elective Orthopedic Patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-03-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46288</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The sample was randomly divided into two groups of 30 patients. Each envelope containing one of the two labels A and B represented one of the intervention groups, Blinding description: In order to eliminate bias from patient's awareness or anesthesia assistant and its possible impact on the outcome of the study, the study will be conducted in a double-blind condition. After receiving written informed consent from patients, local anesthesia was done by giving the same drugs and same volume to the anesthesiologist, then relevant information was recorded in the questionnaire by the anesthesiologist who was not aware of the injection of the drugs. It is obvious that the patient and the anesthesiologist were not aware of the type of drug being administered.</study_design>
      <phase>3</phase>
      <hc_freetext>Forearm surgery.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The first group  3 mg/kg lidocaine 0.5%  diluted with 0.9% normal saline at a total volume of 40 cc. Intervention 2: Intervention group: The second group  3 mg/kg lidocaine  0.5%  diluted with 0.9% normal saline + 4 cc sufentanil at a total volume of 40 cc.</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:
Information about the main outcome can be shared.

When:
Starting the post-access period of the paper was accepted

To whom:
All researchers

Conditions:
Using data to complete clinical studies

Where to obtain:
Shahid Mohammadi Hospital

How to obtain:
By reviewing the researcher's request and providing sufficient documentation of your research and the reason for using the data, it will be possible.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hashem Jarineshin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jomhuri Blvd, Shahid Mohammadi Hospital</address>
        <city>Bandar Abbas</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9791991551</zip>
        <telephone>+98 76 3334 5009</telephone>
        <email>hjarineshin@yahoo.com</email>
        <affiliation>Bandare-abbas University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hashem Jarineshin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jomhuri Blvd, Shahid Mohammadi Hospital</address>
        <city>Bandar Abbas</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9791991551</zip>
        <telephone>+98 76 3334 5009</telephone>
        <email>hjarineshin@yahoo.com</email>
        <affiliation>Bandare-abbas University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All Candidates aged 18-50 years for- forearm surgery with ASA I,II classes</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients who are allergic to sufentanil or topical anesthetic.
Patients with a history of liver or kidney disease.
Patients who have sickle cell anemia  or convulsion.
Patients with Raynaud syndrome and neuropathy.
Patients who have uncontrolled hypertension and opioid addiction.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S52.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Unspecified fracture of forearm</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  3 mg/kg lidocaine 0.5%  diluted with 0.9% normal saline at a total volume of 40 cc.</i_keyword>
      <i_keyword>Intervention group: The second group  3 mg/kg lidocaine  0.5%  diluted with 0.9% normal saline + 4 cc sufentanil at a total volume of 40 cc</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Tourniquet pain. Timepoint: Pain intensity measurement at baseline (before intervention) and 5,10,15 and 20 min after injection. Method of measurement: Patients' severity of pain is based on the Visual Analogues Scale.</prim_outcome>
      <prim_outcome>Quality of local anesthesia. Timepoint: During Surgery. Method of measurement: Numerical scale(1-4) of patient satisfaction.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The evaluation of sensory block. Timepoint: During surgery every 10 minutes. Method of measurement: 22-gauge needle on palm in hypothenar (ulna nerve) and thenar (median nerve) eminences and back of the upper arm between thumb and forefinger (radial nerve).</sec_outcome>
      <sec_outcome>The evaluation of motor block. Timepoint: During surgery every 10 minutes. Method of measurement: Observation.</sec_outcome>
      <sec_outcome>Side effects such as nausea, vomiting, seizures, hypotension, bradycardia, and itching. Timepoint: During and after surgery. Method of measurement: Observation.</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>Bandare-abbas University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-10-07</approval_date>
        <contact_name>Ethics committee of Hormozgan University of Medical Sciences</contact_name>
        <contact_address>Jomhuri Blvd, Shahid Mohammadi Hospital Bandar Abbas Hormozgan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
