<?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>IRCT2014081714333N19</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-09-07</date_registration>
      <primary_sponsor>Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences</primary_sponsor>
      <public_title>The effect of general and epidural anesthesia on respiratory parameters during and after laparoscopic cholecystectomy surgery</public_title>
      <acronym></acronym>
      <scientific_title>The effect of general and epidural anesthesia on respiratory parameters during and after laparoscopic cholecystectomy surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-06-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>58</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/13955</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Laparascopic cholecystectomy.</hc_freetext>
      <i_freetext>Intervention 1: In the first  group(GA),  After pre-medication among GA with midazolam 05.0 mg/kg, intravenous fentalyn 1 µg/kg, patients are anesthetized using propofol 2 mg/kg and atracurium 5.0 mg/kg and standard monitoring is completed. Proper indotratracheal tube is contrived and surgery starts. During the surgery, anesthetization continues through using isoflurane 1.4 1% blended with mixture of air and 50% oxygen. During the surgery ABG is tested and SPO2 is measured accordingly. An hour later, during recovery period, ABG is retested and VC and SPO2 are measured through monitoring. Intervention 2: In the second group (EA), 10 cc Lidocaine and epinephrine 1 in 200000, including 1 cc sodium bicarnonate for each 10 cc of Lidocaine, would be injected in the space between vertebrae of the thoracic using epidural set. ABG and SPO2 would be measured during surgery. ABG would be measured again, and VC and SPO2 would be checked using monitor an hour after surgery during recovery period.</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></firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address></address>
        <city></city>
        <country1></country1>
        <zip></zip>
        <telephone></telephone>
        <email></email>
        <affiliation></affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Ali karbasforushan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Emam Reza Hospital,Razi Boulvard,Sorkhleje</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 83 3427 6309</telephone>
        <email>ali_karbasfrushan@yahoo.com</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Entrance criteria includes written consent by patients; I, II ASA class; age range of 20 to 60; no history on respiratory or cardio problems; no history on diabetes or similar diseases needing treatment. Exclusion criterion is a surgery lasting more than 45 minutes.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K80.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cholecystolithiasis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Surgery</i_code>
      <i_code>Treatment - Surgery</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the first  group(GA),  After pre-medication among GA with midazolam 05.0 mg/kg, intravenous fentalyn 1 µg/kg, patients are anesthetized using propofol 2 mg/kg and atracurium 5.0 mg/kg and standard monitoring is completed. Proper indotratracheal tube is contrived and surgery starts. During the surgery, anesthetization continues through using isoflurane 1.4 1% blended with mixture of air and 50% oxygen. During the surgery ABG is tested and SPO2 is measured accordingly. An hour later, during recovery period, ABG is retested and VC and SPO2 are measured through monitoring.</i_keyword>
      <i_keyword>In the second group (EA), 10 cc Lidocaine and epinephrine 1 in 200000, including 1 cc sodium bicarnonate for each 10 cc of Lidocaine, would be injected in the space between vertebrae of the thoracic using epidural set. ABG and SPO2 would be measured during surgery. ABG would be measured again, and VC and SPO2 would be checked using monitor an hour after surgery during recovery period.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>FEV1. Timepoint: A day before and after surgery. Method of measurement: Using spirometry.</prim_outcome>
      <prim_outcome>VC. Timepoint: During and an hour after surgery. Method of measurement: Using anesthesia machine monitor.</prim_outcome>
      <prim_outcome>SPO2. Timepoint: Before, during and an hour after surgery. Method of measurement: Using pulse oxy meter monitor.</prim_outcome>
      <prim_outcome>PH. Timepoint: Before, during and an hour after surgery. Method of measurement: Using blood gas analysis (ABG).</prim_outcome>
      <prim_outcome>Pao2. Timepoint: Before, during and an hour after surgery. Method of measurement: Using blood gas analysis (ABG).</prim_outcome>
      <prim_outcome>PaCo2. Timepoint: Before, during and an hour after surgery. Method of measurement: Using blood gas analysis (ABG).</prim_outcome>
      <prim_outcome>Hco3. Timepoint: Before, during and an hour after surgery. Method of measurement: Using blood gas analysis (ABG).</prim_outcome>
      <prim_outcome>FVC. Timepoint: A day before and after surgery. Method of measurement: Through spirometry.</prim_outcome>
      <prim_outcome>O2SAT. Timepoint: Before, during and an hour after surgery. Method of measurement: Using blood gas analysis (ABG).</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>Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-06-09</approval_date>
        <contact_name>Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences</contact_name>
        <contact_address>Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences Kermanshah  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
