<?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>IRCT2014091919199N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-04-12</date_registration>
      <primary_sponsor>Arak University of Medical Sciences, Vice chancellor for research</primary_sponsor>
      <public_title>Effect of N-acetyl cysteine on hepatitis risk reduction after anesthesia</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of N-acetyl cysteine vs saline on liver function on general anesthesia with isoflurane in Arak Vali-e-Asr hospital</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-04-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>68</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/17238</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: In a double-blind clinical trial ,patients were randomly divided in two groups,According to medical ethics will obtain consent to enter the study of patients.Data collector will not inform the patient information and patient groups will not inform about their position in the group.</study_design>
      <phase>3</phase>
      <hc_freetext>liver toxicity.</hc_freetext>
      <i_freetext>Intervention 1: In intervention group patients will receive 150 mg/kg N-Acetyl cysteine with 250 ml normal saline in single IV dose and isoflurane will be used for maintenance anesthesia. We injected above mentioned solution before induction.All patients will pre-oxygenated with 100% oxygen.Patients will take Fentanyl 2mc/kg, 3-6 mg/kg sodium thiopental ( logi Chem UK)and 0/5 mg/kg Atracurium(Alborz darou).All patients will take 1 mg/kg fentanyl and 0/2 mg/kg atracurium during anesthesia every 40 minutes.Trial group will receive 12/5 mg/kg N-acetyl cysteine during surgery. Intervention 2: In control group patients will receive only 250 ml normal salinein single IV dose and isoflurane will used for maintenance anesthesia.we injected above solution before induction.All patients will pre-oxygenated with 100% oxygen.Patients will take Fentanyl 2mc/kg, 3-6 mg/kg sodium thiopental ( logi Chem UK)and 0/5 mg/kg Atracurium(Alborz darou).All patients every 40 minutes will take 1 mg/kg fentanyl and 0/2 mg/kg atracurium during 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.Saber Akhtaran</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Arak University Of Medical Science, Basij Sq.</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 86 3417 3645</telephone>
        <email>dr.akhtaran@arakmu.ac.ir</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Saber Akhtaran</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Arak University Of Medical Science, Basij Sq.</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 86 3417 3645</telephone>
        <email>dr.akhtaran@arakmu.ac.ir</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: age between 20 and 60 years old; ASA I or II; Elective surgery took 1-3 hours(except surgery on the liver and biliary tract). Exclusion: Underlying cardiovascular, pulmonary , renal , hepatic , endocrine diseases; Taking warfarin , aspirin , NSAIDS, vitamins, corticosteroids,  Immuno‐Suppressive Drug or any medications interfere with liver function;History of drug abuse, alcohol, cigarettes; History of hepatitis C, B; History of IBD, malabsorption; history of abdominal surgery 5 years ago.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K71</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Toxic liver disease</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>In intervention group patients will receive 150 mg/kg N-Acetyl cysteine with 250 ml normal saline in single IV dose and isoflurane will be used for maintenance anesthesia. We injected above mentioned solution before induction.All patients will pre-oxygenated with 100% oxygen.Patients will take Fentanyl 2mc/kg, 3-6 mg/kg sodium thiopental ( logi Chem UK)and 0/5 mg/kg Atracurium(Alborz darou).All patients will take 1 mg/kg fentanyl and 0/2 mg/kg atracurium during anesthesia every 40 minutes.Trial group will receive 12/5 mg/kg N-acetyl cysteine during surgery.</i_keyword>
      <i_keyword>In control group patients will receive only 250 ml normal salinein single IV dose and isoflurane will used for maintenance anesthesia.we injected above solution before induction.All patients will pre-oxygenated with 100% oxygen.Patients will take Fentanyl 2mc/kg, 3-6 mg/kg sodium thiopental ( logi Chem UK)and 0/5 mg/kg Atracurium(Alborz darou).All patients every 40 minutes will take 1 mg/kg fentanyl and 0/2 mg/kg atracurium during anesthesia</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>AST. Timepoint: Before surgery, 1 and 24 h after it. Method of measurement: With MAK055 Sigma laboratory kit.</prim_outcome>
      <prim_outcome>ALT. Timepoint: Before surgery, 1 and 24 h after it. Method of measurement: With  MAK052 Sigma laboratory kit.</prim_outcome>
      <prim_outcome>LDH. Timepoint: Before surgery, 1 and 24 h after it. Method of measurement: With MAK066 Sigma laboratory kit.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>PT. Timepoint: Before surgery, 1 and 24 h after it. Method of measurement: PT kit \ medical diagnosis laboratory.</sec_outcome>
      <sec_outcome>PTT. Timepoint: Before surgery, 1 and 24 h after it. Method of measurement: Stago PTT laboratory kit.</sec_outcome>
      <sec_outcome>Mean arterial pressure. Timepoint: before and after induction, after intubation and every 10 minute. Method of measurement: sphygmomanometer.</sec_outcome>
      <sec_outcome>Heart rate. Timepoint: before and after induction, after intubation and every 10 minute. Method of measurement: measuring the number of times their heart beats each minute by touching the pulse.</sec_outcome>
      <sec_outcome>O2 saturation. Timepoint: before and after induction, after intubation and every 10 minute. Method of measurement: measuring of o2 saturation by pulse oximetry.</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>Arak University of Medical Sciences, Vice chancellor for research</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-01-29</approval_date>
        <contact_name>Ethics committee of Arak University of medical sciences</contact_name>
        <contact_address>Arak University Of Medical Science, Basij Sq. Arak  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
