<?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>IRCT20200122046216N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-02-10</date_registration>
      <primary_sponsor>Bojnourd University of Medical Sciences</primary_sponsor>
      <public_title>Compare the effect of  TIVA  and isoflurane on the activity of liver enzymes in patients undergoing laparoscopic cholecystectomy</public_title>
      <acronym></acronym>
      <scientific_title>Compare the effect of  TIVA  and isoflurane on the activity of liver enzymes in patients undergoing laparoscopic cholecystectomy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-07-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/45210</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Diagnostic, Randomization description: Patients' entry into this study will be a non-random sampling of "available" type. Then they will be divided into intervention and control groups randomly. The random number table will be used for the random specialization of the samples, Blinding description: The research will be a non-random sampling of the type "available" and then divided into two intervention groups as randomized block allocation using the web system.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Laparoscopic Cholecystectomy Surgery.</hc_freetext>
      <i_freetext>Intervention 1: After the patient enters the operating room, the supine position extends over the operating room bed and is monitored initially. An oximeter probe and pressure gauge cuff are attached to the patient's hand and a ringer serum is provided to the patient. Midazolam (2 mg) and fentanyl (100 mcg) were administered in all patients. Atracurium (0.5 mg / kg) and propofol (2 mg / kg) are used to induce anesthesia. After 3 minutes of hyperventilating the patient and performing the intubation, isoflurane inhaler anesthetic of 1.2 mc is used to maintain anesthesia in the first group. Intervention 2: After the patient enters the operating room, the supine position extends over the operating room bed and is monitored initially. An oximeter probe and pressure gauge cuff are attached to the patient's hand and a ringer serum is provided to the patient. Midazolam (2 mg) and fentanyl (100 mcg) were administered in all patients. Atracurium (0.5 mg / kg) and propofol (2 mg / kg) are used to induce anesthesia. After 3 minutes hyperventilating the patient and performing the intubation, propofol intravenous anesthetic is administered in the anesthetic phase of 100 micrograms per kg body weight plus remifanil (0.1 micrograms per minute body weight).</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:
After the end of the study some data and information will be loaded.

When:
6 months after plan completion

To whom:
Universities and scientific institutes

Conditions:
Citing the source

Where to obtain:
Email to responsible and consent

How to obtain:
It will take up to two months for email to be answered.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahdieh Dartomi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahriar Street - Bojnurd School of Nursing</address>
        <city>Bojnurd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>74877-94149</zip>
        <telephone>+98 58 3229 7095</telephone>
        <email>dartoomi1369m@gmail.com</email>
        <affiliation>Bojnourd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahdieh Dartomi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bojnurd School of Nursing, Shahriar Street</address>
        <city>Bojnurd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>74877-94149</zip>
        <telephone>+98 58 3229 7095</telephone>
        <email>dartoomi1369m@gmail.com</email>
        <affiliation>Bojnourd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Has no history of anesthesia in the past 6 months
The patient's age is between 18 and 70 years old
According to the ASA class, there will be one or two classes of anesthesia</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The patient needs more medication during surgery
Bleeding during surgery
Laparoscopic change to laparotomy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K81</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cholecystitis</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>After the patient enters the operating room, the supine position extends over the operating room bed and is monitored initially. An oximeter probe and pressure gauge cuff are attached to the patient's hand and a ringer serum is provided to the patient. Midazolam (2 mg) and fentanyl (100 mcg) were administered in all patients. Atracurium (0.5 mg / kg) and propofol (2 mg / kg) are used to induce anesthesia. After 3 minutes of hyperventilating the patient and performing the intubation, isoflurane inhaler anesthetic of 1.2 mc is used to maintain anesthesia in the first group.</i_keyword>
      <i_keyword>After the patient enters the operating room, the supine position extends over the operating room bed and is monitored initially. An oximeter probe and pressure gauge cuff are attached to the patient's hand and a ringer serum is provided to the patient. Midazolam (2 mg) and fentanyl (100 mcg) were administered in all patients. Atracurium (0.5 mg / kg) and propofol (2 mg / kg) are used to induce anesthesia. After 3 minutes hyperventilating the patient and performing the intubation, propofol intravenous anesthetic is administered in the anesthetic phase of 100 micrograms per kg body weight plus remifanil (0.1 micrograms per minute body weight).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anesthesia by Tiva. Timepoint: Time to start anesthesia. Method of measurement: Mg / kg body weight.</prim_outcome>
      <prim_outcome>Isoflurane Anesthesia. Timepoint: Anesthesia maintenance time. Method of measurement: Mac Anesthetic Evaporator.</prim_outcome>
      <prim_outcome>ALT Liver Enzyme. Timepoint: Hepatic enzyme activity preoperatively and postoperatively and 24 and 48 hours postoperatively. Method of measurement: Biochemical Autoanalysis Device.</prim_outcome>
      <prim_outcome>AST Liver Enzyme. Timepoint: Hepatic enzyme activity preoperatively and postoperatively and 24 and 48 hours postoperatively. Method of measurement: Biochemical Autoanalysis Device.</prim_outcome>
      <prim_outcome>ALP Liver Enzyme. Timepoint: Hepatic enzyme activity preoperatively and postoperatively and 24 and 48 hours postoperatively. Method of measurement: Biochemical Autoanalysis Device.</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>Bojnourd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-09-19</approval_date>
        <contact_name>Ethics committee of North Khorasan of University of Medical Sciences</contact_name>
        <contact_address>Shahriar Street - Research Assistant Bojnurd North Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
