<?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>IRCT20201214049720N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-01-08</date_registration>
      <primary_sponsor>Qazvin University of Medical Sciences</primary_sponsor>
      <public_title>The effect of lidocaine on pain after gallbladder resection</public_title>
      <acronym></acronym>
      <scientific_title>Assessment the effect of lidocaine intravenous infusion on postoperative pain in patients with laparoscopic cholecystectomy under general anesthesia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53054</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization, Blinding description: In this study, the patient will not be aware of the type of study group in which he is placed, as well as the researcher, patient surgeon, patient care nurse in the operating room, recovery ward and post-surgery ward, as well as data analyzer will not be informed about patient grouping .</study_design>
      <phase>2-3</phase>
      <hc_freetext>cholecystitis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the intervention group, after induction of general anesthesia at the beginning of surgery, intravenous infusion of lidocaine for 10 minutes at a dose of 1.5 mg / kg, and also during surgery until the end of intravenous infusion of lidocaine at a dose of 1.5 mg / min It will be done for all patients. Intervention 2: Control group: In the control group, instead of lidocaine, intravenous infusion of normal saline will be 0.9%.</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:
Data on primary and secondary outcomes can be published.

When:
One year after the results are published

To whom:
Researchers and industry owners

Conditions:
Use the results for further planning and research

Where to obtain:
drmsami709@gmail.com

How to obtain:
drmsami709@gmail.com

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Minoo Sami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University of Medical Sciences, Bahonar Blvd, Qazvin, Iran.</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3419759811</zip>
        <telephone>+98 28 3333 3333</telephone>
        <email>drmsami709@gmail.com</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Hesein Moeini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qazvin University of Medical Sciences, Bahonar Blvd, Qazvin, Iran.</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3419759811</zip>
        <telephone>+98 28 3336 9001</telephone>
        <email>moeini200@gmail.com</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age range 18-150 years
ASA class I-II patients
Candidate for elective laparoscopic cholecystectomy</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of seizures
Allergies
Hypertension
Cardiovascular disease
Need for blood transfusion or its products
Duration of surgery more than 2.5 hours</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K80.01</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Calculus of gallbladder with acute cholecystitis with obstruction</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the intervention group, after induction of general anesthesia at the beginning of surgery, intravenous infusion of lidocaine for 10 minutes at a dose of 1.5 mg / kg, and also during surgery until the end of intravenous infusion of lidocaine at a dose of 1.5 mg / min It will be done for all patients.</i_keyword>
      <i_keyword>Control group: In the control group, instead of lidocaine, intravenous infusion of normal saline will be 0.9%.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Post operational Pain. Timepoint: 2, 4, 6 and 8 hours after surgery. Method of measurement: VAS.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Amount of narcotic drug consumption. Timepoint: Post operation. Method of measurement: Patient Document.</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>Qazvin University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-09-17</approval_date>
        <contact_name>Ethics Committee of Qazvin University of Medical Sciences</contact_name>
        <contact_address>Qazvin University of Medical Sciences, Bahonar Blvd, Qazvin, Iran Qazvin Qazvin Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
