<?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>IRCT20230227057548N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-05-15</date_registration>
      <primary_sponsor>Ilam University of Medical Sciences</primary_sponsor>
      <public_title>comparison of the age effect on the side effects of extubation during the use of lidocaine</public_title>
      <acronym></acronym>
      <scientific_title>comparison of the side effects of extubation during the use of intravenous lidocaine in higher and lower 50 years old people who candidate of internal laparoscopic cholecystectomy surgery.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-03-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>122</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69149</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Other, Purpose: Prevention, Blinding description: In this study, consent is obtained from the participants, but no explanation is given regarding the age range that is the subject of the study, and also the information that reaches the data analyst is coded and blinded. Each of them does not know the information about which age range they are.</study_design>
      <phase>3</phase>
      <hc_freetext>In people undergoing internal laparoscopic cholecystectomy surgery.</hc_freetext>
      <i_freetext>Intervention group: people undergoing internal laparoscopic cholecystectomy surgery, in this study, after obtaining informed consent from the patient's companion and after the completion of the surgery and the need for extubation 90 seconds before extubation, intravenous lidocaine at a dose of 1 mg/kg was injected into the patient. And after that, the parameters of laryngospasm and bronchospasm in the period after extubation until the time of leaving recovery, as well as the two criteria of sore throat and cough, from after extubation to the time of leaving recovery, will be evaluated and charted. In this study, 2% lidocaine ampoule of Caspian Tamim pharmaceutical company will be used..</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:
For each patient, information such as age, gender, underlying disease, treatment services, and the patient's clinical condition are recorded before surgery, and after that, laryngospasm, bronchospasm, sore throat, cough are recorded and shared.

When:
The start of the access period is 5 months after the results are published.

To whom:
People working in medical universities of the country

Conditions:
In case of research on the vital condition of patients, including heart rate, breathing rate, blood pressure before and after surgery, access will be allowed.

Where to obtain:
Those who want access can send a letter to my e-mail at mmohammadifard2001@gmail.com.

How to obtain:
It is required to be a member of the University of Medical Sciences with a valid certificate and also a certificate proving the completion of a research project related to the subject, as well as the amount of information required and the reason for using this information.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>mohammad mohammadifard</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>salet street</address>
        <city>ilam</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6931473414</zip>
        <telephone>+98 84 3337 5525</telephone>
        <email>mmohammadifard2001@gmail.com</email>
        <affiliation>Ilam University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>aminolah vasig</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>salek street</address>
        <city>ilam</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6931473414</zip>
        <telephone>+98 84 3337 5525</telephone>
        <email>aminvasigh1344@gmail.com</email>
        <affiliation>Ilam University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Being at least 18 years old
candidate of internal laparoscopic cholecystectomy surgery
consent to participate in the study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>pregnancy
heart disease
liver failure
history of cardiopulmonary resuscitation
history of respiratory disease
high blood pressure
mental retardation
sensitivity to lidocaine
psychological illness
Kidney failure</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: people undergoing internal laparoscopic cholecystectomy surgery, in this study, after obtaining informed consent from the patient's companion and after the completion of the surgery and the need for extubation 90 seconds before extubation, intravenous lidocaine at a dose of 1 mg/kg was injected into the patient. And after that, the parameters of laryngospasm and bronchospasm in the period after extubation until the time of leaving recovery, as well as the two criteria of sore throat and cough, from after extubation to the time of leaving recovery, will be evaluated and charted. In this study, 2% lidocaine ampoule of Caspian Tamim pharmaceutical company will be used.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>In this study, the primary outcome is the incidence of laryngospasm, which is determined and charted by the capnograph tool. Timepoint: Immediately after extubation until exit from recovery for each patient in the study. Method of measurement: Side stream capnograph is used to measure laryngospasm.</prim_outcome>
      <prim_outcome>The incidence of bronchospasm is determined and charted by the capnograph tool. Timepoint: Immediately after extubation until exit from recovery for each patient in the study. Method of measurement: side stream capnograph is used to measure bronchospasm.</prim_outcome>
      <prim_outcome>The amount of sore throat that will be used through the Visual Analogue Scale. Timepoint: Immediately after extubation until exit from recovery for each patient in the study. Method of measurement: The Visual Analogue Scale for measuring pain represents a 10 cm line printed on a piece of paper with markers at each end indicating "no pain" at one end and "worst pain" at the other end or It is "indescribable pain".</prim_outcome>
      <prim_outcome>The number of coughs counted and charted by the researcher. Timepoint: Immediately after extubation until exit from recovery for each patient in the study. Method of measurement: The number of coughs is counted by the researcher and recorded and charted in three ranges: low, medium, and high.</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>Ilam University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-02-28</approval_date>
        <contact_name>Research Ethics Committee of Ilam University of Medical Sciences</contact_name>
        <contact_address>saleek street ilam Ilam Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
