<?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>IRCT20200825048515N16</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-12-15</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of intracameral lidocaine on hemodynamic parameters and postoperative pain in cataract surgery</public_title>
      <acronym></acronym>
      <scientific_title>The effect of intracameral lidocaine on hemodynamic parameters and postoperative pain in cataract surgery under topical anesthesia and sedation</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-12-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>62</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/52890</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 62 eligible patients will be randomly selected. Then, these patients will be randomly encoded using computer software called "Random Allocation" and automatically divided into two groups. The relevant codes will be entered in the raw checklists and each of these checklists will be randomly assigned to one patient and that patient will be randomly assigned to one of the two study groups, Blinding description: In this study, due to the different nature of lidocaine injection in the intervention group (in the eye chamber), the researcher is aware of the treatment used for the two groups. However, the patient due to lack of consciousness and the person evaluating the patient's hemodynamic parameters and the data analyst,  will not have any information about the two groups.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Cataract extraction.</hc_freetext>
      <i_freetext>Intervention 1: Control group: For patients in this group to cause local anesthesia, a drop of 0.5% tetracaine ocular drug is used topically from 20 minutes before the operation and is repeated every 5 minutes until the start of surgery. And immediately after corneal incision and before capsulorhexis, four drops of sterile BSS solution are injected into the anterior chamber. Intervention 2: Intervention group: Intervention group: For patients in the intervention group to cause local anesthesia, a drop of 0.5% tetracaine ocular drug is used topically from 20 minutes before the operation and is repeated every 5 minutes until the start of surgery. Immediately after corneal incision and before capsulorhexis, four drops of 1% lidocaine are injected into the anterior chamber without preservatives.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Daroush Moradi Farsani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Feiz hospital, Ayatollah Modarres Street, Ghods Square, Isfahan.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8149644874</zip>
        <telephone>+98 31 3445 2034</telephone>
        <email>dmoradi@med.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Daroush Moradi Farsani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Feiz Hospital, Ayatollah Modarres Street, Ghods Square, Isfahan.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8149644874</zip>
        <telephone>+98 31 3445 2034</telephone>
        <email>dmoradi@med.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>An age group of 40 to 80 years old
Candidates for cataract surgery using phaco-emulsification
Under topical anesthesia and sedation
Classified as ASA I and ASA II based on the American Society of Anesthesiologists classification</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of opioids abuse
Allergy to lidocaine or tetracaine
History of alcohol and psychedelic abuse
History of untreated systemic disease and hemodynamic disorder
History of convulsion
Pregnancy and breastfeeding
History of mental illness
Taking painkillers 24 hours before surgery
Body Mass Index (BMI) &gt; 35</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z98.49</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cataract extraction status, unspecified eye</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>Control group: For patients in this group to cause local anesthesia, a drop of 0.5% tetracaine ocular drug is used topically from 20 minutes before the operation and is repeated every 5 minutes until the start of surgery. And immediately after corneal incision and before capsulorhexis, four drops of sterile BSS solution are injected into the anterior chamber.</i_keyword>
      <i_keyword>Intervention group: Intervention group: For patients in the intervention group to cause local anesthesia, a drop of 0.5% tetracaine ocular drug is used topically from 20 minutes before the operation and is repeated every 5 minutes until the start of surgery. Immediately after corneal incision and before capsulorhexis, four drops of 1% lidocaine are injected into the anterior chamber without preservatives.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mean arterial blood pressure. Timepoint: Immediately before the start of relaxation, 15 and 30 minutes after the start of the operation, at the beginning of recovery, 15 minutes, 30 minutes, 2 hours, 4 hours, 8 hours, 24 hours after surgery. Method of measurement: Monitoring device.</prim_outcome>
      <prim_outcome>Heart rate. Timepoint: Immediately before the start of sedation, 15 and 30 minutes after the start of the operation, at the beginning of recovery, 15 minutes, 30 minutes, 2 hours, 4 hours, 8 hours, 24 hours after surgery. Method of measurement: Monitoring device.</prim_outcome>
      <prim_outcome>Respiratory rate. Timepoint: Immediately before the start of sedation, 15 and 30 minutes after the start of the operation, at the beginning of recovery, 15 minutes, 30 minutes, 2 hours, 4 hours, 8 hours, 24 hours after surgery. Method of measurement: Monitoring device.</prim_outcome>
      <prim_outcome>Pain score. Timepoint: Immediately upon entry to recovery, 15 minutes, 30 minutes, 2 hours, 4 hours, 8 hours and 24 hours after surgery. Method of measurement: Visual Analogue Scale.</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>Isfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-10-31</approval_date>
        <contact_name>Ethics committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
