<?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>IRCT20221020056250N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-12-07</date_registration>
      <primary_sponsor>Gorgan University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effects of three drugs, midazolam, propofol and dexmedetomidine, on hemodynamic changes in cataract surgery patients.</public_title>
      <acronym>ندارد</acronym>
      <scientific_title>A comparison between the effects of midazolam, propofol, and dexmedethomidine on hemodynamics variation in patients undergoing cataract surgery under local anesthesia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>110</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66432</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: ندارد, Randomization description: In this study, a simple random allocation method will be used using a table of random numbers, so that in order to hide it, we used the double-blind method, so that neither the patient nor the researchers related to the patients were aware of the type of study group and the selection of the patient. His group and the type of medicine received will be done by one of the researchers not related to the patient (the person injecting the medicine who is an anesthesiologist), Blinding description: In this study, we have used the double-blind method that the patient and the researchers related to the study were not aware of the type of study group, patient selection, patient grouping and the type of drug received by one of the researchers not related to the patient (injector drug, which is an anesthesiologist) was done in such a way that according to the three types of injectable drugs, three types of syringes were used, and only the anesthesiologist was aware of the type of contents of the syringes and the drugs received by the patients.</study_design>
      <phase>4</phase>
      <hc_freetext>Cataract surgery.</hc_freetext>
      <i_freetext>Intervention 1: The first intervention group: midazolam drug with a sedative dose of 100-25 µg/kg is injected as a intravenous bolus once before surgery for one minute. Intervention 2: The second intervention group: propofol with a low sedation dose, 25-100 µg/kg, is injected as a intravenous bolus once before surgery for one minute. Intervention 3: The third intervention group: dexmedetomidine with a low sedation dose of 0.5-1 µg/kg is injected as a intravenous bolus once before surgery for one minute.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is University does not allow publication</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Reza Akbari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan University of Medical Sciences and Health Services, Hirkan Blvd, Gorgan, Golestan, Iran.</address>
        <city>Gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4934174515.</zip>
        <telephone>+98 58 3222 2683</telephone>
        <email>mr.akbari.1344@gmail.com</email>
        <affiliation>Gorgan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyede Mahrokh Alinaghimaddah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan University of Medical Sciences and Health Services, Hirkan Blvd, Gorgan, Golestan, Iran.</address>
        <city>Gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4934174515</zip>
        <telephone>+98 58 3222 2683</telephone>
        <email>mitramaddah2000@yahoo.com</email>
        <affiliation>Gorgan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients who are candidates for surgery
ASA class 2 and 3 patients
patients in the age range of 18-90 years</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>90 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients aged less than 18 years and more than 90 years
The patient is pregnant</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>H59.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Keratopathy (bullous aphakic) following cataract surgery</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The first intervention group: midazolam drug with a sedative dose of 100-25 µg/kg is injected as a intravenous bolus once before surgery for one minute.</i_keyword>
      <i_keyword>The second intervention group: propofol with a low sedation dose, 25-100 µg/kg, is injected as a intravenous bolus once before surgery for one minute.</i_keyword>
      <i_keyword>The third intervention group: dexmedetomidine with a low sedation dose of 0.5-1 µg/kg is injected as a intravenous bolus once before surgery for one minute.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Blood pressure measurement. Timepoint: Blood pressure before the injection of sedative drugs in each group, then 3 minutes after the injection of sedative drugs, and after that, the result every 5 minutes until the end of the surgery, and finally after delivery to recovery, every 15 minutes for an hour. They are measured so that the patient is delivered to the desired department. Method of measurement: The blood pressure of all patients will be taken by an automatic sphygmomanometer from the arm opposite to the surgical site.</prim_outcome>
      <prim_outcome>Arterial blood oxygen. Timepoint: Blood pressure before the injection of sedative drugs in each group, then 3 minutes after the injection of sedative drugs, and after that, the result every 5 minutes until the end of the surgery, and finally after delivery to recovery, every 15 minutes for an hour. They are measured so that the patient is delivered to the desired department. Method of measurement: During the operation, all patients are examined for arterial blood oxygen saturation percentage while receiving 6 liters of oxygen per minute, and this measurement is done with a pulse oximeter device.</prim_outcome>
      <prim_outcome>Nausea and vomiting. Timepoint: Blood pressure before the injection of sedative drugs in each group, then 3 minutes after the injection of sedative drugs, and after that, the result every 5 minutes until the end of the surgery, and finally after delivery to recovery, every 15 minutes for an hour. They are measured so that the patient is delivered to the desired department. Method of measurement: Vomiting and nausea of the patient during the operation, if observed, is recorded by mentioning the number.</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>Gorgan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-03-14</approval_date>
        <contact_name>Ethics Committee of Golestan Medical School</contact_name>
        <contact_address>Golestan university of medical sciences, Hirkan Blvd, Gorgan, Golestan, Iran. Gorgan Golestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
