<?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>IRCT20190626044020N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-12-29</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Comparative Study on the Effect of two  Labetalol-Nitroglycerine Combinations withLabetalol-Hydralazine on volume blood loss During Ducriocysturinostomy with Local Anesthesia</public_title>
      <acronym></acronym>
      <scientific_title>Comparative Study on the Effect of two  Labetalol-Nitroglycerine Combinations withLabetalol-Hydralazine on volume blood loss During Ducriocysturinostomy with Local Anesthesia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/41345</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: Simple randomization
Randomization Unit: Individual
Randomization Tool: Random Number Table, Blinding description: Blindness is that after giving the patient complete information. If there are no criteria for exclusion, the patient will be entered into the study after obtaining informed consent. The patient is not informed about the type of medication used during the study. They also do not know the type of medication used when assistants and health care providers gather information.</study_design>
      <phase>N/A</phase>
      <hc_freetext>stenosis and insufficiency of lacrimal passages.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: After the patient is placed on the baseline monitoring bed including systolic blood pressure, diastolic blood pressure, heart rate and respiratory rate. Then, local anesthesia will be performed by the surgeon using 8 cc lidocaine 2% in both groups. Both groups are given a boletabolol dose of 20 mg within 2 minutes. Doses and rate of intravenous injection are selected based on the policy for hypertension crisis. Then the infusion of labetalol at a rate of 0.5 - 1 mg / min and the maximum dose received will be 300 mg. Group A patients start intravenous infusion of Tri-nitroglycerin 15 - 20 mcg  / min from the lower limit and increase every 5 minutes if necessary to reach target MAP. Intervention 2: Intervention group 1: After the patient is placed on the baseline monitoring bed including systolic blood pressure, diastolic blood pressure, heart rate and respiratory rate. Then, local anesthesia will be performed by the surgeon using 8 cc lidocaine 2% in both groups. Both groups are given a boletabolol dose of 20 mg within 2 minutes. Doses and rate of intravenous injection are selected based on the policy for hypertension crisis. Then the infusion of labetalol at a rate of 0.5 - 1 mg / min and the maximum dose received will be 300 mg. In group B, hydralazine is given 0.5 - 1 mg / min intravenous infusion. The level starts from the lower limit if necessary, increasing every 5 minutes to achieve target MAP.</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 Confidentiality of information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Syed Morteza Heydari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Daneshgah street, Isfahan University of Medical Sciences</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174643446</zip>
        <telephone>+98 31 3445 7701</telephone>
        <email>M_heidari@med.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Syed Morteza Heydari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Daneshgah street, Isfahan University of Medical Sciences</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174643446</zip>
        <telephone>+98 31 3668 5555</telephone>
        <email>M_heidari@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>Patients undergoing DCR surgery who are not contraindicated with hydralazine, tri-nitroglycerin, and labetalol, aged 18 to 80 years
Patient Satisfaction for Inclusion</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Known allergies to medicines
Heart disease
Diabetes mellitus, obvious anemia
Hemoglobinopathy
Polycythemia
Liver disease
Cerebrovascular ischemic disease</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>H04.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>stenosis and insufficiency of lacrimal passages</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>Intervention group 1: After the patient is placed on the baseline monitoring bed including systolic blood pressure, diastolic blood pressure, heart rate and respiratory rate. Then, local anesthesia will be performed by the surgeon using 8 cc lidocaine 2% in both groups. Both groups are given a boletabolol dose of 20 mg within 2 minutes. Doses and rate of intravenous injection are selected based on the policy for hypertension crisis. Then the infusion of labetalol at a rate of 0.5 - 1 mg / min and the maximum dose received will be 300 mg. Group A patients start intravenous infusion of Tri-nitroglycerin 15 - 20 mcg  / min from the lower limit and increase every 5 minutes if necessary to reach target MAP.</i_keyword>
      <i_keyword>Intervention group 1: After the patient is placed on the baseline monitoring bed including systolic blood pressure, diastolic blood pressure, heart rate and respiratory rate. Then, local anesthesia will be performed by the surgeon using 8 cc lidocaine 2% in both groups. Both groups are given a boletabolol dose of 20 mg within 2 minutes. Doses and rate of intravenous injection are selected based on the policy for hypertension crisis. Then the infusion of labetalol at a rate of 0.5 - 1 mg / min and the maximum dose received will be 300 mg. In group B, hydralazine is given 0.5 - 1 mg / min intravenous infusion. The level starts from the lower limit if necessary, increasing every 5 minutes to achieve target MAP.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Determination of the mean volume of bleeding in Dacryocystorhinostomy  to CC. Timepoint: The volume of blood collected in the suction device at the end of surgery. Method of measurement: Blood collected in suction to cc.</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-06-27</approval_date>
        <contact_name>Ethics Committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Daneshgah street, Isfahan University of Medical Sciences Esfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
