<?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>IRCT20120307009229N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-02-14</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Frequency of Oculocardiac Reflex in scleral buckling</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effect of Intravenous Atropine and Hyoscine on the Frequency of Oculocardiac Reflex in Scleral Buckling Surgery: A double-blinded Randomized Controlled Clinical Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-05-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>75</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/52862</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Other design features: none, Randomization description: In this study, a simple randomization method is used and each patient randomly removes a sealed envelope and announces the number inside it to the researcher, Blinding description: In this double-blinded clinical study, the drugs are injected by one person and each drug is prepared in a 2 cc syringe (2ml solution), the researcher who recorded the information and the patient did not know the type of drug prescribed.</study_design>
      <phase>3</phase>
      <hc_freetext>Hypotony of eye and scleral buckling surgery.</hc_freetext>
      <i_freetext>Intervention 1: first Intervention group- Hyoscine n-butyl bromide is injected in 20 mg and 2 ml of tolidaru before induction of anesthesia. Intervention 2: second Intervention group: Atropine sulfate is injected 0.02 mg/kg up to 0.5 mg in two ml made by Caspian before induction of anesthesia. Intervention 3: Control group- Distilled water is injected in two ml before induction of anesthesia.</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:
Demographic characteristics of patients such as age, sex and weight, as well as changes in heart rate and blood pressure during scleral buckling surgery in patients are evaluated and compared with each other.

When:
After 2022 and the publication of articles in scientific journals

To whom:
medical students and professors and journal editors

Conditions:
except of patient nominal information, patient profiles such as age, sex, weight, and intraoperative hemodynamic changes such as heart rate and blood pressure are available, and individuals are allowed to perform any evaluation and analysis.

Where to obtain:
To access the study information in the following ways, people can apply and contact to Mehryar Taghavi Gilani 
tel: 0513858878
taghavim@mums.ac.ir
Address: Mashhad Imam Reza Hospital - Anesthesia Ward

How to obtain:
Contact Mehryar Taghavi Gilani for any information about the type and method of study and statistical results, as well as the Data obtained.
Phone 0513858878

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>mehryar taghavi gilani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>bahar str</address>
        <city>mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9184532435</zip>
        <telephone>+98 51 3858 3878</telephone>
        <email>taghavim@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>mehryar taghavi gilani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>bahar str</address>
        <city>mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9184532435</zip>
        <telephone>+98 51 3858 3878</telephone>
        <email>taghavim@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>American Society of Anesthesiologists (ASA) class I and II</inclusion_criteria>
      <agemin>5 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>ASA &gt; II,
uncontrolled hypertension,
coronary artery disease,
respiratory disease,
addiction,
preoperative beta-blocker use,
hypersensitivity to hyoscine and atropine</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>H44.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Hypotony of eye</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>first Intervention group- Hyoscine n-butyl bromide is injected in 20 mg and 2 ml of tolidaru before induction of anesthesia.</i_keyword>
      <i_keyword>second Intervention group: Atropine sulfate is injected 0.02 mg/kg up to 0.5 mg in two ml made by Caspian before induction of anesthesia.</i_keyword>
      <i_keyword>Control group- Distilled water is injected in two ml before induction of anesthesia</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Oculocardiac reflex. Timepoint: before induction, after induction, and implantation of the endotracheal tube, at the beginning of surgery and every 10 minutes until the end of the operation. Method of measurement: heart rate changes.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Blood pressure. Timepoint: before induction, after induction, and implantation of the endotracheal tube, at the beginning of surgery and every 10 minutes until the end of the operation. Method of measurement: intraoperative monitoring.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-05-15</approval_date>
        <contact_name>Ethics Committee of Mashhad University of Medical Science</contact_name>
        <contact_address>bahar str mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
