<?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>IRCT2015011314333N28</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-01-31</date_registration>
      <primary_sponsor>Kermanshah University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of sedation effects of sufentanil and midazolam with nitrous oxide in cataract surgery</public_title>
      <acronym></acronym>
      <scientific_title>Comparation of sedation sufentanil and midazolam  with nitrous oxide in  patients of cataract surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/13964</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>cataract surgery.</hc_freetext>
      <i_freetext>Intervention 1: The experiment group received a mixture of nitrous oxide (aspiration gas with oxygen made in Iran Darman Gaz) and oxygen company with ratio of %66 and %33 in Face mask with flow of 6 lit/min while it is fixed on the patient’s face. Extra gas and patient’s expiration were vacuumed through the mask which was linked to the air conditioning system. After 3 to 5 minutes after gas emission, operation is accomplished using regional anesthesia perry bulbar. Patients were examined for their blood pressure heart rate, vein blood oxygen saturation before the surgery, beginning the surgery and throughout the surgery every 5 minutes. They were also checked before transferring the patient to recovery room. Intervention 2: The experiment group received 5 Milligram of sufentanil (common treatment) (the injection of  mic/ml made of Teharan Daroopakhsh company-Iran) and 1 milligram of IV  midazolam 5 mg/ml (produced by Teharn daroopakhsh company-Iran) were indoctrinated with oxygen and air in ratio of %50 in a flow of 6 liters in minute in %50. Face with 100 to 500 milliliter liquid was used and patients went under operation using regional anesthesia perry bulbar. Then, patients were examined for their blood pressure heart rate, vein blood oxygen saturation before the surgery, beginning the surgery and throughout the surgery every 5 minutes. They were also checked before transferring the patient to recovery room.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname></firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address></address>
        <city></city>
        <country1></country1>
        <zip></zip>
        <telephone></telephone>
        <email></email>
        <affiliation></affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Bahman Roshani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Emam Khomeyni  hospital, Street of Naghliyeh</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 83 3728 5054</telephone>
        <email>Broshani@yahoo.com</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion: satisfaction of patients; candidates to cataract surgery;&#13;
Exclusion: people under 18 or over 80; pregnant women; patients with chronic lung diseases; heart failure with chronic hypoxemia; addicts; patients who experienced general anesthesia or surgeries longer than 30 minutes.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>H43.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Disorder of vitreous body, unspecified</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>The experiment group received a mixture of nitrous oxide (aspiration gas with oxygen made in Iran Darman Gaz) and oxygen company with ratio of %66 and %33 in Face mask with flow of 6 lit/min while it is fixed on the patient’s face. Extra gas and patient’s expiration were vacuumed through the mask which was linked to the air conditioning system. After 3 to 5 minutes after gas emission, operation is accomplished using regional anesthesia perry bulbar. Patients were examined for their blood pressure heart rate, vein blood oxygen saturation before the surgery, beginning the surgery and throughout the surgery every 5 minutes. They were also checked before transferring the patient to recovery room.</i_keyword>
      <i_keyword>The experiment group received 5 Milligram of sufentanil (common treatment) (the injection of  mic/ml made of Teharan Daroopakhsh company-Iran) and 1 milligram of IV  midazolam 5 mg/ml (produced by Teharn daroopakhsh company-Iran) were indoctrinated with oxygen and air in ratio of %50 in a flow of 6 liters in minute in %50. Face with 100 to 500 milliliter liquid was used and patients went under operation using regional anesthesia perry bulbar. Then, patients were examined for their blood pressure heart rate, vein blood oxygen saturation before the surgery, beginning the surgery and throughout the surgery every 5 minutes. They were also checked before transferring the patient to recovery room.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Blood pressure. Timepoint: Every 5 minutes before the surgery, beginning the surgery and during the surgery; after the surgery and before transferring the patient to recovery room. Method of measurement: Recording blood pressure with monitoring tools.</prim_outcome>
      <prim_outcome>Heart beat. Timepoint: Every 5 minutes before the surgery, beginning the surgery and during the surgery; after the surgery and before transferring the patient to recovery room. Method of measurement: The number of heart beats recorded by monitoring tool.</prim_outcome>
      <prim_outcome>Vain blood oxygen saturation. Timepoint: Every 5 minutes before the surgery, beginning the surgery and during the surgery; after the surgery and before transferring the patient to recovery room. Method of measurement: Based on ratio of vein blood oxygen saturation recorded by monitoring and pulse oximetry tools.</prim_outcome>
      <prim_outcome>Patient movement. Timepoint: Beginning the surgery and  every 5 minutes to the end of the surgery. Method of measurement: By the doctor.</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>Kermanshah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-03-04</approval_date>
        <contact_name>Kermanshah University of Medical Sciences</contact_name>
        <contact_address>Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences Kermanshah  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
