<?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>IRCT20180416039326N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-10-15</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>A comparison of sedative effect with dexmedetomidine -fentanyl versus midazolaml–fentanyl during cataract surgery with phacoemulsification technique</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the sedative effect with Dexmedetomidine-Midazolam and Fentanyl- Midazolam in patients who candidated for Phacoemulsification cataract surgery referred to Isfahan Feyz hospital from 2017-2018</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-06-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/32077</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The division of patients into two groups is based on a  simple random sampling  and Random allocation, Blinding description: The study is double blinded.Patient and researcher are unaware of patient groups and type of medication.The medications are prepared by an anesthetist and encoded  an then injected.Demographic information; Sedation level. The quality of pain relief and hemodynamic variables and complications are collected by a patient who is not aware of the type of drug and patient grouping.</study_design>
      <phase>2</phase>
      <hc_freetext>Cataract surgery.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:patient in group (FD) received 1μg/kg Fentanyl with 0/5 μg/kg Dexmedetomidine in 20cc Normal salin for 10 minutes and then the continuous  infusion of Dexmedetomidine 0/5 μg/kg/hr until the end of surgery. Intervention 2: Control group:patient in group (FM) received 1μg/kg Fentanyl with 0/05 mg/kg Midazolam in 20cc Normal salin for 10 minutes and then the continuous  infusion of Midazolam 0/05 mg/kg/hr until the end of surgery.</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hamidreza Shetabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Feyz hospital, Modares St</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۷۳۴۶۱-۸۱۷۴۶</zip>
        <telephone>+98 31 3668 8138</telephone>
        <email>Hamidshetabi@med.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hamidreza Shetabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Feyz hospital, Modares St</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۷۳۴۶۱-۸۱۷۶۴</zip>
        <telephone>+98 31 3668 5555</telephone>
        <email>Hamidshetabi@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 aged 18–85  years old ASA class 1 &amp; 2 scheduled for phacoemulsification cataract surgery</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>85 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>refusing, mentally challenged patients , history of chronic use of sedatives, narcotics or alcohol , allergy to any of the study medications , patients with severe chronic obstructive pulmonary disease, Asthma,, history of cardiac disease (cardiac block and bradycardia) bradycardia (heart rate less than 50 beats per minute), systolic blood pressure less than 90 mm, Severe hepatic failure, uncontrolled diabetes, left ventricular failure (EF less than 30), and cerebrovascular disease,severe renal failures</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>H28</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cataract in diseases classified elsewhere</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:patient in group (FD) received 1μg/kg Fentanyl with 0/5 μg/kg Dexmedetomidine in 20cc Normal salin for 10 minutes and then the continuous  infusion of Dexmedetomidine 0/5 μg/kg/hr until the end of surgery.</i_keyword>
      <i_keyword>Control group:patient in group (FM) received 1μg/kg Fentanyl with 0/05 mg/kg Midazolam in 20cc Normal salin for 10 minutes and then the continuous  infusion of Midazolam 0/05 mg/kg/hr until the end of surgery.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sedation level. Timepoint: Every 5 minutes during surgery. Method of measurement: Ramsay  sedation score.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Medium atrial Blood pressure. Timepoint: Immediately before surgery, every 5 minutes during surgery and every 10 minutes for 30 minutes in recovery. Method of measurement: Pressure gauge.</sec_outcome>
      <sec_outcome>Oxygen saturation percentage. Timepoint: Immediately before surgery, every 5 minutes during and after surgery every 10 minutes for 30 minutes in recovery. Method of measurement: Pulse oximetry.</sec_outcome>
      <sec_outcome>Heart rate. Timepoint: Immediately before surgery, every 5 minutes during and after surgery every 10 minutes for 30 minutes in recovery. Method of measurement: Pulse oximetry.</sec_outcome>
      <sec_outcome>Surgeon satisfaction. Timepoint: Immediately before surgery, every 5 minutes during and after surgery every 10 minutes for 30 minutes in recovery. Method of measurement: Likert questionnaire.</sec_outcome>
      <sec_outcome>Patient satisfaction. Timepoint: Immediately before surgery, every 5 minutes during and after surgery every 10 minutes for 30 minutes in recovery. Method of measurement: Likert questionnaire.</sec_outcome>
      <sec_outcome>Adverse drug reactions. Timepoint: Immediately before surgery, every 5 minutes during and after surgery every 10 minutes for 30 minutes in recovery. Method of measurement: Adverse drug reaction questionnaire.</sec_outcome>
      <sec_outcome>Pain intensity. Timepoint: Immediately before surgery, every 5 minutes during and after surgery every 10 minutes for 30 minutes in recovery. Method of measurement: Universal Pain assessment tool.</sec_outcome>
      <sec_outcome>Recovery time. Timepoint: After completing the intervention until the withdrawal from the recovery. Method of measurement: Minutes.</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>2018-10-02</approval_date>
        <contact_name>Ethics Committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Isfahan University of medical sciences, Hezar Jarib Street Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
