<?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>IRCT201104236266N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2011-05-09</date_registration>
      <primary_sponsor>none</primary_sponsor>
      <public_title>Target Controlled Infusion of Remifentanil with Propofol or Desflurane under Bispectral Index Guidence: quality of anesthesia and recovery profile</public_title>
      <acronym></acronym>
      <scientific_title>Target Controlled Infusion of Remifentanil with Propofol or Desflurane under Bispectral Index Guidence: quality of anesthesia and recovery profile</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2009-04-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/6711</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2</phase>
      <hc_freetext>Quality of anesthesia and recovery profile.</hc_freetext>
      <i_freetext>Intervention 1: TCI geoup; general anaesthesia will be induced with 3 ng mL-1 and 4 µg mL-1 effect site concentrations (Ce) of remifentanil and propofol. Intervention 2: DES group; general anaesthesia will be induced with 3 ng mL-1 and 4 µg mL-1 effect site concentrations (Ce) of remifentanil and propofol, respectively, after intubation, propofol infusion is ceased in the DES group and desflurane with an initial delivered fraction of 6 % is administered.</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>Ahmet Mahli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Gazi University Faculty of Medicine, Department of Anaesthesiology and Reanimation</address>
        <city>Ankara</city>
        <country1>Turkey</country1>
        <zip>06500</zip>
        <telephone>+90 312 2024166</telephone>
        <email>amahli@gazi.edu.tr</email>
        <affiliation>Gazi University Faculty of Medicine, Department of Anaesthesiology and Reanimation</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ahmet Mahli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Gazi University Faculty of Medicine, Department of Anaesthesiology and Reanimation</address>
        <city>Ankara</city>
        <country1>Turkey</country1>
        <zip>06500</zip>
        <telephone>+90 312 2024166</telephone>
        <email>amahli@gazi.edu.tr</email>
        <affiliation>Gazi University Faculty of Medicine, Department of Anaesthesiology and Reanimation</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Turkey</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:&#13;
Patients aged 18-65 who are candidate for ENT procedures&#13;
Exclusion criteria:&#13;
Taking any sedative or analgesic drugs 24 hours before surgery, significantly hypertensive (diastolic blood pressure less than100 mmHg) or hypotensive (systolic blood pressure less 100 mmHg) and presence the signs of bradyarrhythmic heart disorders</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Y48.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other and unspecified general anaesthetics</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>TCI geoup; general anaesthesia will be induced with 3 ng mL-1 and 4 µg mL-1 effect site concentrations (Ce) of remifentanil and propofol</i_keyword>
      <i_keyword>DES group; general anaesthesia will be induced with 3 ng mL-1 and 4 µg mL-1 effect site concentrations (Ce) of remifentanil and propofol, respectively, after intubation, propofol infusion is ceased in the DES group and desflurane with an initial delivered fraction of 6 % is administered</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mean arterial pressure. Timepoint: During anesthesia. Method of measurement: Equipment.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Heart rate. Timepoint: During anesthesia. Method of measurement: Physical exam.</sec_outcome>
      <sec_outcome>Early emergence from anesthesia. Timepoint: During anesthesia. Method of measurement: Physical exam.</sec_outcome>
      <sec_outcome>Patients’ aldrete score (ARS). Timepoint: During anesthesia. Method of measurement: Physical exam.</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>none</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2009-03-01</approval_date>
        <contact_name>Institutional Ethics Committee</contact_name>
        <contact_address>Gazi University Faculty of Medicine, Department of Anaesthesiology and Reanimation Ankara  Turkey</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
