<?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>IRCT20200825048515N22</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-01-20</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of propofol and ketofol on restlessness after anesthesia in children</public_title>
      <acronym></acronym>
      <scientific_title>Comparative study of the effect of propofol and ketofol on restlessness after anesthesia in children aged 18-6 months under cleft palate surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-01-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>86</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53182</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 86 eligible patients will be randomly selected. Then, these patients will be randomly encoded using computer software called "Random Allocation" and automatically divided into two groups. The relevant codes will be entered in the raw checklists and each of these checklists will be randomly assigned to one patient and that patient will be randomly assigned to one of the two study groups, Blinding description: In this study, propofol and ketofol, are prepared by the pharmacist and placed in coded packages, and delivered daily to an anesthesiologist, who prescribes them without knowing the type of each drug. Also, the person recording the patient's clinical information and the statistical analyst will not be aware of the type of intervention.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Cleft palate.</hc_freetext>
      <i_freetext>Intervention 1: First intervention group: Anesthesia induction is performed for patients by injecting 2 mg/kg propofol(Caspian Tamin Pharmaceutical), 2 μg/kg fentanyl(Caspian Tamin Pharmaceutical), and 0.5 mg/kg atracurium(Caspian Tamin Pharmaceutical). The propofol (Caspian Tamin Pharmaceutical) maintenance anesthesia is administered to the patient at 100 μg/kg/min with 50% oxygen. Intervention 2: Second intervention group: Anesthesia induction is performed for patients by injecting 2 mg/kg propofol(Caspian tamin Pharmaceutical), 2 μg/kg fentanyl(Caspian Tamin Pharmaceutical), and 0.5 mg/kg atracurium(Caspian Tamin Pharmaceutical). The maintenance anesthesia including a combination of propofol (Caspian Tamin Pharmaceutical) at a dose of 75 μg/kg/min and ketamine (Rotex Medica Pharmaceutical) at a dose of 25 μg/kg/min with 50% oxygen, is administered to the patient.</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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Amir Shafa</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Anesthesiology; Al-Zahra Hospital; Sofeh boulevard</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174675731</zip>
        <telephone>+98 31 3620 2020</telephone>
        <email>shafa_amir@yahoo.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Amir Shafa</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Anesthesiology; Al-Zahra Hospital; Sofeh boulevard</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174675731</zip>
        <telephone>+98 31 3620 2020</telephone>
        <email>shafa_amir@yahoo.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Aged 6 to18 months
Candidate for cleft palate surgery
Classified as ASA I and II based on American Society of Anesthesiologists Classification
Consent to participate in the study</inclusion_criteria>
      <agemin>6 months</agemin>
      <agemax>18 months</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Underlying diseases such as mitochondrial metabolic disorders and fat metabolism disorders
History of convulsion
Growth and development retardation</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Q35.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cleft palate, 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>First intervention group: Anesthesia induction is performed for patients by injecting 2 mg/kg propofol(Caspian Tamin Pharmaceutical), 2 μg/kg fentanyl(Caspian Tamin Pharmaceutical), and 0.5 mg/kg atracurium(Caspian Tamin Pharmaceutical). The propofol (Caspian Tamin Pharmaceutical) maintenance anesthesia is administered to the patient at 100 μg/kg/min with 50% oxygen.</i_keyword>
      <i_keyword>Second intervention group: Anesthesia induction is performed for patients by injecting 2 mg/kg propofol(Caspian tamin Pharmaceutical), 2 μg/kg fentanyl(Caspian Tamin Pharmaceutical), and 0.5 mg/kg atracurium(Caspian Tamin Pharmaceutical). The maintenance anesthesia including a combination of propofol (Caspian Tamin Pharmaceutical) at a dose of 75 μg/kg/min and ketamine (Rotex Medica Pharmaceutical) at a dose of 25 μg/kg/min with 50% oxygen, is administered to the patient.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Delirium score. Timepoint: Immediately upon entering the recovery ward and 15, 30 and 45 minutes later in the recovery. Method of measurement: Pediatric Anesthesia Emergence Delirium Scale (PAED).</prim_outcome>
      <prim_outcome>Pain score. Timepoint: 15, 30 and 45 minutes later in the recovery. Method of measurement: Behavioral scale derived from the Face, Leg, Activity, Cry, Consolability (FLACC).</prim_outcome>
      <prim_outcome>Blood Pressure. Timepoint: Immediately after surgery, in the minutes of 15, 30, and 45 during surgery and immediately, 15, 30, and 45 minutes after recovery. Method of measurement: Monitoring device.</prim_outcome>
      <prim_outcome>Heart rate. Timepoint: Immediately after surgery, in the minutes of 15, 30, and 45 during surgery and immediately, 15, 30, and 45 minutes after recovery. Method of measurement: Monitoring device.</prim_outcome>
      <prim_outcome>Percentage of oxygen saturation. Timepoint: Immediately after surgery, in the minutes of 15, 30 and 45 during surgery and immediately, 15, 30 and 45 minutes after recovery. Method of measurement: Monitoring device.</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>Isfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-11-29</approval_date>
        <contact_name>Ethics committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
