<?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>IRCT20231124060161N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-04-29</date_registration>
      <primary_sponsor>CMH Rawalpindi</primary_sponsor>
      <public_title>Dexmedetomidine versus propofol for maintenance of anesthesia after sevoflurane induction in children undergoing MRI.</public_title>
      <acronym></acronym>
      <scientific_title>Dexmedetomidine versus propofol for maintenance of anesthesia after sevoflurane induction in children undergoing MRI.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-01-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>140</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/76119</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Other design features: The patients were randomized into two groups of 70 patients each. After confirming nil per oral status in the recovery room of the MRI suite on the day of the procedure, an informed written consent was taken from the next of kin and they were explained about the parameters of the study protocol, Randomization description: . The patients were randomized into two groups of 70 patients each. After confirming nil per oral status in the recovery room of the MRI suite on the day of the procedure, an informed written consent was taken from the next of kin and they were explained about the parameters of the study protocol. Before going into the MRI suite, age, weight, and gender were recorded by a resident anesthetist unaware of the study protocol. Basic vital monitoring including blood pressure, heart rate, saturation, and electrocardiogram was attached. Pre-oxygenation was done with a good seal and appropriately sized facemask and continued till end-tidal O2 levels on the anesthesia machine were &gt;90%. Inhalational induction with Sevoflurane 1.0 MAC (minimum alveolar concentration) was then carried out and weight and age-appropriate i-gel (Laryngeal mask airway) was inserted to secure the airway. Maintenance of anesthesia was then carried out with IV Propofol and IV Dexmedetomidine in respective groups. Sevoflurane was then shut off and maintenance doses of both drugs were started. Patients in Group P (IV Propofol) received a maintenance infusion of 100 mcg/kg/min whereas patients in Group D (IV Dexmedetomidine) received a dose of 1 mcg/kg/hour titrated in an infusion pump till the time of completion of the procedure. The infusion pumps were marked as X and Y and prepared by the consultant on duty to ensure blinding and parameters studies were recorded on a proforma given to the resident anesthetist on duty in the suite unaware of the study protocol or the drug used. Per-operative bradycardia (HR&lt;80 and &lt;60 according to respective age) was managed with IV atropine 0.02 mg/kg and hypotension (MAP &lt;60) was managed with IV phenylephrine 10 mcg bolus12.</study_design>
      <phase>N/A</phase>
      <hc_freetext>post-operative recovery in children undergoing elective diagnostic MRI (magnetic resonance imaging)..</hc_freetext>
      <i_freetext>Intervention 1: Control group: Inhalational induction with Sevoflurane 1.0 MAC (minimum alveolar concentration) was then carried out and weight and age-appropriate i-gel (Laryngeal mask airway) were inserted to secure the airway. Maintenance of anesthesia was then carried out with IV Propofol and IV Dexmedetomidine in respective groups. Intervention 2: Intervention group: . Patients in Group P (IV Propofol) received a maintenance infusion of 100 mcg/kg/min. Intervention 3: Intervention group: whereas patients in Group D (IV Dexmedetomidine) received a dose of 1 mcg/kg/hour titrated in an infusion pump till the time of completion of the procedure.</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 further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Saddam Hussain</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>CMH road rawalpindi</address>
        <city>Rawalpindi</city>
        <country1>Pakistan</country1>
        <zip>46000</zip>
        <telephone>+92 333 1959678</telephone>
        <email>saddam13315@gmail.com</email>
        <affiliation>CMH Rawalpindi</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Saddam Hussain</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>CMH road rawalpindi</address>
        <city>Rawalpindi</city>
        <country1>Pakistan</country1>
        <zip>46000</zip>
        <telephone>+92 333 1959678</telephone>
        <email>saddam13315@gmail.com</email>
        <affiliation>CMH Rawalpindi</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>all children aged 1-12 years of age presenting to the pre-anesthesia clinic for diagnostic MRI.</inclusion_criteria>
      <agemin>1 year</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>patients &lt;1 and &gt;18 years.
children with congenital heart disease or other congenital anomalies of major organs.
children with known allergy to propofol or dexmedetomidine.
children with major cardiac or respiratory disease.
history of general anesthesia in the last 8 weeks.
children with respiratory tract infections and children requiring intubation during the procedure for any indication required..</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Y48.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Anaesthetic, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: Inhalational induction with Sevoflurane 1.0 MAC (minimum alveolar concentration) was then carried out and weight and age-appropriate i-gel (Laryngeal mask airway) were inserted to secure the airway. Maintenance of anesthesia was then carried out with IV Propofol and IV Dexmedetomidine in respective groups.</i_keyword>
      <i_keyword>Intervention group: . Patients in Group P (IV Propofol) received a maintenance infusion of 100 mcg/kg/min.</i_keyword>
      <i_keyword>Intervention group: whereas patients in Group D (IV Dexmedetomidine) received a dose of 1 mcg/kg/hour titrated in an infusion pump till the time of completion of the procedure.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Heart rate. Timepoint: Before intervention and after 5 minutes after. Method of measurement: Cardiac monitor, pulse oximetry, ECG.</prim_outcome>
      <prim_outcome>Mean arterial pressure. Timepoint: Before intervention and after 5 minutes after. Method of measurement: Cardiac monitor, sphygmomanometer.</prim_outcome>
      <prim_outcome>Respiratory rate. Timepoint: Before intervention and after 5 minutes after. Method of measurement: Ventilator parameter.</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>CMH Rawalpindi</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-08-01</approval_date>
        <contact_name>Ethical  committee Review board</contact_name>
        <contact_address>CMH road rawalpindi Rawalpindi Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
