<?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>IRCT20160307026950N54</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-10-17</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>study of the combination of dexmedetomidine-propofol, dexmedetomidine and propofol for sedation</public_title>
      <acronym></acronym>
      <scientific_title>Comparative study of the combination of dexmedetomidine-propofol, dexmedetomidine and propofol for sedation during mechanical ventilation in patients hospitalized in the intensive care unit</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/73156</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is done in a simple way. The samples are randomly placed in three intervention groups 1, 2 and 3 by means of random allocation software. Sampling continues until the samples in all three groups reach the set limit, Blinding description: This study is a three-way blind clinical trial, so that the patient is included in the study but does not know the type of intervention applied and is blind, the person who records the patient's symptoms is also different from the person who injects the medicine. And without knowing the type of medicine, he only records the patient's symptoms during the study and therefore is kept blind. The analysts who analyze the data collected during the study also do not know the type of intervention applied in each group and are blind.</study_design>
      <phase>3</phase>
      <hc_freetext>Need for sedation during mechanical ventilation.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the first group, the loading dose of dexmedetomidine was 1 µg kg–1 h–1 within 10 minutes and then the infusion 0.1 µg kg–1h–1. Intervention 2: Intervention group: In the second group, propofol (1%) loading dose of 1 mg kg-1 within 10 minutes and then infusion of 1 mg kg-1 kg-1h-1. Intervention 3: Intervention group: In the second group, propofol (1%) loading dose of 1 mg kg-1 within 10 minutes and then infusion of 1 mg kg-1 kg-1h-1.</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 There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sayed a olfactory mousavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>soffeh boulevard, shahid keshvari highwayAlzahra hospital</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174675731</zip>
        <telephone>+98 31 3620 2020</telephone>
        <email>sayedmousavi88888@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Behzad nazemoroaya</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Alzahra hospital, soffeh boulevard, shahid keshvari highway</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174675731</zip>
        <telephone>+98 31 3620 2020</telephone>
        <email>behzad_nazem@med.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age over 18 years and under 70 mechanical ventilation hospitalized in the intensive care unit, Glasgow coma number is less than 9.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with contraindications to dexmedetomidine and propofol
Patients with serious mental disorders and dementia
People with acute infectious diseases or severe underlying diseases including liver dysfunction, cardiovascular disorders including heart block, heart rate ≤ 60, heart failure with ejection fraction ≤ 30%, diabetes or severe blood pressure (120/180)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></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>Intervention group: In the first group, the loading dose of dexmedetomidine was 1 µg kg–1 h–1 within 10 minutes and then the infusion 0.1 µg kg–1h–1</i_keyword>
      <i_keyword>Intervention group: In the second group, propofol (1%) loading dose of 1 mg kg-1 within 10 minutes and then infusion of 1 mg kg-1 kg-1h-1</i_keyword>
      <i_keyword>Intervention group: In the second group, propofol (1%) loading dose of 1 mg kg-1 within 10 minutes and then infusion of 1 mg kg-1 kg-1h-1</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sedation rate of patients. Timepoint: At the base time (before the start of the intervention) and then every 24 hours. Method of measurement: The level of patient sedation will be evaluated using the Ramsay criterion, whose validity and reliability have been confirmed by a recent study.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Mean arterial pressure. Timepoint: Baseline time (before the start of the intervention) then every 6 hours. Method of measurement: barometer.</sec_outcome>
      <sec_outcome>Heart Rate. Timepoint: Baseline time (before the start of the intervention) then every 6 hours. Method of measurement: ECG.</sec_outcome>
      <sec_outcome>Arterial blood oxygen saturation. Timepoint: Baseline time (before the start of the intervention) then every 6 hours. Method of measurement: pulse oximeter.</sec_outcome>
      <sec_outcome>Blood pressure. Timepoint: Baseline time (before the start of the intervention) then every 6 hours. Method of measurement: Barometer.</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>2023-10-14</approval_date>
        <contact_name>Minimum ethics in the research of medical school of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Hear jerib Esfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
