<?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>IRCT20190117042390N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-10-12</date_registration>
      <primary_sponsor>Rafsanjan University of Medical Sciences</primary_sponsor>
      <public_title>Compare effects propofol and dexmedetomidine in hemodynamic Changes and delirium in trauma patients in the ICU of Ali Ebn Abitaleb Hospital of Rafsanjani years 2023</public_title>
      <acronym></acronym>
      <scientific_title>Compare effects propofol and dexmedetomidine in hemodynamic Changes and delirium in trauma patients in the ICU</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-09-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69538</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Crossover, Purpose: Treatment, Other design features: And the exclusion criteria include patients with unstable hemodynamics and drug sensitivity to propofol (due to the possibility of delayed seizures, the patient should be cared for until one day after the operation) as well as patients with a history of drug abuse, drug abuse, or Dependence on alcohol, history of neurological, neuromuscular or psychiatric diseases, especially history of seizures or epilepsy, history of pulmonary and cardiovascular diseases, long-term and chronic use of pain relievers including cyclooxygenase 2 inhibitors are also excluded from the study. used in This research consists of: 1- Propofol with the brand name Pofol (it is a drug that is used by short-acting intravenous injection method and causes a decrease in the level of consciousness or anesthesia. This drug is used to start anesthesia and also maintain anesthesia during surgery. and in the form of 20ml ampoules containing 1% propofol. Due to the use of emulsion, soy and egg, a history of sensitivity to these substances can indicate sensitivity to propofol. 2- Dexmedetomidine, which is a sedative drug and is used in patients who are carefully are under medical care and require mechanical ventilation. Dexmedetomidine is administered as a slow intravenous injection by the medical staff using a slow drug injection device, and it contains 200 mg of dexmedetomidine in ampoules of 20 ml, Randomization description: Sampling was simple random and until the completion of the sample size among eligible clients. Then, the samples are divided into two similar groups of 20 people, dexmedetomidine and propofol, using the table of random numbers.
And they are divided into two groups D and P and they are placed in one of the two groups according to the order of entry into the study (even and odd), Blinding description: There are 40 trauma patients with an age range of 18-55 years.
The study subjects will be divided into two groups of 20 people receiving dexmedetomidine and propofol, and hemodynamic changes and delirium will be investigated.</study_design>
      <phase>4</phase>
      <hc_freetext>Condition 1: head trauma patients. Condition 2: thorax trouma.</hc_freetext>
      <i_freetext>Intervention group:Two groups of 20 people receiving dexmedetomidine and propofol.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
If the request is received, the desired information will be sent via email

When:
Up to one year after publication

To whom:
hamid pakzad

Conditions:
If there is a request from official sources to use new research in line with the topic under study

Where to obtain:
Send to the responsible author's email

How to obtain:
Sending to email, checking and verifying the test and resending to the requester

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyed Hamid Pakzad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Meraj 64</address>
        <city>Rafsanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7737144459</zip>
        <telephone>+98 34 3428 0042</telephone>
        <email>pakzadmoghadam@gmail.com</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>hamid pakzad moghadam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>meraj 64</address>
        <city>Rafsanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7737144459</zip>
        <telephone>+98 34 3428 0042</telephone>
        <email>pakzadmoghadam@gmail.com</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The entry criteria for the study, including all people with trauma in the ICU, and the age range of 18-55 years and the presence of a companion, will be considered as the entry criteria. They are distributed randomly</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S00-S09</hc_code>
      <hc_code>520-529</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>تروما به سر</hc_keyword>
      <hc_keyword>ترومای قفسه سینه</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:Two groups of 20 people receiving dexmedetomidine and propofol</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Hemodynamic changes and delirium. Timepoint: 3 months. Method of measurement: This study is a clinical trial study that will be conducted on 40 trauma patients with an age range of 18-55 years, divided into two groups, that is, under anesthesia with propofol and under anesthesia with dexmedetomidine. In the end, 20 people from each group will be tested for a total of 40 people. Considering the first type error of 5% and the power of 80% and the ability to show the average difference between the two groups that is statistically significant (size effect = 0.5), 20 cases were considered for each group.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Hemodynamic changes and delirium. Timepoint: 16-12-24-48 hours after starting the drug. Method of measurement: questionnaire.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id>401014</sec_id>
        <issuing_authority>مرکز تحقیقات عوامل اجتماعی موثر بر سلامت</issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Rafsanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-09-14</approval_date>
        <contact_name>Ethics Committee of Rafsanjan University of Medical Sciences</contact_name>
        <contact_address>Meraj - Alley65 Rafsanjan Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
