<?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>IRCT20141001019359N14</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-09-28</date_registration>
      <primary_sponsor>Bojnourd University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of Dexmedetomidine with intravenous Paracetamol on Pain induced by Propofol</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of Dexmedetomidine with intravenous Paracetamol on Pain induced by Propofol 4oc injection; A double-Blind Randomized Clinical Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-10-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65748</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Sampling in this study will be that first in order to enter the study patients will be in the form of non-random sampling of the type "available" and then divide them into three groups by randomly assigned blocking using a web-based system. Random blocking at www.randomization.com will be done in 15 blocks of 6. So that in each block, there are 2 people in the first group (A), two people in the second group (B) and two people in the third group (C). After a random sequence was identified in all blocks, cards were written by writing C, B, and A to indicate which group each patient was assigned to, and by someone other than the research team from 1 to 90 in all blocks, respectively. They are numbered and these cards are placed in sealed non-transparent envelopes, respectively. Then, in order to hide the random allocation, when the patient visits, the opaque sealed envelope will be opened and then one by one, it will be determined for each sample of the relevant group, Blinding description: None of the participants in the study will be aware of the randomization list, and in order to conceal the randomization process, the groups will be placed in closed envelopes in the reception area and will be assigned to the eligible individuals who enter the study. Also, in order to blind the patients to the study groups, all patients will receive the desired drugs intravenously and In order to blind the anesthetist nurse (who is responsible for injecting drugs intravenously for patients), the arms of all patients will be covered with a cloth.</study_design>
      <phase>3</phase>
      <hc_freetext>Pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group A: Before induction of anesthesia, Dexmedetomidine (0.5 µg/kg) will be slowly injected for 5 minutes. Intervention 2: Intervention group B: Before induction of anesthesia, Paracetamol (2 mg/kg) will be slowly injected for 5 minutes. Intervention 3: Control group: Before induction of anesthesia 40 mg of Lidocaine is dissolved in a 10 cc syringe and will be slowly injected to the patient over a period of 3 minutes.</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>Ali Esmaeili</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>North Khorasan School of Medicine, Bojnurd, iran</address>
        <city>Bojnurd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9416678894</zip>
        <telephone>+98583151</telephone>
        <email>dresmaely8@gmail.com</email>
        <affiliation>Bojnourd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Esmaeili</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>North Khorasan School of Medicine, Bojnurd, iran</address>
        <city>Bojnurd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9416678894</zip>
        <telephone>+98583151</telephone>
        <email>dresmaely8@gmail.com</email>
        <affiliation>Bojnourd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The patient must be alert
The patient must be a candidate for surgery under general anesthesia
The patient must not have coagulation problems
The patient must not be allergic to Propofol or the other drugs in the study
The patient must not have cardiovascular problems</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients who are addictive or have drug abuse
Patients with hepatic failure</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R52.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pain, not elsewhere classified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group A: Before induction of anesthesia, Dexmedetomidine (0.5 µg/kg) will be slowly injected for 5 minutes.</i_keyword>
      <i_keyword>Intervention group B: Before induction of anesthesia, Paracetamol (2 mg/kg) will be slowly injected for 5 minutes.</i_keyword>
      <i_keyword>Control group: Before induction of anesthesia 40 mg of Lidocaine is dissolved in a 10 cc syringe and will be slowly injected to the patient over a period of 3 minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Propofol injection pain. Timepoint: Measuring pain in a time interval of 5 to 10 seconds during Propofol injection. Method of measurement: Visual Analog Score (VAS) Form of pain and Numeric rating scale (NRS) For rating the pain.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Mean Arterial Pressure (MAP). Timepoint: Before Propofol injection, 5 seconds after Propofol injection, 30 seconds after Propofol injection. Method of measurement: Use of Monitoring device.</sec_outcome>
      <sec_outcome>Heart Rate (HR). Timepoint: Before Propofol injection, 5 seconds after Propofol injection, 30 seconds after Propofol injection. Method of measurement: Use of monitoring device.</sec_outcome>
      <sec_outcome>Length of recovery and return from anesthesia. Timepoint: From extubation until the patient regains consciousness. Method of measurement: Time observation.</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>Bojnourd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-09-04</approval_date>
        <contact_name>Ethics committee of North Khorasan University of Medical Sciences</contact_name>
        <contact_address>Vice Chancellor for Research of North Khorasan University of Medical Sciences, Bojnurd Bojnord North Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
