<?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>IRCT20220111053694N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-08-07</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of adding a very low dose of naloxone to remifentanil infusion on pain</public_title>
      <acronym></acronym>
      <scientific_title>Addition of a very low dose of naloxone to remifentanil infusion on postoperative pain in patients undergoing total hip replacement surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-02-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61362</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this randomized clinical trial study, patients are randomly divided into groups with a ratio of 1:1 in two equal parts and using block randomization and sealed envelopes. allocation Concealment is done with a sealed envelope. The envelope method is that the envelopes will be prepared and printed by a member of the research team and random numbers with the help of Randomaize.com and placed inside the envelope. The lid of the envelopes will be closed and its contents will not be visible from the outside, Blinding description: In this study, patients and outcome assessors were unaware of the intervention and control groups.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Patients undergoing complete hip replacement surgery.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the intervention group, naloxone (Caspian tamin pharmaceutical co) with a very low dose (0.05 μg/kg/h) was added to remifentanil (Exir pharmaceutical co) infusion (with a dose of 0.3 μg/kg/min) as IV and through a continuous injection pump until the end of the operation in Patients undergoing total hip replacement surgery. The treatment method is based on the effect of narcotics on peripheral and central µu receptors and the effect of naloxone agonists and antagonists on these receptors. Intervention 2: Control group: Only remifentanil (Exir pharmaceutical co) infusion at a dose of 0.3 μg/kg/min as IV and through a continuous injection pump until the end of the operation was prescribed for patients undergoing total hip replacement surgery.</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 Respecting the privacy of the participants in the study and ethical principles according to the Declaration of Helsinki</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Saeid Jamalie Bastami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>50 Sayad St., No. 28</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9197815861</zip>
        <telephone>+98 51 3884 4186</telephone>
        <email>dr.saeidjamalie98@gmail.com</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Saeid Jamalie bastami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>50 Sayad St., No. 28</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9197815861</zip>
        <telephone>+98 51 3884 4186</telephone>
        <email>drr.saeidjamalie@gmail.com</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>In this study, clinical trial of patients undergoing hip replacement surgery under general anesthesia
No contraindications for general anesthesia
No chronic pain
Between 18 and 65 years
With physical condition ASA I-II (scoring status Physical, American Society of Anesthesiologists)
Filled out a written informed consent form</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Obesity (BMI ≥ 30 kg / m2 )
Pregnancy (based on B-HCG check)
Dependence on drugs and alcohol
Use of any painkillers in the last 24 hours
Unusual bleeding
Ischemic heart disease
History of seizures
Decrease or increase in blood pressure by more than 30% of baseline
Any surgical complications such as prosthetic fractures or enlargement of the surgery due to extensive fractures of the pelvis
Postoperative exclusion criteria include reoperation
Excessive bleeding
Long-term ventilation (&gt; 12 hours)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z96.6</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Presence of orthopaedic joint implants</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>Intervention group: In the intervention group, naloxone (Caspian tamin pharmaceutical co) with a very low dose (0.05 μg/kg/h) was added to remifentanil (Exir pharmaceutical co) infusion (with a dose of 0.3 μg/kg/min) as IV and through a continuous injection pump until the end of the operation in Patients undergoing total hip replacement surgery. The treatment method is based on the effect of narcotics on peripheral and central µu receptors and the effect of naloxone agonists and antagonists on these receptors.</i_keyword>
      <i_keyword>Control group: Only remifentanil (Exir pharmaceutical co) infusion at a dose of 0.3 μg/kg/min as IV and through a continuous injection pump until the end of the operation was prescribed for patients undergoing total hip replacement surgery.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The patient's pain level. Timepoint: before the intervention and 4, 8, 12 and 24 hours after the intervention. Method of measurement: VAS scale (Based on this scale, a score between 1-10 is defined for the patient's pain).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Need to be sedated. Timepoint: The need for other painkillers after surgery to reduce the patient's pain. Method of measurement: Checklist.</sec_outcome>
      <sec_outcome>Time to first sedative. Timepoint: after surgery. Method of measurement: Checklist based on the patient's needs and pain.</sec_outcome>
      <sec_outcome>Cumulative dose of painkiller used. Timepoint: The first 24 hours after the surgery. Method of measurement: Checklist (total dose used).</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-01-20</approval_date>
        <contact_name>Ethics Committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Department of anesthesia, Qaem Hospital, Ahmedabad Blvd, Mashhad, Iran. Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
