<?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>IRCT20121204011662N15</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-12-03</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Survey the effect of mixture of two anesthetic drugs on control of  postoperative pain  of opioid dependent patients undergoing orthopedic  ankle surgery.</public_title>
      <acronym></acronym>
      <scientific_title>Survey the effect of Ketodex on postoperative pain management of opioid-dependent patients undergoing orthopedic ankle surgery.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-12-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/51842</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly allocated into two groups by block randomization. In this technique, a permutation block of size 4 will be made for patients of two groups A &amp; B. In each block, equal numbers for two groups will be considered in alternative positions. Then 15 blocks of size 4 will be selected randomly and 
patients will be allocated randomly and equally into three groups according to these permutation block, Blinding description: For blindness, All of the drugs solution (ketodex and normal saline) of this study will be prepared in  50 ml syringes that are similar and equal in shape, by a nurse of anesthesia who is aware of patients' grouping. These syringes will have labels A or B. An anesthesiologist who will use these syringes will not aware of the content of these syringes, and just will use syringes with label A for patients in group A and syringes with label B for patients in group B. Patients and all medical staffs who will collaborate in data gathering, will not be aware of the content of these syringes.</study_design>
      <phase>3</phase>
      <hc_freetext>Acute pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: patients in group A, Ketodex infusion (Ketamine 0.1mg/Kg/min and Dexmedetomidine 0.1 mic/Kg/min ) will be started through a 50 ml syringe with the label A after induction of anesthesia till the end of surgery. Intervention 2: Control group: after induction of anesthesia, patients in group B will  received intravenous infusion of the  normal saline  through a 50 ml syringe with the label B till end of 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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>MohammadAli Sahmeddini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Anesthesia Department, Operation Room, Nemazee hospital, Nemazee square, Zand boulevard</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7193711351</zip>
        <telephone>+98 71 3647 4270</telephone>
        <email>sahmeddin@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>MohammadAli Sahmeddini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Anesthesia and Critical Research Center, Anesthesia Department, Operation Room, Nemazee Hospital, Nemazee square</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7193711351</zip>
        <telephone>+98 71 3647 4270</telephone>
        <email>sahmeddini@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All opioid dependent patients  who will be candidate for orthopedic ankle surgery under general anesthesia.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients  with history of cardiovascular disorders
Patients  with history of seizure disorder
Patients  with history of brain tumor
Patients  with history of taking illicit medications
Patients  with history of psychologic disorder
If  general anesthetic  will  not be used.
If patient has ASA class  III  or more.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G89.18</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other acute postprocedural pain</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: patients in group A, Ketodex infusion (Ketamine 0.1mg/Kg/min and Dexmedetomidine 0.1 mic/Kg/min ) will be started through a 50 ml syringe with the label A after induction of anesthesia till the end of surgery.</i_keyword>
      <i_keyword>Control group: after induction of anesthesia, patients in group B will  received intravenous infusion of the  normal saline  through a 50 ml syringe with the label B till end of surgery.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Postoperative analgesia. Timepoint: Every 15 min after patients will become awake in post-anesthesia care unit (PACU). During the first 24 h, postoperative analgesia will be evaluated every 2 hr for 8 hr then every 4 hr till 24 hr. Method of measurement: By using Numerical Rating Pain Score (0= No pain,...10= the most severe pain that could imagine).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Sedation. Timepoint: Every 15 minute in PACU (post anesthesia care unit ). Method of measurement: By using   Ramsay sedation score: 0 = Restless , 1 = Calm, 2 = Sleepy, 3 = Drowsy with response to verbal stimuli , 4 = Drowsy without response to verbal stimuli, 5 = Without response to painfull stimuli.</sec_outcome>
      <sec_outcome>Postoperative nausea and vomiting. Timepoint: Every 4 hr. during first 24 hr. post operation. Method of measurement: By using 3-point scale: 0 = no nausea, vomiting, 1 = nausea only, and 2 = retching or/and vomiting.</sec_outcome>
      <sec_outcome>Mean arterial blood pressure (MAP). Timepoint: Values will record  every 15 minutes till end of surgery. Method of measurement: Non invasive blood pressure monitoring.</sec_outcome>
      <sec_outcome>Heart rate per minute. Timepoint: Values will record  every 15 minutes till end of surgery. Method of measurement: Electrocardiogram.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-10-13</approval_date>
        <contact_name>Ethics Committee of Shiraz Medical School</contact_name>
        <contact_address>3rd Floor, 3rd buiding of the Shiraz Medical School, Zand Blvd. Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
