<?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>IRCT2014062412789N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-09-13</date_registration>
      <primary_sponsor>Vice Chancellor for Research, Kurdistan University of Medical Sciences</primary_sponsor>
      <public_title>Ketamine efficacy on succinylcholine induced myalgia in outpatient surgeries</public_title>
      <acronym></acronym>
      <scientific_title>Comparison the effect of Ketamin and placebo on succinylcholine induced Myalgia in candidates of outpatient surgeries - A Double Blind Randomized Controlled Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>144</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/12794</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: With randomized block method in categories of four persons, patients were divided into two intervention and control groups. Injection was performed by an anesthesiologist who was informed about patients grouping. Myalgia was measured by an observer who was not aware about injected drug (ketamine or distilled water). Researcher also was not aware of patients grouping and patients did not know to which group (control or intervention) they are located. Monitoring team was aware of patients grouping.</study_design>
      <phase>3</phase>
      <hc_freetext>Myalgia.</hc_freetext>
      <i_freetext>Intervention 1: ketamine 0.5 Mg per Kg (By adding distilled water the volume was reached to 5 mm)  was injected to patients in the intervention group. Then 1.5 mic per kg fentanyl was injected as pre-medication prior to induction of anesthesia and 3 minutes after administration of ketamine and fentanyl, induction of anesthesia using propofol 2 to 2.5 mg per kg was performed. After the disappearance of the corneal reflex succinylcholine 1.5 mg/kg was used for muscle relaxation. Intervention 2: In the intervention group 5 mm distilled water was injected. Then 1.5 mic per kg fentanyl was injected as pre-medication prior to induction of anesthesia and 3 minutes after administration of ketamine and fentanyl, induction of anesthesia using propofol 2 to 2.5 mg per kg was performed. After the disappearance of the corneal reflex succinylcholine 1.5 mg/kg was used for muscle relaxation.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sanaz Arvin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Keshavarz St., Mardokh Four Way,  Besat Hospital</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 87 3328 5910</telephone>
        <email>sanazarvin66@gmail.com</email>
        <affiliation>Kurdistan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Karim Nasseri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Keshavarz St., Mardokh Four Way,  Besat Hospital</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 87 3328 8199</telephone>
        <email>nasseri_k@muk.ac.ir</email>
        <affiliation>Kurdistan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: candidates for elective outpatient surgery, physical condition in accordance with classes I and II of American Society of Anesthesiologists Classification&#13;
 Exclusion criteria: history of allergy to drugs, a history of malignant hyperthermia, history of neuromuscular disease (myopathy)</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M79.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Myalgia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>ketamine 0.5 Mg per Kg (By adding distilled water the volume was reached to 5 mm)  was injected to patients in the intervention group. Then 1.5 mic per kg fentanyl was injected as pre-medication prior to induction of anesthesia and 3 minutes after administration of ketamine and fentanyl, induction of anesthesia using propofol 2 to 2.5 mg per kg was performed. After the disappearance of the corneal reflex succinylcholine 1.5 mg/kg was used for muscle relaxation.</i_keyword>
      <i_keyword>In the intervention group 5 mm distilled water was injected. Then 1.5 mic per kg fentanyl was injected as pre-medication prior to induction of anesthesia and 3 minutes after administration of ketamine and fentanyl, induction of anesthesia using propofol 2 to 2.5 mg per kg was performed. After the disappearance of the corneal reflex succinylcholine 1.5 mg/kg was used for muscle relaxation.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Hemodynamic changes. Timepoint: Before induction of anesthesia, immediately before intubation and 5 minutes after intubation. Method of measurement: Heart rate and blood pressure that measured by machine would be read on monitor and recorded in check list. After complete relaxation, intubation is performed and again after 5 minutes, blood pressure and heart rate would measure and recorded in check list.</prim_outcome>
      <prim_outcome>Myalgia. Timepoint: 24 hours after surgery. Method of measurement: 4-point scale: nil = no muscle pains or stiffness; mild = muscle pains or stiffness at one site but not causing disability or limiting activities; moderate = muscle pains or stiffness at more than one site but not causing disability or limiting activities; severe = muscle pains or stiffness at one site or more and causing disability or limiting activities, e.g., difficulty getting out of bed or turning the head.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Complications. Timepoint: During the surgery and in recovery room. Method of measurement: Observation and monitoring the patient in the recovery room by the researcher.</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>Vice Chancellor for Research, Kurdistan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-06-30</approval_date>
        <contact_name>Ethics Committee of Kurdistan University of Medical Sciences</contact_name>
        <contact_address>Pasdaran St.,Kurdistan University of Medical Sciences Sanandaj  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
