<?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>IRCT201205089684N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-06-23</date_registration>
      <primary_sponsor>Babol University of Medical Sciences</primary_sponsor>
      <public_title>The comparison of Clonidine and Granisetron in the prevention of postoperative shivering, nausea and vomiting.</public_title>
      <acronym></acronym>
      <scientific_title>The comparison of Clonidine and Granisetron in the prevention of postoperative shivering, nausea and vomiting.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-06-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/10253</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>2</phase>
      <hc_freetext>General anesthesia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Administration of Granisetron 40 mcg/kg intravenous immediately before induction of General Anesthesia. Intervention 2: Control group:A tablet 0.2 mg clonidine with 50 ml of water will be administered and performed induction of general anesthesia after 60 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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ommelaila Rabiee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University of Medical Sciences Babol - Paramedicin Sciences</address>
        <city>babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>47176</zip>
        <telephone>+98 11 1223 4274</telephone>
        <email>syasin36@yahoo.com  -    ol.rabiee@gmail.com – amir.9632@gmail.com</email>
        <affiliation>Research Assistant of Babol University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Doctor Ebrahim AliJanpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Babol. Gangafroz state. Rohani Hospital. Department of Anesthesiology</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>47176</zip>
        <telephone>+98 112238296</telephone>
        <email>dralijanpour@yahoo.com</email>
        <affiliation>Research Assistant of babol University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: elective orthopedic surgery, the patients' age ranged from 18 to 65 years old; BMI (Body Mass Index) less than 30 kg/m2 and a maximum of 2 hours of surgery time.&#13;
 Exclusion criteria: emergency surgery; history of seizures, diabetes, Parkinson's or any other diseases that can cause shivering; motion sickness and migraine; history of psychotropic substances or sedatives drugs; addiction to alcohol or opoide; blood transfusion and that products, administration of vasoactive drugs during anesthesia; existence of active infection before anesthesia; receive any anti vomiting 48 hours preoperative; intra operative use of propofol; systolic blood pressure less than 90 or greater than 160 mmHg; patients with difficult intubation and body temperature less than 36 or more than 37.5 degrees centigrade</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></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: Administration of Granisetron 40 mcg/kg intravenous immediately before induction of General Anesthesia.</i_keyword>
      <i_keyword>Control group:A tablet 0.2 mg clonidine with 50 ml of water will be administered and performed induction of general anesthesia after 60 minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Nausea and vomiting. Timepoint: During recovery and world at the 6 hours. Method of measurement: The patients are assessed of the incidence of nausea and vomiting, by a trained individual which is not aware to administrate any drug, and then items to be recorded. Nausea will be assess and recorded base on feeling with the scale of a Multiple Choice without nausea, moderate and severe nausea. If patient can feel nausea at least 5 minutes it is considered an episode of nausea. The severe vomiting will be recorded base on without vomiting, once vomiting (mild), two or three occasions vomiting (moderate) and more than three times vomiting (severe). If there was between vomiting an interspaced at least one minute, each one of them is considered on episode vomiting. Meanwhile, retching can be considered equivalent to vomiting. In items that, patients had a severe nausea or twice vomiting and or the patient's own requests, are prescribed 8 mg Intravenous Metoclopramide as anti-nausea drugs supplemental.</prim_outcome>
      <prim_outcome>Shiviring. Timepoint: The end of anesthesia and during recovery. Method of measurement: The shivering of patients will be evaluated after end anesthesia and during recovery with visual assessment scale, including: Zero =the cases without shivering, degree 1 = status of vasoconstriction and peripheral cyanosis without other cause (or straight hair, but without visible muscular activity), degree 2 = visible muscular activity confined to one muscle group (or mild fasciculation face and neck), degree 3= Visible, Shivering in more than one group of muscle, degree 4= Muscle activity visible that include all body. The items by a person trained and experienced and without the knowledge of the prescribed medicines will be assessed and are recorded in the relevant information. If grade of shivering was 3 or 4, the patient is treated with 25 mg intravenous pethidine.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Systolic blood pressure. Timepoint: Variables of vital signs at intervals before, 10 and 20 minutes after drug administration and immediately after transfer to the recovery are controlled. Method of measurement: Sphygmomanometer.</sec_outcome>
      <sec_outcome>Core temperature (Tempan). Timepoint: Variables of vital signs at intervals before, 10 and 20 minutes after drug administration and immediately after transfer to the recovery are controlled. Method of measurement: Thermometer Tempanic.</sec_outcome>
      <sec_outcome>Diastolic blood pressure. Timepoint: Variables of vital signs at intervals before, 10 and 20 minutes after drug administration and immediately after transfer to the recovery are controlled. Method of measurement: Sphygmomanometer.</sec_outcome>
      <sec_outcome>Surface temperature (axillary). Timepoint: Variables of vital signs at intervals before, 10 and 20 minutes after drug administration and immediately after transfer to the recovery are controlled. Method of measurement: Thermometer's Axillary.</sec_outcome>
      <sec_outcome>Heart rate. Timepoint: Variables of vital signs at intervals before, 10 and 20 minutes after drug administration and immediately after transfer to the recovery are controlled. Method of measurement: Pulsoxymetri.</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>Babol University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-04-24</approval_date>
        <contact_name>Babol University of Medical Sciences</contact_name>
        <contact_address>Babol. gangafroz state .University of Medical Sciences babol Babol  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
