<?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>IRCT20231002059586N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-10-23</date_registration>
      <primary_sponsor>Gorgan University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation the effect of ketamine as a prevention of shivering after spinal anesthesia in lower limb orthopedic surgery in 5Azar hospital in 1402(2023)</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation the effect of ketamine as a prevention of shivering after spinal anesthesia in lower limb orthopedic surgery in 5Azar hospital in 1402(2023)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-11-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72908</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: people Participating in this study are randomly assigned to two groups of ketamine and placebo. In this way, using a 6-sided dice, the samples are assigned to their groups. A number is written on each side, and each number is assigned to one of the blocks in the table, which shows the desired drug group.
K	K	P	K	P	1
P	P	K	P	K	2
K	K	P	P	K	3
K	P	P	K	P	4
P	P	K	P	K	5
P	K	K	K	P	6, Blinding description: The patients are not aware of the type of study group and the selection of the patient, each patient's group and the type of medication received will be delivered by one of the researchers related to the patient. The anesthesiology technician in charge of the patient will not know the type of drug in order to reduce the confounding factors, so according to the two groups of injectable drugs, two types of similar syringes that have no specifications will be used and related medication will be prepared by the anesthesia assistant.</study_design>
      <phase>3</phase>
      <hc_freetext>The effect of ketamine in the prevention of shivering after spinal anesthesia..</hc_freetext>
      <i_freetext>Intervention group: Ketamine injection.</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 The reason for this is due to the observance of ethical principles and the observance of the confidentiality of the patient's personal information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Pparvaneh Ebrahimzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>5 Azar Hospital,5 Azar Street</address>
        <city>Gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4917763681</zip>
        <telephone>+98 17 3115 3367</telephone>
        <email>dr.parvaneh.ez@gmail.com</email>
        <affiliation>Gorgan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>kazem kazemnejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>5 Azar Hospital, 5 Azar Street</address>
        <city>gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4917763681</zip>
        <telephone>+98 17 3115 3367</telephone>
        <email>kazemnejad@goums.ac.ir</email>
        <affiliation>Gorgan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The age of the study subjects is 18-60 years
ASA1, 2
Orthopedic surgery of the lower limb
PT-PTT tests are normal
The patient must consent to the research.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patient dissatisfaction with spinal anesthesia
ASA 3,4,5
Neurological and psychiatric diseases
Myelopathy and peripheral neuropathies
Spinal canal stenosis
Aortic stenosis
Infection
High blood pressure is not controlled
History of cerebral aneurysms
High intracerebral pressure
Pregnancy
MI in the last 3 months</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>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Ketamine injection</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Shivering. Timepoint: The occurrence of shivering is checked in 15, 30, 45, 60, 75 minutes after the spinal procedure. Method of measurement: Based on the patient's clinical symptoms of having or not having shivering, it is done.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Hemodynamic changes including: Change in mean arterial pressure. Timepoint: It is measured after spinal anesthesia in 15, 30, 45, 60, 75 minutes. Method of measurement: mmHg, number per minute, percent.</sec_outcome>
      <sec_outcome>Nausea and vomiting. Timepoint: The occurrence of nausea and vomiting after spinal anesthesia is checked in 15, 30, 45, 60, 75 minutes. Method of measurement: It is evaluated based on the occurrence of symptoms of nausea and vomiting.</sec_outcome>
      <sec_outcome>Change in heart rate. Timepoint: It is checked based on the rate of heart rate change after spinal anesthesia in 15, 30, 45, 60, 75 minutes. Method of measurement: It is measured by the number of heartbeats per minute.</sec_outcome>
      <sec_outcome>Hallucination: Misunderstanding of objects or events that involve human senses. Visual hallucinations are more common in the use of ketamine. Timepoint: It is checked based on the occurrence of hallucination symptoms after spinal anesthesia in 15, 30, 45, 60, 75 minutes. Method of measurement: Hallucination is evaluated based on having or not having clinical symptoms.</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>Gorgan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-07-25</approval_date>
        <contact_name>Ethics Committee of Golestan University of Medical Sciences</contact_name>
        <contact_address>5 Azar Hospital, 5 Azar Street gorganodhfhk 5 Golestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
