<?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>IRCT20100908004715N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-01-19</date_registration>
      <primary_sponsor>Babol University of Medical Sciences</primary_sponsor>
      <public_title>The effect of temperature of Intravenous Injection of Serum on postoperative shivering</public_title>
      <acronym></acronym>
      <scientific_title>The effect of iIntravenous Injection of Serum temperature on hemoglobin saturation with oxygen, hemodynamic changes, shivering and postoperative recovery time in patients under general anesthesia and spinal anesthesia in subjects aged 16 to 55 years</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>200</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/32956</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: In this project, 200 patients are selected as samples, divided into two equal groups of 100 general anesthesia and spinal anesthesia. Each  group of 100 people is divided into two groups of 50 cases and controls.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Shivering after operation.</hc_freetext>
      <i_freetext>Intervention 1: In this study, 100 patients between the ages of 16 and 55 undergoing lower limb orthopedic surgery with general anesthesia or spinal anesthesia, with the duration of surgery of more than one hour, were randomly assigned to two groups of 50. The first group, including the general anesthesia group, and spinal anesthesia, with angiocath No18 through the elbow vein of the 1 ml of blood loss 3 ml dextrose saline crystalloid, plus 2 ml per kg body weight, is injected as a preservative dose from the same dextrose saline crystalloid. Blood is also prescribed if the patient's bleeding is more than 15% of the body's blood volume. Liquids administered to the patient (serum and blood) are injected through a fluid heater (warmer) at 37 C. Intervention 2: In this study, 100 patients between the ages of 16 and 55 undergoing lower limb orthopedic surgery with general anesthesia or spinal anesthesia, with the duration of surgery of more than one hour, were randomly assigned to two groups of 50. The first group, including the general anesthesia group, and spinal anesthesia, with angiocath No18 through the elbow vein of the 1 ml of blood loss 3 ml dextrose saline crystalloid, plus 2 ml per kg body weight, is injected as a preservative dose from the same dextrose saline crystalloid. Blood is also prescribed if the patient's bleeding is more than 15% of the body's blood volume. With the exception that in the control group, the dextrose saline crystalloid and the blood may be administered at the same operating temperature (22 C). After the operation, Intervention and control group evaluated for the Hemoglobin saturation with oxygen, hemodynamic changes, shivering and recovery time. The operation temperature is checked by thermometer.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
After completing the project, all information will be provided

When:
At least two months after the completion of the project

To whom:
All employees and students  at hospitals and medical universities

Conditions:
After asking the parson and confirming all the executives of the project

Where to obtain:
Send mail to the messenger

How to obtain:
After sending an email, administrators can respond whithin a maximum of two weeks to one month

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Yousef Mortazavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Babol university of medical sciences</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>47176-47745</zip>
        <telephone>+98 11 3220 8143</telephone>
        <email>Y.mortazavi@mubabol.ac.ir</email>
        <affiliation>Babol University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Yousef Mortazavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Babol university of medical sciences</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>47176-47745</zip>
        <telephone>+98 11 3220 8143</telephone>
        <email>Y.mortazavi@mubabol.ac.ir</email>
        <affiliation>Babol University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All patient aged 16 to 55 years undergoing orthopedic surgery are lower extremity.
The patients surgery should last longer than 1 hour and be used for general anesthesia or spinal anesthesia.</inclusion_criteria>
      <agemin>16 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The patient has Underlying problems such as obesity, vascular problems،  pregnancy and anemia.</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>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In this study, 100 patients between the ages of 16 and 55 undergoing lower limb orthopedic surgery with general anesthesia or spinal anesthesia, with the duration of surgery of more than one hour, were randomly assigned to two groups of 50. The first group, including the general anesthesia group, and spinal anesthesia, with angiocath No18 through the elbow vein of the 1 ml of blood loss 3 ml dextrose saline crystalloid, plus 2 ml per kg body weight, is injected as a preservative dose from the same dextrose saline crystalloid. Blood is also prescribed if the patient's bleeding is more than 15% of the body's blood volume. Liquids administered to the patient (serum and blood) are injected through a fluid heater (warmer) at 37 C.</i_keyword>
      <i_keyword>In this study, 100 patients between the ages of 16 and 55 undergoing lower limb orthopedic surgery with general anesthesia or spinal anesthesia, with the duration of surgery of more than one hour, were randomly assigned to two groups of 50. The first group, including the general anesthesia group, and spinal anesthesia, with angiocath No18 through the elbow vein of the 1 ml of blood loss 3 ml dextrose saline crystalloid, plus 2 ml per kg body weight, is injected as a preservative dose from the same dextrose saline crystalloid. Blood is also prescribed if the patient's bleeding is more than 15% of the body's blood volume. With the exception that in the control group, the dextrose saline crystalloid and the blood may be administered at the same operating temperature (22 C). After the operation, Intervention and control group evaluated for the Hemoglobin saturation with oxygen, hemodynamic changes, shivering and recovery time. The operation temperature is checked by thermometer.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Hemoglobin saturation with oxygen, postoperative shivering and hemodynamic changes. Timepoint: In the first hour, every 15 minutes and up to 4 hours after surgery, every 1 hour once. Method of measurement: Warmers and thermocouple.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Age and sex and type of anesthesia and patient body temperature. Timepoint: Before surgery. Method of measurement: Through the questionnaire.</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>2018-05-27</approval_date>
        <contact_name>The Ethics Committee of Babol University of Medical Sciences</contact_name>
        <contact_address>Mazandaran, Babol, Ganj Afrouz Avenue,  Babol University of Medical Sciences Babol Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
