<?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>IRCT20121216011766N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-01-09</date_registration>
      <primary_sponsor>Urology Research Center, Guilan University of Medical Sciences</primary_sponsor>
      <public_title>Effect of irrigation fluid temperature on hypothermia and other outcomes of anesthesia</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of irrigation fluid at room temperature with irrigation fluid to body temperature on hypothermia and other intraoperative and postoperative outcomes in patients undergoing transurethral resection of prostate (TURP) under spinal anesthesia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-12-12</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>76</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/52278</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Block randomization with blocks of size 4 with a ratio of 1 to 1 (as two groups A and B) via a online program named sealed envelop/randomisation, Blinding description: One of the researchers (anesthesia resident) will allocate serums to patients in two groups A (serum at room temperature) and B (serum heated to body temperature 37 degrees) based on a table prepared from random blocks. Neither the patient nor the evaluator is aware of the type of serum assigned to the surgery. At the top of the checklist which be completed for each patient, the group type (A or B) will be recorded.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Hypothermia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Irrigation fluid (normal saline 0.9%) warmed to body temperature (37 degrees) using boiler device (made in Iran, sazgar steam (sazgarmed), with a capacity of 9 serums 35 * 30 * 30) to the required number, which varies for each patient depending on individual characteristics and operation time. Intervention 2: Control group: Irrigation fluid (normal saline 0.9%) with room temperature (between 21 and 23 degrees).</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 Due to the possibility of prolonging the study and publication of the article, researchers will decide regarding the details of sharing the unidentifiable personal data of the participants after  the end of the study and publication of the results in the form of an article.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Sadegh Foroughifar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Razi Hospital, Sardar Jangal St.</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>41448-95655</zip>
        <telephone>+98 13 3352 5259</telephone>
        <email>dr_forooghifar@yahoo.com</email>
        <affiliation>Guilan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hossein Khoshrang</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sardar-e-Jangal Ave.</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>41448-95655</zip>
        <telephone>+98 13 3352 5259</telephone>
        <email>hkhoshrang@yahoo.com</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All patients candidate for elective transurethral prostatectomy under spinal anesthesia
The ASA Physical Status Classification I,II (normal healthy patient or patient with mild systemic disease)
Age between 40 to 75 years
Body mass index (BMI) more than 18 and less than 30 kg/m2
Operating time less than 2 hours</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>75 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Active infection
taking antipyretic drugs within 24 hours before surgery
neuropathy
thyroid dysfunction or thyroid hormone use
peripheral vascular disease
skin lesions or history of severe skin contact allergies
contraindications to spinal anesthesia
history of ACEI or CCB use due to impaired self-regulatory mechanism of the patient's body temperature
history of bleeding disorders
history of taking anticoagulants</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T88.51</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Hypothermia following anesthesia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Irrigation fluid (normal saline 0.9%) warmed to body temperature (37 degrees) using boiler device (made in Iran, sazgar steam (sazgarmed), with a capacity of 9 serums 35 * 30 * 30) to the required number, which varies for each patient depending on individual characteristics and operation time</i_keyword>
      <i_keyword>Control group: Irrigation fluid (normal saline 0.9%) with room temperature (between 21 and 23 degrees)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Hypothermia. Timepoint: Upon arrival of the patient in the operating room, at the beginning of the operation, 30 minutes after the start of the operation, at the end of the operation, in the recovery. Method of measurement: The tympanic method means placing a thermometer in the patient's ear and monitoring the temperature during surgery.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Heart rate. Timepoint: Heart rate are recorded every 5 minutes during surgery. Method of measurement: Register in the checklist.</sec_outcome>
      <sec_outcome>Blood pressure. Timepoint: Blood pressure are recorded every 5 minutes during surgery. Method of measurement: Register in the checklist.</sec_outcome>
      <sec_outcome>Hemoglobin. Timepoint: Hemoglobin is checked before and after surgery through a blood test. Method of measurement: Register in the checklist.</sec_outcome>
      <sec_outcome>The amount of transfusion. Timepoint: The amount of transfusion will also be recorded in the operating room. Method of measurement: Register in the checklist.</sec_outcome>
      <sec_outcome>Recovery time. Timepoint: The recovery time is recorded in the patient file in the operating room. Method of measurement: Register in the checklist.</sec_outcome>
      <sec_outcome>Hospital stay. Timepoint: The hospital stay is calculated on the day of discharge. Method of measurement: Register in the checklist.</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>Urology Research Center, Guilan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-10-07</approval_date>
        <contact_name>Ethics Committee of Guilan University of Medical Sciences</contact_name>
        <contact_address>Razi Hospital, Sardar Jangal street Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
