<?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>IRCT20240204060903N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-02-24</date_registration>
      <primary_sponsor>Istanbul Bahçelievler State Hospital, Türkiye</primary_sponsor>
      <public_title>Comparison of Sensory and Motor Block Efficacy at Different Reverse Trendelenburg Angles in Patients Undergoing Spinal Anesthesia with Heavy Marcain</public_title>
      <acronym>Comparison of Sensory and Motor Block Efficacy</acronym>
      <scientific_title>Comparison of Sensory and Motor Block Efficacy at Different Reverse Trendelenburg Angles in Patients Undergoing Spinal Anesthesia with Heavy Marcain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-02-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>150</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/75398</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Basic scienece, Other design features: People will be randomly divided into 6 groups. A study is planned in 150 patients, Randomization description: People will be randomly divided into 6 groups. Working in groups will be done according to the plan according to the selected angle. Patients are randomly divided into groups. While patients are included in the groups, a blind evaluation will be made.</study_design>
      <phase>0 (exploratory trials)</phase>
      <hc_freetext>Istanbul Bahcelievler State Hospital.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:Patients in this group will be at 10, 30, 50, 70 and 90 degrees. 10 mg heavy marcain will be administered into the spinal space. Heavy bupivacaine is frequently used in the surgical field for subarachnoid block.  While bupivacaine is a 0.5% plain form that does not contain dextrose, the hyperbaric form is the form that occurs with the addition of glucose (80 mg/ml) to plain bubivacaine. The effectiveness of hyperbaric bupivacaine has been studied in many studies, and the sensory block pattern has been observed to be more predictable in hyperbaric bupivacaine than in bupivacaine. Another difference between hyperbaric and plan bupivacaine is the nature and duration of the motor block. Hyperbaric bupivacaine generally has a safer level of effectiveness than bupivacane.  In studies, the effectiveness of hyperbaric bupivacaine and other local anesthetic agents has been compared at different doses and in different surgeries, but no study comparing their effectiveness according to different angles in the supine reverse trandelenburg position of the patient has been found in the literature.The standard spinal anesthesia approach in anorectal surgery is performed in a sitting position and frequently with the application of hyperbaric bupivacaine. The applied doses are generally between 5-10 mg. Hyperbaric bupivacaine provides long-term pain relief in the postoperative period. Intervention 2: Control group: Patients in this group will be at 0 degrees. 10 mg heavy marcain will be administered into the spinal space.</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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Yücel Özgür</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bahçelievler District Saklıvadi Street  Ağaoğlu Mycity 30B2 D29</address>
        <city>Bahçelievler</city>
        <country1>Turkey</country1>
        <zip>34180</zip>
        <telephone>+90 505 524 21 40</telephone>
        <email>anstz@hotmail.com</email>
        <affiliation>Istanbul Bahçelievler State Hospital</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Şenel Altun</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bahçelievler District</address>
        <city>Bahçelievler</city>
        <country1>Turkey</country1>
        <zip>34180</zip>
        <telephone>+90 505 524 21 40</telephone>
        <email>altunsenel@gmail.com</email>
        <affiliation>Istanbul Bahçelievler State Hospital</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Turkey</country2>
    </countries>
    <criteria>
      <inclusion_criteria>ASA (American Society of Anesthesiologists) I-II,
150 patients between the ages of 18-55 who are scheduled for elective anorectal surgery will be included in the study.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients who do not want to participate in the study will not be included in the study.
Patients who use blood thinners and are pregnant will not be included in the study.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Y48.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Local anaesthetics</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Surgery</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:Patients in this group will be at 10, 30, 50, 70 and 90 degrees. 10 mg heavy marcain will be administered into the spinal space. Heavy bupivacaine is frequently used in the surgical field for subarachnoid block.  While bupivacaine is a 0.5% plain form that does not contain dextrose, the hyperbaric form is the form that occurs with the addition of glucose (80 mg/ml) to plain bubivacaine. The effectiveness of hyperbaric bupivacaine has been studied in many studies, and the sensory block pattern has been observed to be more predictable in hyperbaric bupivacaine than in bupivacaine. Another difference between hyperbaric and plan bupivacaine is the nature and duration of the motor block. Hyperbaric bupivacaine generally has a safer level of effectiveness than bupivacane.  In studies, the effectiveness of hyperbaric bupivacaine and other local anesthetic agents has been compared at different doses and in different surgeries, but no study comparing their effectiveness according to different angles in the supine reverse trandelenburg position of the patient has been found in the literature.The standard spinal anesthesia approach in anorectal surgery is performed in a sitting position and frequently with the application of hyperbaric bupivacaine. The applied doses are generally between 5-10 mg. Hyperbaric bupivacaine provides long-term pain relief in the postoperative period.</i_keyword>
      <i_keyword>Control group: Patients in this group will be at 0 degrees. 10 mg heavy marcain will be administered into the spinal space.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>As a result of spinal anesthesia, block levels will vary depending on the patient's back angle. Timepoint: Results will be collected from patients within 2 hours. Method of measurement: The level of spinal block will be evaluated by cold test and pinprick test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Istanbul Bahçelievler State Hospital, Türkiye</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-06-05</approval_date>
        <contact_name>Bakırkoy Dr. Sadi Konuk Traınıng And Research Hospıtal| Clınıcal Studıes Ethıcs Commıttee Decısıon</contact_name>
        <contact_address>Bahçelievler Mah Saklıvadi Sok. Ağaoğlu Mycity 30B2 D29 Bahçelıevler Istanbul Turkey</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
