<?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>IRCT20161126031095N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-07-13</date_registration>
      <primary_sponsor>Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the additive effect of dexmedetomidine and neostigmine to bupivacaine  on pain intensity after cesarean section with spinal anesthesia</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the additive effect of dexmedetomidine and neostigmine to bupivacaine  on pain intensity after cesarean section with spinal anesthesia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-11-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>110</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/56460</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization is done by randomized block method with various block sizes (multiples of 2). The unit is individual and is made by statistical software and delivered in a sealed envelope, Blinding description: The facilitator, the senior assistant performing spinal anesthesia, and the anesthesist present at the patient's bedside, as well as the first-year assistant filling out research forms were kept blind for each patient' administered drugs. The drugs were the same color and volume in the same syringes that could not be differentiated by the above individuals.</study_design>
      <phase>2</phase>
      <hc_freetext>Other acute postprocedural pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group1: 1 microgram of dexmedetomidine is equivalent to a volume of 0.5 ml plus 2.5 ml of 0.5% bupivacaine. As a result, the total injection volume in each sample is 3 ml, which have the same color and shape. No. 25 and is performed from the lumbar intervertebral space in the cerebrospinal fluid. Intervention 2: Intervention group2:10 micrograms of neostigmine is equivalent to a volume of 0.5 ml plus 2.5 ml of 0.5% bupivacaine. As a result, the total injection volume in each sample is 3 ml, which have the same color and shape. Spinal cord No. 25 and is performed from the lumbar intervertebral space in the cerebrospinal fluid.</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 I have not decided yet</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Iman Asdaghi Jahromi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Clinical Research Development Center, Imam Khomeini Hospital, Amir Mazandarani Boulevard</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>48166-33131</zip>
        <telephone>+98 11 3335 5080</telephone>
        <email>Iman.asdaghi@gmail.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Alieh Zamani Kiasari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Clinical Research Development Center, Imam Khomeini Hospital, Amir Mazandarani Boulevard</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>48166-33131</zip>
        <telephone>+98 11 3335 5080</telephone>
        <email>aliehzamani@yahoo.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women who have had a cesarean delivery</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Patients who have refused to participate
Drug addiction
Have underlying diseases (moderate or severe heart, kidney, lung or nerve disease, significant scoliosis, kyphosis, obesity or blood clotting disease)
Patients with a height of less than 130 cm or aBody mass Index ( BMI) of more than 35</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G89.18</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other acute postprocedural pain</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 group1: 1 microgram of dexmedetomidine is equivalent to a volume of 0.5 ml plus 2.5 ml of 0.5% bupivacaine. As a result, the total injection volume in each sample is 3 ml, which have the same color and shape. No. 25 and is performed from the lumbar intervertebral space in the cerebrospinal fluid</i_keyword>
      <i_keyword>Intervention group2:10 micrograms of neostigmine is equivalent to a volume of 0.5 ml plus 2.5 ml of 0.5% bupivacaine. As a result, the total injection volume in each sample is 3 ml, which have the same color and shape. Spinal cord No. 25 and is performed from the lumbar intervertebral space in the cerebrospinal fluid</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain after cesarean section. Timepoint: Hours 0, 2, 4, 8 and 12. Method of measurement: According to the Visual Analogue Scale criteria.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Sedation. Timepoint: 0,2,4,8,12. Method of measurement: Ramsay Criteria.</sec_outcome>
      <sec_outcome>Immobilization. Timepoint: 0,2,4,8,12. Method of measurement: Bromage scale.</sec_outcome>
      <sec_outcome>Moderate arterial blood pressure. Timepoint: 0,2,4,8,12. Method of measurement: Checklist.</sec_outcome>
      <sec_outcome>Oxygen saturation. Timepoint: 0,2,4,8,12. Method of measurement: pulse oximetry.</sec_outcome>
      <sec_outcome>Apgar score. Timepoint: 0,2,4,8,12. Method of measurement: 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>Mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-11-25</approval_date>
        <contact_name>Ethics Committee of Imam Khomeini Hospital of Sari - Mazandaran University of Medical Sciences</contact_name>
        <contact_address>Office Building Ethics Committee of Imam Khomeini Hospital Amir Mazandarani Blvd. Sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
