<?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>IRCT20191025045235N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-08-22</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>the effect of dexamethasone on nausea and vomiting</public_title>
      <acronym></acronym>
      <scientific_title>The effect of dexamethasone in control of postoperative nausea and vomiting in cesarean section surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72043</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: People were divided into two groups completely randomly based on the random block permutation method. For example, for blocks of four, we imagined 6 blocks ABBA, AABB, ABAB, BABA, BBAA, BAAB, which should be n/4 We sampled from these blocks in the form of placement. The random sequence was obtained from the website www.sealedenevelope.com.
Patients are entered in the order of entry, Blinding description: the patient and the anesthesia technician are unware of the type of injected drug.the medicine is already prepare and given to the technician.</study_design>
      <phase>3</phase>
      <hc_freetext>vomiting.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Dexamethasone group, including 30 people, will be injected before surgery for the purpose of PONV prophylaxis by a trained anesthesiologist who will be unaware of the type of drug injected, then the patients will be under spinal anesthesia with a 25-gauge spinal needle in the L4 space. L5 with 12.5 mg marcaine. During the surgery, the frequency of nausea, vomiting and shivering, blood pressure, and heart rate will be recorded by him, and after the operation, these parameters will be recorded in the ward at 1, 2, 4, 6, and 12 hours. and vomiting, through the V&amp;N scoring table. The patient's shivering score is also recorded. Intervention 2: Control group: before surgery, normal saline group including 30 people will be injected for prophylaxis of PONV by a trained anesthesiologist, who will be unaware of the type of drug injected, then the patients will be under spinal anesthesia with a 25 gage spinal needle in the L4 space. - L5 with 5.12 mg marcaine. During the surgery, the frequency of nausea, vomiting and shivering, blood pressure, and heart rate will be recorded by him, and after the operation, these parameters will be recorded in the ward at 1, 2, 4, 6, and 12 hours. and vomiting, through the V&amp;N scoring table. The patient's shivering score is also recorded.</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:
All data is potentially shareable after de-identifying individuals

When:
The access period starts 6 months after the results are published

To whom:
It will be available for researchers working in academic and scientific institutions

Conditions:
Age, hemodynamics of the patient. The degree of response to the drug

Where to obtain:
Through the published article

How to obtain:
Email a request or receive information from a published article

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyedeh Fatemeh Hosseininejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Emam Khomeini Hospital,Azadegan Street , Ahwaz</address>
        <city>Ahwaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6155883505</zip>
        <telephone>009833113861</telephone>
        <email>drhosseininejad@yahoo.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyedeh Fatemeh Hosseininejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Emam Khomeini Hospital,Azadegan Street, Ahwaz</address>
        <city>Ahwaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6155883505</zip>
        <telephone>009833113861</telephone>
        <email>drhosseininejad@yahoo.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>pregnant womanwith cesarean section indication
age between 18 and 40
consent to participate in the study
ASA class 1,ASA class 2
no history of heart disease</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>patient  dissatisfaction
numbness above T4
HTN before pregnancy ,preeclampsia,eclampsia
drug allergy
a bleeding process that leads to generalization of the patient</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R11.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Vomiting</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Dexamethasone group, including 30 people, will be injected before surgery for the purpose of PONV prophylaxis by a trained anesthesiologist who will be unaware of the type of drug injected, then the patients will be under spinal anesthesia with a 25-gauge spinal needle in the L4 space. L5 with 12.5 mg marcaine. During the surgery, the frequency of nausea, vomiting and shivering, blood pressure, and heart rate will be recorded by him, and after the operation, these parameters will be recorded in the ward at 1, 2, 4, 6, and 12 hours. and vomiting, through the V&amp;N scoring table. The patient's shivering score is also recorded</i_keyword>
      <i_keyword>Control group: before surgery, normal saline group including 30 people will be injected for prophylaxis of PONV by a trained anesthesiologist, who will be unaware of the type of drug injected, then the patients will be under spinal anesthesia with a 25 gage spinal needle in the L4 space. - L5 with 5.12 mg marcaine. During the surgery, the frequency of nausea, vomiting and shivering, blood pressure, and heart rate will be recorded by him, and after the operation, these parameters will be recorded in the ward at 1, 2, 4, 6, and 12 hours. and vomiting, through the V&amp;N scoring table. The patient's shivering score is also recorded</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Severe nausea and vomiting after surgery. Timepoint: 1,2,4,6,12hours after surgery. Method of measurement: V&amp;N score table.</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>Jundishapur University of Ahvaz</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-03-21</approval_date>
        <contact_name>Ethics committee of Jondishapoor Ahvaz University of Medical Sciences</contact_name>
        <contact_address>EmamKhomeini Hospital,Azadegan Street,Ahvaz Ahwaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
