<?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>IRCT20160307026950N25</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-09-20</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Dexamethasone on Nausea and Vomitting after cholecystectomy</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the efficacy of Intraperitoneal Dexamethasone with intravenous Dexamethasone on Nausea and Vomiting after Laparoscopic Cholecystectomy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-09-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>81</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50286</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: In this study, for the first time, we used Intrapritoneal Dexamethasone in laparoscopic cholecystectomy, Randomization description: Randomization will be done simply in which patients will enter into groups A, B, and C respectively, according to their time of admission, then the next three patients will enter into these groups in the same way to complete of number of patients in each three groups, Blinding description: Drugs and Placebo are prepared and coded in the same appearance. The patient, the injecting specialist, the surgeon, and the respondent are unaware of the contents of the injected drug and are blind.</study_design>
      <phase>3</phase>
      <hc_freetext>Laparoscopic Cholecystectomy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group A: Patients receive 2cc intrapritoneal Normal saline and 8mg  intravenous Dexamethasone in base of Gallbladder  after removing last clamp and exiting laparoscope. Intervention 2: Intervention group B: Patients  receive 2cc intravenous Normal saline and 8mg intrapritoneal Dexamethasone in base of  Gallbladder after removing last clamp and exiting laparoscope. Intervention 3: Control group: Patients  receive 2cc intravenous Normal saline and 2cc intrapritoneal Normal saline in base of  Gallbladder after removing last clamp and exiting laparoscope.</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 more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Alireza Arabzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kooye emam،khosro poor street,Valid alley,No.242</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8169844181</zip>
        <telephone>+98 31 3669 1460</telephone>
        <email>alirezaarabzadeh994@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Behzad Nazem Roaya</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezar jarib street</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8146713543</zip>
        <telephone>+98 31 3620 2020</telephone>
        <email>behzad_nazem@med.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age above 18 years
Candidate for laparoscopic Cholecystectomy
Physical Situation ASAP and ASA2
Agreement on Participation in Study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnancy
Allergy and Reaction to Corticosteroids
Using corticosteroids before Surgery
Existing of Nausea and Vomitting before Surgery</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>بیماریهای </hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>K00-K93</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group A: Patients receive 2cc intrapritoneal Normal saline and 8mg  intravenous Dexamethasone in base of Gallbladder  after removing last clamp and exiting laparoscope.</i_keyword>
      <i_keyword>Intervention group B: Patients  receive 2cc intravenous Normal saline and 8mg intrapritoneal Dexamethasone in base of  Gallbladder after removing last clamp and exiting laparoscope.</i_keyword>
      <i_keyword>Control group: Patients  receive 2cc intravenous Normal saline and 2cc intrapritoneal Normal saline in base of  Gallbladder after removing last clamp and exiting laparoscope.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Nausea. Timepoint: After entry to Recovery, every 15 minute  until the exit of recovery and then 2,4,8,12 and 24 hours in the first 24 hour after surgery in all 3 group. Method of measurement: Ask the patient.</prim_outcome>
      <prim_outcome>Vomitting. Timepoint: After entry to Recovery, every 15 minute  until the exit of recovery and then 2,4,8,12 and 24 hours in the first 24 hour after surgery in all 3 group. Method of measurement: Ask the patient.</prim_outcome>
      <prim_outcome>Systolic blood pressure. Timepoint: Before Anesthesia, After Anesthesia and after injection of Dexamethasone at 1,5,10 minutes and every 15 minute until the end of surgery in all groups. Method of measurement: Non invasive blood pressure measurement.</prim_outcome>
      <prim_outcome>Diastolic blood pressure. Timepoint: Before Anesthesia, After Anesthesia and after injection of Dexamethasone at 1,5,10 minutes and every 15 minute until the end of surgery in all groups. Method of measurement: Non invasive blood pressure measurement.</prim_outcome>
      <prim_outcome>Heart rate. Timepoint: Before Anesthesia, After Anesthesia and after injection of Dexamethasone at 1,5,10 minutes and every 15 minute until the end of surgery in all groups. Method of measurement: ECG Monitoring.</prim_outcome>
      <prim_outcome>Oxygen saturation. Timepoint: Before Anesthesia, After Anesthesia and after injection of Dexamethasone at 1,5,10 minutes and every 15 minute until the end of surgery in all groups. Method of measurement: Pulse oximeter.</prim_outcome>
      <prim_outcome>Pain. Timepoint: After entry to Recovery, every 15 minute  until the exit of recovery and then 2,4,8,12 and 24 hours in the first 24 hour after surgery in all 3 group. Method of measurement: VAS score system.</prim_outcome>
      <prim_outcome>Patients satisfaction. Timepoint: First 24 hour after surgery. Method of measurement: Likert scale system.</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-07-30</approval_date>
        <contact_name>Ethics committee of Isfahan university of Medical sciences</contact_name>
        <contact_address>Hezar jarib street Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
