<?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>IRCT20230506058101N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-05-31</date_registration>
      <primary_sponsor>Arak University of Medical Sciences</primary_sponsor>
      <public_title>The effect of dexamethasone, droperidol and ginger on controlling nausea and vomiting</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the prophylactic effect of dexamethasone and droperidol in comparison with dexamethasone and ginger on nausea and vomiting in patients undergoing laparoscopic cholecystectomy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-06-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>152</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70115</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: To allocate the samples, the block randomization method with blocks of size 8 will be used. In this way, by using the software to generate random numbers using the block method and the randomization sequence, it will be produced according to the required sample size for the two groups. The two letters A and B can be arranged together in a block of size 8, and then a block is randomly selected from among the blocks, and the arrangement pattern in that block will be used to allocate the participants. Then this block in The original container will be placed and another block will be selected again. All these works will be done with a software called sealed envelope, Blinding description: In order to comply with blinding, firstly, the patients do not know the type of drug received, and after informed consent, they will enter the plan without knowing the type of drug received.
In the droperidol group, the same capsule as the ginger capsule is used, in which flour is placed and will be given to the patient, and in the ginger group, a syringe identical to the droperidol syringe containing distilled water will be used. In order to comply with the blinding, the drugs will be prepared in advance by the anesthesiologist (project guide) in syringes of the same shape and labels 1 and 2 will be placed on them, and then they will be given to the anesthesiologist of the project for injection. The study does not know will be placed. Also, the flour and ginger capsules are prepared in the same way under the supervision of the anesthesiologist in charge of the project (supervisor) and will be given to the patients by the intern in charge of the project who does not know about the groups, so the project will be implemented in a double-blind manner. After the surgery, the project questions will be completed by the intern responsible for the project (he is not aware of the groups).</study_design>
      <phase>3</phase>
      <hc_freetext>cholecystitis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In group A, 8 mg of intravenous dexamethasone and 75 μg/kg droperidol and 4 oral capsules of flour are given as a placebo instead of 4 oral ginger capsules before induction of anesthesia. Intervention 2: Intervention group: In group B, patients receive 8 mg of intravenous dexamethasone and 4 ginger capsules orally and a syringe containing distilled water as a placebo instead of a syringe containing intravenous droperidol.</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>Atefeh Mozafary Jalal</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Arak University of Medical Sciences, Basij square</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3819693345</zip>
        <telephone>+98 86 3313 6055</telephone>
        <email>www.atefehmozaffari45@gmail.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Atefeh Mozafary Jalal</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Arak University of Medical Sciences, Basij square</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3819693345</zip>
        <telephone>+98 86 3313 6055</telephone>
        <email>www.atefehmozaffari45@gmail.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Candidates for laparoscopic cholecystectomy who will be electively referred to Amir al-Momenin and Valiasr Arak hospitals
Age range between 18-65 years
ASA anesthesia class I, II
Candidates for general anesthesia
All candidate patients for laparoscopic cholecystectomy who undergo surgery
Not being allergic to droperidol and ginger
The duration of surgery between 60-150 minutes</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Sensitivity to Droperidol and Ginger</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K81</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cholecystitis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In group A, 8 mg of intravenous dexamethasone and 75 μg/kg droperidol and 4 oral capsules of flour are given as a placebo instead of 4 oral ginger capsules before induction of anesthesia.</i_keyword>
      <i_keyword>Intervention group: In group B, patients receive 8 mg of intravenous dexamethasone and 4 ginger capsules orally and a syringe containing distilled water as a placebo instead of a syringe containing intravenous droperidol.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Vomiting score during recovery. Timepoint: 2, 4, 8 and 12 hours after surgery. Method of measurement: Vomiting scoring checklist.</prim_outcome>
      <prim_outcome>Nausea. Timepoint: in post-operative recovery. Method of measurement: Ask the patient.</prim_outcome>
      <prim_outcome>Shivering. Timepoint: in post-operative recovery. Method of measurement: Ask the patient.</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>Arak University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-12-18</approval_date>
        <contact_name>Ethics cmmittee of Arak University of Medical Sciences</contact_name>
        <contact_address>Arak University of Medical Sciences , Basij square Arak Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
