<?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>IRCT20101211005362N27</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-01-22</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of ondansetron and dexmedetomidine in reducing nausea and vomiting</public_title>
      <acronym></acronym>
      <scientific_title>Comparative study of the preemptive  Dexmedetomidine with Ondansetron effect  in reducing the post-operative nausea and vomiting after elective middle ear surgery  under general anesthesia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>165</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/56239</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: 165 people are selected by easy random method. The way to randomize is that anesthesiologist from a dark-colored bag containing 165 cards with titles
O ( Ondansetron), D ( Dexmedetomidine), P ( placebo) that there are 55 of each card, and according to the card that is picked up the patient enters the investigation. (Output card will not be replaced), Blinding description: Drug injections are performed by an anesthesiologist without knowing the contents of the syringes. (Also, all syringes have the same color and volume). The way to randomize is that anesthesiologist from a dark-colored bag containing 165 cards with titles O ( ondansetron), D ( dexmedetomidine), P ( placebo) that there are 55 of each card, and according to the card that is picked up The patient enters the investigation.(Output card will not be replaced). Patients also do not know about the medication they are receiving.</study_design>
      <phase>3</phase>
      <hc_freetext>Post operative  nausea and vomiting.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: they receive 0/1 mg per kg ondansetron in 10 cc normal saline in 10 minute. Intervention 2: Control group:  10 cc normal saline in 10 minute. Intervention 3: Intervention group: they recieve  1 microgram per kilogram in 10 cc normal saline in 10 minute.</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 no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyed Mohammadreza Safavi Homami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Alzahra hospital, Sofe Boulevard, Shahid Keshvari highway</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174675731</zip>
        <telephone>+98 31 3620 2020</telephone>
        <email>safavi@med.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyed Mohammadreza Safavi Homami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Alzahra hospital, Sofe Boulevard, Shahid Keshvari highway</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174675731</zip>
        <telephone>+98 31 3620 2020</telephone>
        <email>safavi@med.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>People who willingly want to participate in the study
ASA class 1,2
People between the ages of 18 and 65 y/o
No motion sickness or Parkinson's disease</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Heart, liver, kidney failure
Previous sensitivity to the drugs used in the study
Obese patients (BMI more than 30)
Patients with mental retardation
Patients who have taken antiemetic before operation.
Any change in anesthesia
Patient death during surgery
Surgeries that cause severe nausea and vomiting, such as surgery on the labyrinth (otosclerosis, cholesteatoma with fistula, etc.)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R11.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Nausea after surgery; Postoperative nausea; Nausea NOS; Nausea without vomiting</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Placebo</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: they receive 0/1 mg per kg ondansetron in 10 cc normal saline in 10 minute</i_keyword>
      <i_keyword>Control group:  10 cc normal saline in 10 minute</i_keyword>
      <i_keyword>Intervention group: they recieve  1 microgram per kilogram in 10 cc normal saline in 10 minute</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mean severity of post operative  nausea. Timepoint: Every 15 minutes for 1 hour and then every 6 hours for 24 hours. Method of measurement: Visual analog scale.</prim_outcome>
      <prim_outcome>Frequency of post operative vomiting. Timepoint: Every 15 minutes for 1 hour and then every 6 hours for 24 hours. Method of measurement: According to percentage.</prim_outcome>
      <prim_outcome>The average dose of antiemetic used. Timepoint: In the  recovery and the first 24 hours after surgery. Method of measurement: Dose of drug used.</prim_outcome>
      <prim_outcome>The average of first time, antiemetic needed. Timepoint: In the  recovery and the first 24 hours after surgery. Method of measurement: Time that drug used.</prim_outcome>
      <prim_outcome>The first time that the fluid diet tolerated. Timepoint: The first 24 hours after surgery. Method of measurement: Time the diet tolerated.</prim_outcome>
      <prim_outcome>The average time took to tolerate solid diet. Timepoint: The first 48 hours after surgery. Method of measurement: Time the diet tolerated.</prim_outcome>
      <prim_outcome>Mean patient satisfaction score. Timepoint: The first 24 hours after surgery. Method of measurement: Visual analog scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Duration of anesthesia of patient. Timepoint: During the operation and 24 hour after that. Method of measurement: Minute.</sec_outcome>
      <sec_outcome>Duration of surgery of patient. Timepoint: During the operation. Method of measurement: Minute.</sec_outcome>
      <sec_outcome>Average length of stay in recovery. Timepoint: During the presence in recovery. Method of measurement: Modified aldrete score.</sec_outcome>
      <sec_outcome>Average of pain intensity. Timepoint: The first 24 hour after surgery. Method of measurement: visual analog scale.</sec_outcome>
      <sec_outcome>Average time of extubation. Timepoint: After surgery. Method of measurement: Minute.</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>2021-09-21</approval_date>
        <contact_name>Ethics committee of Esfahan university of medical sciences</contact_name>
        <contact_address>Heza Jjarib street, Isfahan University of Medical Sciences Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
