<?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>IRCT20180416039326N13</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-06-15</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Effect of intranasal dexamethasone on prevention of postoperative nausea and vomiting in hysterectomy</public_title>
      <acronym></acronym>
      <scientific_title>Comparative study of the effect of intranasal dexamethasone on prevention of postoperative nausea and vomiting in hysterectomy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-06-14</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/47288</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Random allocation to intervention and control groups using Random allocation software.70 patients who have candidated for elective hysterectomy will divided randomly to intervention group who will recieve nasal dexamethasone (group A) and control group who will recieve nasal normal saline, Blinding description: Anesthesiologist who has no function in collection of dates devides drugs in two groups A and B with same volume and then describes them . In this double-blind clinical trial the patient and the observer who records dates are unware of patients groups and drugs which are being studied but the analyzer is aware.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Postoperative Nausea and Vomiting.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: After receiving 10ml/kg of ringer lactate and pre-oxygenation for patients, the same anesthetic induction was performed including Fentanyl 2mcg / kg, Propofol 2 mg / kg and Atracurium 0.5 to 0.7 mg / kg, midazolam 0.3 to 0.5mcg / kg and the patients underwent mechanical ventilation by mask  and ambobag for three minutes. Immediately after intubation, 1 cc of dexamethasone (4mg) was injected in each nostril. Intervention 2: Control group:  After receiving 10ml/kg of ringer lactate and pre-oxygenation for patients, the same anesthetic induction was performed including Fentanyl 2mcg / kg, Propofol 2 mg / kg and Atracurium 0.5to 0.7mg / kg, midazolam 0.3to 0.5mcg / kg and the patients underwent mechanical ventilation by mask  and ambobag for three minutes. Immediately after intubation, 1 ml of normal saline was injected in each nostril.</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>Hamidreza Shetabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Al-Zahra Therapeutic Training Center, Sofeh Boulevard</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174675731</zip>
        <telephone>+98 31 3620 1818</telephone>
        <email>hamidshetabi@med.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hamidreza Shetabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Al-Zahra Therapeutic Training Center, Sofeh Boulevard</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174675731</zip>
        <telephone>+98 31 3620 1818</telephone>
        <email>hamidshetabi@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>Women older than 18 years
American society of anesthesiologists(ASA) physical status classification 1 or 2
Filled informed consent form
Hysterectomy under general anesthesia</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Patient with sever and uncontroled cardiovascular ، renal ، liver and chronic lung diseases
Systemic fungal infection
Contraindication for dexamethasone
Taking antiemetic and analgesics drugs during last 24 hours before surgery
Pregnant women
Menstural period
Patients with motion sickness and GI problems and history of postoperative nausea and vomiting
Patients with History of psycologic problem and Parkinson  disease
History of chemotherapy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R11</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Nausea and Vomiting</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: After receiving 10ml/kg of ringer lactate and pre-oxygenation for patients, the same anesthetic induction was performed including Fentanyl 2mcg / kg, Propofol 2 mg / kg and Atracurium 0.5 to 0.7 mg / kg, midazolam 0.3 to 0.5mcg / kg and the patients underwent mechanical ventilation by mask  and ambobag for three minutes. Immediately after intubation, 1 cc of dexamethasone (4mg) was injected in each nostril.</i_keyword>
      <i_keyword>Control group:  After receiving 10ml/kg of ringer lactate and pre-oxygenation for patients, the same anesthetic induction was performed including Fentanyl 2mcg / kg, Propofol 2 mg / kg and Atracurium 0.5to 0.7mg / kg, midazolam 0.3to 0.5mcg / kg and the patients underwent mechanical ventilation by mask  and ambobag for three minutes. Immediately after intubation, 1 ml of normal saline was injected in each nostril.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Incidence of nausea. Timepoint: At recovery (every 10min or having symptom) and 2 and 12 and 24 hours after surgery. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Score of nausea. Timepoint: At recovery (every 10min or having symptom) and 2 and 12 and 24 hours after surgery. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Incidence of vomiting. Timepoint: At recovery (every 10min or having symptom) and 2 and 12 and 24 hours after surgery. Method of measurement: scoring system for vomiting.</prim_outcome>
      <prim_outcome>Score of vomiting. Timepoint: At recovery (every 10min or having symptom) and 2 and 12 and 24 hours after surgery. Method of measurement: Scoring system for vomiting.</prim_outcome>
      <prim_outcome>Score of pain. Timepoint: At recovery (every 10min or having symptom) and 2 and 12 and 24 hours after surgery. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>First time using anti emetic drug. Timepoint: 24 hours after entering recovery. Method of measurement: minute.</prim_outcome>
      <prim_outcome>Total dose of anti emetic. Timepoint: 24 hours after entering recovery. Method of measurement: file.</prim_outcome>
      <prim_outcome>Frequency of using anti emetic drug. Timepoint: 24 hours after entering recovery. Method of measurement: file.</prim_outcome>
      <prim_outcome>Extubation time. Timepoint: After Extubation. Method of measurement: minute.</prim_outcome>
      <prim_outcome>Length of stay in recovery. Timepoint: After exiting recovery. Method of measurement: minute.</prim_outcome>
      <prim_outcome>Patient satisfaction score. Timepoint: 24 hours after entering recovery. Method of measurement: Likert scale.</prim_outcome>
      <prim_outcome>Beginning time of using liquid foods. Timepoint: after using liquid foods. Method of measurement: minute.</prim_outcome>
      <prim_outcome>Beginning time of using solid foods. Timepoint: after using solid foods. Method of measurement: minute.</prim_outcome>
      <prim_outcome>Length of stay in hospital. Timepoint: After exiting hospital. Method of measurement: day.</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>2020-03-16</approval_date>
        <contact_name>Ethics committee of Esfahan University of Medical Sciences</contact_name>
        <contact_address>Hezar Jerib St Esfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
