<?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>IRCT138810293104N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-08-24</date_registration>
      <primary_sponsor>Deputy research and tecnology in kerman medical university</primary_sponsor>
      <public_title>Comparison the effects of fentanyl, sufentanil and alfentanil as premedication on postoperative nausea and vomiting in diagnostic gynecologic laparascopy</public_title>
      <acronym></acronym>
      <scientific_title>Comparison the effects of fentanyl, sufentanil and alfentanil as premedication on postoperative nausea and vomiting in diagnostic gynecologic laparascopy in hundred eighty patients (ASA I and II), aged 18-35 year</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2010-03-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>180</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/3109</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>gynecologic.</hc_freetext>
      <i_freetext>Intervention 1: Midazolam 1mg and alfentanil 2cc (1000μg). Induction of every three group was performed using thiopental (5mg/kg) and succynyl choline (1.5mg/kg), anesthesia was maintained using isoflurane 1.2% gas and a mixture of N2O-O2 with 50/50 ratio. Due to the short duration of surgery, there was no need to repeat administration of opioid drug and in the case of surgery lasting more than 45 minutes and repetition of opioid administration, patient was excluded from the study. Intervention 2: Midazolam 1mg and fentanil 2cc (100μg);  was administered to the patients two minutes before I.V. induction of anesthesia to the patient (each 1cc of the three drugs has equal power). Induction of every three group was performed using thiopental (5mg/kg) and succynyl choline (1.5mg/kg), anesthesia was maintained using isoflurane 1.2% gas and a mixture of N2O-O2 with 50/50 ratio. Due to the short duration of surgery, there was no need to repeat administration of opioid drug and in the case of surgery lasting more than 45 minutes and repetition of opioid administration, patient was excluded from the study. Intervention 3: Midazolam 1mg and sufentanil 2cc (10μg) was administered to the patients two minutes before I.V. induction of anesthesia to the patient (each 1cc of the three drugs has equal power). Induction of every three group was performed using thiopental (5mg/kg) and succynyl choline (1.5mg/kg), anesthesia was maintained using isoflurane 1.2% gas and a mixture of N2O-O2 with 50/50 ratio. Due to the short duration of surgery, there was no need to repeat administration of opioid drug and in the case of surgery lasting more than 45 minutes and repetition of opioid administration, patient was excluded from the study.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Shabani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kerman</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 34 1226 4198</telephone>
        <email>shabanimoh@yahoo.com</email>
        <affiliation>Kerman Neuroscience Research Center</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Shabani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Neuroscience Research Center- kerman medical universi</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 34 1226 4196</telephone>
        <email>shabani@kmu.ac.ir</email>
        <affiliation>Neuroscience Research Center- kerman medical university</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion Criteria: Patients were selected from those who referred to afzalipoor hospital of Kerman for diagnostic GLS and were aged 18-35 with ASA I or II. &#13;
 Exclusion criteria: diabetes mellitus; addiction to drugs; history of nausea or vomiting and or using drugs with known anti-emetic properties (like metformin, clomifen, medroxy progestron, bromocriptin) 24 hours before the surgery; smoking; motion disease history; previous experience of PONV; surgical duration more than 45 minutes; usage of opioids after surgery in recovery period and weight more than 70kg. After signing informed consent by all the patients, 180 subjects were enrolled in the study.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N80-N98</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>N80-N98</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Midazolam 1mg and alfentanil 2cc (1000μg). Induction of every three group was performed using thiopental (5mg/kg) and succynyl choline (1.5mg/kg), anesthesia was maintained using isoflurane 1.2% gas and a mixture of N2O-O2 with 50/50 ratio. Due to the short duration of surgery, there was no need to repeat administration of opioid drug and in the case of surgery lasting more than 45 minutes and repetition of opioid administration, patient was excluded from the study.</i_keyword>
      <i_keyword>Midazolam 1mg and fentanil 2cc (100μg);  was administered to the patients two minutes before I.V. induction of anesthesia to the patient (each 1cc of the three drugs has equal power). Induction of every three group was performed using thiopental (5mg/kg) and succynyl choline (1.5mg/kg), anesthesia was maintained using isoflurane 1.2% gas and a mixture of N2O-O2 with 50/50 ratio. Due to the short duration of surgery, there was no need to repeat administration of opioid drug and in the case of surgery lasting more than 45 minutes and repetition of opioid administration, patient was excluded from the study.</i_keyword>
      <i_keyword>Midazolam 1mg and sufentanil 2cc (10μg) was administered to the patients two minutes before I.V. induction of anesthesia to the patient (each 1cc of the three drugs has equal power). Induction of every three group was performed using thiopental (5mg/kg) and succynyl choline (1.5mg/kg), anesthesia was maintained using isoflurane 1.2% gas and a mixture of N2O-O2 with 50/50 ratio. Due to the short duration of surgery, there was no need to repeat administration of opioid drug and in the case of surgery lasting more than 45 minutes and repetition of opioid administration, patient was excluded from the study.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Vomitting. Timepoint: 0-24, 0-2, 2-24(0-24 hours after surgury). Method of measurement: Observation.</prim_outcome>
      <prim_outcome>Nausea. Timepoint: 0-24, 0-2, 2-24(0-24 hours after surgury). Method of measurement: Observation.</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>Deputy research and tecnology in kerman medical university</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2009-04-21</approval_date>
        <contact_name>Kerman University of Medical Sciences Ethics Committee</contact_name>
        <contact_address>Somayeh crossroad- Kerman Neuroscience Research Center Kerman  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
