<?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>IRCT20100102002963N30</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-04-24</date_registration>
      <primary_sponsor>Azad Islamic University Of Yazd</primary_sponsor>
      <public_title>Comparison of the effect of intravenous labetalol administration with intravenous lidocaine on hemodynamic variables and postoperative nausea and vomiting</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of intravenous labetalol administration with intravenous lidocaine on hemodynamic variables during laryngoscopy and endotracheal intubation and postoperative nausea and vomiting in female patients undergoing abdominal surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-05-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53321</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In order to randomly allocate 64 eligible applicants, we randomly divide them into two groups of 32 people. For this purpose, we use Random allocation software version 1.0 under Windows to create a sequence, and by using this software we make A list which is specified from 1 to 64 with group A or B treatment
By Using this list, we give the first person who is eligible to enter the study, number one and the last person the number 64, then based on the random allocation list and by the software, it is determined which group A or B each person is in, Blinding description: This study is a single-blind randomized clinical trial in which patients are unaware of the type of drug being prescribed, so that the two drugs are prepared and coded in two identical syringes.
And according to random numbers, the specified code is given to the patients.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Comparison of the effect of intravenous labetalol with intravenous lidocaine on hemodynamic variables during laryngoscopy and endotracheal intubation and postoperative nausea and vomiting in patients undergoing abdominal surgery.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group1: In this group, 10 mg of labetalol, from Kern pharma company is injected intravenously and once immediately before induction of general anesthesia to eligible patients. Intervention 2: Intervention group2: In this group, lidocaine 1.5 mg per kg body weight of the patient, from Caspian tamin company is injected intravenously and once immediately before induction of general anesthesia to eligible patients.</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>Dr. Shekoufeh Behdad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Sadoughi Hospital, Ebnesina Blv, Safayieh, Yazd</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916886938</zip>
        <telephone>+98 35 3822 4000</telephone>
        <email>drbehdad@ssu.ac.ir</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Shekofeh Behdad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Sadoughi Hospital, Ebnesina Blv, Safayieh, Yazd</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916886938</zip>
        <telephone>+98 35 3822 4000</telephone>
        <email>drbehdad@ssu.ac.ir</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All women candidates for abdominal surgery
All women between the ages of 25 and 65 years
All women with systolic blood pressure between 90 mm hg and 160 mm Hg
All women with normal body mass index
All women with diastolic blood pressure between 70 and 100 mm Hg
American Society of Anesthesiologists (ASA) class 1 :a normal healthy patient ,for Example: Fit, nonobese (BMI under 30), a nonsmoking patient with good exercise tolerance.
American Society of Anesthesiologists (ASA) class 2 : a patient with a mild systemic disease ,for Example: Patients with no functional limitations and a well-controlled disease (for example treated hypertension, obesity with BMI under 35, frequent social drinker or a cigarette smoker)</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>65 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Arterial hypertension
Ischemic heart disease
Heart failure
Pulmonary disease
Addiction
Renal disease
Liver disease</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group1: In this group, 10 mg of labetalol, from Kern pharma company is injected intravenously and once immediately before induction of general anesthesia to eligible patients.</i_keyword>
      <i_keyword>Intervention group2: In this group, lidocaine 1.5 mg per kg body weight of the patient, from Caspian tamin company is injected intravenously and once immediately before induction of general anesthesia to eligible patients.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Changes in systolic blood pressure. Timepoint: Immediately before drug injection Immediately before laryngoscopy Immediately after intubation Immediately after skin incision. Method of measurement: Operating room monitoring with Blood pressure cuf connected to the monitor and recording information in a questionnaire.</prim_outcome>
      <prim_outcome>Determining and comparing the incidence of bradycardia (heart rate &lt;50 ). Timepoint: Immediately after the operation in recovery room. Method of measurement: Monitoring in the recovery room with a blood pressure monitor connected to the monitor and recording information in a questionnaire.</prim_outcome>
      <prim_outcome>Determining and comparing the incidence of vomiting and nausea. Timepoint: Immediately after the operation in recovery room. Method of measurement: Question from the patient and registration in the questionnaire.</prim_outcome>
      <prim_outcome>Changes in diastolic blood pressure. Timepoint: Immediately before drug injection Immediately before laryngoscopy Immediately after intubation Immediately after skin incision. Method of measurement: Operating room monitoring with Blood pressure cuff connected to the monitor and recording information in a questionnaire.</prim_outcome>
      <prim_outcome>Changes in mean arterial blood pressure. Timepoint: Immediately before drug injection Immediately before laryngoscopy Immediately after intubation Immediately after skin incision. Method of measurement: Operating room monitoring with Blood pressure cuff connected to the monitor and recording information in a questionnaire.</prim_outcome>
      <prim_outcome>Changes in heart rates. Timepoint: Immediately before drug injection Immediately before laryngoscopy Immediately after intubation Immediately after skin incision. Method of measurement: Operating room monitoring with Blood pressure cuff connected to the monitor and recording information in a questionnaire.</prim_outcome>
      <prim_outcome>Determining and comparing the incidence of hypotension side effects (systolic blood pressure &lt; 9 ) or a drop of more than 20% of the base rate. Timepoint: Immediately after the operation in recovery room. Method of measurement: Monitoring in the recovery room with a blood pressure monitor connected to the monitor and recording information in a questionnaire.</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>Azad Islamic University Of Yazd</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-06-29</approval_date>
        <contact_name>Ethics Committee of Ali Ibn Abi Talib Medical School (AS), Islamic Azad University, Yazd Branch</contact_name>
        <contact_address>Safaieh, Boulevard of the Shohadaie Gomnam Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
