<?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>IRCT2017012510599N14</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-08-17</date_registration>
      <primary_sponsor>Iran University of Medical sciences</primary_sponsor>
      <public_title>Control Blood Pressure and Heart Rate during Laparoscopic Surgery with Stellate Ganglion Block</public_title>
      <acronym></acronym>
      <scientific_title>The effect of  Stellate Ganglion Block on hemodynamic intraoperative and postoperative complications of Laparoscopic Surgery in women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-08-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/11068</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Patients randomized method with block randomization divided in two groups of intervention and control groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Relationship of Stellate Ganglion Blood with Hemodynamics During Operation and Post-Operative Complications in women.</hc_freetext>
      <i_freetext>Intervention 1: Group Intervention: Fifteen minutes before induction of anesthesia in the operating room, after moving Vdrp and appropriate positions under the guidance of sonography in patients with 10 mL of 1% lidocaine blockade of the stellate ganglion block. we used the linear high frequency trancducer (6-13 mhz). Intervention 2: Control group: Fifteen minutes before induction of anesthesia in the operating room, after moving Vdrp and appropriate positions under the guidance of sonography in patients with 10 ml of distilled water are placed under the stellate ganglion block.   we used the linear high frequency trancducer (6-13 mhz).</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>Maryam Khodaverdi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rasoul Akram Hospital, Niayesh St, Sattarkhan, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6655 3921</telephone>
        <email>maryamkhodaverdi@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Pupak Rahim Zadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rasoul Akram Hospital, Niayesh St, Sattarkhan, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6650 9059</telephone>
        <email>pupak_rah@hotmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: women 40-20 years; Candidate for elective laparoscopic surgery; ASA I-II class &#13;
Exclusion criteria: ASA III class or above; Emergency Surgery; chronic use of pain medication, alcohol or drug addiction; BMI over 30 ; ischemic heart disease; hypertension; renal dysfunction;  Diabetes; Anti-coagulant therapy</inclusion_criteria>
      <agemin>19 years</agemin>
      <agemax>39 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z01.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Examination Of Blood Pressure</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Group Intervention: Fifteen minutes before induction of anesthesia in the operating room, after moving Vdrp and appropriate positions under the guidance of sonography in patients with 10 mL of 1% lidocaine blockade of the stellate ganglion block. we used the linear high frequency trancducer (6-13 mhz).</i_keyword>
      <i_keyword>Control group: Fifteen minutes before induction of anesthesia in the operating room, after moving Vdrp and appropriate positions under the guidance of sonography in patients with 10 ml of distilled water are placed under the stellate ganglion block.   we used the linear high frequency trancducer (6-13 mhz).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>BloodPressure. Timepoint: In the beginning, after induction, after intubation, after insufilation gas, while repositioning, the net outflow of gas, in recovery. Method of measurement: Automatic non-invasive blood pressure measurement.</prim_outcome>
      <prim_outcome>Heart Reate. Timepoint: At first- after induction, after intubation, after insuffilation Tzyq gas, while repositioning, the net outflow of gas, in recovery. Method of measurement: Continuous monitoring heart rate.</prim_outcome>
      <prim_outcome>Post operative pain. Timepoint: The beginning of the recovery, 30 minutes later, 24 hours after surgery. Method of measurement: Numerical  pain scale (NRS is a standard measure).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Conjectival and nasal congestion. Timepoint: Immediately after injection. Method of measurement: visual.</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>Iran University of Medical sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-12-10</approval_date>
        <contact_name>Iran University of Medical Sciences</contact_name>
        <contact_address>Hemat exp Way, Tehran, Iran tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
