<?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>IRCT20211108053010N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-05-28</date_registration>
      <primary_sponsor>Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of intravenous magnesium sulfate and labetalol on intraoperative bleeding and postoperative edema and ecchymosis in rhinoplasty</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of intravenous magnesium sulfate and labetalol on intraoperative bleeding and postoperative edema and ecchymosis in rhinoplasty</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-05-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63583</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: The samples are randomly divided into two groups using PASS11 software.  Random allocation was performed by Efron method with one thousand repetitions and due to this method, an equal number of samples in each block are placed in two groups of magnesium sulfate and labetalol.  In randomization, equal chances are provided for all samples to be in one of the two groups.  The researcher does not interfere in determining the group for the samples, Blinding description: Blindness is such that only the anesthesiologist is aware of the type of drug being used and all patients, researchers and surgeons are unaware of the patient's reception.</study_design>
      <phase>3</phase>
      <hc_freetext>Condition 1: Bleeding during rhinoplasty. Condition 2: Edema and ecchymosis after rhinoplasty.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  In the sulfate group, 30 to 50 mg / kg intravenous magnesium sulfate is given before induction of anesthesia, and 10 to 20 mg / kg intravenous magnesium sulfate is infused during surgery. Magnesium sulfate is prepared from Shahid Ghazi Pharmaceutical Company, Tabriz, Iran. Intervention 2: Intervention group:  In the labetalol group, the infusion of labetalol is 1 mg / min intraoperatively (limit less than 300 mg). Labetalol is produced by Restagen Daru Pharmaceutical Company, Tehran, Iran.</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 There is no more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shaghayegh Rezaeekia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mehr Town, 103 Mehr Alley, Block 42, Unit 11</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4196936484</zip>
        <telephone>+98 13 3346 9321</telephone>
        <email>shaghayeghrezaeekia1375@gmail.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hooshang Akbari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Farahabad Street</address>
        <city>sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4815733971</zip>
        <telephone>0098 11 330440001</telephone>
        <email>hooshangakbari48@yahoo.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>over 18 years old
consent to participate in the study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>history of hypertension
peripheral vascular problems
renal, hepatic or hematologic disorders
pregnancy
obesity
diabetic neuropathy
uncontrollable hypertension
previous treatment with any antihypertensive drug, opioid or anticoagulant
magnesium supplementation
consumption  Chronic drug
drug use such as aspirin
allergy to magnesium sulfate, drugs or other drugs under study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:  In the sulfate group, 30 to 50 mg / kg intravenous magnesium sulfate is given before induction of anesthesia, and 10 to 20 mg / kg intravenous magnesium sulfate is infused during surgery. Magnesium sulfate is prepared from Shahid Ghazi Pharmaceutical Company, Tabriz, Iran.</i_keyword>
      <i_keyword>Intervention group:  In the labetalol group, the infusion of labetalol is 1 mg / min intraoperatively (limit less than 300 mg). Labetalol is produced by Restagen Daru Pharmaceutical Company, Tehran, Iran.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The amount of bleeding during the operation. Timepoint: End of operation. Method of measurement: Measure lost blood by examining gases and suction.</prim_outcome>
      <prim_outcome>The rate of ecchymosis. Timepoint: 24 hours and one week after surgery. Method of measurement: Standard tool for scoring degree of ecchymosis.</prim_outcome>
      <prim_outcome>The amount of edema. Timepoint: 24 hours and one week after surgery. Method of measurement: Standard tool for scoring degree of edema.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Sore throat. Timepoint: Postoperatively and 24 hours after surgery. Method of measurement: 4 degree scale of sore throat.</sec_outcome>
      <sec_outcome>Headache. Timepoint: 24 hours after surgery. Method of measurement: Question.</sec_outcome>
      <sec_outcome>Orthostatic hypotension. Timepoint: 24 hours after surgery. Method of measurement: Barometer.</sec_outcome>
      <sec_outcome>Respiratory depression. Timepoint: 24 hours after surgery. Method of measurement: See the number of breaths per minute.</sec_outcome>
      <sec_outcome>Surgeon consent. Timepoint: After surgery. Method of measurement: Boezaart criteria.</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>Mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-05-15</approval_date>
        <contact_name>Ethics committee of Mazandaran University of Medical Sciences</contact_name>
        <contact_address>Farahabad Street sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
