<?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>IRCT20231014059718N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-02-03</date_registration>
      <primary_sponsor>Bandare-abbas University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of two anesthesia methods, sevoflurane fentanyl and propofol fentanyl, on the severity of cough and laryngospasm in orthopedic surgeries under one hour.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of two anesthesia methods, sevoflurane fentanyl and propofol fentanyl, on the severity of cough and laryngospasm in orthopedic surgeries under one hour.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>148</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/74874</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Generating random numbers from the table of random numbers: Considering that 148 patients are needed in this study, a number was chosen randomly in the table of random numbers and the two digits on the right side of it were taken into account. If these two digits were an even number, the patient was intervention group A, and if there is an individual, they will be assigned to control group B. For example, in the table of random numbers, the number 63 was chosen, since 63 is an odd number, so the first sample will be assigned to the control group. People are divided into two groups, Blinding description: In each of the groups, the desired drug is injected into the patient by an anesthesiologist, but the desired information for the research is recorded by an independent researcher who does not know the type of drug and the study group.</study_design>
      <phase>3</phase>
      <hc_freetext>Respiratory system problem.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: 100 mcg per kilogram of body weight will receive propofol for induction of anesthesia. Intervention 2: Intervention group 2: will receive sevoflurane with MAC=2 for anesthesia.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Comparison of two anesthesia methods, sevoflurane fentanyl and propofol fentanyl, on the severity of cough and laryngospasm in patients who return to the orthopedic surgery department for orthopedic surgery.

When:
Up to one year after the publication of the article

To whom:
Authors and officials of Bandar Abbas University of Medical Sciences

Conditions:
For use in statistical work and larger studies

Where to obtain:
first author

How to obtain:
Send an email to the first author and request the use of the data

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Majid vatankhah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahidmohammadi hospital street</address>
        <city>Bandarabbas</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7916613885</zip>
        <telephone>+98 76 5224 1819</telephone>
        <email>hormozgan91@yahoo.com</email>
        <affiliation>Bandare-abbas University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr majid vatan khah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahidmohammadi hospital</address>
        <city>Bandarabbas</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7916613885</zip>
        <telephone>+98 933 091 1441</telephone>
        <email>hormozgan91@yahoo.com</email>
        <affiliation>Bandare-abbas University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 18 to 75
Consent to participate in the study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Heart and kidney diseases
Hemodynamic instability
Drug abuse</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J95.89</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other postprocedural complications and disorders of respiratory system, not elsewhere classified</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 group 1: 100 mcg per kilogram of body weight will receive propofol for induction of anesthesia.</i_keyword>
      <i_keyword>Intervention group 2: will receive sevoflurane with MAC=2 for anesthesia.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Severity of cough. Timepoint: During the operation and after casteob and fifteen minutes later and half an hour and an hour later. Method of measurement: Aldrete score.</prim_outcome>
      <prim_outcome>Laryngospasm. Timepoint: During the operation and after casteob and fifteen minutes later and half an hour and an hour later. Method of measurement: Aldrete score.</prim_outcome>
      <prim_outcome>Oxygen saturation percentage of arterial blood. Timepoint: During the operation and after casteob and fifteen minutes later and half an hour and an hour later. Method of measurement: Pulse oximeter.</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>Research Vice President of Bandar Abbas University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-12-31</approval_date>
        <contact_name>Ethics commitee of Hormozgan university of medical sciences</contact_name>
        <contact_address>Shahid moءhammadi hospital, Jomhori Eslami Blvd. Bandarabbas Hormozgan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
