<?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>IRCT20250421065412N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-05-29</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Xylapy cream 5% on Postoperative Sore Throat in Adults</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the Effect of Xylapy cream 5% on Postoperative Sore Throat in Adults Following General Anesthesia with a Laryngeal Mask Airway: A Double-Blind Clinical Trial Study"</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-05-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>300</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/83042</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, the block random allocation method will be employed. First, the randomization sequence will be generated before the study commences and patient recruitment, ensuring that the initial blocks containing 4 parts are created by considering all possible allocation scenarios for the intervention group (I) and control group (C) within each block (such as I-I-C-C, I-C-I-C, etc.). Then, the created blocks will be randomly numbered using the Excel RAND function. After sorting the numbers from smallest to largest, the order of block selection will be determined, and we will proceed to select the blocks. Block selection will continue until the required sample size is reached. To conceal the allocation, the treatments will be coded and placed in sealed envelopes. These envelopes will be opened only after the patient is registered in the study. In each block, 4 allocations (2 cases in the intervention group and 2 cases in the control group) will occur, and this process will continue until the target sample size is met, Blinding description: Since the treatment methods used are unnamed and will be identified by specific codes, the outcome assessor and analyst will remain blinded to the type of intervention.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Anesthesia methods in surgeries.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this group, Zylapril 5% cream (a topical anesthetic combining 2.5% lidocaine + 2.5% prilocaine, manufactured by Tehran Chemi Pharmaceutical Company) will be applied once to the cuff of their laryngeal airway mask. The anesthesia protocol included midazolam (0.03–0.05 mg/kg), fentanyl (3 mcg/kg), lidocaine (1 mg/kg), and propofol (2–3 mg/kg), with anesthesia maintained using isoflurane (MAC 1.5). The size of the airway mask was selected based on the patient’s weight, and the material and manufacturer of the mask were standardized for all patients. Intervention 2: Control Group: No local anesthetic agent will be applied to the cuff of their laryngeal airway mask (LMA). The anesthesia protocol included midazolam (0.03–0.05 mg/kg), fentanyl (3 mcg/kg), lidocaine (1 mg/kg), and propofol (2–3 mg/kg), with anesthesia maintained using isoflurane (MAC 1.5). The size of the airway mask was determined based on the patient’s weight, and the material and manufacturer of the mask will be standardized for all 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 Data will be collected for research purposes, and the analyzed results will be published in reports and articles. However, raw data may also be disclosed if deemed appropriate.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sina forghani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran University of Medical Sciences, next to Milad Tower, Hemmat Highway, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1449614535</zip>
        <telephone>+98 21 86721</telephone>
        <email>drsinaforghani@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sina Forfghani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran University of Medical Sciences, next to Milad Tower, Hemmat Highway, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1449614535</zip>
        <telephone>+98 21 86721</telephone>
        <email>drsinaforghani@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Adult patients of both genders,
aged 18 to 65 years,
classified as ASA (American Society of Anesthesiologists) physical status I and II, who are candidates for surgery lasting 1 to 3 hours under general anesthesia with a laryngeal mask airway</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Known hypersensitivity to local anesthetics
More than two attempts required for Laryngeal Mask Airway insertion.
Patients undergoing head and neck surgeries involving the airway.
Airway injuries
Preoperative pharyngeal pain
Congenital oral anomalies.
Loose or artificial dentures
Anticipated difficult airway.</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>N/A</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In this group, Zylapril 5% cream (a topical anesthetic combining 2.5% lidocaine + 2.5% prilocaine, manufactured by Tehran Chemi Pharmaceutical Company) will be applied once to the cuff of their laryngeal airway mask. The anesthesia protocol included midazolam (0.03–0.05 mg/kg), fentanyl (3 mcg/kg), lidocaine (1 mg/kg), and propofol (2–3 mg/kg), with anesthesia maintained using isoflurane (MAC 1.5). The size of the airway mask was selected based on the patient’s weight, and the material and manufacturer of the mask were standardized for all patients.</i_keyword>
      <i_keyword>Control Group: No local anesthetic agent will be applied to the cuff of their laryngeal airway mask (LMA). The anesthesia protocol included midazolam (0.03–0.05 mg/kg), fentanyl (3 mcg/kg), lidocaine (1 mg/kg), and propofol (2–3 mg/kg), with anesthesia maintained using isoflurane (MAC 1.5). The size of the airway mask was determined based on the patient’s weight, and the material and manufacturer of the mask will be standardized for all patients.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Postoperative sore throat rate. Timepoint: Patients will be assessed for the incidence and severity of postoperative sore throat at two times: once after surgery and during recovery, and a second time 3 hours after surgery. Method of measurement: Using a Likert scale that divides severity into category 1: mild; category 2: moderate; category 3: severe.</prim_outcome>
      <prim_outcome>Coughing after surgery. Timepoint: After surgery in recovery  and 3 hours after surgery,. Method of measurement: Questioning the patient.</prim_outcome>
      <prim_outcome>Voice change after surgery. Timepoint: After surgery  in recovery and 3 hours after surgery,. Method of measurement: Questioning the patient.</prim_outcome>
      <prim_outcome>Hypoxia. Timepoint: After surgery  in recovery and 3 hours after surgery. 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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-02-03</approval_date>
        <contact_name>Ethics Committee of the Faculty of Medicine, Iran University of Medical Sciences</contact_name>
        <contact_address>Iran University of Medical Sciences,next to Milad Tower,Shahid Hemmat Highway Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
