<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03253497</url>
  </required_header>
  <id_info>
    <org_study_id>savaş</org_study_id>
    <nct_id>NCT03253497</nct_id>
  </id_info>
  <brief_title>To Evaluate the Effect of Chlorhexidine-benzidamine Administration</brief_title>
  <official_title>To Evaluate the Effect of Chlorhexidine-benzidamine Administration Prior to the Use of the Laryngeal Mask</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Diskapi Yildirim Beyazit Education and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Diskapi Yildirim Beyazit Education and Research Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The use of laryngeal mask (LMA) for the purpose of providing airway safety of patients is a&#xD;
      common method in general anesthesia practice. This practice does not require laryngoscopy and&#xD;
      there is no laryngeal and tracheal stimulation until endotracheal intubation, so an increased&#xD;
      hemodynamic response is not expected in the patient. LMA is an airway control device&#xD;
      consisting of a silicon mask commonly used in cases where endotracheal intubation (ETE) is&#xD;
      not required and a silicone tubing connected by 30 degrees. The glottic settles around the&#xD;
      entrance. There is no obligation for muscle relaxation as LMA is intubated. However, if a&#xD;
      muscle relaxant agent is not used, pharyngolaryngeal side effects such as patient wounds,&#xD;
      hiccups, coughs, involuntary muscle movement, hypoxia, laryngospasm can be seen when LMA is&#xD;
      inserted. In these patients complications such as throat burning, sore throat, ear pain,&#xD;
      voice anxiety, swallowing difficulties are seen depending on the difficulty of LMA placement&#xD;
      in the postoperative period.&#xD;
&#xD;
      Benzidamine is an anti-inflammatory analgesic agent that is not related to the steroid group&#xD;
      as the structure. Benzidamine is different from other non-steroidal anti-inflammatory agents&#xD;
      in terms of base formation. Benzidamine has local anesthetic effect in concentrations used in&#xD;
      topical treatment. Chlorhexidine grams (+) gram (-) bacteria are most effective in&#xD;
      microorganisms such as yeast and some fungi and viruses. Chlorhexidine delays bacterial&#xD;
      spread with delayed surface effect. It is absorptive from the microbial cell walls and causes&#xD;
      membrane leakage.&#xD;
&#xD;
      In this study, investigators aimed to reveal the effects of topical chlorhexidine and&#xD;
      benzidamine containing spray (chlorobenzene 30 Ml Spray) used before LMA placement on&#xD;
      hemodynamic response with postoperative throat and ear pain, swallowing difficulty, voice&#xD;
      anxiety and soft LMA removal.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      50 participants with American Society of Anesthesiologists (ASA) physical score I-II.&#xD;
      laryngeal mask (LMA) will use in general anesthesia.&#xD;
&#xD;
      all participants will be premedicated with 0.05 mg/kg midazolam 30 minutes before the&#xD;
      operation. ASA, age, sex, body mass index (BMI) will record. peripheral oxygen saturation&#xD;
      (SaO2) ,electrocardiography and non invasive blood pressure will monitored. A venous cannula&#xD;
      will place on the back of the hand. participants will randomly divide into 2 groups by closed&#xD;
      envelope method.&#xD;
&#xD;
      before 15 minute anesthesia induction topical chlorobenzene 30 Ml Spray will use. Than LMA&#xD;
      will placement on and record hemodynamic response and postoperative throat and ear pain,&#xD;
      swallowing difficulty, voice anxiety and soft LMA removal.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2, 2017</start_date>
  <completion_date type="Actual">December 2, 2017</completion_date>
  <primary_completion_date type="Actual">October 2, 2017</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Removal to soft LMA</measure>
    <time_frame>First minute after extubation</time_frame>
    <description>was assessed because of coughing, tooth clenching, desaturation, and lack of laryngeal spasm</description>
  </primary_outcome>
  <primary_outcome>
    <measure>complications</measure>
    <time_frame>after operation 1th, 6th, 12th and 24th hour</time_frame>
    <description>sore throat, ear pain, swallowing difficulty, nausea and vomiting</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>hemodynamic response</measure>
    <time_frame>before LMA and at 1 minute after LMA applied</time_frame>
    <description>systolic, diastolic and mean blood pressure will record before LMA and post LMA used at first minute.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate</measure>
    <time_frame>before LMA and at 1 minute after LMA applied</time_frame>
    <description>Heart rate will record before LMA insertion and post LMA used at first minute.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Effects of Topical Chlorhexidine and Benzidine Spray</condition>
  <arm_group>
    <arm_group_label>Chlorhexidine- benzidamine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>before 15 minute anesthesia induction Chlorhexidine-benzidamine spray will be administrated to oropharynx</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>before 15 minute normal salin will be administrated to oropharynx</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chlorobenzene Liquid</intervention_name>
    <description>before induction will be used for oropharynx</description>
    <arm_group_label>Chlorhexidine- benzidamine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  general anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  using anti-inflammatory drugs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ministry of Health Diskapi Yıldırım Beyazıt Training and Research Hospital</name>
      <address>
        <city>Ankara</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>August 11, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 18, 2017</study_first_posted>
  <last_update_submitted>December 22, 2017</last_update_submitted>
  <last_update_submitted_qc>December 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Diskapi Yildirim Beyazit Education and Research Hospital</investigator_affiliation>
    <investigator_full_name>Savas Altinsoy</investigator_full_name>
    <investigator_title>Diskapi Yildirim Beyazit Education and Research Hospital anestehesia and reanimation</investigator_title>
  </responsible_party>
  <keyword>chlorhexidine, benzidamine, laryngeal mask</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03253497
org study id: savaş
nct id: NCT03253497
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The use of laryngeal mask (LMA) for the purpose of providing airway safety of patients is a
      common method in general anesthesia practice. This practice does not require laryngoscopy and
      there is no laryngeal and tracheal stimulation until endotracheal intubation, so an increased
      hemodynamic response is not expected in the patient. LMA is an airway control device
      consisting of a silicon mask commonly used in cases where endotracheal intubation (ETE) is
      not required and a silicone tubing connected by 30 degrees. The glottic settles around the
      entrance. There is no obligation for muscle relaxation as LMA is intubated. However, if a
      muscle relaxant agent is not used, pharyngolaryngeal side effects such as patient wounds,
      hiccups, coughs, involuntary muscle movement, hypoxia, laryngospasm can be seen when LMA is
      inserted. In these patients complications such as throat burning, sore throat, ear pain,
      voice anxiety, swallowing difficulties are seen depending on the difficulty of LMA placement
      in the postoperative period.

      Benzidamine is an anti-inflammatory analgesic agent that is not related to the steroid group
      as the structure. Benzidamine is different from other non-steroidal anti-inflammatory agents
      in terms of base formation. Benzidamine has local anesthetic effect in concentrations used in
      topical treatment. Chlorhexidine grams (+) gram (-) bacteria are most effective in
      microorganisms such as yeast and some fungi and viruses. Chlorhexidine delays bacterial
      spread with delayed surface effect. It is absorptive from the microbial cell walls and causes
      membrane leakage.

      In this study, investigators aimed to reveal the effects of topical chlorhexidine and
      benzidamine containing spray (chlorobenzene 30 Ml Spray) used before LMA placement on
      hemodynamic response with postoperative throat and ear pain, swallowing difficulty, voice
      anxiety and soft LMA removal.
50 participants with American Society of Anesthesiologists (ASA) physical score I-II.
      laryngeal mask (LMA) will use in general anesthesia.

      all participants will be premedicated with 0.05 mg/kg midazolam 30 minutes before the
      operation. ASA, age, sex, body mass index (BMI) will record. peripheral oxygen saturation
      (SaO2) ,electrocardiography and non invasive blood pressure will monitored. A venous cannula
      will place on the back of the hand. participants will randomly divide into 2 groups by closed
      envelope method.

      before 15 minute anesthesia induction topical chlorobenzene 30 Ml Spray will use. Than LMA
      will placement on and record hemodynamic response and postoperative throat and ear pain,
      swallowing difficulty, voice anxiety and soft LMA removal.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Removal to soft LMA
time frame: First minute after extubation
description: was assessed because of coughing, tooth clenching, desaturation, and lack of laryngeal spasm
measure: complications
time frame: after operation 1th, 6th, 12th and 24th hour
description: sore throat, ear pain, swallowing difficulty, nausea and vomiting
measure: hemodynamic response
time frame: before LMA and at 1 minute after LMA applied
description: systolic, diastolic and mean blood pressure will record before LMA and post LMA used at first minute.
measure: Heart rate
time frame: before LMA and at 1 minute after LMA applied
description: Heart rate will record before LMA insertion and post LMA used at first minute.
arm group label: Chlorhexidine- benzidamine
arm group type: Active Comparator
description: before 15 minute anesthesia induction Chlorhexidine-benzidamine spray will be administrated to oropharynx
arm group label: Control
arm group type: No Intervention
description: before 15 minute normal salin will be administrated to oropharynx
intervention type: Drug
intervention name: Chlorobenzene Liquid
description: before induction will be used for oropharynx
arm group label: Chlorhexidine- benzidamine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Diskapi Yildirim Beyazit Education and Research Hospital
investigator full name: Savas Altinsoy
investigator title: Diskapi Yildirim Beyazit Education and Research Hospital anestehesia and reanimation