xml: <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/NCT05975346</url>
    </required_header>
    <id_info>
      <org_study_id>soh-Med-23-07-20MS</org_study_id>
      <nct_id>NCT05975346</nct_id>
    </id_info>
    <brief_title>Evaluation of the Efficacy of Preoperative Ketamine Nebulization on Postoperative Sore Throat Due to Tracheal Intubation for Adult Patients Under General Anesthesia, A Prospective Randomized Controlled Study</brief_title>
    <official_title>Evaluation of the Efficacy of Preoperative Ketamine Nebulization on Postoperative Sore Throat Due to Tracheal Intubation for Adult Patients Under General Anesthesia, A Prospective Randomized Controlled Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sohag University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sohag University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Sore throat includes specific symptoms such as dysphagia, dysphonia, hoarseness, continuous&#xD;
        throat pain, and pharyngeal dryness. Patients rated postoperative sore throat (POST) as the&#xD;
        eighth most undesirable outcome in the postoperative period POST has a reported incidence of&#xD;
        up to 62% following general anesthesia (GA). The incidence of POST is more common in GA with&#xD;
        tracheal intubation than in GA with the supraglottic airway Ketamine is an&#xD;
        N-methyl-D-aspartate (NMDA) receptor antagonist and has been used as a gargle for reducing&#xD;
        the incidence and severity of POST due to its anti-nociceptive and anti-inflammatory effects&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">January 2024</completion_date>
    <primary_completion_date type="Anticipated">January 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>the incidence and severity of POST</measure>
      <time_frame>at immediate recovery (0 h), 2, 4, 6, 8, 12 and 24 h post-operatively.</time_frame>
      <description>the study is to measure the incidence and severity of POST at immediate recovery (0 h), 2, 4, 6, 8, 12 and 24 h post-operatively. in adult patients undergoing surgery of a duration less than 2h.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>evaluation of side effects including nausea, vomiting, cough, and dry mouth in both groups.</measure>
      <time_frame>at immediate recovery (0 h), 2, 4, 6, 8, 12 and 24 h post-operatively.</time_frame>
      <description>evaluation of side effects including nausea, vomiting, cough, and dry mouth in both groups.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Post Operative Sore Throat</condition>
    <arm_group>
      <arm_group_label>(K) Ketamine group</arm_group_label>
      <description>40 patients will receive ketamine 50mg (1.0 ml with 4.0 ml of the saline) nebulization</description>
    </arm_group>
    <arm_group>
      <arm_group_label>(S) Saline group</arm_group_label>
      <description>40 patients will receive saline nebulization (5ml).</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Ketamine</intervention_name>
      <description>description</description>
      <arm_group_label>(K) Ketamine group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>saline nebulization</intervention_name>
      <description>description</description>
      <arm_group_label>(S) Saline group</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          1. Age 16-60 years.&#xD;
  &#xD;
            2. Of both sex.&#xD;
  &#xD;
            3. American Society of Anesthesiologists Physical Status (ASA PS) I-II.&#xD;
  &#xD;
            4. Undergoing general anesthesia with endotracheal intubation with surgery duration less&#xD;
               than two hours.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age 16-60 years.&#xD;
  &#xD;
            2. Of both sex.&#xD;
  &#xD;
            3. American Society of Anesthesiologists Physical Status (ASA PS) I-II.&#xD;
  &#xD;
            4. Undergoing general anesthesia with endotracheal intubation with surgery duration less&#xD;
               than two hours.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  a- History of chronic obstructive History of sore throat or upper respiratory tract&#xD;
               infection.&#xD;
  &#xD;
               b- Intraoral and intrapharyngeal surgery. c- airway disease or Asthma. d- Mallampati&#xD;
               grade more than II. e- Known allergic to study drug. f- More than one attempt is&#xD;
               required for intubation. g- Hypertensive patients. h- Epileptic patients. i- cerebral&#xD;
               palsy or any neurological disorders. j- Psychiatry patients. k- Cardiac patients. l-&#xD;
               Perioperative use of anti-inflammatory drugs (Non-steroidal anti-inflammatory drug or&#xD;
               steroids).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>16 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
    </eligibility>
    <overall_contact>
      <last_name>Doaa A Abdellatif, resident</last_name>
      <phone>01119950167</phone>
      <email>doaaahmed@med.sohag.edu.eg</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>fawzy A Badawy, assistant professor</last_name>
      <phone>01004862474</phone>
    </overall_contact_backup>
    <reference>
      <citation>Cairns A, Battleday FM, Velikova G, Brunelli A, Bell H, Favo J, Patella M, Lindner O, Pompili C. General patient satisfaction after elective and acute thoracic surgery is associated with postoperative complications. J Thorac Dis. 2020 May;12(5):2088-2095. doi: 10.21037/jtd-19-3345b.</citation>
      <PMID>32642112</PMID>
    </reference>
    <reference>
      <citation>Hailu S, Shiferaw A, Regasa T, Getahun YA, Mossie A, Besha A. Incidence of Postoperative Sore Throat and Associated Factors Among Pediatric Patients Undergoing Surgery Under General Anesthesia at Hawassa University Comprehensive Specialized Hospital, a Prospective Cohort Study. Int J Gen Med. 2023 Feb 18;16:589-598. doi: 10.2147/IJGM.S397519. eCollection 2023. Erratum In: Int J Gen Med. 2023 Apr 06;16:1237-1238.</citation>
      <PMID>36845340</PMID>
    </reference>
    <reference>
      <citation>Thomas D, Bejoy R, Zabrin N, Beevi S. Preoperative ketamine nebulization attenuates the incidence and severity of postoperative sore throat: A randomized controlled clinical trial. Saudi J Anaesth. 2018 Jul-Sep;12(3):440-445. doi: 10.4103/sja.SJA_47_18.</citation>
      <PMID>30100844</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Sohag University</investigator_affiliation>
      <investigator_full_name>Doaa Ahmed Abdellatif</investigator_full_name>
      <investigator_title>Resident-anesthesia,ICU and pain manegment department-sohag hospital university</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pharyngitis</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Ketamine</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05975346
  org study id: soh-Med-23-07-20MS
  nct id: NCT05975346
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Sore throat includes specific symptoms such as dysphagia, dysphonia, hoarseness, continuous
        throat pain, and pharyngeal dryness. Patients rated postoperative sore throat (POST) as the
        eighth most undesirable outcome in the postoperative period POST has a reported incidence of
        up to 62% following general anesthesia (GA). The incidence of POST is more common in GA with
        tracheal intubation than in GA with the supraglottic airway Ketamine is an
        N-methyl-D-aspartate (NMDA) receptor antagonist and has been used as a gargle for reducing
        the incidence and severity of POST due to its anti-nociceptive and anti-inflammatory effects
  observational model: Case-Control
  time perspective: Prospective
  measure: the incidence and severity of POST
  time frame: at immediate recovery (0 h), 2, 4, 6, 8, 12 and 24 h post-operatively.
  description: the study is to measure the incidence and severity of POST at immediate recovery (0 h), 2, 4, 6, 8, 12 and 24 h post-operatively. in adult patients undergoing surgery of a duration less than 2h.
  measure: evaluation of side effects including nausea, vomiting, cough, and dry mouth in both groups.
  time frame: at immediate recovery (0 h), 2, 4, 6, 8, 12 and 24 h post-operatively.
  description: evaluation of side effects including nausea, vomiting, cough, and dry mouth in both groups.
  arm group label: (K) Ketamine group
  description: 40 patients will receive ketamine 50mg (1.0 ml with 4.0 ml of the saline) nebulization
  arm group label: (S) Saline group
  description: 40 patients will receive saline nebulization (5ml).
  intervention type: Drug
  intervention name: Ketamine
  description: description
  arm group label: (K) Ketamine group
  intervention type: Other
  intervention name: saline nebulization
  description: description
  arm group label: (S) Saline group
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 16 Years
  maximum age: 60 Years
  last name: Doaa A Abdellatif, resident
  phone: 01119950167
  email: doaaahmed@med.sohag.edu.eg
  last name: fawzy A Badawy, assistant professor
  phone: 01004862474
  citation: Cairns A, Battleday FM, Velikova G, Brunelli A, Bell H, Favo J, Patella M, Lindner O, Pompili C. General patient satisfaction after elective and acute thoracic surgery is associated with postoperative complications. J Thorac Dis. 2020 May;12(5):2088-2095. doi: 10.21037/jtd-19-3345b.
  PMID: 32642112
  citation: Hailu S, Shiferaw A, Regasa T, Getahun YA, Mossie A, Besha A. Incidence of Postoperative Sore Throat and Associated Factors Among Pediatric Patients Undergoing Surgery Under General Anesthesia at Hawassa University Comprehensive Specialized Hospital, a Prospective Cohort Study. Int J Gen Med. 2023 Feb 18;16:589-598. doi: 10.2147/IJGM.S397519. eCollection 2023. Erratum In: Int J Gen Med. 2023 Apr 06;16:1237-1238.
  PMID: 36845340
  citation: Thomas D, Bejoy R, Zabrin N, Beevi S. Preoperative ketamine nebulization attenuates the incidence and severity of postoperative sore throat: A randomized controlled clinical trial. Saudi J Anaesth. 2018 Jul-Sep;12(3):440-445. doi: 10.4103/sja.SJA_47_18.
  PMID: 30100844
  responsible party type: Principal Investigator
  investigator affiliation: Sohag University
  investigator full name: Doaa Ahmed Abdellatif
  investigator title: Resident-anesthesia,ICU and pain manegment department-sohag hospital university
  mesh term: Pharyngitis
  mesh term: Ketamine
  sharing ipd: Undecided