<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/NCT04471597</url>
  </required_header>
  <id_info>
    <org_study_id>12-7-2020</org_study_id>
    <nct_id>NCT04471597</nct_id>
  </id_info>
  <brief_title>Topical Bupivacaine Effect On The Response To Awake Extubation During Emergence From General Anesthesia</brief_title>
  <official_title>Topical Bupivacaine Effect On The Response To Awake Extubation During Emergence From General Anesthesia In Patients Undergoing Elective Thyroidectomy. A Randomized Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zagazig University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zagazig University</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>
      -  Emergence from general anesthesia is often complicated by the ETT-induced emergence&#xD;
           phenomena (EP), which include coughing, sympathetic stimulation, sore throat, increased&#xD;
           bleeding from the surgical site, and increased intracranial and intraocular pressures.&#xD;
&#xD;
        -  Techniques that have been used to help diminish coughing during emergence include &quot;deep&quot;&#xD;
           extubation (removal of the endotracheal tube [ETT] while the patient is still in a deep&#xD;
           plane of general anesthesia), administration of intravenous (IV) narcotics, or&#xD;
           administration of IV lidocaine prior to emergence since systemic narcotics and lidocaine&#xD;
           have antitussive properties. However, each of these techniques has limitations. A&#xD;
           reliable technique for improving ETT tolerance while facilitating rapid and full&#xD;
           emergence from general anesthesia would be desirable in many situations.&#xD;
&#xD;
        -  Topical application of bupivacaine to the pharyngeal, laryngeal, and tracheal mucosa&#xD;
           will attenuate or even abolish coughing as well as a hemodynamic response during&#xD;
           extubation, thus result in increasing the patient's comfort and avoiding potential&#xD;
           complications of extubation process.&#xD;
&#xD;
        -  Up to the investigator's knowledge there is no study done to evaluate the effect of&#xD;
           topical bupivacaine on the incidence of coughing and hemodynamic response during&#xD;
           emergence from general anesthesia in patients undergoing elective thyroidectomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The process of manipulation of the airway during laryngoscopy, endotracheal intubation, and&#xD;
      extubation is usually associated with exaggerated hemodynamic response including tachycardia,&#xD;
      hypertension as well as increase intraocular and intracranial pressure[1,2]. The exact&#xD;
      mechanism to these hemodynamic responses may be due to the release of catecholamine in the&#xD;
      blood by stimulating the sympathetic nervous system during these stressful periods. Acute&#xD;
      hemodynamic changes during extubation may lead to life-threatening myocardial ischemia,&#xD;
      arrhythmias, pulmonary edema, acute heart failure, or cerebrovascular hemorrhage in high-risk&#xD;
      patients and this can increase morbidity and mortality of the patients [3].&#xD;
&#xD;
      Respiratory complications after tracheal extubation are three times more common than&#xD;
      induction of anesthesia and intubation [4], as intratracheal tube induces laryngeal&#xD;
      irritation that transmitted through rapidly acting receptors which are located throughout the&#xD;
      trachea, involved in the cough reflex and subsequently lead to coughing and bucking that&#xD;
      frequently occur during extubation and may lead to negative pressure pulmonary edema as well&#xD;
      as, laryngeal edema and sore throat [5, 6].&#xD;
&#xD;
      Various techniques have been applied to attenuate the hemodynamic responses and coughing&#xD;
      during emergence and extubation. They include deep extubation, administration of intravenous&#xD;
      (IV) short-acting narcotics, calcium channel blockers, and dexmedetomidine [7,8], as well as&#xD;
      lidocaine which is considered one of the commonly used drugs either through IV route,&#xD;
      endotracheal tube (ETT) cuff, or laryngotracheal route[1,9]. Concern about the use of these&#xD;
      drugs includes respiratory depression, delayed emergence from anesthesia, postoperative&#xD;
      nausea and vomiting, sedative effects, and short action time [10].&#xD;
&#xD;
      Bupivacaine is a kind of sodium channel blocker local anesthetics used as topical anesthesia&#xD;
      that suppresses cough by inhibiting the progression of the action potential in the tracheal&#xD;
      touch-sensitive Aδ fibers (cough receptors)[10]. The plasma protein binding of bupivacaine&#xD;
      exceeds 90%, whereas lidocaine protein binding is 65- 75%, [11] and it is well known that the&#xD;
      duration of local anesthetics is influenced by their protein binding characteristics, as the&#xD;
      affinity for plasma proteins corresponds to the affinity for protein binding at the sodium&#xD;
      channel receptor site, that results in prolongation of the presence of the anesthetic effect&#xD;
      at the site of action [12, 13].&#xD;
&#xD;
      the investigators hypothesize that usage of topical bupivacaine may have an impact on&#xD;
      decreasing incidence of coughing and alleviating hemodynamic response during awake extubation&#xD;
      and emergence from general anesthesia in post-thyroidectomy patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 12, 2020</start_date>
  <completion_date type="Anticipated">September 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>The patients will be divided randomly by a computer-generated randomization table into two equal groups</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>double-blinded ( patient and outcome assessors)</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Grade of coughing</measure>
    <time_frame>procedure (measured within the extubation time)</time_frame>
    <description>will be assessed as Grade 0: no cough; Grade 1: single cough with mild severity; Grade 2: cough lasting less than 5 s with moderate severity; Grade 3: sustained bouts of persistent cough more than 5 s.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>oxygen saturation(SpO2)</measure>
    <time_frame>will be recorded at base line, after administration of the study drug, before extubation, then at 1 min, 2min, 5min, and 10 min immediately following extubation.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>heart rate</measure>
    <time_frame>will be recorded at base line, after administration of the study drug, before extubation, then at 1 min, 2min, 5min, and 10 min immediately following extubation.</time_frame>
    <description>Hemodynamics</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mean arterial blood pressure</measure>
    <time_frame>will be recorded at base line, after administration of the study drug, before extubation, then at 1 min, 2min, 5min, and 10 min immediately following extubation.</time_frame>
    <description>Hemodynamics</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Extubation time</measure>
    <time_frame>Procedure -from the end of the anesthesia (discontinuation of isoflurane) to the time the endotracheal tube will be pulled out</time_frame>
    <description>removal of the endotracheal tube [ETT] while the patient is still in a deep plane of general anesthesia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sore throat degree</measure>
    <time_frame>1 , 2 , 4, 6 and 12 hours postoperatively.</time_frame>
    <description>will be assessed by visual analogue scale (VAS) scale, On a scale of 0-10, the patient will learn to quantify postoperative sore throat pain where 0= No pain and 10= Maximum worst pain.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">48</enrollment>
  <condition>Thyroid Diseases</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>patients will receive 5ml of normal saline 0.9% topically 15 min before the expected end of surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>bupivacaine group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patients will receive 5ml of bupivacaine 0.5% topically 15 min before the expected end of surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>normal saline 0.9%</intervention_name>
    <description>5ml of normal saline 0.9% topically 15 min will be installed topically around the ETT using ordinary syringe before the expected end of the surgery, this will be followed by manual ventilation using about the double tidal volume for 6-8 times or more to get air bubbles distributed within the upper airway to anesthetize the oropharynx and spread around ETT to the adjacent mucosal structures (laryngopharynx, larynx, and upper part of the trachea) then the cuff will be inflated to the previous pressure and the patient will be mechanically ventilated as usual.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine Hydrochloride</intervention_name>
    <description>5 ml of bupivacaine 0.5% will be installed topically around the ETT using ordinary syringe before the expected end of the surgery, this will be followed by manual ventilation using about the double tidal volume for 6-8 times or more to get air bubbles distributed within the upper airway to anesthetize the oropharynx and spread around ETT to the adjacent mucosal structures (laryngopharynx, larynx, and upper part of the trachea) then the cuff will be inflated to the previous pressure and patient will be mechanically ventilated as usual.</description>
    <arm_group_label>bupivacaine group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patient acceptance. BMI &lt; 35kg/m2. ASA I and ASA II. Scheduled for elective thyroidectomy&#xD;
        under general anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patient refusal. History or anticipated difficult intubation. Chronic respiratory disease&#xD;
        such as chronic obstructive pulmonary disease or asthma.&#xD;
&#xD;
        Recent respiratory tract infection in the last month, chronic cough, and current smoking.&#xD;
&#xD;
        History of laryngeal or tracheal surgery or pathology. Patients with symptomatic gastric&#xD;
        reflux. Patients with a known history of allergy to study drugs.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Shereen E Abd Ellatif, MD</last_name>
    <phone>01007948840</phone>
    <phone_ext>002</phone_ext>
    <email>shosh.again@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Rehab A Wahdan, MD</last_name>
    <phone>01003481323</phone>
    <phone_ext>002</phone_ext>
    <email>obz13w@yahoo.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Faculty of medicine, zagazig university</name>
      <address>
        <city>Zagazig</city>
        <state>Elsharqya</state>
        <zip>44519</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Howaida A Kamal, MD</last_name>
      <phone>01225096755</phone>
      <phone_ext>002</phone_ext>
      <email>k.howaida@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Shabnum T, Ali Z, Naqash IA, Mir AH, Azhar K, Zahoor SA, Mir AW. Effects of Lignocaine Administered Intravenously or Intratracheally on Airway and Hemodynamic Responses during Emergence and Extubation in Patients Undergoing Elective Craniotomies in Supine Position. Anesth Essays Res. 2017 Jan-Mar;11(1):216-222. doi: 10.4103/0259-1162.200239.</citation>
    <PMID>28298788</PMID>
  </reference>
  <reference>
    <citation>Meng YF, Cui GX, Gao W, Li ZW. Local airway anesthesia attenuates hemodynamic responses to intubation and extubation in hypertensive surgical patients. Med Sci Monit. 2014 Aug 26;20:1518-24. doi: 10.12659/MSM.890703.</citation>
    <PMID>25175842</PMID>
  </reference>
  <reference>
    <citation>Fang P, Zong Z, Lu Y, Han X, Liu X. Effect of topical ropivacaine on the response to endotracheal tube during emergence from general anesthesia: a prospective randomized double-blind controlled study. BMC Anesthesiol. 2018 Sep 27;18(1):134. doi: 10.1186/s12871-018-0601-x.</citation>
    <PMID>30261837</PMID>
  </reference>
  <reference>
    <citation>Phero JC, Prithvi Raj P, Knarr D, Turner P, Denson DD, Vigdorth E, Edstrom HH. Absorption of bupivacaine after topical application to the oropharynx. Anesth Prog. 1987 Sep-Oct;34(5):187-90.</citation>
    <PMID>3479919</PMID>
  </reference>
  <reference>
    <citation>Mogensen S, Sverrisdottir E, Sveinsdottir K, Treldal C, Jensen K, Jensen AB, Kristensen CA, Jacobsen J, Kreilgaard M, Petersen J, Andersen O. Absorption of Bupivacaine after Administration of a Lozenge as Topical Treatment for Pain from Oral Mucositis. Basic Clin Pharmacol Toxicol. 2017 Jan;120(1):71-78. doi: 10.1111/bcpt.12644. Epub 2016 Sep 26.</citation>
    <PMID>27430990</PMID>
  </reference>
  <reference>
    <citation>Fisman EZ, Shapira I, Motro M, Pines A, Tenenbaum A. The combined cough frequency/severity scoring: a new approach to cough evaluation in clinical settings. J Med. 2001;32(3-4):181-7.</citation>
    <PMID>11563816</PMID>
  </reference>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>July 12, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>July 11, 2023</last_update_submitted>
  <last_update_submitted_qc>July 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zagazig University</investigator_affiliation>
    <investigator_full_name>Shereen Elsayed Abd Ellatif</investigator_full_name>
    <investigator_title>principal investigator, lecturer</investigator_title>
  </responsible_party>
  <keyword>topical bupivacaine</keyword>
  <keyword>awake extubation</keyword>
  <keyword>thyroidectomy</keyword>
  <keyword>general anesthesia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thyroid Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bupivacaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>planned after the completion of the study and publication</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>planned after the completion of the study and publication</ipd_time_frame>
    <ipd_access_criteria>principal investigator</ipd_access_criteria>
  </patient_data>
  <!-- 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/NCT04471597
org study id: 12-7-2020
nct id: NCT04471597
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
-  Emergence from general anesthesia is often complicated by the ETT-induced emergence
           phenomena (EP), which include coughing, sympathetic stimulation, sore throat, increased
           bleeding from the surgical site, and increased intracranial and intraocular pressures.

        -  Techniques that have been used to help diminish coughing during emergence include "deep"
           extubation (removal of the endotracheal tube [ETT] while the patient is still in a deep
           plane of general anesthesia), administration of intravenous (IV) narcotics, or
           administration of IV lidocaine prior to emergence since systemic narcotics and lidocaine
           have antitussive properties. However, each of these techniques has limitations. A
           reliable technique for improving ETT tolerance while facilitating rapid and full
           emergence from general anesthesia would be desirable in many situations.

        -  Topical application of bupivacaine to the pharyngeal, laryngeal, and tracheal mucosa
           will attenuate or even abolish coughing as well as a hemodynamic response during
           extubation, thus result in increasing the patient's comfort and avoiding potential
           complications of extubation process.

        -  Up to the investigator's knowledge there is no study done to evaluate the effect of
           topical bupivacaine on the incidence of coughing and hemodynamic response during
           emergence from general anesthesia in patients undergoing elective thyroidectomy.
The process of manipulation of the airway during laryngoscopy, endotracheal intubation, and
      extubation is usually associated with exaggerated hemodynamic response including tachycardia,
      hypertension as well as increase intraocular and intracranial pressure[1,2]. The exact
      mechanism to these hemodynamic responses may be due to the release of catecholamine in the
      blood by stimulating the sympathetic nervous system during these stressful periods. Acute
      hemodynamic changes during extubation may lead to life-threatening myocardial ischemia,
      arrhythmias, pulmonary edema, acute heart failure, or cerebrovascular hemorrhage in high-risk
      patients and this can increase morbidity and mortality of the patients [3].

      Respiratory complications after tracheal extubation are three times more common than
      induction of anesthesia and intubation [4], as intratracheal tube induces laryngeal
      irritation that transmitted through rapidly acting receptors which are located throughout the
      trachea, involved in the cough reflex and subsequently lead to coughing and bucking that
      frequently occur during extubation and may lead to negative pressure pulmonary edema as well
      as, laryngeal edema and sore throat [5, 6].

      Various techniques have been applied to attenuate the hemodynamic responses and coughing
      during emergence and extubation. They include deep extubation, administration of intravenous
      (IV) short-acting narcotics, calcium channel blockers, and dexmedetomidine [7,8], as well as
      lidocaine which is considered one of the commonly used drugs either through IV route,
      endotracheal tube (ETT) cuff, or laryngotracheal route[1,9]. Concern about the use of these
      drugs includes respiratory depression, delayed emergence from anesthesia, postoperative
      nausea and vomiting, sedative effects, and short action time [10].

      Bupivacaine is a kind of sodium channel blocker local anesthetics used as topical anesthesia
      that suppresses cough by inhibiting the progression of the action potential in the tracheal
      touch-sensitive Aδ fibers (cough receptors)[10]. The plasma protein binding of bupivacaine
      exceeds 90%, whereas lidocaine protein binding is 65- 75%, [11] and it is well known that the
      duration of local anesthetics is influenced by their protein binding characteristics, as the
      affinity for plasma proteins corresponds to the affinity for protein binding at the sodium
      channel receptor site, that results in prolongation of the presence of the anesthetic effect
      at the site of action [12, 13].

      the investigators hypothesize that usage of topical bupivacaine may have an impact on
      decreasing incidence of coughing and alleviating hemodynamic response during awake extubation
      and emergence from general anesthesia in post-thyroidectomy patients.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The patients will be divided randomly by a computer-generated randomization table into two equal groups
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: double-blinded ( patient and outcome assessors)
measure: Grade of coughing
time frame: procedure (measured within the extubation time)
description: will be assessed as Grade 0: no cough; Grade 1: single cough with mild severity; Grade 2: cough lasting less than 5 s with moderate severity; Grade 3: sustained bouts of persistent cough more than 5 s.
measure: oxygen saturation(SpO2)
time frame: will be recorded at base line, after administration of the study drug, before extubation, then at 1 min, 2min, 5min, and 10 min immediately following extubation.
measure: heart rate
time frame: will be recorded at base line, after administration of the study drug, before extubation, then at 1 min, 2min, 5min, and 10 min immediately following extubation.
description: Hemodynamics
measure: mean arterial blood pressure
time frame: will be recorded at base line, after administration of the study drug, before extubation, then at 1 min, 2min, 5min, and 10 min immediately following extubation.
description: Hemodynamics
measure: Extubation time
time frame: Procedure -from the end of the anesthesia (discontinuation of isoflurane) to the time the endotracheal tube will be pulled out
description: removal of the endotracheal tube [ETT] while the patient is still in a deep plane of general anesthesia
measure: Sore throat degree
time frame: 1 , 2 , 4, 6 and 12 hours postoperatively.
description: will be assessed by visual analogue scale (VAS) scale, On a scale of 0-10, the patient will learn to quantify postoperative sore throat pain where 0= No pain and 10= Maximum worst pain.
arm group label: Control group
arm group type: Placebo Comparator
description: patients will receive 5ml of normal saline 0.9% topically 15 min before the expected end of surgery.
arm group label: bupivacaine group
arm group type: Active Comparator
description: patients will receive 5ml of bupivacaine 0.5% topically 15 min before the expected end of surgery.
intervention type: Drug
intervention name: normal saline 0.9%
description: 5ml of normal saline 0.9% topically 15 min will be installed topically around the ETT using ordinary syringe before the expected end of the surgery, this will be followed by manual ventilation using about the double tidal volume for 6-8 times or more to get air bubbles distributed within the upper airway to anesthetize the oropharynx and spread around ETT to the adjacent mucosal structures (laryngopharynx, larynx, and upper part of the trachea) then the cuff will be inflated to the previous pressure and the patient will be mechanically ventilated as usual.
arm group label: Control group
intervention type: Drug
intervention name: Bupivacaine Hydrochloride
description: 5 ml of bupivacaine 0.5% will be installed topically around the ETT using ordinary syringe before the expected end of the surgery, this will be followed by manual ventilation using about the double tidal volume for 6-8 times or more to get air bubbles distributed within the upper airway to anesthetize the oropharynx and spread around ETT to the adjacent mucosal structures (laryngopharynx, larynx, and upper part of the trachea) then the cuff will be inflated to the previous pressure and patient will be mechanically ventilated as usual.
arm group label: bupivacaine group
criteria: 
gender: All
minimum age: 21 Years
maximum age: 60 Years
healthy volunteers: No
last name: Shereen E Abd Ellatif, MD
phone: 01007948840
phone ext: 002
email: shosh.again@gmail.com
last name: Rehab A Wahdan, MD
phone: 01003481323
phone ext: 002
email: obz13w@yahoo.com
facility: 
status: Recruiting
contact: 
country: Egypt
citation: Shabnum T, Ali Z, Naqash IA, Mir AH, Azhar K, Zahoor SA, Mir AW. Effects of Lignocaine Administered Intravenously or Intratracheally on Airway and Hemodynamic Responses during Emergence and Extubation in Patients Undergoing Elective Craniotomies in Supine Position. Anesth Essays Res. 2017 Jan-Mar;11(1):216-222. doi: 10.4103/0259-1162.200239.
PMID: 28298788
citation: Meng YF, Cui GX, Gao W, Li ZW. Local airway anesthesia attenuates hemodynamic responses to intubation and extubation in hypertensive surgical patients. Med Sci Monit. 2014 Aug 26;20:1518-24. doi: 10.12659/MSM.890703.
PMID: 25175842
citation: Fang P, Zong Z, Lu Y, Han X, Liu X. Effect of topical ropivacaine on the response to endotracheal tube during emergence from general anesthesia: a prospective randomized double-blind controlled study. BMC Anesthesiol. 2018 Sep 27;18(1):134. doi: 10.1186/s12871-018-0601-x.
PMID: 30261837
citation: Phero JC, Prithvi Raj P, Knarr D, Turner P, Denson DD, Vigdorth E, Edstrom HH. Absorption of bupivacaine after topical application to the oropharynx. Anesth Prog. 1987 Sep-Oct;34(5):187-90.
PMID: 3479919
citation: Mogensen S, Sverrisdottir E, Sveinsdottir K, Treldal C, Jensen K, Jensen AB, Kristensen CA, Jacobsen J, Kreilgaard M, Petersen J, Andersen O. Absorption of Bupivacaine after Administration of a Lozenge as Topical Treatment for Pain from Oral Mucositis. Basic Clin Pharmacol Toxicol. 2017 Jan;120(1):71-78. doi: 10.1111/bcpt.12644. Epub 2016 Sep 26.
PMID: 27430990
citation: Fisman EZ, Shapira I, Motro M, Pines A, Tenenbaum A. The combined cough frequency/severity scoring: a new approach to cough evaluation in clinical settings. J Med. 2001;32(3-4):181-7.
PMID: 11563816
responsible party type: Principal Investigator
investigator affiliation: Zagazig University
investigator full name: Shereen Elsayed Abd Ellatif
investigator title: principal investigator, lecturer
mesh term: Thyroid Diseases
mesh term: Bupivacaine
sharing ipd: Yes
ipd description: planned after the completion of the study and publication
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Analytic Code
ipd time frame: planned after the completion of the study and publication
ipd access criteria: principal investigator