<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/NCT03031808</url>
  </required_header>
  <id_info>
    <org_study_id>AB3383</org_study_id>
    <nct_id>NCT03031808</nct_id>
  </id_info>
  <brief_title>Comparison of Two Induction Regimens Using Topical Lidocaine or Muscle Relaxant on Sore Throat and Hemodynamics</brief_title>
  <official_title>Comparison of Two Induction Regimens Using Topical Lidocaine or Muscle Relaxant; Impact on Postoperative Sore Throat and Haemodynamics</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ostfold Hospital Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ostfold Hospital Trust</source>
  <oversight_info>
    <has_dmc>Yes</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>
      When a surgical procedure is performed under general anesthesia, the Airways are often&#xD;
      secured With an endotracheal tube. Some patients experience sore throat thereafter. Studies&#xD;
      have shown a reduction of these side effects when by use of muscle relaxants or a lidocain&#xD;
      spray prior to the intubation. At Ostfold Hospital Trust, the investigators use one of the&#xD;
      two methods or nothing. These methods will be studied systematically.&#xD;
&#xD;
      Heart rate and blood pressure rise during the intubation procedure. The investigators will&#xD;
      also study the differences between the groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Post-operative sore throat and cough are common complications of endotracheal intubation and&#xD;
      occurs in 30% to 70% of patients. Spraying with Lidocaine reduces this incident of&#xD;
      postoperative sore Throat (POST). The use of neuromuscular blocking agents (NMBA) alone will&#xD;
      also diminish the incidence of adverse postoperative upper airway symptoms. The use of&#xD;
      topical Lidocaine is shown to reduce the cardiovascular responses during and after&#xD;
      endotracheal intubation.&#xD;
&#xD;
      Hypertension and tachycardia as a response to endotracheal intubation are probably of little&#xD;
      consequence in healthy individuals. These reactions might though be harmful in patients with&#xD;
      cardiovascular diseases.&#xD;
&#xD;
      Postoperative sore throat is an undesired outcome for the patient. Topical or systemic&#xD;
      pharmacological interventions is shown to reduce the POST.&#xD;
&#xD;
      Our anesthetists practice very different. The investigators sometime use topical lidocaine 2%&#xD;
      as a spray, sometime muscle relaxants and often nothing but propofol and remifentanil prior&#xD;
      to laryngoscopy an endotracheal intubation.&#xD;
&#xD;
      The objective of this study is to determine, whether the use of topical administered&#xD;
      lidocaine, 2 %, has a better impact on POST compared with NMBA alone in general anesthesia&#xD;
      with propofol and remifentanil. Patients receiving nothing but propofol and remifentanil will&#xD;
      be the reference group. Assessment of the intubation conditions will be done according to a&#xD;
      standard scheme&#xD;
&#xD;
      The primary endpoint:&#xD;
&#xD;
        -  Differences in the intubation conditions between the three groups.&#xD;
&#xD;
        -  Cardiovascular responses caused by the laryngoscopy and intubation.&#xD;
&#xD;
      The secondary endpoint:&#xD;
&#xD;
      • Post operative upper airways symptoms. Power and Sample Size Calculator To detect a&#xD;
      decrease in the incidence of pharyngolaryngeal symptoms from 60% to 45%, we calculated that&#xD;
      we needed 150 patients per study arm (power of the study, 0,8; type I error, 0,05).&#xD;
&#xD;
      450 adult patients have to be scheduled for the study.&#xD;
&#xD;
      The study is double blind, randomized:&#xD;
&#xD;
        -  Group Topical lidocaine 4%:&#xD;
&#xD;
        -  Group NMBA&#xD;
&#xD;
        -  Control group Premedication: Paracetamol 2g General anaesthesia: TCI (Target Control of&#xD;
           Infusion is a principle, an anesthesia infusion after protocol): Propofol and&#xD;
           Remifentanil Surgical procedure: Not specified short lasting (&lt;1 h) procedures The&#xD;
           experienced anesthesiologist performing the intubating procedure will not be in the room&#xD;
           until immediately before the intubation.&#xD;
&#xD;
      Postoperatively:&#xD;
&#xD;
        -  Oral paracetamol and codeine-fixed combination up to 1000 mg and 60 mg, respectively,&#xD;
           every 6 h&#xD;
&#xD;
        -  When nausea and vomiting occurs postoperatively, ondansetron 4 mg IV administers as the&#xD;
           drug of first choice followed by droperidol 0,625 mg IV if the nausea/vomiting persists.&#xD;
&#xD;
      Collected data:&#xD;
&#xD;
        -  Patient characteristics inclusive smoke habits&#xD;
&#xD;
        -  Intubation conditions according to the Copenhagen score&#xD;
&#xD;
        -  Blood pressure prior to laryngoscopy and after 1, 3, 5, 7, 9, 11, 13 and 15 minutes,&#xD;
           then every 15 min.&#xD;
&#xD;
        -  Cuff pressure&#xD;
&#xD;
        -  Pharyngolaryngeal discomfort 2 and 24 hours (telephone interview if released from&#xD;
           hospital) after extubation&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 31, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sore Throat postoperative. Assessment of complaints and changes in complaints</measure>
    <time_frame>2 h and 24 h after extubation</time_frame>
    <description>Postoperative sore throat, described 2 h and 24 h after extubation. If the patient has sore throat or is hoarse, the complaint is assessed on a VAS (Visual Analogue Scale) 1 - 10.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intubation conditions directly after induction of anesthesia</measure>
    <time_frame>90 sec. after established general anesthesia</time_frame>
    <description>Describes the intubation conditions: Jaw relaxation, resistance to laryngoscopy blade, the position and movement of vocal cords, the movement of limbs and coughing. Each variable rates as excellent, good or poor. Intubation conditions are many variables described once and should not be divided into several outcomes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hemodynamic parameters, change in HR (Heart Rate) is being assessed</measure>
    <time_frame>Prior to induction, then every second minute the next 15 minutes, thereafter every 15 minute until end of surgery (max. 2 h.)</time_frame>
    <description>Describes changes in HR (Heart Rate)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hemodynamic parameters, change in BP (blood pressure) is being assessed</measure>
    <time_frame>Prior to induction, then every second minute the next 15 minutes, thereafter every 15 minute until end of surgery (max. 2 h.)</time_frame>
    <description>Describes changes in BP(Blood Pressure)</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Intubation Complication</condition>
  <arm_group>
    <arm_group_label>Lidocaine spray</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Endotracheal lidocaine spray prior to intubation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Muscle relaxant</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Muscle relaxant prior to intubation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Muscle relaxant, no Lidocaine</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>'No Muscle relaxant, no Lidocaine Control group</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lidocaine spray (2%)</intervention_name>
    <description>Spraying trachea from 2 cm above the vocal cords and 5 cm down with a straw with multiple side holes</description>
    <arm_group_label>Lidocaine spray</arm_group_label>
    <other_name>Xylocain 2% Astra Zeneca</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Muscle Relaxant (Rocuronium)</intervention_name>
    <description>After induction of anesthesia, the participants are given 0,6 mg/kg bodyweight intravenously.</description>
    <arm_group_label>Muscle relaxant</arm_group_label>
    <other_name>Esmeron MSD</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No Muscle relaxant, no Lidocaine</intervention_name>
    <description>This group get general anesthesia without Rocuronium or Lidocaine</description>
    <arm_group_label>No Muscle relaxant, no Lidocaine</arm_group_label>
    <other_name>Control group</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Scheduled elective surgery with general anesthesia and planned endotracheal&#xD;
             intubation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ASA≥3,&#xD;
&#xD;
          -  20&gt;BMI&lt;35&#xD;
&#xD;
          -  Allergy to local anesthetics or neuromuscular blocking agents.&#xD;
&#xD;
          -  The ASA physical status classification system is a system for assessing the fitness of&#xD;
             patients before surgery. BMI is Body Mass Index measured in kilograms/square meter.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jan Sverre Vamnes, MD, Ph.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Senior consultant</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jan Sverre Vamnes, MD, Ph.D</last_name>
    <phone>+47 913 05 016</phone>
    <email>jan.sverre.vamnes@so-hf.no</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Knut Inge Solbakk, MD</last_name>
    <phone>+47 909 33 106</phone>
    <email>knut.inge.solbakk@so-hf.no</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Ostfold Hospital Trust, Moss</name>
      <address>
        <city>Grålum</city>
        <state>Ostfold</state>
        <zip>1714</zip>
        <country>Norway</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jan Sverre Vamnes, MD, Ph.D.</last_name>
      <phone>+47 91608896</phone>
      <email>janvam@so-hf.no</email>
    </contact>
    <contact_backup>
      <last_name>Knut Inge Solbakk, md</last_name>
      <phone>+47 90933106</phone>
      <email>knisol@so-hf.no</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <reference>
    <citation>Banihashem N, Alijanpour E, Hasannasab B, Zarei A. Prophylactic Effects of Lidocaine or Beclomethasone Spray on Post-Operative Sore Throat and Cough after Orotracheal Intubation. Iran J Otorhinolaryngol. 2015 May;27(80):179-84.</citation>
    <PMID>26082898</PMID>
  </reference>
  <reference>
    <citation>Blobner M, Mirakhur RK, Wierda JM, Wright PM, Olkkola KT, Debaene B, Pendeville P, Engbaek J, Rietbergen H, Sparr HJ. Rapacuronium 2.0 or 2.5 mg kg-1 for rapid-sequence induction: comparison with succinylcholine 1.0 mg kg-1. Br J Anaesth. 2000 Nov;85(5):724-31. doi: 10.1093/bja/85.5.724.</citation>
    <PMID>11094588</PMID>
  </reference>
  <reference>
    <citation>Combes X, Andriamifidy L, Dufresne E, Suen P, Sauvat S, Scherrer E, Feiss P, Marty J, Duvaldestin P. Comparison of two induction regimens using or not using muscle relaxant: impact on postoperative upper airway discomfort. Br J Anaesth. 2007 Aug;99(2):276-81. doi: 10.1093/bja/aem147. Epub 2007 Jun 15.</citation>
    <PMID>17573390</PMID>
  </reference>
  <reference>
    <citation>Domaoal AM, Weniger FC, Wolfson B. &quot;Precurarization&quot; using pancuronium. Anesth Analg. 1975 Jan-Feb;54(1):71-5. doi: 10.1213/00000539-197501000-00014.</citation>
    <PMID>1167764</PMID>
  </reference>
  <reference>
    <citation>Doyle DJ. Airway anesthesia: theory and practice. Anesthesiol Clin. 2015 Jun;33(2):291-304. doi: 10.1016/j.anclin.2015.02.013.</citation>
    <PMID>25999003</PMID>
  </reference>
  <reference>
    <citation>Kalil DM, Silvestro LS, Austin PN. Novel preoperative pharmacologic methods of preventing postoperative sore throat due to tracheal intubation. AANA J. 2014 Jun;82(3):188-97.</citation>
    <PMID>25109156</PMID>
  </reference>
  <reference>
    <citation>Martin C, Bonneru JJ, Brun JP, Albanese J, Gouin F. Vecuronium or suxamethonium for rapid sequence intubation: which is better? Br J Anaesth. 1987 Oct;59(10):1240-4. doi: 10.1093/bja/59.10.1240.</citation>
    <PMID>2890365</PMID>
  </reference>
  <reference>
    <citation>Mostafa SM, Murthy BV, Barrett PJ, McHugh P. Comparison of the effects of topical lignocaine spray applied before or after induction of anaesthesia on the pressor response to direct laryngoscopy and intubation. Eur J Anaesthesiol. 1999 Jan;16(1):7-10. doi: 10.1046/j.1365-2346.1999.00410.x.</citation>
    <PMID>10084094</PMID>
  </reference>
  <reference>
    <citation>Koller ME, Husby P. High-dose vecuronium may be an alternative to suxamethonium for rapid-sequence intubation. Acta Anaesthesiol Scand. 1993 Jul;37(5):465-8. doi: 10.1111/j.1399-6576.1993.tb03747.x.</citation>
    <PMID>7741805</PMID>
  </reference>
  <reference>
    <citation>Qi DY, Wang K, Zhang H, Du BX, Xu FY, Wang L, Zou Z, Shi XY. Efficacy of intravenous lidocaine versus placebo on attenuating cardiovascular response to laryngoscopy and tracheal intubation: a systematic review of randomized controlled trials. Minerva Anestesiol. 2013 Dec;79(12):1423-35. Epub 2013 Jul 9.</citation>
    <PMID>23839320</PMID>
  </reference>
  <reference>
    <citation>Tanaka Y, Nakayama T, Nishimori M, Sato Y, Furuya H. Lidocaine for preventing postoperative sore throat. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD004081. doi: 10.1002/14651858.CD004081.pub2.</citation>
    <PMID>19588349</PMID>
  </reference>
  <reference>
    <citation>Viby-Mogensen J, Engbaek J, Eriksson LI, Gramstad L, Jensen E, Jensen FS, Koscielniak-Nielsen Z, Skovgaard LT, Ostergaard D. Good clinical research practice (GCRP) in pharmacodynamic studies of neuromuscular blocking agents. Acta Anaesthesiol Scand. 1996 Jan;40(1):59-74. doi: 10.1111/j.1399-6576.1996.tb04389.x.</citation>
    <PMID>8904261</PMID>
  </reference>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>December 21, 2016</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <last_update_submitted>March 12, 2019</last_update_submitted>
  <last_update_submitted_qc>March 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ostfold Hospital Trust</investigator_affiliation>
    <investigator_full_name>Jan Sverre Vamnes</investigator_full_name>
    <investigator_title>Senior consultant, Ph.D.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pharyngitis</mesh_term>
    <mesh_term>Muscle Hypotonia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
    <mesh_term>Rocuronium</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No sharing plan so far.</ipd_description>
  </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/NCT03031808
org study id: AB3383
nct id: NCT03031808
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
When a surgical procedure is performed under general anesthesia, the Airways are often
      secured With an endotracheal tube. Some patients experience sore throat thereafter. Studies
      have shown a reduction of these side effects when by use of muscle relaxants or a lidocain
      spray prior to the intubation. At Ostfold Hospital Trust, the investigators use one of the
      two methods or nothing. These methods will be studied systematically.

      Heart rate and blood pressure rise during the intubation procedure. The investigators will
      also study the differences between the groups.
Post-operative sore throat and cough are common complications of endotracheal intubation and
      occurs in 30% to 70% of patients. Spraying with Lidocaine reduces this incident of
      postoperative sore Throat (POST). The use of neuromuscular blocking agents (NMBA) alone will
      also diminish the incidence of adverse postoperative upper airway symptoms. The use of
      topical Lidocaine is shown to reduce the cardiovascular responses during and after
      endotracheal intubation.

      Hypertension and tachycardia as a response to endotracheal intubation are probably of little
      consequence in healthy individuals. These reactions might though be harmful in patients with
      cardiovascular diseases.

      Postoperative sore throat is an undesired outcome for the patient. Topical or systemic
      pharmacological interventions is shown to reduce the POST.

      Our anesthetists practice very different. The investigators sometime use topical lidocaine 2%
      as a spray, sometime muscle relaxants and often nothing but propofol and remifentanil prior
      to laryngoscopy an endotracheal intubation.

      The objective of this study is to determine, whether the use of topical administered
      lidocaine, 2 %, has a better impact on POST compared with NMBA alone in general anesthesia
      with propofol and remifentanil. Patients receiving nothing but propofol and remifentanil will
      be the reference group. Assessment of the intubation conditions will be done according to a
      standard scheme

      The primary endpoint:

        -  Differences in the intubation conditions between the three groups.

        -  Cardiovascular responses caused by the laryngoscopy and intubation.

      The secondary endpoint:

      • Post operative upper airways symptoms. Power and Sample Size Calculator To detect a
      decrease in the incidence of pharyngolaryngeal symptoms from 60% to 45%, we calculated that
      we needed 150 patients per study arm (power of the study, 0,8; type I error, 0,05).

      450 adult patients have to be scheduled for the study.

      The study is double blind, randomized:

        -  Group Topical lidocaine 4%:

        -  Group NMBA

        -  Control group Premedication: Paracetamol 2g General anaesthesia: TCI (Target Control of
           Infusion is a principle, an anesthesia infusion after protocol): Propofol and
           Remifentanil Surgical procedure: Not specified short lasting (<1 h) procedures The
           experienced anesthesiologist performing the intubating procedure will not be in the room
           until immediately before the intubation.

      Postoperatively:

        -  Oral paracetamol and codeine-fixed combination up to 1000 mg and 60 mg, respectively,
           every 6 h

        -  When nausea and vomiting occurs postoperatively, ondansetron 4 mg IV administers as the
           drug of first choice followed by droperidol 0,625 mg IV if the nausea/vomiting persists.

      Collected data:

        -  Patient characteristics inclusive smoke habits

        -  Intubation conditions according to the Copenhagen score

        -  Blood pressure prior to laryngoscopy and after 1, 3, 5, 7, 9, 11, 13 and 15 minutes,
           then every 15 min.

        -  Cuff pressure

        -  Pharyngolaryngeal discomfort 2 and 24 hours (telephone interview if released from
           hospital) after extubation
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Sore Throat postoperative. Assessment of complaints and changes in complaints
time frame: 2 h and 24 h after extubation
description: Postoperative sore throat, described 2 h and 24 h after extubation. If the patient has sore throat or is hoarse, the complaint is assessed on a VAS (Visual Analogue Scale) 1 - 10.
measure: Intubation conditions directly after induction of anesthesia
time frame: 90 sec. after established general anesthesia
description: Describes the intubation conditions: Jaw relaxation, resistance to laryngoscopy blade, the position and movement of vocal cords, the movement of limbs and coughing. Each variable rates as excellent, good or poor. Intubation conditions are many variables described once and should not be divided into several outcomes.
measure: Hemodynamic parameters, change in HR (Heart Rate) is being assessed
time frame: Prior to induction, then every second minute the next 15 minutes, thereafter every 15 minute until end of surgery (max. 2 h.)
description: Describes changes in HR (Heart Rate)
measure: Hemodynamic parameters, change in BP (blood pressure) is being assessed
time frame: Prior to induction, then every second minute the next 15 minutes, thereafter every 15 minute until end of surgery (max. 2 h.)
description: Describes changes in BP(Blood Pressure)
arm group label: Lidocaine spray
arm group type: Other
description: Endotracheal lidocaine spray prior to intubation
arm group label: Muscle relaxant
arm group type: Other
description: Muscle relaxant prior to intubation
arm group label: No Muscle relaxant, no Lidocaine
arm group type: Other
description: 'No Muscle relaxant, no Lidocaine Control group
intervention type: Drug
intervention name: Lidocaine spray (2%)
description: Spraying trachea from 2 cm above the vocal cords and 5 cm down with a straw with multiple side holes
arm group label: Lidocaine spray
other name: Xylocain 2% Astra Zeneca
intervention type: Drug
intervention name: Muscle Relaxant (Rocuronium)
description: After induction of anesthesia, the participants are given 0,6 mg/kg bodyweight intravenously.
arm group label: Muscle relaxant
other name: Esmeron MSD
intervention type: Other
intervention name: No Muscle relaxant, no Lidocaine
description: This group get general anesthesia without Rocuronium or Lidocaine
arm group label: No Muscle relaxant, no Lidocaine
other name: Control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Jan Sverre Vamnes, MD, Ph.D.
role: Study Chair
affiliation: Senior consultant
last name: Jan Sverre Vamnes, MD, Ph.D
phone: +47 913 05 016
email: jan.sverre.vamnes@so-hf.no
last name: Knut Inge Solbakk, MD
phone: +47 909 33 106
email: knut.inge.solbakk@so-hf.no
facility: 
status: Recruiting
contact: 
contact backup: 
country: Norway
citation: Banihashem N, Alijanpour E, Hasannasab B, Zarei A. Prophylactic Effects of Lidocaine or Beclomethasone Spray on Post-Operative Sore Throat and Cough after Orotracheal Intubation. Iran J Otorhinolaryngol. 2015 May;27(80):179-84.
PMID: 26082898
citation: Blobner M, Mirakhur RK, Wierda JM, Wright PM, Olkkola KT, Debaene B, Pendeville P, Engbaek J, Rietbergen H, Sparr HJ. Rapacuronium 2.0 or 2.5 mg kg-1 for rapid-sequence induction: comparison with succinylcholine 1.0 mg kg-1. Br J Anaesth. 2000 Nov;85(5):724-31. doi: 10.1093/bja/85.5.724.
PMID: 11094588
citation: Combes X, Andriamifidy L, Dufresne E, Suen P, Sauvat S, Scherrer E, Feiss P, Marty J, Duvaldestin P. Comparison of two induction regimens using or not using muscle relaxant: impact on postoperative upper airway discomfort. Br J Anaesth. 2007 Aug;99(2):276-81. doi: 10.1093/bja/aem147. Epub 2007 Jun 15.
PMID: 17573390
citation: Domaoal AM, Weniger FC, Wolfson B. "Precurarization" using pancuronium. Anesth Analg. 1975 Jan-Feb;54(1):71-5. doi: 10.1213/00000539-197501000-00014.
PMID: 1167764
citation: Doyle DJ. Airway anesthesia: theory and practice. Anesthesiol Clin. 2015 Jun;33(2):291-304. doi: 10.1016/j.anclin.2015.02.013.
PMID: 25999003
citation: Kalil DM, Silvestro LS, Austin PN. Novel preoperative pharmacologic methods of preventing postoperative sore throat due to tracheal intubation. AANA J. 2014 Jun;82(3):188-97.
PMID: 25109156
citation: Martin C, Bonneru JJ, Brun JP, Albanese J, Gouin F. Vecuronium or suxamethonium for rapid sequence intubation: which is better? Br J Anaesth. 1987 Oct;59(10):1240-4. doi: 10.1093/bja/59.10.1240.
PMID: 2890365
citation: Mostafa SM, Murthy BV, Barrett PJ, McHugh P. Comparison of the effects of topical lignocaine spray applied before or after induction of anaesthesia on the pressor response to direct laryngoscopy and intubation. Eur J Anaesthesiol. 1999 Jan;16(1):7-10. doi: 10.1046/j.1365-2346.1999.00410.x.
PMID: 10084094
citation: Koller ME, Husby P. High-dose vecuronium may be an alternative to suxamethonium for rapid-sequence intubation. Acta Anaesthesiol Scand. 1993 Jul;37(5):465-8. doi: 10.1111/j.1399-6576.1993.tb03747.x.
PMID: 7741805
citation: Qi DY, Wang K, Zhang H, Du BX, Xu FY, Wang L, Zou Z, Shi XY. Efficacy of intravenous lidocaine versus placebo on attenuating cardiovascular response to laryngoscopy and tracheal intubation: a systematic review of randomized controlled trials. Minerva Anestesiol. 2013 Dec;79(12):1423-35. Epub 2013 Jul 9.
PMID: 23839320
citation: Tanaka Y, Nakayama T, Nishimori M, Sato Y, Furuya H. Lidocaine for preventing postoperative sore throat. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD004081. doi: 10.1002/14651858.CD004081.pub2.
PMID: 19588349
citation: Viby-Mogensen J, Engbaek J, Eriksson LI, Gramstad L, Jensen E, Jensen FS, Koscielniak-Nielsen Z, Skovgaard LT, Ostergaard D. Good clinical research practice (GCRP) in pharmacodynamic studies of neuromuscular blocking agents. Acta Anaesthesiol Scand. 1996 Jan;40(1):59-74. doi: 10.1111/j.1399-6576.1996.tb04389.x.
PMID: 8904261
responsible party type: Principal Investigator
investigator affiliation: Ostfold Hospital Trust
investigator full name: Jan Sverre Vamnes
investigator title: Senior consultant, Ph.D.
mesh term: Pharyngitis
mesh term: Muscle Hypotonia
mesh term: Lidocaine
mesh term: Rocuronium
sharing ipd: No
ipd description: No sharing plan so far.