<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/NCT04472689</url>
  </required_header>
  <id_info>
    <org_study_id>0304701</org_study_id>
    <nct_id>NCT04472689</nct_id>
  </id_info>
  <brief_title>Effects of Lidocaine Infusion on Quality of Recovery and Agitation After Functional Endoscopic Sinus Surgery</brief_title>
  <official_title>Effects of Lidocaine Infusion on Quality of Recovery and Agitation After Functional Endoscopic Sinus Surgery: Randomized Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alexandria University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Alexandria 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>
      The essential anesthesia requirements for FESS include airway management, considerations for&#xD;
      facilitating surgical access, provision of a clear and still surgical field for precision&#xD;
      surgery, assuring quick and non-stimulating emergence from anesthesia, and fast-tracking&#xD;
      patients for discharge. Postoperative agitation, although short-lived, is potentially harmful&#xD;
      to both patients and recovery room staff, it has a potential for self-injury by removing&#xD;
      intravenous catheters, tubing, oxygen masks and nasal packs. Furthermore, very agitated&#xD;
      patients can pose an immediate danger to operating theatre staff.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Lidocaine is an amino amide-type short-acting local anesthetic (LA). It has a short&#xD;
      half-life, and a favorable safety profile, and is therefore the LA of choice for continuous&#xD;
      IV administration, it has analgesic, and anti-inflammatory effects that are induced by&#xD;
      reduction of cytokines production through inhibition of neutrophil activation, and the&#xD;
      analgesia may persist even after plasma concentration reduction. It can blunt the pressor&#xD;
      response to endotracheal intubation also systemic lidocaine was effective in producing&#xD;
      controlled hypotension.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Anticipated">October 20, 2020</completion_date>
  <primary_completion_date type="Anticipated">September 20, 2020</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>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>quality of postoperative recovery</measure>
    <time_frame>48hours</time_frame>
    <description>assessed using the Quality of Recovery-40 questionnaire.8, which assesses ﬁve dimensions of recovery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Emergence agitation</measure>
    <time_frame>30 minutes postoperative</time_frame>
    <description>using the Richmond agitation-sedation scale</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Chronic Polypous Rhinosinusitis</condition>
  <arm_group>
    <arm_group_label>Lidocaine group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patients will receive a loading dose of IV lidocaine 1.5mg/kg slowly diluted with 20 ml normal saline just before induction of anesthesia, then the lidocaine infusion started at a rate of 2mg/kg/h diluted in normal saline by rate of 2 ml/ kg/h.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>patients will receive an equal volume of normal saline (both the loading, and the infusion). The infusion in both groups will be started just after induction of anesthesia induction, and continued until the end of the operation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lidocaine</intervention_name>
    <description>patients will receive a loading dose of IV lidocaine 1.5mg/kg slowly diluted with 20 ml normal saline just before induction of anesthesia, then the lidocaine infusion started at a rate of 2mg/kg/h diluted in normal saline by rate of 2 ml/ kg/h.</description>
    <arm_group_label>Lidocaine group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal saline</intervention_name>
    <description>patients will receive an equal volume of normal saline (both the loading, and the infusion). The infusion in both groups will be started just after induction of anesthesia induction, and continued until the end of the operation</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients scheduled for elective functional endoscopic sinus surgery;&#xD;
&#xD;
          -  ASA class I-II,&#xD;
&#xD;
          -  aged (20-60 years).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Body mass index &gt;35 kg/m2&#xD;
&#xD;
          -  History of allergic reaction to local anesthetic agents especially lignocaine.&#xD;
&#xD;
          -  History of preoperative use of opioids.&#xD;
&#xD;
          -  Patients with history of uncontrolled hypertension, A-V conduction block.&#xD;
&#xD;
          -  History of sleep apnea.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rehab A. Abd Elaziz, Ass.Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Alexandria University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Rehab A. Abd Elaziz, Ass. Prof.</last_name>
    <phone>01001073703</phone>
    <phone_ext>020</phone_ext>
    <email>trcium2002@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Rehab Abd Elraof Abd Elaziz</name>
      <address>
        <city>Alexandria</city>
        <zip>000000</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rehab A. Abd Elaziz, Ass. Prof.</last_name>
      <phone>01001073703</phone>
      <phone_ext>020</phone_ext>
      <email>trcium2002@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 11, 2020</study_first_submitted>
  <study_first_submitted_qc>July 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>August 16, 2020</last_update_submitted>
  <last_update_submitted_qc>August 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Alexandria University</investigator_affiliation>
    <investigator_full_name>rehab zayed</investigator_full_name>
    <investigator_title>Assisstant Professor of Anesthesia</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psychomotor Agitation</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
  </intervention_browse>
  <!-- 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/NCT04472689
org study id: 0304701
nct id: NCT04472689
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The essential anesthesia requirements for FESS include airway management, considerations for
      facilitating surgical access, provision of a clear and still surgical field for precision
      surgery, assuring quick and non-stimulating emergence from anesthesia, and fast-tracking
      patients for discharge. Postoperative agitation, although short-lived, is potentially harmful
      to both patients and recovery room staff, it has a potential for self-injury by removing
      intravenous catheters, tubing, oxygen masks and nasal packs. Furthermore, very agitated
      patients can pose an immediate danger to operating theatre staff.
Lidocaine is an amino amide-type short-acting local anesthetic (LA). It has a short
      half-life, and a favorable safety profile, and is therefore the LA of choice for continuous
      IV administration, it has analgesic, and anti-inflammatory effects that are induced by
      reduction of cytokines production through inhibition of neutrophil activation, and the
      analgesia may persist even after plasma concentration reduction. It can blunt the pressor
      response to endotracheal intubation also systemic lidocaine was effective in producing
      controlled hypotension.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Double (Participant, Investigator)
measure: quality of postoperative recovery
time frame: 48hours
description: assessed using the Quality of Recovery-40 questionnaire.8, which assesses ﬁve dimensions of recovery
measure: Emergence agitation
time frame: 30 minutes postoperative
description: using the Richmond agitation-sedation scale
arm group label: Lidocaine group
arm group type: Active Comparator
description: patients will receive a loading dose of IV lidocaine 1.5mg/kg slowly diluted with 20 ml normal saline just before induction of anesthesia, then the lidocaine infusion started at a rate of 2mg/kg/h diluted in normal saline by rate of 2 ml/ kg/h.
arm group label: Control group
arm group type: Placebo Comparator
description: patients will receive an equal volume of normal saline (both the loading, and the infusion). The infusion in both groups will be started just after induction of anesthesia induction, and continued until the end of the operation.
intervention type: Drug
intervention name: Lidocaine
description: patients will receive a loading dose of IV lidocaine 1.5mg/kg slowly diluted with 20 ml normal saline just before induction of anesthesia, then the lidocaine infusion started at a rate of 2mg/kg/h diluted in normal saline by rate of 2 ml/ kg/h.
arm group label: Lidocaine group
intervention type: Drug
intervention name: Normal saline
description: patients will receive an equal volume of normal saline (both the loading, and the infusion). The infusion in both groups will be started just after induction of anesthesia induction, and continued until the end of the operation
arm group label: Control group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: No
last name: Rehab A. Abd Elaziz, Ass.Prof.
role: Principal Investigator
affiliation: Alexandria University
last name: Rehab A. Abd Elaziz, Ass. Prof.
phone: 01001073703
phone ext: 020
email: trcium2002@yahoo.com
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Alexandria University
investigator full name: rehab zayed
investigator title: Assisstant Professor of Anesthesia
mesh term: Psychomotor Agitation
mesh term: Lidocaine