<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/NCT03833947</url>
  </required_header>
  <id_info>
    <org_study_id>AligarhMUmzm</org_study_id>
    <nct_id>NCT03833947</nct_id>
  </id_info>
  <brief_title>Dexamethasone vs Bicarbonate to Intracuff Lignocaine 2% in General Anaesthesia</brief_title>
  <official_title>Comparision of Addition of Dexamethasone vs Bicarbonate to Intracuff Lignocaine 2% in Terms of Extubation Characteristics and Patient Satisfaction Undergoing General Anaesthesia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aligarh Muslim University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aligarh Muslim 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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed to evaluate and compare the effect on hemodynamics, extubation&#xD;
      response and patients satisfaction score in patients with ETT cuff filled with either mixture&#xD;
      of lignocaine with sodium bicarbonate or with a mixture of lignocaine with dexamethasone.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective Recently multiple studies have shown better outcomes with usage of dexamethasone or&#xD;
      alkalinized lignocaine instead of air for filling endotracheal tube (ETT) cuff. So this study&#xD;
      is designed to evaluate and compare the effect on hemodynamics, extubation response and&#xD;
      patients satisfaction score in patients with ETT cuff filled with either mixture of&#xD;
      lignocaine with sodium bicarbonate or with a mixture of lignocaine with dexamethasone.&#xD;
&#xD;
      Design and setting:&#xD;
&#xD;
      This is a prospective single blind, randomized controlled study at the department of&#xD;
      anesthesiology, JNMCH, AMU, Aligarh.&#xD;
&#xD;
      Materials and methods:&#xD;
&#xD;
      Investigators plan to include 100 patients of age group within 18-60 years with American&#xD;
      Society of Anesthesiologists (ASA) class I &amp; II, posted for elective surgery of duration &gt;120&#xD;
      minutes, performed under general anesthesia; administered as per institutional protocols.&#xD;
      Patients with ASA III &amp; IV, cardiovascular morbidities, known drug allergy, pregnancy will be&#xD;
      excluded from the study. Patients will be divided into two groups randomly according to&#xD;
      chit-in-box method, viz Group A &amp; Group D with fifty patients in each group. Patient group&#xD;
      allocation, preparation of drug mixture for endotracheal cuff filling as per group assigned&#xD;
      and analysis of observed data will be done by a separate anesthetist not involved in the&#xD;
      perioperative management of the patient. In patients belonging to Group (A), ETT cuff will be&#xD;
      filled with mixture of 7.5% sodium bicarbonate with 2% lignocaine in the proportions of 0.5:&#xD;
      9.5 ml while in Group D the ETT cuff will be filled with mixture of dexamethasone with 2%&#xD;
      lignocaine in the proportions of 0.5: 9.5 ml . The cuff of the ETT will be slowly inflated&#xD;
      until no leak is heard at all during the peak airway pressure of the ventilator cycle while&#xD;
      auscultating the trachea . Volume of drug mixture in the cuff will be noted at start and end&#xD;
      of surgery. Total duration of anesthesia will be noted.&#xD;
&#xD;
      Hemodynamic stability at the time of extubation will be meausred in terms of changes in rate&#xD;
      pressure product (RPP) which will denote the product of heart rate and systolic blood&#xD;
      pressure. RPP values recorded immediately after stoppage of the anesthetic agents at the end&#xD;
      of surgery will be compared to the values measured just after the extubation of trachea.&#xD;
      Patient's satisfaction from anesthesia given will be recorded, based on VAS. The presence of&#xD;
      coughing and bucking will also be noted. Incidence of postoperative sore throat and cough&#xD;
      will be recorded at 1 hour and 24 hours post extubation.&#xD;
&#xD;
      The results will be presented in number, percentage, mean, and standard deviation as&#xD;
      appropriate. Appropriate statistical tests will be applied and P value less than 0.05 will be&#xD;
      considered as statistically significant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 15, 2019</start_date>
  <completion_date type="Actual">December 30, 2019</completion_date>
  <primary_completion_date type="Actual">October 30, 2019</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>Supportive Care</primary_purpose>
    <masking>Single (Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>smoothness of extubation</measure>
    <time_frame>time from adequate reversal of anaesthesia &amp; muscle paralysis (head holding &gt;5sec, eye opening on command, train of four ratio &gt;0.9) till removal of endotracheal tube.</time_frame>
    <description>Grade 1= coughing, bucking, tube biting, agitatation present. Grade 2= mild bucking/coughing. Grade 3= completely comfortable, tolerating tube in situ, no coughing/bucking/agitation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>patient satisfaction score</measure>
    <time_frame>post operative 1 hour</time_frame>
    <description>rated on visual analog scale varying 0 to 10; where 0 is worst experience and 10 is best. completely</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Haemodynamic stability at the time of extubation.</measure>
    <time_frame>values of product of systolic blood pressure and heart rate will be compared after stopping the anesthetic agents and immediately after the extubation</time_frame>
    <description>Rate pressure product (RPP); [RPP=Product of systolic blood pressure(mmHg) and heart rate (beats per min)] measured after stopping the anaesthetic agents at the end of surgery will be taken as baseline and then compared to values measured immediately after the removal of endotracheal tube.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>amount of drug diffused through endotracheal tube cuff</measure>
    <time_frame>from start till end of surgery.</time_frame>
    <description>Volume of drug mixture in the cuff was noted at start and end of surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>incidence of post operative cough and sore throat</measure>
    <time_frame>after 1 and 24 hour post extubation</time_frame>
    <description>incidence of post operative cough and sore throat</description>
  </secondary_outcome>
  <other_outcome>
    <measure>duration of surgery</measure>
    <time_frame>duration of surgery</time_frame>
    <description>duration of surgery</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Anesthesia</condition>
  <condition>Anesthesia; Adverse Effect</condition>
  <condition>Anesthesia Intubation Complication</condition>
  <arm_group>
    <arm_group_label>lignocaine with bicarbonate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Endotracheal tube cuff was filled with mixture of 7.5% sodium bicarbonate with 2% lignocaine in a ratio of 0.5:9.5 ml</description>
  </arm_group>
  <arm_group>
    <arm_group_label>lignocaine with dexamethasone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Endotracheal tube cuff was filled with mixture of dexamethasone with 2% lignocaine in a ratio of 0.5:9.5 ml</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>lignocaine+bicarbonate</intervention_name>
    <description>ETT cuff was filled with mixture of 2% lignocaine with bicarbonate</description>
    <arm_group_label>lignocaine with bicarbonate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>lignocaine+dexamethasone</intervention_name>
    <description>ETT cuff was filled with mixture of 2% lignocaine with dexamethasone</description>
    <arm_group_label>lignocaine with dexamethasone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) class I &amp; II.&#xD;
&#xD;
          -  Elective surgery&#xD;
&#xD;
          -  General anesthesia of duration &gt;120 minutes.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with ASA III &amp; IV.&#xD;
&#xD;
          -  Known Cardiovascular morbidities.&#xD;
&#xD;
          -  Pregnancy.&#xD;
&#xD;
          -  Allergic to used drugs.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Jawaharlal Nehru Medical College</name>
      <address>
        <city>Aligarh</city>
        <state>Uttar Pradesh</state>
        <zip>450331</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>January 24, 2019</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 7, 2019</study_first_posted>
  <last_update_submitted>January 1, 2020</last_update_submitted>
  <last_update_submitted_qc>January 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aligarh Muslim University</investigator_affiliation>
    <investigator_full_name>MUAZZAM HASAN</investigator_full_name>
    <investigator_title>Assistant Professor, Department of Anaesthesiology</investigator_title>
  </responsible_party>
  <keyword>Intracuff Dexamethasone</keyword>
  <keyword>Intracuff Alkalinized lignocaine</keyword>
  <keyword>General anesthesia</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
    <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/NCT03833947
org study id: AligarhMUmzm
nct id: NCT03833947
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This study is designed to evaluate and compare the effect on hemodynamics, extubation
      response and patients satisfaction score in patients with ETT cuff filled with either mixture
      of lignocaine with sodium bicarbonate or with a mixture of lignocaine with dexamethasone.
Objective Recently multiple studies have shown better outcomes with usage of dexamethasone or
      alkalinized lignocaine instead of air for filling endotracheal tube (ETT) cuff. So this study
      is designed to evaluate and compare the effect on hemodynamics, extubation response and
      patients satisfaction score in patients with ETT cuff filled with either mixture of
      lignocaine with sodium bicarbonate or with a mixture of lignocaine with dexamethasone.

      Design and setting:

      This is a prospective single blind, randomized controlled study at the department of
      anesthesiology, JNMCH, AMU, Aligarh.

      Materials and methods:

      Investigators plan to include 100 patients of age group within 18-60 years with American
      Society of Anesthesiologists (ASA) class I & II, posted for elective surgery of duration >120
      minutes, performed under general anesthesia; administered as per institutional protocols.
      Patients with ASA III & IV, cardiovascular morbidities, known drug allergy, pregnancy will be
      excluded from the study. Patients will be divided into two groups randomly according to
      chit-in-box method, viz Group A & Group D with fifty patients in each group. Patient group
      allocation, preparation of drug mixture for endotracheal cuff filling as per group assigned
      and analysis of observed data will be done by a separate anesthetist not involved in the
      perioperative management of the patient. In patients belonging to Group (A), ETT cuff will be
      filled with mixture of 7.5% sodium bicarbonate with 2% lignocaine in the proportions of 0.5:
      9.5 ml while in Group D the ETT cuff will be filled with mixture of dexamethasone with 2%
      lignocaine in the proportions of 0.5: 9.5 ml . The cuff of the ETT will be slowly inflated
      until no leak is heard at all during the peak airway pressure of the ventilator cycle while
      auscultating the trachea . Volume of drug mixture in the cuff will be noted at start and end
      of surgery. Total duration of anesthesia will be noted.

      Hemodynamic stability at the time of extubation will be meausred in terms of changes in rate
      pressure product (RPP) which will denote the product of heart rate and systolic blood
      pressure. RPP values recorded immediately after stoppage of the anesthetic agents at the end
      of surgery will be compared to the values measured just after the extubation of trachea.
      Patient's satisfaction from anesthesia given will be recorded, based on VAS. The presence of
      coughing and bucking will also be noted. Incidence of postoperative sore throat and cough
      will be recorded at 1 hour and 24 hours post extubation.

      The results will be presented in number, percentage, mean, and standard deviation as
      appropriate. Appropriate statistical tests will be applied and P value less than 0.05 will be
      considered as statistically significant.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Care Provider)
measure: smoothness of extubation
time frame: time from adequate reversal of anaesthesia & muscle paralysis (head holding >5sec, eye opening on command, train of four ratio >0.9) till removal of endotracheal tube.
description: Grade 1= coughing, bucking, tube biting, agitatation present. Grade 2= mild bucking/coughing. Grade 3= completely comfortable, tolerating tube in situ, no coughing/bucking/agitation.
measure: patient satisfaction score
time frame: post operative 1 hour
description: rated on visual analog scale varying 0 to 10; where 0 is worst experience and 10 is best. completely
measure: Haemodynamic stability at the time of extubation.
time frame: values of product of systolic blood pressure and heart rate will be compared after stopping the anesthetic agents and immediately after the extubation
description: Rate pressure product (RPP); [RPP=Product of systolic blood pressure(mmHg) and heart rate (beats per min)] measured after stopping the anaesthetic agents at the end of surgery will be taken as baseline and then compared to values measured immediately after the removal of endotracheal tube.
measure: amount of drug diffused through endotracheal tube cuff
time frame: from start till end of surgery.
description: Volume of drug mixture in the cuff was noted at start and end of surgery.
measure: incidence of post operative cough and sore throat
time frame: after 1 and 24 hour post extubation
description: incidence of post operative cough and sore throat
measure: duration of surgery
time frame: duration of surgery
description: duration of surgery
arm group label: lignocaine with bicarbonate
arm group type: Experimental
description: Endotracheal tube cuff was filled with mixture of 7.5% sodium bicarbonate with 2% lignocaine in a ratio of 0.5:9.5 ml
arm group label: lignocaine with dexamethasone
arm group type: Active Comparator
description: Endotracheal tube cuff was filled with mixture of dexamethasone with 2% lignocaine in a ratio of 0.5:9.5 ml
intervention type: Drug
intervention name: lignocaine+bicarbonate
description: ETT cuff was filled with mixture of 2% lignocaine with bicarbonate
arm group label: lignocaine with bicarbonate
intervention type: Drug
intervention name: lignocaine+dexamethasone
description: ETT cuff was filled with mixture of 2% lignocaine with dexamethasone
arm group label: lignocaine with dexamethasone
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: India
responsible party type: Principal Investigator
investigator affiliation: Aligarh Muslim University
investigator full name: MUAZZAM HASAN
investigator title: Assistant Professor, Department of Anaesthesiology
mesh term: Dexamethasone
mesh term: Lidocaine