<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/NCT04441073</url>
  </required_header>
  <id_info>
    <org_study_id>Lignocaine nebulization stress</org_study_id>
    <nct_id>NCT04441073</nct_id>
  </id_info>
  <brief_title>Lignocaine Nebulization for Attenuation of Intubation Stress Response</brief_title>
  <official_title>Lignocaine Nebulization for Attenuation of Intubation Stress Response in Patients With Severe Pre-eclampsia: a Prospective Double-blinded Placebo-controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut 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>
      To study the effect of lignocaine nebulization on attenuation of the pressor response during&#xD;
      induction and emergence of anesthesia in patients with severe pre-eclampsia&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The pressor response to laryngoscopy and tracheal intubation is a very important issue in&#xD;
      hypertensive pregnant patients that can lead to increased maternal intracranial pressure,&#xD;
      cerebral haemorrhage, and cardiac failure with pulmonary oedema and may result in maternal&#xD;
      mortality. The catecholamine release associated with laryngoscopy and intubation also causes&#xD;
      uteroplacental vasoconstriction and adversely affect the neonate well-being.&#xD;
&#xD;
      Therefore, the precise control of stress is necessary during general anesthesia in&#xD;
      pre-eclamptic patients.Various drugs are used to suppress the pressor response including&#xD;
      opioids, lidocaine, along with α and β adrenergic blockers.&#xD;
&#xD;
      in this study the investigators will evaluate the effect of lignocaine nebulization on&#xD;
      attenuation of the pressor response.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 24, 2021</start_date>
  <completion_date type="Anticipated">February 23, 2022</completion_date>
  <primary_completion_date type="Anticipated">February 23, 2022</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>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Systolic, diastolic, mean arterial blood pressure</measure>
    <time_frame>Preoperative-Intraoperative</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Heart rate</measure>
    <time_frame>Preoperative-Intraoperative</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Peripheral oxygen saturation</measure>
    <time_frame>Preoperative-Intraoperative</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cough score during emergence</measure>
    <time_frame>Up to one hour after extubation</time_frame>
    <description>Grade of coughing (grade 0: no cough; grade 1: single cough with mild severity; grade 2: cough lasting less than 5 seconds with moderate severity; grade 3: more than 5 seconds of persistent cough)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>APGAR score</measure>
    <time_frame>One, 5 and 10 minutes after delivery of the fetus</time_frame>
    <description>APGAR stands for &quot;Appearance, Pulse, Grimace, Activity, and Respiration.&quot;&#xD;
In the test, five things are used to check a baby's health. Each is scored on a scale of 0 to 2, with 2 being the best score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sore throat and hoarseness of voice</measure>
    <time_frame>Postoperative (one, 6 and 24 hours)</time_frame>
    <description>The incidences and severities of postoperative sore throat and hoarseness of voice will be measured using direct questions</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Pressor Response</condition>
  <arm_group>
    <arm_group_label>Lignocaine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>preoperative nebulization of lignocaine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>preoperative nebulization of normal saline (Nacl 0.9%) as a placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lignocaine</intervention_name>
    <description>preoperative nebulization of lignocaine</description>
    <arm_group_label>Lignocaine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>preoperative nebulization of normal saline (Nacl 0.9%) as a placebo</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Normal saline (Nacl 0.9%)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologist (ASA) II , III with severe pre-eclampsia&#xD;
&#xD;
          -  Scheduled for caesarean deliveries under general anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe obesity (BMI ≥ 40 )&#xD;
&#xD;
          -  Cardiac patients&#xD;
&#xD;
          -  History of diabetes&#xD;
&#xD;
          -  Renal dysfunction (Elevated creatinine ≥ 2 mg\dl)&#xD;
&#xD;
          -  Hepatic dysfunction (Elevated hepatic enzymes three times above normal value)&#xD;
&#xD;
          -  Known fetal anomalies&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Fatma N. Mohamed, M.D.</last_name>
    <phone>+201003633992</phone>
    <email>fatmanabil2012@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Alaa A. Gharib, M.B.B.Ch.</last_name>
    <email>lola.gh2022@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Assiut University</name>
      <address>
        <city>Assiut</city>
        <zip>71515</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fatma N. Mohamed, M.D.</last_name>
      <phone>+201003633992</phone>
      <email>fatmanabil2012@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Alaa Gharib</last_name>
      <email>lola.gh2022@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>January 16, 2022</last_update_submitted>
  <last_update_submitted_qc>January 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>FATMA NABIL AHMED MOHAMED</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>pressor response</keyword>
  <keyword>pre-eclampsia</keyword>
  <keyword>Lignocaine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pre-Eclampsia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT04441073
org study id: Lignocaine nebulization stress
nct id: NCT04441073
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To study the effect of lignocaine nebulization on attenuation of the pressor response during
      induction and emergence of anesthesia in patients with severe pre-eclampsia
The pressor response to laryngoscopy and tracheal intubation is a very important issue in
      hypertensive pregnant patients that can lead to increased maternal intracranial pressure,
      cerebral haemorrhage, and cardiac failure with pulmonary oedema and may result in maternal
      mortality. The catecholamine release associated with laryngoscopy and intubation also causes
      uteroplacental vasoconstriction and adversely affect the neonate well-being.

      Therefore, the precise control of stress is necessary during general anesthesia in
      pre-eclamptic patients.Various drugs are used to suppress the pressor response including
      opioids, lidocaine, along with α and β adrenergic blockers.

      in this study the investigators will evaluate the effect of lignocaine nebulization on
      attenuation of the pressor response.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Systolic, diastolic, mean arterial blood pressure
time frame: Preoperative-Intraoperative
measure: Heart rate
time frame: Preoperative-Intraoperative
measure: Peripheral oxygen saturation
time frame: Preoperative-Intraoperative
measure: Cough score during emergence
time frame: Up to one hour after extubation
description: Grade of coughing (grade 0: no cough; grade 1: single cough with mild severity; grade 2: cough lasting less than 5 seconds with moderate severity; grade 3: more than 5 seconds of persistent cough)
measure: APGAR score
time frame: One, 5 and 10 minutes after delivery of the fetus
description: APGAR stands for "Appearance, Pulse, Grimace, Activity, and Respiration."
In the test, five things are used to check a baby's health. Each is scored on a scale of 0 to 2, with 2 being the best score
measure: Sore throat and hoarseness of voice
time frame: Postoperative (one, 6 and 24 hours)
description: The incidences and severities of postoperative sore throat and hoarseness of voice will be measured using direct questions
arm group label: Lignocaine
arm group type: Experimental
description: preoperative nebulization of lignocaine
arm group label: Placebo
arm group type: Placebo Comparator
description: preoperative nebulization of normal saline (Nacl 0.9%) as a placebo
intervention type: Drug
intervention name: Lignocaine
description: preoperative nebulization of lignocaine
arm group label: Lignocaine
intervention type: Drug
intervention name: Placebo
description: preoperative nebulization of normal saline (Nacl 0.9%) as a placebo
arm group label: Placebo
other name: Normal saline (Nacl 0.9%)
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Fatma N. Mohamed, M.D.
phone: +201003633992
email: fatmanabil2012@gmail.com
last name: Alaa A. Gharib, M.B.B.Ch.
email: lola.gh2022@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: FATMA NABIL AHMED MOHAMED
investigator title: Principal Investigator
mesh term: Pre-Eclampsia
mesh term: Lidocaine
sharing ipd: Undecided