<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/NCT03809065</url>
  </required_header>
  <id_info>
    <org_study_id>N53-2016</org_study_id>
    <nct_id>NCT03809065</nct_id>
  </id_info>
  <brief_title>Effects of Nitroglycerin Versus Labetalol on Tissue Perfusion During Deliberate Hypotension</brief_title>
  <official_title>Effects of Nitroglycerin Versus Labetalol on Tissue Perfusion During Deliberate Hypotension for Sinus Endoscopic Surgery.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</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>
      Deliberate hypotension is used to provide bloodless field during endoscopic sinus surgery;&#xD;
      however, hypotension might impair perfusion of vital organs. The aim of this work is to&#xD;
      compare the impact of nitroglycerin and labetalol on peripheral perfusion when used for&#xD;
      induction of deliberate hypotension&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hypotensive anesthesia is associated with the risk of reduced tissue perfusion. The usual&#xD;
      target mean arterial pressure during deliberate hypotension is 50- 65 mmHg; however, the&#xD;
      status of peripheral perfusion under this target is not well investigated. Nitroglycerin and&#xD;
      Labetalol are commonly used drugs to achieve deliberate hypotension. Nitroglycerin is a&#xD;
      direct vasodilator and its main action is through venodilation, while labetalol combines a&#xD;
      selective α1 and non selective beta-adrenergic blocking activity. Both drugs were previously&#xD;
      compared during deliberate hypotension with regard to surgical field quality and blood loss.&#xD;
      No study to date compared the effects of both drugs on peripheral perfusion when used for&#xD;
      induction of deliberate hypotension. The Peripheral Perfusion Index (PPI) is the ratio&#xD;
      between pulsatile and non-pulsatile components of peripheral circulation. Measurement of PPI&#xD;
      is based on analysis of the pulse oximetry signal. PPI showed increasing popularity as a non&#xD;
      invasive monitor of peripheral perfusion. Serum lactate is another frequently used marker of&#xD;
      global tissue perfusion.The aim of this study is to compare the influence of nitroglycerin&#xD;
      and labetalol on tissue perfusion when used for induction of deliberate hypotension during&#xD;
      FESS operations. Tissue perfusion will be evaluated using PPI and serum lactate as markers of&#xD;
      peripheral and global tissue perfusion respectively.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 19, 2019</start_date>
  <completion_date type="Actual">May 25, 2019</completion_date>
  <primary_completion_date type="Actual">May 25, 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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Peripheral perfusion index</measure>
    <time_frame>4 hours</time_frame>
    <description>Peripheral perfusion index will be used as a marker of peripheral perfusion.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in serum lactate concentration</measure>
    <time_frame>Immediately before induction of anesthesia and after 60 minutes post recovery.</time_frame>
    <description>Serum lactate concentration will be used as a marker of global tissue perfusion.Two samples will be obtained.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total blood loss</measure>
    <time_frame>from beginning of surgery till the end of the procedure</time_frame>
    <description>Total blood loss will be measured from the suction device and gauzes that will be used to dry the surgical field.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgical field score (SFS)</measure>
    <time_frame>from beginning of surgery till the end of the procedure.</time_frame>
    <description>SFS ranges from 0 to 5 as follows: 0: No bleeding, 1: Slight bleeding-no suctioning of blood required, 2: Slight bleeding-occasional suctioning required. Surgical field not threatened. 3: Slight bleeding-frequent suctioning required. Bleeding threatens surgical field a few seconds after suction is removed, 4: Moderate bleeding-frequent suctioning required. Bleeding threatens surgical field directly after suction is removed, 5: Severe bleeding-constant suctioning required. Bleeding appears faster that can be removed by suction. Surgical field severely threatened and surgery not possible.&#xD;
Adequate surgical field is defined as SFS &lt;3</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean arterial blood pressure</measure>
    <time_frame>4 hours</time_frame>
    <description>Target mean arterial pressure during deliberate hypotension will be 55-65mmHg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate</measure>
    <time_frame>4 hours</time_frame>
    <description>Number of heart beats per minute</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Tissue Perfusion</condition>
  <condition>Deliberate Hypotension</condition>
  <condition>Sinus Endoscopic Surgery</condition>
  <arm_group>
    <arm_group_label>group N</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this group will receive Nitroglycerin infusion for deliberate hypotension at a rate of 0.5-2 μg /kg/min .</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group L</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in this group will receive Labetalol infusion for deliberate hypotension at a rate of be 0.5-2 mg/kg/h .</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nitroglycerin</intervention_name>
    <description>Nitroglycerin is a direct vasodilator and its main action is through venodilation. Nitroglycerin will be diluted by adding 3 mL (3 mg) to 47 mL normal saline in a 50 mL syringe and will be infused after endotracheal intubation with a starting dose of 0.5 mL/Kg/ hr to have a starting dose of 0.5 μg/Kg/min. The rate of nitroglycerin infusion will be 0.5-2 μg /kg/min .The infusion rate will be finely adjusted to maintain MAP around 55-65mmHg or till reaching adequate surgical field {defined as surgical field score (SFS) &lt;3}.</description>
    <arm_group_label>group N</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Labetalol</intervention_name>
    <description>Labetalol is an α and β - adrenergic receptors competitive antagonist. Labetalol will be diluted by adding 10 mL (50 mg) to 40 mL normal saline in a 50 mL syringe and will be infused after endotracheal intubation with a starting dose of 0.5 mL/Kg/ hr. The rate of Labetalol infusion will be 0.5-2 mg/kg/h.The infusion rate will be finely adjusted to maintain MAP around 55-65mmHg or till reaching adequate surgical field {defined as surgical field score (SFS) &lt;3}.</description>
    <arm_group_label>group L</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult male or female patients&#xD;
&#xD;
          -  18-45 years&#xD;
&#xD;
          -  ASA physical status I-II&#xD;
&#xD;
          -  scheduled for FESS operations&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  uncontrolled hypertension&#xD;
&#xD;
          -  cerebrovascular disorders&#xD;
&#xD;
          -  coagulation disorders&#xD;
&#xD;
          -  cardiovascular diseases&#xD;
&#xD;
          -  renal impairment&#xD;
&#xD;
          -  liver impairment&#xD;
&#xD;
          -  history of allergic reaction to any of the study medications&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kasr Al Ainy</name>
      <address>
        <city>Cairo</city>
        <zip>11562</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>January 13, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>April 23, 2020</last_update_submitted>
  <last_update_submitted_qc>April 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Heba Nassar,MD</investigator_full_name>
    <investigator_title>Associate professor of Anesthesia</investigator_title>
  </responsible_party>
  <keyword>Deliberate hypotension</keyword>
  <keyword>Nitroglycerin</keyword>
  <keyword>Labetalol</keyword>
  <keyword>Peripheral perfusion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypotension</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Labetalol</mesh_term>
    <mesh_term>Nitroglycerin</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/NCT03809065
org study id: N53-2016
nct id: NCT03809065
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Deliberate hypotension is used to provide bloodless field during endoscopic sinus surgery;
      however, hypotension might impair perfusion of vital organs. The aim of this work is to
      compare the impact of nitroglycerin and labetalol on peripheral perfusion when used for
      induction of deliberate hypotension
Hypotensive anesthesia is associated with the risk of reduced tissue perfusion. The usual
      target mean arterial pressure during deliberate hypotension is 50- 65 mmHg; however, the
      status of peripheral perfusion under this target is not well investigated. Nitroglycerin and
      Labetalol are commonly used drugs to achieve deliberate hypotension. Nitroglycerin is a
      direct vasodilator and its main action is through venodilation, while labetalol combines a
      selective α1 and non selective beta-adrenergic blocking activity. Both drugs were previously
      compared during deliberate hypotension with regard to surgical field quality and blood loss.
      No study to date compared the effects of both drugs on peripheral perfusion when used for
      induction of deliberate hypotension. The Peripheral Perfusion Index (PPI) is the ratio
      between pulsatile and non-pulsatile components of peripheral circulation. Measurement of PPI
      is based on analysis of the pulse oximetry signal. PPI showed increasing popularity as a non
      invasive monitor of peripheral perfusion. Serum lactate is another frequently used marker of
      global tissue perfusion.The aim of this study is to compare the influence of nitroglycerin
      and labetalol on tissue perfusion when used for induction of deliberate hypotension during
      FESS operations. Tissue perfusion will be evaluated using PPI and serum lactate as markers of
      peripheral and global tissue perfusion respectively.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Triple (Participant, Care Provider, Investigator)
measure: Peripheral perfusion index
time frame: 4 hours
description: Peripheral perfusion index will be used as a marker of peripheral perfusion.
measure: Change in serum lactate concentration
time frame: Immediately before induction of anesthesia and after 60 minutes post recovery.
description: Serum lactate concentration will be used as a marker of global tissue perfusion.Two samples will be obtained.
measure: Total blood loss
time frame: from beginning of surgery till the end of the procedure
description: Total blood loss will be measured from the suction device and gauzes that will be used to dry the surgical field.
measure: Surgical field score (SFS)
time frame: from beginning of surgery till the end of the procedure.
description: SFS ranges from 0 to 5 as follows: 0: No bleeding, 1: Slight bleeding-no suctioning of blood required, 2: Slight bleeding-occasional suctioning required. Surgical field not threatened. 3: Slight bleeding-frequent suctioning required. Bleeding threatens surgical field a few seconds after suction is removed, 4: Moderate bleeding-frequent suctioning required. Bleeding threatens surgical field directly after suction is removed, 5: Severe bleeding-constant suctioning required. Bleeding appears faster that can be removed by suction. Surgical field severely threatened and surgery not possible.
Adequate surgical field is defined as SFS <3
measure: Mean arterial blood pressure
time frame: 4 hours
description: Target mean arterial pressure during deliberate hypotension will be 55-65mmHg
measure: Heart rate
time frame: 4 hours
description: Number of heart beats per minute
arm group label: group N
arm group type: Experimental
description: Patients in this group will receive Nitroglycerin infusion for deliberate hypotension at a rate of 0.5-2 μg /kg/min .
arm group label: group L
arm group type: Active Comparator
description: Patients in this group will receive Labetalol infusion for deliberate hypotension at a rate of be 0.5-2 mg/kg/h .
intervention type: Drug
intervention name: Nitroglycerin
description: Nitroglycerin is a direct vasodilator and its main action is through venodilation. Nitroglycerin will be diluted by adding 3 mL (3 mg) to 47 mL normal saline in a 50 mL syringe and will be infused after endotracheal intubation with a starting dose of 0.5 mL/Kg/ hr to have a starting dose of 0.5 μg/Kg/min. The rate of nitroglycerin infusion will be 0.5-2 μg /kg/min .The infusion rate will be finely adjusted to maintain MAP around 55-65mmHg or till reaching adequate surgical field {defined as surgical field score (SFS) <3}.
arm group label: group N
intervention type: Drug
intervention name: Labetalol
description: Labetalol is an α and β - adrenergic receptors competitive antagonist. Labetalol will be diluted by adding 10 mL (50 mg) to 40 mL normal saline in a 50 mL syringe and will be infused after endotracheal intubation with a starting dose of 0.5 mL/Kg/ hr. The rate of Labetalol infusion will be 0.5-2 mg/kg/h.The infusion rate will be finely adjusted to maintain MAP around 55-65mmHg or till reaching adequate surgical field {defined as surgical field score (SFS) <3}.
arm group label: group L
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Heba Nassar,MD
investigator title: Associate professor of Anesthesia
mesh term: Hypotension
mesh term: Labetalol
mesh term: Nitroglycerin