<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/NCT03774693</url>
  </required_header>
  <id_info>
    <org_study_id>FMASU R66/2018</org_study_id>
    <nct_id>NCT03774693</nct_id>
  </id_info>
  <brief_title>Regional Block of the Nose for Hypotensive Anaesthesia in Septo-rhinoplasty</brief_title>
  <official_title>Efficacy of Regional Block of the Nose in Achieving Hypotensive Anaesthesia in Septo-rhinoplasty Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams 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>
      Septorhinoplasty is a cosmetic surgery that many people are choosing to undergo. It can be&#xD;
      done under general anesthesia, twilight anesthesia or regional anesthesia. Controlled&#xD;
      hypotensive anesthesia is required to minimize bruising, swelling, and bleeding that reduces&#xD;
      visibility in the operative field and hence satisfactory surgical outcome.&#xD;
&#xD;
      The goal of our study to prove that regional block of the nose provides efficient hypotensive&#xD;
      anesthesia&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">November 28, 2018</start_date>
  <completion_date type="Anticipated">March 2019</completion_date>
  <primary_completion_date type="Anticipated">February 2019</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>Other</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hypotensive anesthesia</measure>
    <time_frame>Intraoperative</time_frame>
    <description>Measurement of Mean arterial blood pressure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Requirements of Fentanyl</measure>
    <time_frame>Intraoperative</time_frame>
    <description>Assessment of intraoperative fentanyl doses of [Fentanyl boluses of 0.5 mcg.Kg-1 will be given to maintain mean arterial pressure (MAP) between 55-65 mmHg with a maximum dose of 3 mcg.Kg-1]</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Average category scale (ACS)</measure>
    <time_frame>Intraoperative</time_frame>
    <description>The surgeon will be asked, at the end of surgery, to assess bleeding in the surgical field using the average category scale 0-5 scale where [0=No bleeding and5=Severe bleeding]</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Hypotensive Anesthesia</condition>
  <arm_group>
    <arm_group_label>GS [General anesthesia]</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive general anesthesia with Fentanyl boluses of 0.5 mcg.Kg-1 given to maintain MAP between 55-65 mmHg with a maximum dose of 3 mcg.Kg-1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GR [General anesthesia + regional block]</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive general anesthesia with Fentanyl boluses of 0.5 mcg.Kg-1 given to maintain MAP between 55-65 mmHg with a maximum dose of 3 mcg.Kg-1.&#xD;
Also patients will receive trans-oral bilateral sphenopalatine ganglion block and trans-oral bilateral infraorbital nerve block. Fentanyl boluses of 0.5 mcg.Kg-1 will be given when needed to maintain MAP between 55-65 mmHg with a maximum dose of 3 mcg.Kg-1.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>General anesthesia with fentanyl boluses</intervention_name>
    <description>Patients will receive general anesthesia with Fentanyl boluses of 0.5 mcg.Kg-1 given to maintain MAP between 55-65 mmHg with a maximum dose of 3 mcg.Kg-1</description>
    <arm_group_label>GR [General anesthesia + regional block]</arm_group_label>
    <arm_group_label>GS [General anesthesia]</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Regional block</intervention_name>
    <description>Patients will receive trans-oral bilateral sphenopalatine ganglion block and trans-oral bilateral infraorbital nerve block.</description>
    <arm_group_label>GR [General anesthesia + regional block]</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) physical status I-II&#xD;
&#xD;
          -  Scheduled for elective septo-rhinoplasty surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with hypertension or coronary artery disease,&#xD;
&#xD;
          -  Patients with renal, hepatic or cerebral insufficiency,&#xD;
&#xD;
          -  Patients with coagulopathy or receiving drugs influencing blood coagulation,&#xD;
&#xD;
          -  Patients with known sensitivity to any of the study drug&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ain Shams University</name>
      <address>
        <city>Cairo</city>
        <zip>11591</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 13, 2018</study_first_posted>
  <last_update_submitted>December 14, 2018</last_update_submitted>
  <last_update_submitted_qc>December 14, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Hanan Mahmoud Farag Awad</investigator_full_name>
    <investigator_title>Assisstant Professor</investigator_title>
  </responsible_party>
  <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>Fentanyl</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/NCT03774693
org study id: FMASU R66/2018
nct id: NCT03774693
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Septorhinoplasty is a cosmetic surgery that many people are choosing to undergo. It can be
      done under general anesthesia, twilight anesthesia or regional anesthesia. Controlled
      hypotensive anesthesia is required to minimize bruising, swelling, and bleeding that reduces
      visibility in the operative field and hence satisfactory surgical outcome.

      The goal of our study to prove that regional block of the nose provides efficient hypotensive
      anesthesia
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Double (Participant, Outcomes Assessor)
measure: Hypotensive anesthesia
time frame: Intraoperative
description: Measurement of Mean arterial blood pressure
measure: Requirements of Fentanyl
time frame: Intraoperative
description: Assessment of intraoperative fentanyl doses of [Fentanyl boluses of 0.5 mcg.Kg-1 will be given to maintain mean arterial pressure (MAP) between 55-65 mmHg with a maximum dose of 3 mcg.Kg-1]
measure: Average category scale (ACS)
time frame: Intraoperative
description: The surgeon will be asked, at the end of surgery, to assess bleeding in the surgical field using the average category scale 0-5 scale where [0=No bleeding and5=Severe bleeding]
arm group label: GS [General anesthesia]
arm group type: Active Comparator
description: Patients will receive general anesthesia with Fentanyl boluses of 0.5 mcg.Kg-1 given to maintain MAP between 55-65 mmHg with a maximum dose of 3 mcg.Kg-1.
arm group label: GR [General anesthesia + regional block]
arm group type: Active Comparator
description: Patients will receive general anesthesia with Fentanyl boluses of 0.5 mcg.Kg-1 given to maintain MAP between 55-65 mmHg with a maximum dose of 3 mcg.Kg-1.
Also patients will receive trans-oral bilateral sphenopalatine ganglion block and trans-oral bilateral infraorbital nerve block. Fentanyl boluses of 0.5 mcg.Kg-1 will be given when needed to maintain MAP between 55-65 mmHg with a maximum dose of 3 mcg.Kg-1.
intervention type: Other
intervention name: General anesthesia with fentanyl boluses
description: Patients will receive general anesthesia with Fentanyl boluses of 0.5 mcg.Kg-1 given to maintain MAP between 55-65 mmHg with a maximum dose of 3 mcg.Kg-1
arm group label: GR [General anesthesia + regional block]
arm group label: GS [General anesthesia]
intervention type: Procedure
intervention name: Regional block
description: Patients will receive trans-oral bilateral sphenopalatine ganglion block and trans-oral bilateral infraorbital nerve block.
arm group label: GR [General anesthesia + regional block]
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Hanan Mahmoud Farag Awad
investigator title: Assisstant Professor
mesh term: Hypotension
mesh term: Fentanyl
sharing ipd: Undecided