<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/NCT03815435</url>
  </required_header>
  <id_info>
    <org_study_id>KARIM-01-ENSURGERY</org_study_id>
    <nct_id>NCT03815435</nct_id>
  </id_info>
  <brief_title>The Influence of Blood Pressure Upon the Clarity of Surgical Field in Endonasal Surgery</brief_title>
  <official_title>The Influence of Blood Pressure Upon the Clarity of Surgical Field in Endonasal Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Ostrava</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Ostrava</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The work compares the effect of different various values of arterial blood pressure on the&#xD;
      clarity of the surgical field in pansinusoperation in patients with chronic rhinosinusitis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The work compares the effect of different values of arterial pressure on the clarity of the&#xD;
      surgical field in pansinus operation in patients with chronic rhinosinusitis. A secondary&#xD;
      goal of the study is to compare circulatory parameters, depth of anaesthesia, near-infrared&#xD;
      spectroscopy (NIRS) and consumption of hypotensives.&#xD;
&#xD;
      Null hypothesis: There is no difference in the clarity of the surgical field at various&#xD;
      levels of the mean arterial pressure.&#xD;
&#xD;
      This study is being realized in accordance with the Declaration of Helsinki and has been&#xD;
      approved by the Ethics Committee of the University Hospital Ostrava (849/2018). According to&#xD;
      the statement of the State Institute for Drug Control of 26th April 2019 (reference number&#xD;
      Sukl96964/2019), the trial is not considered a clinical trial of medicinal products.&#xD;
&#xD;
      Study type: Single-blind study (the surgeon does not know the value of the patient's blood&#xD;
      pressure) prospective study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">March 31, 2020</completion_date>
  <primary_completion_date type="Actual">January 31, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>The study subjects will be enrolled into one arm.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>The physician performing the surgery and assessing the surgical field clarity will be masked as to the value of the blood pressure in the individual patient.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Surgical field clarity in relation to the value of arterial pressure</measure>
    <time_frame>13 months</time_frame>
    <description>Clarity of the surgical field will be assessed on a scale of 0-5, according to the Boezaart's system (1995)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>13 months</time_frame>
    <description>Blood pressure will be measured in the morning before surgery, on arrival at the operating theatre and further 5 minutes after anaesthesia, and every five minutes during the surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate</measure>
    <time_frame>13 months</time_frame>
    <description>Heart rate will be measured in the morning before surgery, on arrival at the operating theatre and further 5 minutes after anaesthesia, and every five minutes during the surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depth of anaesthesia</measure>
    <time_frame>13 months</time_frame>
    <description>Depth of anaesthesia will be measured using the BIS value every 5 minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Near infrared spectroscopy (NIRS)</measure>
    <time_frame>13 months</time_frame>
    <description>Cerebral perfusion will be measured using the NIRS value every 5 minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Consumption of hypotensives</measure>
    <time_frame>13 months</time_frame>
    <description>Consumption of hypotensives (Nitro Pohl) will be measured in mg/hr</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood loss</measure>
    <time_frame>13 months</time_frame>
    <description>Blood loss (ml) during the surgery will be measured</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recovery from anaesthesia duration</measure>
    <time_frame>13 months</time_frame>
    <description>The interval from the end of surgery to eye opening in minutes will be measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative pain</measure>
    <time_frame>13 months</time_frame>
    <description>Postoperative pain will be measured using the VAS (Visual Analogue Scale) upon arrival to the recovery room and the standard ward.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive function</measure>
    <time_frame>13 months</time_frame>
    <description>The standardised clock-drawing test will be performed at the ward, 2 hours after surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative nausea</measure>
    <time_frame>13 months</time_frame>
    <description>The presence of postoperative nausea (YES/NO) will be observed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative vomiting</measure>
    <time_frame>13 months</time_frame>
    <description>The presence of postoperative vomiting (YES/NO) will be observed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications of controlled hypotension</measure>
    <time_frame>13 months</time_frame>
    <description>The presence of complications of controlled hypotension (stroke, myocardial infarction, kidney injury - YES/NO) will be observed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of tamponade</measure>
    <time_frame>13 months</time_frame>
    <description>The need to use tamponade due to bleeding (YES/NO) will be observed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgical revision</measure>
    <time_frame>13 months</time_frame>
    <description>The need for surgical revision due to bleeding (YES/NO) will be observed.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Chronic Rhinosinusitis (Diagnosis)</condition>
  <arm_group>
    <arm_group_label>Controlled hypotension</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Controlled hypotension will be administered according to the clarity of the surgical field evaluated according to the Boezaart scale (1995).</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Controlled hypotension</intervention_name>
    <description>Controlled hypotension will be administered according to the clarity of the surgical field.</description>
    <arm_group_label>Controlled hypotension</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with chronic rhinosinusitis undergoing pansinusoperation&#xD;
&#xD;
          -  Age over 18 years&#xD;
&#xD;
          -  Concrete surgeon (Petr Matoušek, MD, Ph.D., MBA)&#xD;
&#xD;
          -  Concrete anaesthetist (Michal Parma, MD)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Coagulopathy&#xD;
&#xD;
          -  Thrombocytopathies&#xD;
&#xD;
          -  Vascular wall disorders&#xD;
&#xD;
          -  Thrombophlebitis&#xD;
&#xD;
          -  Anticoagulation or anti-aggregation therapy&#xD;
&#xD;
          -  History of malignancy&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ondřej Jor, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Ostrava</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Ostrava</name>
      <address>
        <city>Ostrava</city>
        <state>Moravian-Silesian Region</state>
        <zip>70852</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Czechia</country>
  </location_countries>
  <reference>
    <citation>Thongrong C, Kasemsiri P, Carrau RL, Bergese SD. Control of bleeding in endoscopic skull base surgery: current concepts to improve hemostasis. ISRN Surg. 2013 Jun 13;2013:191543. doi: 10.1155/2013/191543. Print 2013.</citation>
    <PMID>23844295</PMID>
  </reference>
  <reference>
    <citation>Kelly EA, Gollapudy S, Riess ML, Woehlck HJ, Loehrl TA, Poetker DM. Quality of surgical field during endoscopic sinus surgery: a systematic literature review of the effect of total intravenous compared to inhalational anesthesia. Int Forum Allergy Rhinol. 2013 Jun;3(6):474-81. doi: 10.1002/alr.21125. Epub 2012 Dec 19.</citation>
    <PMID>23258603</PMID>
  </reference>
  <reference>
    <citation>Athanasiadis T, Beule A, Embate J, Steinmeier E, Field J, Wormald PJ. Standardized video-endoscopy and surgical field grading scale for endoscopic sinus surgery: a multi-centre study. Laryngoscope. 2008 Feb;118(2):314-9. doi: 10.1097/MLG.0b013e318157f764.</citation>
    <PMID>17989575</PMID>
  </reference>
  <reference>
    <citation>Milonski J, Zielinska-Blizniewska H, Golusinski W, Urbaniak J, Sobanski R, Olszewski J. Effects of three different types of anaesthesia on perioperative bleeding control in functional endoscopic sinus surgery. Eur Arch Otorhinolaryngol. 2013 Jul;270(7):2045-50. doi: 10.1007/s00405-012-2311-1. Epub 2012 Dec 22.</citation>
    <PMID>23263204</PMID>
  </reference>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>January 21, 2019</study_first_submitted>
  <study_first_submitted_qc>January 21, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>March 29, 2023</last_update_submitted>
  <last_update_submitted_qc>March 29, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Surgical field clarity</keyword>
  <keyword>Endonasal surgery</keyword>
  <keyword>Intraoperative bleeding</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sinusitis</mesh_term>
    <mesh_term>Chronic Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is no plan to make individual participant data available to other researchers.</ipd_description>
  </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/NCT03815435
org study id: KARIM-01-ENSURGERY
nct id: NCT03815435
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The work compares the effect of different various values of arterial blood pressure on the
      clarity of the surgical field in pansinusoperation in patients with chronic rhinosinusitis.
The work compares the effect of different values of arterial pressure on the clarity of the
      surgical field in pansinus operation in patients with chronic rhinosinusitis. A secondary
      goal of the study is to compare circulatory parameters, depth of anaesthesia, near-infrared
      spectroscopy (NIRS) and consumption of hypotensives.

      Null hypothesis: There is no difference in the clarity of the surgical field at various
      levels of the mean arterial pressure.

      This study is being realized in accordance with the Declaration of Helsinki and has been
      approved by the Ethics Committee of the University Hospital Ostrava (849/2018). According to
      the statement of the State Institute for Drug Control of 26th April 2019 (reference number
      Sukl96964/2019), the trial is not considered a clinical trial of medicinal products.

      Study type: Single-blind study (the surgeon does not know the value of the patient's blood
      pressure) prospective study.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: The study subjects will be enrolled into one arm.
primary purpose: Treatment
masking: None (Open Label)
masking description: The physician performing the surgery and assessing the surgical field clarity will be masked as to the value of the blood pressure in the individual patient.
measure: Surgical field clarity in relation to the value of arterial pressure
time frame: 13 months
description: Clarity of the surgical field will be assessed on a scale of 0-5, according to the Boezaart's system (1995)
measure: Blood pressure
time frame: 13 months
description: Blood pressure will be measured in the morning before surgery, on arrival at the operating theatre and further 5 minutes after anaesthesia, and every five minutes during the surgery.
measure: Heart rate
time frame: 13 months
description: Heart rate will be measured in the morning before surgery, on arrival at the operating theatre and further 5 minutes after anaesthesia, and every five minutes during the surgery.
measure: Depth of anaesthesia
time frame: 13 months
description: Depth of anaesthesia will be measured using the BIS value every 5 minutes
measure: Near infrared spectroscopy (NIRS)
time frame: 13 months
description: Cerebral perfusion will be measured using the NIRS value every 5 minutes
measure: Consumption of hypotensives
time frame: 13 months
description: Consumption of hypotensives (Nitro Pohl) will be measured in mg/hr
measure: Blood loss
time frame: 13 months
description: Blood loss (ml) during the surgery will be measured
measure: Recovery from anaesthesia duration
time frame: 13 months
description: The interval from the end of surgery to eye opening in minutes will be measured.
measure: Postoperative pain
time frame: 13 months
description: Postoperative pain will be measured using the VAS (Visual Analogue Scale) upon arrival to the recovery room and the standard ward.
measure: Cognitive function
time frame: 13 months
description: The standardised clock-drawing test will be performed at the ward, 2 hours after surgery.
measure: Postoperative nausea
time frame: 13 months
description: The presence of postoperative nausea (YES/NO) will be observed.
measure: Postoperative vomiting
time frame: 13 months
description: The presence of postoperative vomiting (YES/NO) will be observed.
measure: Complications of controlled hypotension
time frame: 13 months
description: The presence of complications of controlled hypotension (stroke, myocardial infarction, kidney injury - YES/NO) will be observed.
measure: Use of tamponade
time frame: 13 months
description: The need to use tamponade due to bleeding (YES/NO) will be observed.
measure: Surgical revision
time frame: 13 months
description: The need for surgical revision due to bleeding (YES/NO) will be observed.
arm group label: Controlled hypotension
arm group type: Experimental
description: Controlled hypotension will be administered according to the clarity of the surgical field evaluated according to the Boezaart scale (1995).
intervention type: Procedure
intervention name: Controlled hypotension
description: Controlled hypotension will be administered according to the clarity of the surgical field.
arm group label: Controlled hypotension
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ondřej Jor, MD
role: Principal Investigator
affiliation: University Hospital Ostrava
facility: 
country: Czechia
citation: Thongrong C, Kasemsiri P, Carrau RL, Bergese SD. Control of bleeding in endoscopic skull base surgery: current concepts to improve hemostasis. ISRN Surg. 2013 Jun 13;2013:191543. doi: 10.1155/2013/191543. Print 2013.
PMID: 23844295
citation: Kelly EA, Gollapudy S, Riess ML, Woehlck HJ, Loehrl TA, Poetker DM. Quality of surgical field during endoscopic sinus surgery: a systematic literature review of the effect of total intravenous compared to inhalational anesthesia. Int Forum Allergy Rhinol. 2013 Jun;3(6):474-81. doi: 10.1002/alr.21125. Epub 2012 Dec 19.
PMID: 23258603
citation: Athanasiadis T, Beule A, Embate J, Steinmeier E, Field J, Wormald PJ. Standardized video-endoscopy and surgical field grading scale for endoscopic sinus surgery: a multi-centre study. Laryngoscope. 2008 Feb;118(2):314-9. doi: 10.1097/MLG.0b013e318157f764.
PMID: 17989575
citation: Milonski J, Zielinska-Blizniewska H, Golusinski W, Urbaniak J, Sobanski R, Olszewski J. Effects of three different types of anaesthesia on perioperative bleeding control in functional endoscopic sinus surgery. Eur Arch Otorhinolaryngol. 2013 Jul;270(7):2045-50. doi: 10.1007/s00405-012-2311-1. Epub 2012 Dec 22.
PMID: 23263204
responsible party type: Sponsor
mesh term: Sinusitis
mesh term: Chronic Disease
sharing ipd: No
ipd description: There is no plan to make individual participant data available to other researchers.