<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/NCT03029676</url>
  </required_header>
  <id_info>
    <org_study_id>U/1/2017</org_study_id>
    <nct_id>NCT03029676</nct_id>
  </id_info>
  <brief_title>The Assessment of POCD After TURBT Under Spinal Anesthesia</brief_title>
  <official_title>The Assessment of Postoperative Cognitive Dysfunction After Transurethral Resection of Bladder Tumor Under Spinal Anesthesia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Warsaw</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Warsaw</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>
      This study evaluates the influence of premedication on cognitive functions in patients&#xD;
      undergoing transurethral resection of bladder tumor under spinal anesthesia. The aims of&#xD;
      premedication are anxiolysis, analgesia and the reduction of perioperative risk among the&#xD;
      patients with comorbidities. The patients will be randomly allocated to receive premedication&#xD;
      either with opioid solely or with benzodiazepine combined with opioid. The anesthetic&#xD;
      technique is standardized.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Trans-urethral resection of bladder tumor (TURBT) is the basic endoscopic procedure for&#xD;
      management of bladder cancer and if there are no contraindications, it is performed under&#xD;
      spinal anesthesia. The condition usually occurs among elderly patients, every 9 of 10 is&#xD;
      older than 55 years. At this age the postoperative cognitive dysfunction (POCD) is a common&#xD;
      complication as the risk increases with age. There are some studies indicating that using&#xD;
      benzodiazepines during the perioperative period can also increase the number of registered&#xD;
      POCD in patients undergoing anesthesia. Postoperative cognitive dysfunction (POCD) occurs&#xD;
      after operations under regional and general anesthesia as well. The study was planed to&#xD;
      evaluate the risk of POCD among urological patients and to asses whether combining&#xD;
      benzodiazepines with opioids for premedication increases this risk.&#xD;
&#xD;
      The participants after giving the informed consent can participate in the study. The Beck&#xD;
      Depression Inventory is performed to rule out the patients with depression. The cognitive&#xD;
      functions are tested with Montreal Cognitive Assessment before the surgery and subsequently&#xD;
      in the first 24 hours after surgery, three weeks later (while patients come back to receive&#xD;
      histopathological examination), and finally six months after surgery (during control&#xD;
      cystoscopy).&#xD;
&#xD;
      During anesthesia, the patients will be randomly allocated to receive premedication either&#xD;
      with opioid solely or with benzodiazepine combined with opioid. The anesthetic technique is&#xD;
      standardized. If the premedication is needed before the surgery the hydroxyzine will be&#xD;
      administrated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Anticipated">June 30, 2018</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2017</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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>the participant is not performed about the type of premedication performed</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>postoperative cognitive disfunction</measure>
    <time_frame>6 months</time_frame>
    <description>evaluated by Montreal Cognitive Assesment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the influence of benzodiazepines on POCD</measure>
    <time_frame>6 months</time_frame>
    <description>evaluated by Montreal Cognitive Assesment</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Bladder Tumor</condition>
  <condition>Postoperative Cognitive Dysfunction</condition>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>spinal anesthesia premedication with benzodiazepine and opioid</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group K</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>spinal anesthesia premedication with opioid</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>benzodiazepines</intervention_name>
    <description>sedative</description>
    <arm_group_label>Group B</arm_group_label>
    <other_name>midazolam</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>opioid</intervention_name>
    <description>analgetic, sedative</description>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_label>Group K</arm_group_label>
    <other_name>fentanyl</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>spinal anesthesia</intervention_name>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_label>Group K</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  informed consent&#xD;
&#xD;
          -  transurethral resection of the bladder tumor&#xD;
&#xD;
          -  spinal anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients' refusal&#xD;
&#xD;
          -  contraindications for spinal anesthesia&#xD;
&#xD;
          -  skin lesions at injection site&#xD;
&#xD;
          -  depression&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>I Department of Anaesthesiology and Intensive Care, Medical University of Warsaw</name>
      <address>
        <city>Warsaw</city>
        <zip>02-005</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Karolina Dobronska, MD</last_name>
      <phone>+48 22 501 17 27</phone>
      <email>karolinapladzyk@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Lidia I Jureczko, PhD MD</last_name>
      <phone>+48 22 501 17 27</phone>
      <email>jureczko@gmail.com</email>
    </contact_backup>
    <investigator>
      <last_name>Karolina Dobronska, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Lidia I Jureczko, PhD MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 20, 2017</study_first_submitted>
  <study_first_submitted_qc>January 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 24, 2017</study_first_posted>
  <last_update_submitted>January 20, 2017</last_update_submitted>
  <last_update_submitted_qc>January 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Warsaw</investigator_affiliation>
    <investigator_full_name>Karolina Dobrońska</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>spinal anesthesia, TURBT, POCD, premedication</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Bladder Neoplasms</mesh_term>
    <mesh_term>Postoperative Cognitive Complications</mesh_term>
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fentanyl</mesh_term>
    <mesh_term>Midazolam</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03029676
org study id: U/1/2017
nct id: NCT03029676
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates the influence of premedication on cognitive functions in patients
      undergoing transurethral resection of bladder tumor under spinal anesthesia. The aims of
      premedication are anxiolysis, analgesia and the reduction of perioperative risk among the
      patients with comorbidities. The patients will be randomly allocated to receive premedication
      either with opioid solely or with benzodiazepine combined with opioid. The anesthetic
      technique is standardized.
Trans-urethral resection of bladder tumor (TURBT) is the basic endoscopic procedure for
      management of bladder cancer and if there are no contraindications, it is performed under
      spinal anesthesia. The condition usually occurs among elderly patients, every 9 of 10 is
      older than 55 years. At this age the postoperative cognitive dysfunction (POCD) is a common
      complication as the risk increases with age. There are some studies indicating that using
      benzodiazepines during the perioperative period can also increase the number of registered
      POCD in patients undergoing anesthesia. Postoperative cognitive dysfunction (POCD) occurs
      after operations under regional and general anesthesia as well. The study was planed to
      evaluate the risk of POCD among urological patients and to asses whether combining
      benzodiazepines with opioids for premedication increases this risk.

      The participants after giving the informed consent can participate in the study. The Beck
      Depression Inventory is performed to rule out the patients with depression. The cognitive
      functions are tested with Montreal Cognitive Assessment before the surgery and subsequently
      in the first 24 hours after surgery, three weeks later (while patients come back to receive
      histopathological examination), and finally six months after surgery (during control
      cystoscopy).

      During anesthesia, the patients will be randomly allocated to receive premedication either
      with opioid solely or with benzodiazepine combined with opioid. The anesthetic technique is
      standardized. If the premedication is needed before the surgery the hydroxyzine will be
      administrated.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
masking description: the participant is not performed about the type of premedication performed
measure: postoperative cognitive disfunction
time frame: 6 months
description: evaluated by Montreal Cognitive Assesment
measure: the influence of benzodiazepines on POCD
time frame: 6 months
description: evaluated by Montreal Cognitive Assesment
arm group label: Group B
arm group type: Experimental
description: spinal anesthesia premedication with benzodiazepine and opioid
arm group label: Group K
arm group type: Active Comparator
description: spinal anesthesia premedication with opioid
intervention type: Drug
intervention name: benzodiazepines
description: sedative
arm group label: Group B
other name: midazolam
intervention type: Drug
intervention name: opioid
description: analgetic, sedative
arm group label: Group B
arm group label: Group K
other name: fentanyl
intervention type: Procedure
intervention name: spinal anesthesia
arm group label: Group B
arm group label: Group K
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: Poland
responsible party type: Principal Investigator
investigator affiliation: Medical University of Warsaw
investigator full name: Karolina Dobrońska
investigator title: MD
mesh term: Urinary Bladder Neoplasms
mesh term: Postoperative Cognitive Complications
mesh term: Cognitive Dysfunction
mesh term: Fentanyl
mesh term: Midazolam
sharing ipd: No