<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/NCT01665586</url>
  </required_header>
  <id_info>
    <org_study_id>4-2011-0927</org_study_id>
    <nct_id>NCT01665586</nct_id>
  </id_info>
  <brief_title>Effective Dose of Dexmedetomidine for Sedation in Patients Undergoing TURP/TURB Under Spinal Anesthesia With or Without Fentanyl by Age Groups: Randomized Comparative Study</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Recently many studies reported that intraoperative dexmedetomidine administration undergoing&#xD;
      spinal anesthesia give a satisfactory sedation in elderly patients and cause less respiratory&#xD;
      depressions compared other sedatives(e.g. benzodiazepine) But the optimal dose of&#xD;
      dexmedetomidine for sedative effect in elderly patients undergoing spinal anesthesia was not&#xD;
      got general consensus.&#xD;
&#xD;
      The investigators hypothesized that the dose requirements would be lower than in elderly&#xD;
      patients than young patients. Furthermore, intrathecal small dose opioids enhance the&#xD;
      analgesia provided by bupivacaine due to synergistic effects and it would reduce the dose of&#xD;
      dexmedetomidine.&#xD;
&#xD;
      The purpose of this study was to determine the dose of dexmedetomidine to provide&#xD;
      satisfactory sedation undergoing spinal anesthesia with or without additive small dose&#xD;
      intrathecal opioids.&#xD;
&#xD;
      Elderly patients(65~85 years old) undergoing TURP or TURB were enrolled in this&#xD;
      single-blinded study. Forty patients were randomly assigned to receive intrathecal hyperbaric&#xD;
      bupivacaine 6mg coadministered with 20mcg fentanyl or placebo normal saline 0.4cc. After the&#xD;
      induction (bilateral T10 sensory level to pinprick within 5 mins of intrathecal drug&#xD;
      administration), continuous intravenous dexmedetomidine was started in dose of 0.8, 0.6, 0.5,&#xD;
      0.4, 0.3, or 0.2mcg. Successful sedation was defined as OASS score 3 or 4 within 20 minutes&#xD;
      of dexmedetomidine infusion. The dose of dexmedetomidine was selected for each patient&#xD;
      according to an up and down method. Intraoperative arterial pressure, heart rate, and&#xD;
      bispectral index was compared. Postoperative pain score, the time for the regression of&#xD;
      sensory and motor was recorded for further analysis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2012</start_date>
  <completion_date type="Actual">September 2013</completion_date>
  <primary_completion_date type="Actual">September 2013</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>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Observer's Assessment of Alertness/Sedation scale, OAA/S</measure>
    <time_frame>from 5 min after study drug (dexmedetomidine or placebo) adminstration to the ending point of surgery.</time_frame>
    <description>Observer's Assessment of Alertness/Sedation scale, OAA/S 5 Responds readily to name spoken in normal tone 4 Lethargic response to name spoken in normal tone 3 Responds only after name is called loudly and/or repeatedly 2 Responds only after mild prodding or shaking&#xD;
1 Responds only after painful trapezius squeeze 0 No response after painful trapezius squeeze 0 No response after painful trapezius squeeze</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">82</enrollment>
  <condition>Benign Prostate Hyperplasia</condition>
  <condition>Bladder Tumor</condition>
  <arm_group>
    <arm_group_label>Group C</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>: Spinal anesthesia with 6mg bupivacaine and intrathecal placebo(normal saline) added</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group F</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>: Spinal anesthesia with 6mg bupivacaine and intrathecal small dose of fentanyl(20micro gram)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>dexmedetomidine</intervention_name>
    <description>Spinal anesthesia regimen Group F: 6mg bupivacaine + 20mcg fentanyl (intrathecal) + o.4 cc 5% dextrose water Group C: 6mg bupivacaine + 0.4 cc normal saline + 0.4cc 5% dextrose water&#xD;
dexmedetomidine 0.2~0.8 micro gram/kg intravenous administration after the sterilization of the spinal anesthesia level, and prehydration</description>
    <arm_group_label>Group C</arm_group_label>
    <arm_group_label>Group F</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Elderly patients aged 65~85 years olds undergoing TURB or TURP.&#xD;
&#xD;
          -  No contraindication of spinal anesthesia.&#xD;
&#xD;
          -  ASA class I and II.&#xD;
&#xD;
          -  Patients consented to spinal anesthesia were enrolled.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with hypovolemia, coagulation disorders, local infection at the site of&#xD;
             operation, history of headache, heart diseases, and history of allergy, chronic&#xD;
             alcohol use or abuse, anemia, congenital heart diseases, bundle block, congestive&#xD;
             heart failure or arrythmias, and patients who had recently received sedative drugs or&#xD;
             were under antidepressant treatment were not included in the study.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Anesthesiology and Pain Medicine, and Anesthesia and Pain Research Institute</name>
      <address>
        <city>Seoul</city>
        <zip>120-752</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 31, 2012</study_first_submitted>
  <study_first_submitted_qc>August 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2012</study_first_posted>
  <last_update_submitted>July 24, 2014</last_update_submitted>
  <last_update_submitted_qc>July 24, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 28, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>dexmedetomidine</keyword>
  <keyword>sedation in elderly patient</keyword>
  <keyword>spinal anesthesia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Bladder Neoplasms</mesh_term>
    <mesh_term>Prostatic Hyperplasia</mesh_term>
    <mesh_term>Hyperplasia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexmedetomidine</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/NCT01665586
org study id: 4-2011-0927
nct id: NCT01665586
lead sponsor: 
has dmc: No
Recently many studies reported that intraoperative dexmedetomidine administration undergoing
      spinal anesthesia give a satisfactory sedation in elderly patients and cause less respiratory
      depressions compared other sedatives(e.g. benzodiazepine) But the optimal dose of
      dexmedetomidine for sedative effect in elderly patients undergoing spinal anesthesia was not
      got general consensus.

      The investigators hypothesized that the dose requirements would be lower than in elderly
      patients than young patients. Furthermore, intrathecal small dose opioids enhance the
      analgesia provided by bupivacaine due to synergistic effects and it would reduce the dose of
      dexmedetomidine.

      The purpose of this study was to determine the dose of dexmedetomidine to provide
      satisfactory sedation undergoing spinal anesthesia with or without additive small dose
      intrathecal opioids.

      Elderly patients(65~85 years old) undergoing TURP or TURB were enrolled in this
      single-blinded study. Forty patients were randomly assigned to receive intrathecal hyperbaric
      bupivacaine 6mg coadministered with 20mcg fentanyl or placebo normal saline 0.4cc. After the
      induction (bilateral T10 sensory level to pinprick within 5 mins of intrathecal drug
      administration), continuous intravenous dexmedetomidine was started in dose of 0.8, 0.6, 0.5,
      0.4, 0.3, or 0.2mcg. Successful sedation was defined as OASS score 3 or 4 within 20 minutes
      of dexmedetomidine infusion. The dose of dexmedetomidine was selected for each patient
      according to an up and down method. Intraoperative arterial pressure, heart rate, and
      bispectral index was compared. Postoperative pain score, the time for the regression of
      sensory and motor was recorded for further analysis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Participant)
measure: Observer's Assessment of Alertness/Sedation scale, OAA/S
time frame: from 5 min after study drug (dexmedetomidine or placebo) adminstration to the ending point of surgery.
description: Observer's Assessment of Alertness/Sedation scale, OAA/S 5 Responds readily to name spoken in normal tone 4 Lethargic response to name spoken in normal tone 3 Responds only after name is called loudly and/or repeatedly 2 Responds only after mild prodding or shaking
1 Responds only after painful trapezius squeeze 0 No response after painful trapezius squeeze 0 No response after painful trapezius squeeze
arm group label: Group C
arm group type: Placebo Comparator
description: : Spinal anesthesia with 6mg bupivacaine and intrathecal placebo(normal saline) added
arm group label: Group F
arm group type: Active Comparator
description: : Spinal anesthesia with 6mg bupivacaine and intrathecal small dose of fentanyl(20micro gram)
intervention type: Drug
intervention name: dexmedetomidine
description: Spinal anesthesia regimen Group F: 6mg bupivacaine + 20mcg fentanyl (intrathecal) + o.4 cc 5% dextrose water Group C: 6mg bupivacaine + 0.4 cc normal saline + 0.4cc 5% dextrose water
dexmedetomidine 0.2~0.8 micro gram/kg intravenous administration after the sterilization of the spinal anesthesia level, and prehydration
arm group label: Group C
arm group label: Group F
criteria: 
gender: Male
minimum age: 45 Years
maximum age: 85 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Urinary Bladder Neoplasms
mesh term: Prostatic Hyperplasia
mesh term: Hyperplasia
mesh term: Dexmedetomidine