<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/NCT03251651</url>
  </required_header>
  <id_info>
    <org_study_id>B-1704/391-304</org_study_id>
    <nct_id>NCT03251651</nct_id>
  </id_info>
  <brief_title>Intraoperative Sedatives and Postoperative Deilirium</brief_title>
  <official_title>The Incidence of Postoperative Delirium According to the Different Intraoperative Sedatives, Dexmedetomidine vs. Propofol, in Elderly Patients Undergoing Orthopedic Lower Limb Surgery With Spinal Anesthesia: A Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Bundang Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Bundang Hospital</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>
      Delirium occurs commonly in elderly patients. Its incidence after orthopedic surgery has been&#xD;
      reported to be 5-61%. Delirium is classified into three sub-types: Hypoactive, hyperactive,&#xD;
      and mixed. Although hyperactive delirium is not as common as hypoactive delirium, the&#xD;
      abnormal behavior pattern of hyperactive delirium, such as agitation, confusion, or&#xD;
      aggressiveness, is considered to be harmful to patients and medical personnel. Thus, it is&#xD;
      important to promptly manage such behaviors associated with hyperactive delirium.&#xD;
      Intraoperative sedation plays an important role in relieving anxiety or stress response of&#xD;
      patients. Propofol-a common sedative agent-was reported to cause delirium more frequently,&#xD;
      compared with dexmedetomidine, in post-cardiac surgery patients or mechanically-ventilated&#xD;
      patients in the intensive care unit (ICU). In addition to the benefits of reducing opioid&#xD;
      consumption and postoperative nausea/vomiting, dexmedetomidine is most often used for ICU&#xD;
      sedation or procedural sedation. However, there has not been any prospective randomized study&#xD;
      investigating how intraoperative dexmedetomidine sedation during regional anesthesia affects&#xD;
      postoperative consciousness, perception, memory, behavior, emotion, and so on. In this study,&#xD;
      based on the hypothesis that intraoperative dexmedetomidine sedation may reduce the incidence&#xD;
      of abnormal psycho-motor behavior compared with propofol sedation, investigators&#xD;
      prospectively will investigate the incidence of postoperative delirium in elderly patients&#xD;
      who undergo orthopedic surgery with regional anesthesia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 15, 2017</start_date>
  <completion_date type="Actual">October 15, 2021</completion_date>
  <primary_completion_date type="Actual">October 15, 2021</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>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative delirium</measure>
    <time_frame>Within 3 day postoperatively</time_frame>
    <description>The incidence of postoperative delirium</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Numerical rating scale</measure>
    <time_frame>Postoperative 24 hour</time_frame>
    <description>Postoperative pain score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Numerical rating scale</measure>
    <time_frame>Postoperative 48 hour</time_frame>
    <description>Postoperative pain score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Numerical rating scale</measure>
    <time_frame>Postoperative 72 hour</time_frame>
    <description>Postoperative pain score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient controlled analgesia (PCA)</measure>
    <time_frame>Postoperative 24 hour</time_frame>
    <description>Amounts of the PCA consumption</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient controlled analgesia (PCA)</measure>
    <time_frame>Postoperative 48 hour</time_frame>
    <description>Amounts of the PCA consumption</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient controlled analgesia (PCA)</measure>
    <time_frame>Postoperative 72 hour</time_frame>
    <description>Amounts of the PCA consumption</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rescue analgesics</measure>
    <time_frame>Postoperative 24 hour</time_frame>
    <description>Amounts of the analgesics administered to manage the postoperative pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rescue analgesics</measure>
    <time_frame>postoperative 48 hour</time_frame>
    <description>Amounts of the analgesics administered to manage the postoperative pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rescue analgesics</measure>
    <time_frame>Postoperative 72 hour</time_frame>
    <description>Amounts of the analgesics administered to manage the postoperative pain</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">748</enrollment>
  <condition>Lower Extremity Problem</condition>
  <condition>Delirium</condition>
  <condition>Propofol</condition>
  <condition>Dexmedetomidine</condition>
  <arm_group>
    <arm_group_label>PPF</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient who received propofol during the operation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DEX</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient who received dexmedetomidine during the operation</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Propofol</intervention_name>
    <description>Propofol is infused continuously via the target-controlled infusion device (Orchestra®, Fresenius vial, Brezins, France), and the effect-site concentration is maintained within 0.5-2.0 μg/ml.</description>
    <arm_group_label>PPF</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexmedetomidine</intervention_name>
    <description>Dexmedetomidine is diluted with 0.9% saline to make a concentration of 4 μg/ml. As a loading dose, 1 μg/kg dexmedetomidine is administered over a 10-min period, which is then administered continuously at 0.1-0.5 μg/kg/h.</description>
    <arm_group_label>DEX</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who undergo orthopedic surgery under spinal anesthesia&#xD;
&#xD;
          -  Patients who want to sedation during the surgery&#xD;
&#xD;
          -  Age of 65 years or greater&#xD;
&#xD;
          -  American Society of Anesthesiologists physical status classification 1 and 2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  General anesthesia&#xD;
&#xD;
          -  Age &lt; 65 years&#xD;
&#xD;
          -  Patients who do not want to sedation during the surgery&#xD;
&#xD;
          -  Patients who do not receive patient controlled analgesia postoperatively.&#xD;
&#xD;
          -  Cognitive disorders&#xD;
&#xD;
          -  Central nervous system disease, including dementia and Parkinson's disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hyo-Seok Na, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Bundang Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam-si</city>
        <state>Gyeonggi-do</state>
        <zip>13620</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <last_update_submitted>July 7, 2022</last_update_submitted>
  <last_update_submitted_qc>July 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Bundang Hospital</investigator_affiliation>
    <investigator_full_name>Hyo-Seok Na</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Delirium</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexmedetomidine</mesh_term>
    <mesh_term>Propofol</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/NCT03251651
org study id: B-1704/391-304
nct id: NCT03251651
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Delirium occurs commonly in elderly patients. Its incidence after orthopedic surgery has been
      reported to be 5-61%. Delirium is classified into three sub-types: Hypoactive, hyperactive,
      and mixed. Although hyperactive delirium is not as common as hypoactive delirium, the
      abnormal behavior pattern of hyperactive delirium, such as agitation, confusion, or
      aggressiveness, is considered to be harmful to patients and medical personnel. Thus, it is
      important to promptly manage such behaviors associated with hyperactive delirium.
      Intraoperative sedation plays an important role in relieving anxiety or stress response of
      patients. Propofol-a common sedative agent-was reported to cause delirium more frequently,
      compared with dexmedetomidine, in post-cardiac surgery patients or mechanically-ventilated
      patients in the intensive care unit (ICU). In addition to the benefits of reducing opioid
      consumption and postoperative nausea/vomiting, dexmedetomidine is most often used for ICU
      sedation or procedural sedation. However, there has not been any prospective randomized study
      investigating how intraoperative dexmedetomidine sedation during regional anesthesia affects
      postoperative consciousness, perception, memory, behavior, emotion, and so on. In this study,
      based on the hypothesis that intraoperative dexmedetomidine sedation may reduce the incidence
      of abnormal psycho-motor behavior compared with propofol sedation, investigators
      prospectively will investigate the incidence of postoperative delirium in elderly patients
      who undergo orthopedic surgery with regional anesthesia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Postoperative delirium
time frame: Within 3 day postoperatively
description: The incidence of postoperative delirium
measure: Numerical rating scale
time frame: Postoperative 24 hour
description: Postoperative pain score
measure: Numerical rating scale
time frame: Postoperative 48 hour
description: Postoperative pain score
measure: Numerical rating scale
time frame: Postoperative 72 hour
description: Postoperative pain score
measure: Patient controlled analgesia (PCA)
time frame: Postoperative 24 hour
description: Amounts of the PCA consumption
measure: Patient controlled analgesia (PCA)
time frame: Postoperative 48 hour
description: Amounts of the PCA consumption
measure: Patient controlled analgesia (PCA)
time frame: Postoperative 72 hour
description: Amounts of the PCA consumption
measure: Rescue analgesics
time frame: Postoperative 24 hour
description: Amounts of the analgesics administered to manage the postoperative pain
measure: Rescue analgesics
time frame: postoperative 48 hour
description: Amounts of the analgesics administered to manage the postoperative pain
measure: Rescue analgesics
time frame: Postoperative 72 hour
description: Amounts of the analgesics administered to manage the postoperative pain
arm group label: PPF
arm group type: Experimental
description: Patient who received propofol during the operation
arm group label: DEX
arm group type: Experimental
description: Patient who received dexmedetomidine during the operation
intervention type: Drug
intervention name: Propofol
description: Propofol is infused continuously via the target-controlled infusion device (Orchestra®, Fresenius vial, Brezins, France), and the effect-site concentration is maintained within 0.5-2.0 μg/ml.
arm group label: PPF
intervention type: Drug
intervention name: Dexmedetomidine
description: Dexmedetomidine is diluted with 0.9% saline to make a concentration of 4 μg/ml. As a loading dose, 1 μg/kg dexmedetomidine is administered over a 10-min period, which is then administered continuously at 0.1-0.5 μg/kg/h.
arm group label: DEX
criteria: 
gender: All
minimum age: 65 Years
maximum age: 90 Years
healthy volunteers: No
last name: Hyo-Seok Na, MD, PhD
role: Principal Investigator
affiliation: Seoul National University Bundang Hospital
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Bundang Hospital
investigator full name: Hyo-Seok Na
investigator title: Associate Professor
mesh term: Delirium
mesh term: Dexmedetomidine
mesh term: Propofol
sharing ipd: No