<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/NCT04494828</url>
  </required_header>
  <id_info>
    <org_study_id>KY2019-091-02A</org_study_id>
    <nct_id>NCT04494828</nct_id>
  </id_info>
  <brief_title>Impact Dexmedetomidine on Postoperative Delirium in Patients After Intracranial Operation for Brain Tumor</brief_title>
  <official_title>Impact of Prophylactic Use of Dexmedetomidine on Postoperative Delirium in Patients After Intracranial Operation for Brain Tumor: a Pilot Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Capital Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Capital Medical University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Postoperative delirium is one of the most common serious complications after major surgery&#xD;
      and is associated with undesirable consequences. Prevention of postoperative delirium is&#xD;
      recommended in the clinical guidelines and consensus statements. Dexmedetomidine, a highly&#xD;
      selective α2-adrenergic receptor agonist, has been investigated as a pharmacological&#xD;
      intervention to prevent postoperative delirium. Several randomized controlled trials have&#xD;
      shown that prophylactic use of low-dose dexmedetomidine may decrease the incidence of&#xD;
      postoperative delirium in patients after cardiac and non-cardiac operations. However,&#xD;
      neurosurgical patients are often excluded from previous studies due to potential&#xD;
      consciousness and cognition impairment. The investigators design this pilot study aiming to&#xD;
      clarify the feasibility and safety of use of low-dose dexmedetomidine for prevention of&#xD;
      postoperative delirium in patients after intracranial operation for brain tumor.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Postoperative delirium is one of the most common serious complications after major surgery&#xD;
      and is associated with undesirable consequences. Prevention of postoperative delirium is&#xD;
      recommended in the clinical guidelines and consensus statements. Dexmedetomidine, a highly&#xD;
      selective α2-adrenergic receptor agonist, has been investigated as a pharmacological&#xD;
      intervention to prevent postoperative delirium. Several randomized controlled trials have&#xD;
      shown that prophylactic use of low-dose dexmedetomidine (0.1 ug/kg/hour without loading&#xD;
      infusion) may decrease the incidence of postoperative delirium in patients after cardiac and&#xD;
      non-cardiac operations. However, neurosurgical patients are often excluded from previous&#xD;
      studies due to potential consciousness and cognition impairment. The investigators design&#xD;
      this pilot randomized controlled trial aiming to clarify the feasibility and safety of use of&#xD;
      low-dose dexmedetomidine for prevention of postoperative delirium in patients after&#xD;
      intracranial operation for brain tumor.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 10, 2020</start_date>
  <completion_date type="Actual">December 21, 2020</completion_date>
  <primary_completion_date type="Actual">December 12, 2020</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of study agent interruption during the study</measure>
    <time_frame>From the start of study agent infusion to postoperative day 1</time_frame>
    <description>Predicted adverse events in the present study included bradycardia (defined as heart rate lower than 50 beats/min), hypotension (defined as systolic blood pressure lower than 90 mmHg), tachycardia (defined as heart rate greater than 100 beats/min), hypertension (defined as systolic blood pressure greater than 160 mmHg) and hypoxemia (defined as pulse oxygen saturation lower than 90%). The treatment of adverse events was determined by the responsible attending ICU physicians, who could stop the study agent infusion when the treatment failure or other conditions deemed necessary.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time from the end of operation to randomization</measure>
    <time_frame>From the end of operation until the randomization, assessed up to 24 hours</time_frame>
    <description>Time from the end of operation to randomization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of study agent infusion</measure>
    <time_frame>From the start of study agent infusion to postoperative day 1</time_frame>
    <description>Duration of study agent infusion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events from the start of study agent infusion until 24 hours or until ICU discharge</measure>
    <time_frame>From the start of study agent infusion to postoperative day 1</time_frame>
    <description>Include bradycardia (defined as heart rate lower than 55 beats/min), hypotension (defined as systolic blood pressure lower than 90 mmHg), and hypoxemia (defined as pulse oxygen saturation lower than 90%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Non-delirium complications</measure>
    <time_frame>From the start of study agent infusion to postoperative day 28</time_frame>
    <description>Include airway obstruction and apnea, respiratory failure, cardiac events, coma, epilepsy, cerebral hemorrhage or infarction, renal injury and infection</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Central Nervous System Diseases</condition>
  <arm_group>
    <arm_group_label>Dexmedetomidine group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Continuously intravenous infusion of dexmedetomidine hydrochloride at a rate of 0.1 μg/ kg/hour (0.025 ml/kg/hour) started immediately after enrollment until 08:00 AM on the postoperative day one.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal saline group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Continuously intravenous infusion of normal saline at a rate of 0.025 ml/kg/hour started immediately after enrollment until 08:00 AM on the postoperative day one.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexmedetomidine</intervention_name>
    <description>Dexmedetomidine hydrochloride (200 μg/2 ml) is diluted with normal saline to 50 ml and is continuously intravenous infused at a rate of 0.025 ml/kg/hour (dexmedetomidine 0.1 μg/kg/hour). The intravenous infusion begins immediately after enrollment until 08:00 AM on the postoperative day one.</description>
    <arm_group_label>Dexmedetomidine group</arm_group_label>
    <other_name>Dexmedetomidine hydrochloride</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal saline group</intervention_name>
    <description>Normal saline is also diluted with normal saline to 50 ml and is continuously intravenous infused at a rate of 0.025 ml/kg/hour, which is the same with the dexmedetomidine group. The intravenous infusion begins immediately after enrollment until 08:00 AM on the postoperative day one.</description>
    <arm_group_label>Normal saline group</arm_group_label>
    <other_name>0.9% Sodium Chloride</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients after elective intracranial operation for brain tumor under general&#xD;
             anesthesia and who are admitted to the ICU directly from the operating room or&#xD;
             postoperative care unit.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age under 18 years;&#xD;
&#xD;
          -  admitted to the ICU after 22:00 PM;&#xD;
&#xD;
          -  medical records documented preoperative history of mental or cognitive disorders&#xD;
             including schizophrenia, epilepsy, Parkinsonism, or dementia;&#xD;
&#xD;
          -  medical records documented inability to communicate in the preoperative period due to&#xD;
             coma or language barrier;&#xD;
&#xD;
          -  history of drug abuse of psychoactive and anesthetic drugs;&#xD;
&#xD;
          -  known preoperative severe bradycardia (lower than 50 beats/min), sick sinus syndrome,&#xD;
             second- or third-degree atrioventricular block, or left ventricular ejection fraction&#xD;
             lower than 30%;&#xD;
&#xD;
          -  serious hepatic dysfunction defined as Child-Pugh class C;&#xD;
&#xD;
          -  severe renal dysfunction requiring renal replacement therapy before the surgery;&#xD;
&#xD;
          -  allergies to ingredients or components of dexmedetomidine hydrochloride;&#xD;
&#xD;
          -  American Society of Anesthesiologists classification of IV to VI;&#xD;
&#xD;
          -  moribund condition with low likelihood of survival for more than 24 hours;&#xD;
&#xD;
          -  pregnancy or lactation women;&#xD;
&#xD;
          -  current enrollment in another clinical trial;&#xD;
&#xD;
          -  refusal to participate.&#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>Jian-Xin Zhou, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Capital Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>ICU, Beijing Tiantan Hospital, Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100050</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2020</study_first_posted>
  <last_update_submitted>January 10, 2021</last_update_submitted>
  <last_update_submitted_qc>January 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Capital Medical University</investigator_affiliation>
    <investigator_full_name>Jian-Xin Zhou</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>delirium</keyword>
  <keyword>postoperative</keyword>
  <keyword>dexmedetomidine</keyword>
  <keyword>intracranial operation</keyword>
  <keyword>prevention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Delirium</mesh_term>
    <mesh_term>Nervous System Diseases</mesh_term>
    <mesh_term>Emergence Delirium</mesh_term>
    <mesh_term>Central Nervous System Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexmedetomidine</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/NCT04494828
org study id: KY2019-091-02A
nct id: NCT04494828
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Postoperative delirium is one of the most common serious complications after major surgery
      and is associated with undesirable consequences. Prevention of postoperative delirium is
      recommended in the clinical guidelines and consensus statements. Dexmedetomidine, a highly
      selective α2-adrenergic receptor agonist, has been investigated as a pharmacological
      intervention to prevent postoperative delirium. Several randomized controlled trials have
      shown that prophylactic use of low-dose dexmedetomidine may decrease the incidence of
      postoperative delirium in patients after cardiac and non-cardiac operations. However,
      neurosurgical patients are often excluded from previous studies due to potential
      consciousness and cognition impairment. The investigators design this pilot study aiming to
      clarify the feasibility and safety of use of low-dose dexmedetomidine for prevention of
      postoperative delirium in patients after intracranial operation for brain tumor.
Postoperative delirium is one of the most common serious complications after major surgery
      and is associated with undesirable consequences. Prevention of postoperative delirium is
      recommended in the clinical guidelines and consensus statements. Dexmedetomidine, a highly
      selective α2-adrenergic receptor agonist, has been investigated as a pharmacological
      intervention to prevent postoperative delirium. Several randomized controlled trials have
      shown that prophylactic use of low-dose dexmedetomidine (0.1 ug/kg/hour without loading
      infusion) may decrease the incidence of postoperative delirium in patients after cardiac and
      non-cardiac operations. However, neurosurgical patients are often excluded from previous
      studies due to potential consciousness and cognition impairment. The investigators design
      this pilot randomized controlled trial aiming to clarify the feasibility and safety of use of
      low-dose dexmedetomidine for prevention of postoperative delirium in patients after
      intracranial operation for brain tumor.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Incidence of study agent interruption during the study
time frame: From the start of study agent infusion to postoperative day 1
description: Predicted adverse events in the present study included bradycardia (defined as heart rate lower than 50 beats/min), hypotension (defined as systolic blood pressure lower than 90 mmHg), tachycardia (defined as heart rate greater than 100 beats/min), hypertension (defined as systolic blood pressure greater than 160 mmHg) and hypoxemia (defined as pulse oxygen saturation lower than 90%). The treatment of adverse events was determined by the responsible attending ICU physicians, who could stop the study agent infusion when the treatment failure or other conditions deemed necessary.
measure: Time from the end of operation to randomization
time frame: From the end of operation until the randomization, assessed up to 24 hours
description: Time from the end of operation to randomization
measure: Duration of study agent infusion
time frame: From the start of study agent infusion to postoperative day 1
description: Duration of study agent infusion
measure: Incidence of adverse events from the start of study agent infusion until 24 hours or until ICU discharge
time frame: From the start of study agent infusion to postoperative day 1
description: Include bradycardia (defined as heart rate lower than 55 beats/min), hypotension (defined as systolic blood pressure lower than 90 mmHg), and hypoxemia (defined as pulse oxygen saturation lower than 90%)
measure: Non-delirium complications
time frame: From the start of study agent infusion to postoperative day 28
description: Include airway obstruction and apnea, respiratory failure, cardiac events, coma, epilepsy, cerebral hemorrhage or infarction, renal injury and infection
arm group label: Dexmedetomidine group
arm group type: Experimental
description: Continuously intravenous infusion of dexmedetomidine hydrochloride at a rate of 0.1 μg/ kg/hour (0.025 ml/kg/hour) started immediately after enrollment until 08:00 AM on the postoperative day one.
arm group label: Normal saline group
arm group type: Placebo Comparator
description: Continuously intravenous infusion of normal saline at a rate of 0.025 ml/kg/hour started immediately after enrollment until 08:00 AM on the postoperative day one.
intervention type: Drug
intervention name: Dexmedetomidine
description: Dexmedetomidine hydrochloride (200 μg/2 ml) is diluted with normal saline to 50 ml and is continuously intravenous infused at a rate of 0.025 ml/kg/hour (dexmedetomidine 0.1 μg/kg/hour). The intravenous infusion begins immediately after enrollment until 08:00 AM on the postoperative day one.
arm group label: Dexmedetomidine group
other name: Dexmedetomidine hydrochloride
intervention type: Drug
intervention name: Normal saline group
description: Normal saline is also diluted with normal saline to 50 ml and is continuously intravenous infused at a rate of 0.025 ml/kg/hour, which is the same with the dexmedetomidine group. The intravenous infusion begins immediately after enrollment until 08:00 AM on the postoperative day one.
arm group label: Normal saline group
other name: 0.9% Sodium Chloride
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jian-Xin Zhou, MD
role: Study Chair
affiliation: Capital Medical University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Capital Medical University
investigator full name: Jian-Xin Zhou
investigator title: Professor
mesh term: Delirium
mesh term: Nervous System Diseases
mesh term: Emergence Delirium
mesh term: Central Nervous System Diseases
mesh term: Dexmedetomidine
sharing ipd: No