<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/NCT02224443</url>
  </required_header>
  <id_info>
    <org_study_id>Ma sedation</org_study_id>
    <nct_id>NCT02224443</nct_id>
  </id_info>
  <brief_title>Effects of Different Doses of Dexmedetomidine on Postoperative Cognitive Dysfunction in Elderly Hypertensive Patients</brief_title>
  <official_title>Effects of Different Doses of Dexmedetomidine on Postoperative Cognitive Dysfunction in Elderly Hypertensive Patients-A Single Center,Randomized, Double-blinded,Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>First Affiliated Hospital Xi'an Jiaotong University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>First Affiliated Hospital Xi'an Jiaotong University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to identify the effects of different doses of dexmedetomidine on&#xD;
      postoperative cognitive dysfunction in elderly hypertensive patients&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">September 2015</completion_date>
  <primary_completion_date type="Anticipated">August 2015</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline to postoperation in cognitive function</measure>
    <time_frame>One day before operation,third day after operation,sixth day after operaion</time_frame>
    <description>Mini-mental State Examination</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline to postoperation in recent memory</measure>
    <time_frame>One day before operation,third day after operation,sixth day after operation</time_frame>
    <description>Rey Auditory Verbal Learning Test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline to postoperation in visual space and directional force</measure>
    <time_frame>One day before operation,third day after operation,sixth day after operaion</time_frame>
    <description>Trail Making Test A,Trail Making Test B</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline to postoperation in attention</measure>
    <time_frame>One day before operation,third day after operation,sixth day after operaion</time_frame>
    <description>Digit Span Test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline to postoperation in pain scores</measure>
    <time_frame>One day before operation,third day after operation,sixth day after operation</time_frame>
    <description>Visual analog scales</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline to postoperation in depression scale</measure>
    <time_frame>One day before operation,third day after operation,sixth day after operation</time_frame>
    <description>Beck Depression Inventory</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The duration of operation</measure>
    <time_frame>From begining of cutting skin to the end of skin closure,an expected average of 3 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The blood volume during the operation</measure>
    <time_frame>From begining of cutting skin to the end of skin closure,an expected average of 3 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The urine volume during operation</measure>
    <time_frame>From begining of cutting skin to the end of skin closure,an expected average of 3 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The dose of drugs used during operation</measure>
    <time_frame>From begining of cutting skin to the end of skin closure,an expected average of 3 hours</time_frame>
    <description>The dose of ephedrine, urapidil, atropine used during operation</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Postoperative Cognitive Dysfunction</condition>
  <arm_group>
    <arm_group_label>Group A, dexmedetomidine , 0.3µg.kg-1.h-1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Continuous pump infusion dexmedetomidine with loading dose at 0.8µg.kg-1 over 10 minutes,followed Continuous pump infusion dexmedetomidine at 0.3µg.kg-1.h-1 until 30 minutes before end of operation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B,dexmedetomidine , 0.5µg.kg-1.h-1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Continuous pump infusion dexmedetomidine with loading dose at 0.8µg.kg-1 over 10 minutes,followed continuous pump infusion dexmedetomidine at 0.5µg.kg-1.h-1 until 30 minutes before end of operation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group C ,normal saline</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Normal saline infusion will be given with the same infusion volume as group A and B</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>dexmedetomidine</intervention_name>
    <description>Experimental: Group A, Continuous pump infusion dexmedetomidine with loading dose at 0.8µg.kg-1 over 10 minutes,followed continuous pump infusion dexmedetomidine at 0.3µg.kg-1.h-1 until 30 minutes before end of operation</description>
    <arm_group_label>Group A, dexmedetomidine , 0.3µg.kg-1.h-1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>dexmedetomidine</intervention_name>
    <description>Group B, Continuous pump infusion dexmedetomidine with loading dose at 0.8µg.kg-1 over 10 minutes,followed continuous pump infusion dexmedetomidine at 0.5µg.kg-1.h-1 until 30 minutes before end of operation</description>
    <arm_group_label>Group B,dexmedetomidine , 0.5µg.kg-1.h-1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>normal saline</intervention_name>
    <description>Group C , Normal saline infusion will be given with the same infusion volume as group A and B</description>
    <arm_group_label>Group C ,normal saline</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>midazolam,fentanyl,etomidate,Cisatracurium besylate</intervention_name>
    <description>Anesthesia induction : 0.05 mg.kg-1 midazolam,4~5μg.kg-1 fentanyl,1.0~1.5mg.kg-1etomidate and 0.15 mg.kg-1Cisatracurium besylate</description>
    <arm_group_label>Group A, dexmedetomidine , 0.3µg.kg-1.h-1</arm_group_label>
    <arm_group_label>Group B,dexmedetomidine , 0.5µg.kg-1.h-1</arm_group_label>
    <arm_group_label>Group C ,normal saline</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>cisatracurium besylate,propofol,remifentanil,sevoflurane</intervention_name>
    <description>Maintenance of anesthesia :Continuous pump infusion 0.05~0.1mg.kg-1.h-1cisatracurium besylate,4~8mg.kg-1.h-1propofol,0.1~0.2μg.kg-1.min-1 remifentanil and sevoflurane inhalation with 0.6%~1.0%</description>
    <arm_group_label>Group A, dexmedetomidine , 0.3µg.kg-1.h-1</arm_group_label>
    <arm_group_label>Group B,dexmedetomidine , 0.5µg.kg-1.h-1</arm_group_label>
    <arm_group_label>Group C ,normal saline</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
          -  Elective gastrointestinal surgery&#xD;
&#xD;
          -  American Society of Anesthesiologists class II to III&#xD;
&#xD;
          -  Aged between 65 and 80 years old&#xD;
&#xD;
          -  Weight between 45 and 75 kilogram,Body Mass Index between 19 and 24 kg.m-2&#xD;
&#xD;
          -  With primary hypertension reaching or more than 1 year&#xD;
&#xD;
          -  Normal cognitive function,mini-mental state examination more than 27&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe arrhythmia,atrioventricular block and secondary hypertension&#xD;
&#xD;
          -  Liver and kidney dysfunction,pulmonary disease,endocrine disease&#xD;
&#xD;
          -  Suspected or confirmed difficult airway&#xD;
&#xD;
          -  Any disease or pathologic change will interfere study result&#xD;
&#xD;
          -  Inability to exchange with serious visual and hearing impairment&#xD;
&#xD;
          -  Long term use of sedative-hypnotic drugs and antidepressant drug&#xD;
&#xD;
          -  Addicted to alcohol, tobacco or drug&#xD;
&#xD;
          -  Neuromuscular disease&#xD;
&#xD;
          -  Suspected of malignant hyperthermia&#xD;
&#xD;
          -  Allergic to investigational products or with other contraindication&#xD;
&#xD;
          -  Participated in other study within 30 days&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 21, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 25, 2014</study_first_posted>
  <last_update_submitted>August 21, 2014</last_update_submitted>
  <last_update_submitted_qc>August 21, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 25, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>First Affiliated Hospital Xi'an Jiaotong University</investigator_affiliation>
    <investigator_full_name>Ma Zhengmin</investigator_full_name>
    <investigator_title>Anaesthetist</investigator_title>
  </responsible_party>
  <keyword>Dexmedetomidine,postoperative cognitive dysfunction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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>
    <mesh_term>Dexmedetomidine</mesh_term>
    <mesh_term>Remifentanil</mesh_term>
    <mesh_term>Propofol</mesh_term>
    <mesh_term>Etomidate</mesh_term>
    <mesh_term>Sevoflurane</mesh_term>
    <mesh_term>Atracurium</mesh_term>
    <mesh_term>Cisatracurium</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/NCT02224443
org study id: Ma sedation
nct id: NCT02224443
lead sponsor: 
has dmc: Yes
The purpose of this study is to identify the effects of different doses of dexmedetomidine on
      postoperative cognitive dysfunction in elderly hypertensive patients
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change from baseline to postoperation in cognitive function
time frame: One day before operation,third day after operation,sixth day after operaion
description: Mini-mental State Examination
measure: Change from baseline to postoperation in recent memory
time frame: One day before operation,third day after operation,sixth day after operation
description: Rey Auditory Verbal Learning Test
measure: Change from baseline to postoperation in visual space and directional force
time frame: One day before operation,third day after operation,sixth day after operaion
description: Trail Making Test A,Trail Making Test B
measure: Change from baseline to postoperation in attention
time frame: One day before operation,third day after operation,sixth day after operaion
description: Digit Span Test
measure: Change from baseline to postoperation in pain scores
time frame: One day before operation,third day after operation,sixth day after operation
description: Visual analog scales
measure: Change from baseline to postoperation in depression scale
time frame: One day before operation,third day after operation,sixth day after operation
description: Beck Depression Inventory
measure: The duration of operation
time frame: From begining of cutting skin to the end of skin closure,an expected average of 3 hours
measure: The blood volume during the operation
time frame: From begining of cutting skin to the end of skin closure,an expected average of 3 hours
measure: The urine volume during operation
time frame: From begining of cutting skin to the end of skin closure,an expected average of 3 hours
measure: The dose of drugs used during operation
time frame: From begining of cutting skin to the end of skin closure,an expected average of 3 hours
description: The dose of ephedrine, urapidil, atropine used during operation
arm group label: Group A, dexmedetomidine , 0.3µg.kg-1.h-1
arm group type: Experimental
description: Continuous pump infusion dexmedetomidine with loading dose at 0.8µg.kg-1 over 10 minutes,followed Continuous pump infusion dexmedetomidine at 0.3µg.kg-1.h-1 until 30 minutes before end of operation
arm group label: Group B,dexmedetomidine , 0.5µg.kg-1.h-1
arm group type: Experimental
description: Continuous pump infusion dexmedetomidine with loading dose at 0.8µg.kg-1 over 10 minutes,followed continuous pump infusion dexmedetomidine at 0.5µg.kg-1.h-1 until 30 minutes before end of operation
arm group label: Group C ,normal saline
arm group type: Placebo Comparator
description: Normal saline infusion will be given with the same infusion volume as group A and B
intervention type: Drug
intervention name: dexmedetomidine
description: Experimental: Group A, Continuous pump infusion dexmedetomidine with loading dose at 0.8µg.kg-1 over 10 minutes,followed continuous pump infusion dexmedetomidine at 0.3µg.kg-1.h-1 until 30 minutes before end of operation
arm group label: Group A, dexmedetomidine , 0.3µg.kg-1.h-1
intervention type: Drug
intervention name: dexmedetomidine
description: Group B, Continuous pump infusion dexmedetomidine with loading dose at 0.8µg.kg-1 over 10 minutes,followed continuous pump infusion dexmedetomidine at 0.5µg.kg-1.h-1 until 30 minutes before end of operation
arm group label: Group B,dexmedetomidine , 0.5µg.kg-1.h-1
intervention type: Drug
intervention name: normal saline
description: Group C , Normal saline infusion will be given with the same infusion volume as group A and B
arm group label: Group C ,normal saline
intervention type: Drug
intervention name: midazolam,fentanyl,etomidate,Cisatracurium besylate
description: Anesthesia induction : 0.05 mg.kg-1 midazolam,4~5μg.kg-1 fentanyl,1.0~1.5mg.kg-1etomidate and 0.15 mg.kg-1Cisatracurium besylate
arm group label: Group A, dexmedetomidine , 0.3µg.kg-1.h-1
arm group label: Group B,dexmedetomidine , 0.5µg.kg-1.h-1
arm group label: Group C ,normal saline
intervention type: Drug
intervention name: cisatracurium besylate,propofol,remifentanil,sevoflurane
description: Maintenance of anesthesia :Continuous pump infusion 0.05~0.1mg.kg-1.h-1cisatracurium besylate,4~8mg.kg-1.h-1propofol,0.1~0.2μg.kg-1.min-1 remifentanil and sevoflurane inhalation with 0.6%~1.0%
arm group label: Group A, dexmedetomidine , 0.3µg.kg-1.h-1
arm group label: Group B,dexmedetomidine , 0.5µg.kg-1.h-1
arm group label: Group C ,normal saline
criteria: 
gender: All
minimum age: 65 Years
maximum age: 80 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: First Affiliated Hospital Xi'an Jiaotong University
investigator full name: Ma Zhengmin
investigator title: Anaesthetist
mesh term: Postoperative Cognitive Complications
mesh term: Cognitive Dysfunction
mesh term: Fentanyl
mesh term: Midazolam
mesh term: Dexmedetomidine
mesh term: Remifentanil
mesh term: Propofol
mesh term: Etomidate
mesh term: Sevoflurane
mesh term: Atracurium
mesh term: Cisatracurium