<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/NCT02225210</url>
  </required_header>
  <id_info>
    <org_study_id>Shu 2014</org_study_id>
    <nct_id>NCT02225210</nct_id>
  </id_info>
  <brief_title>Effects of Dexmedetomidine Sedation on Delirium and Haemodynamic in Mechanical Ventilated Elderly Patients</brief_title>
  <official_title>Effects of Dexmedetomidine Sedation on Delirium and Haemodynamic in Mechanical Ventilated Elderly Patients -a Single Center,Randomized and Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fuling Central Hospital of Chongqing City</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fuling Central Hospital of Chongqing City</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study was designed to observe the effects of dexmedetomidine on delirium and&#xD;
      haemodynamic in mechanical ventilated elderly patients,and to evaluate the safety of&#xD;
      dexmedetomidine.&#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">July 2015</completion_date>
  <primary_completion_date type="Anticipated">June 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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in blood pressure within 48 hours after drug intervention</measure>
    <time_frame>Within 48 hours after drug intervention</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants with blood pressure decrease more than 20% of the baseline value or systolic pressure less than 100 mmHg</measure>
    <time_frame>within 48 hours afer drug intervention</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>The number of cases who develop delirium</measure>
    <time_frame>Within 48 hours after drug intervention</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in heart rate</measure>
    <time_frame>Within 48 hours after drug intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in respiratory rate</measure>
    <time_frame>Within 48 hours after drug intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in central venous pressure</measure>
    <time_frame>Within 48 hours after drug intervention</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Safety of Dexmedetomidine Sedation</condition>
  <arm_group>
    <arm_group_label>Group dexmedetomidine ,dexmedetomidine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Continuous pump infusion dexmedetomidine with loading dose of 0.4μg.kg-1 for 10 minutes ,then followed by maintenance dose of 0.2~0.7µg.kg-1 to maintain Sedation-Agitation Scale between 3 and 4.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group midazolam,midazolam,fentanyl</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Quickly inject midazolam and fentanyl with loading dose of 0.1mg.kg-1 and 1 μg.kg-1 separately until attaining Sedation-Agitation Scale between 3 and 4,then followed by maintenance dose of 0.05~0.1mg.kg-1.h-1 and fentanyl 0.5~1μg.kg-1.h-1 separately.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexmedetomidine</intervention_name>
    <description>Loading dose:0.4μg.kg-1 Maintenance dose :0.2~0.7µg.kg-1 Sedation-Agitation Scale: maintain between 3 and 4.</description>
    <arm_group_label>Group dexmedetomidine ,dexmedetomidine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Midazolam</intervention_name>
    <description>Loading dose of midazolam:0.1mg.kg-1 . Maintenance dose of midazolam :0.05~0.1mg.kg-1.h-1 . Sedation-Agitation Scale: maintain between 3 and 4</description>
    <arm_group_label>Group midazolam,midazolam,fentanyl</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fentanyl</intervention_name>
    <description>Loading dose of fentanyl:1 μg.kg-1 . Maintenance dose of fentanyl: 0.5~1μg.kg-1.h-1 . Sedation-Agitation Scale: maintain between 3 and 4</description>
    <arm_group_label>Group midazolam,midazolam,fentanyl</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
          -  Intensive care unit patients who need mechanical ventilation&#xD;
&#xD;
          -  Anticipate duration of mechanical ventilation longer than 24 hours,and shorter than 96&#xD;
             hours prior to giving investigational products&#xD;
&#xD;
          -  Acute physiology and chronic health evaluation II score more than 10&#xD;
&#xD;
          -  Aged between 60 to 80 years old&#xD;
&#xD;
          -  Weight between plus or minus 20% of the standard weight. Male: (height cm - 80) × 70%&#xD;
             = standard weight Female: (height cm - 70) × 60% = standard weight&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Trauma and burn patients&#xD;
&#xD;
          -  Any kind of dialysis&#xD;
&#xD;
          -  Suspected or confirmed difficult airway&#xD;
&#xD;
          -  Use of neuromuscular blocking drugs(Except using for intubation )&#xD;
&#xD;
          -  Neuromuscular disease&#xD;
&#xD;
          -  Epidural or subarachnoid anesthesia&#xD;
&#xD;
          -  Plan to give general anesthesia before 24 hours drugs intervention or after giving&#xD;
             investigational drugs&#xD;
&#xD;
          -  Serious central nervous system disease&#xD;
&#xD;
          -  Mental disability or mental disease&#xD;
&#xD;
          -  Acute hepatitis and serious liver disease(Child-Pugh C)&#xD;
&#xD;
          -  Unstable angina and acute myocardium infarction&#xD;
&#xD;
          -  Left ventricular ejection volume less than 30%,heart rate less than 50 beats per&#xD;
             minute&#xD;
&#xD;
          -  II and III degree atrioventricular block&#xD;
&#xD;
          -  Systolic pressure less than 90 mmHg after giving vasopressors twice before beginning&#xD;
             of this study&#xD;
&#xD;
          -  Consciousness disturbance patients whose blood pressure less than 70mmHg and blood&#xD;
             lactate more than 4.0mmol/L&#xD;
&#xD;
          -  Suspected or confirmed long term use of narcotic analgesics&#xD;
&#xD;
          -  Subjects who are breastfeeding or pregnant&#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>60 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 22, 2014</study_first_submitted>
  <study_first_submitted_qc>August 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 26, 2014</study_first_posted>
  <last_update_submitted>August 24, 2014</last_update_submitted>
  <last_update_submitted_qc>August 24, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 26, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fuling Central Hospital of Chongqing City</investigator_affiliation>
    <investigator_full_name>Shuaiya</investigator_full_name>
    <investigator_title>physician</investigator_title>
  </responsible_party>
  <keyword>Dexmedetomidine ,Delirium ,Haemodynamic, Mechanical ventilation</keyword>
  <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>Fentanyl</mesh_term>
    <mesh_term>Midazolam</mesh_term>
    <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/NCT02225210
org study id: Shu 2014
nct id: NCT02225210
lead sponsor: 
has dmc: No
This study was designed to observe the effects of dexmedetomidine on delirium and
      haemodynamic in mechanical ventilated elderly patients,and to evaluate the safety of
      dexmedetomidine.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Changes in blood pressure within 48 hours after drug intervention
time frame: Within 48 hours after drug intervention
measure: Number of Participants with blood pressure decrease more than 20% of the baseline value or systolic pressure less than 100 mmHg
time frame: within 48 hours afer drug intervention
measure: The number of cases who develop delirium
time frame: Within 48 hours after drug intervention
measure: Changes in heart rate
time frame: Within 48 hours after drug intervention
measure: Changes in respiratory rate
time frame: Within 48 hours after drug intervention
measure: Changes in central venous pressure
time frame: Within 48 hours after drug intervention
arm group label: Group dexmedetomidine ,dexmedetomidine
arm group type: Experimental
description: Continuous pump infusion dexmedetomidine with loading dose of 0.4μg.kg-1 for 10 minutes ,then followed by maintenance dose of 0.2~0.7µg.kg-1 to maintain Sedation-Agitation Scale between 3 and 4.
arm group label: Group midazolam,midazolam,fentanyl
arm group type: Active Comparator
description: Quickly inject midazolam and fentanyl with loading dose of 0.1mg.kg-1 and 1 μg.kg-1 separately until attaining Sedation-Agitation Scale between 3 and 4,then followed by maintenance dose of 0.05~0.1mg.kg-1.h-1 and fentanyl 0.5~1μg.kg-1.h-1 separately.
intervention type: Drug
intervention name: Dexmedetomidine
description: Loading dose:0.4μg.kg-1 Maintenance dose :0.2~0.7µg.kg-1 Sedation-Agitation Scale: maintain between 3 and 4.
arm group label: Group dexmedetomidine ,dexmedetomidine
intervention type: Drug
intervention name: Midazolam
description: Loading dose of midazolam:0.1mg.kg-1 . Maintenance dose of midazolam :0.05~0.1mg.kg-1.h-1 . Sedation-Agitation Scale: maintain between 3 and 4
arm group label: Group midazolam,midazolam,fentanyl
intervention type: Drug
intervention name: Fentanyl
description: Loading dose of fentanyl:1 μg.kg-1 . Maintenance dose of fentanyl: 0.5~1μg.kg-1.h-1 . Sedation-Agitation Scale: maintain between 3 and 4
arm group label: Group midazolam,midazolam,fentanyl
criteria: 
gender: All
minimum age: 60 Years
maximum age: 80 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Fuling Central Hospital of Chongqing City
investigator full name: Shuaiya
investigator title: physician
mesh term: Delirium
mesh term: Fentanyl
mesh term: Midazolam
mesh term: Dexmedetomidine