<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/NCT02197403</url>
  </required_header>
  <id_info>
    <org_study_id>an00543</org_study_id>
    <nct_id>NCT02197403</nct_id>
  </id_info>
  <brief_title>Paradoxical Excitement Response During Sedation Between Dexmedetomidine and Propofol in Hazardous Alcohol Drinker</brief_title>
  <acronym>DEX</acronym>
  <official_title>Comparative Study on Development of Paradoxical Excitement Response During Sedation Using Dexmedetomidine or Propofol in Hazardous Alcohol Drinkers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chonnam National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chonnam National University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      1. Adequate sedation with classical sedative agents, propofol&#xD;
&#xD;
        2. Sedation with propofol may induce paradoxical excitement response in heavy alcohol&#xD;
           drinkers&#xD;
&#xD;
        3. Dexmedetomidine, α2 receptor agonist, may provide adequate sedation in heavy alcohol&#xD;
           drinkers&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Adequate sedation during surgery provide anxiolysis and comfort to patient. Insufficient&#xD;
           sedation can't provide comfort to patient during surgery, otherwise excessive sedation&#xD;
           can cause variable complications like respiratory depression or delayed awakening.&#xD;
&#xD;
        2. Dexmedetomidine is a centrally acting α2 receptor agonist that is increasingly being&#xD;
           used as a sedative for MAC and intensive care with mechanical ventilated patients&#xD;
           because of its analgesic properties, &quot;cooperative sedation,&quot; and lack of respiratory&#xD;
           depression.&#xD;
&#xD;
        3. Because of the different site of action between dexmedetomidine and propofol, we assumed&#xD;
           that paradoxical excitement responses which appeared in heavy alcohol drinkers in&#xD;
           midazolam or propofol-induced sedation might be less observed in dexmedetomidine-induced&#xD;
           sedation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2013</start_date>
  <completion_date type="Anticipated">May 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">May 31, 2019</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>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Paradoxical excitement response</measure>
    <time_frame>Every 5 minutes up to 120minutes after drug infusion</time_frame>
    <description>Paradoxical excitement responses (verbal/movement) 0, none : no excitement response&#xD;
mild : increased talkativeness, irrational talking / brief spontaneous movement with position remaining&#xD;
moderate : restlessness, loss of cooperation, spontaneous movements requiring repositioning with no need of restraint&#xD;
severe : agitation and spontaneous movements with a need to restrain the patient</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>OAA/S</measure>
    <time_frame>Every 5minutes up to 120minutes after drug infusion</time_frame>
    <description>Observer''s Assessment of Alertness/Sedation Scale (OAA/S)&#xD;
:Does not respond to mild prodding or shaking&#xD;
:Responds only after mild prodding or shaking&#xD;
:Responds only after name is spoken loudly and/or repeatedly&#xD;
:Lethargic response to name spoken in normal tone&#xD;
:Responds readily to name spoken in normal tone&#xD;
Goal to sedation : 3</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vital signs</measure>
    <time_frame>During operation</time_frame>
    <description>Check blood pressure, heart rate, oxygen saturation, bispectral index</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">110</enrollment>
  <condition>Anesthesia, Spinal</condition>
  <condition>Sedation, Conscious</condition>
  <condition>Dexmedetomidine</condition>
  <condition>Alcohol Drinking</condition>
  <condition>Anesthesia, Epidural</condition>
  <condition>Propofol</condition>
  <arm_group>
    <arm_group_label>alcohol drinker &amp; dexmedetomidine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>dexmedetomidine, 200mcg in 50mL of normal saline 0.75mcg/Kg bolus injection in 10 minutes 0.1~1.0mcg/Kg infusion during surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>alcohol drinker &amp; propofol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Propofol (2% fresofol) 25~75mcg/kg/min continuous infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-alcohol drinker &amp; dexmedetomidine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>dexmedetomidine, 200mcg in 50mL of normal saline 0.75mcg/Kg bolus injection in 10 minutes 0.1~1.0mcg/Kg infusion during surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-alcohol drinker &amp; propofol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Propofol (2% fresofol) 25~75mcg/kg/min continuous infusion</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexmedetomidine</intervention_name>
    <description>200mcg in 50mL of normal saline 0.75mcg/Kg bolus injection in 10 minutes 0.1~1.0mcg/Kg infusion</description>
    <arm_group_label>Non-alcohol drinker &amp; dexmedetomidine</arm_group_label>
    <arm_group_label>alcohol drinker &amp; dexmedetomidine</arm_group_label>
    <other_name>Precedex</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Propofol</intervention_name>
    <description>25~75mcg/kg/min continuous infusion</description>
    <arm_group_label>Non-alcohol drinker &amp; propofol</arm_group_label>
    <arm_group_label>alcohol drinker &amp; propofol</arm_group_label>
    <other_name>Fresofol</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  19~65 yr-old patients who is scheduled to undergo knee surgery with regional&#xD;
             anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of taking anxiolytics, hypnotics, antiepileptic drugs&#xD;
&#xD;
          -  Abnormal liver function test (eg: Liver cirrhosis, elevated liver enzymes)&#xD;
&#xD;
          -  History of allergic reaction with dexmedetomidine or propofol&#xD;
&#xD;
          -  Contraindication with regional anesthesia&#xD;
&#xD;
          -  American society of anesthesiologist Physical status III or IV&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hyunjung Lee, MD, Master</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chonnam National University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jeongil Choi, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Chonnam National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chonnam National University Hwasun Hospital</name>
      <address>
        <city>Hwasun</city>
        <state>Jeollanamdo</state>
        <zip>501-757</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Changbeom Park, Master</last_name>
      <phone>82-61-379-7598</phone>
      <email>cnuhpch@naver.com</email>
    </contact>
    <investigator>
      <last_name>Hyunjung Lee, M.D, master</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jeongil Choi, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <results_reference>
    <citation>Jeong S, Lee HG, Kim WM, Jeong CW, Lee SH, Yoon MH, Choi JI. Increase of paradoxical excitement response during propofol-induced sedation in hazardous and harmful alcohol drinkers. Br J Anaesth. 2011 Dec;107(6):930-3. doi: 10.1093/bja/aer275. Epub 2011 Sep 7.</citation>
    <PMID>21903640</PMID>
  </results_reference>
  <results_reference>
    <citation>Adams R, Brown GT, Davidson M, Fisher E, Mathisen J, Thomson G, Webster NR. Efficacy of dexmedetomidine compared with midazolam for sedation in adult intensive care patients: a systematic review. Br J Anaesth. 2013 Nov;111(5):703-10. doi: 10.1093/bja/aet194. Epub 2013 Jun 7.</citation>
    <PMID>23748199</PMID>
  </results_reference>
  <results_reference>
    <citation>Jakob SM, Ruokonen E, Grounds RM, Sarapohja T, Garratt C, Pocock SJ, Bratty JR, Takala J; Dexmedetomidine for Long-Term Sedation Investigators. Dexmedetomidine vs midazolam or propofol for sedation during prolonged mechanical ventilation: two randomized controlled trials. JAMA. 2012 Mar 21;307(11):1151-60. doi: 10.1001/jama.2012.304.</citation>
    <PMID>22436955</PMID>
  </results_reference>
  <results_reference>
    <citation>Candiotti KA, Bergese SD, Bokesch PM, Feldman MA, Wisemandle W, Bekker AY; MAC Study Group. Monitored anesthesia care with dexmedetomidine: a prospective, randomized, double-blind, multicenter trial. Anesth Analg. 2010 Jan 1;110(1):47-56. doi: 10.1213/ane.0b013e3181ae0856. Epub 2009 Aug 27.</citation>
    <PMID>19713256</PMID>
  </results_reference>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>July 21, 2014</study_first_submitted>
  <study_first_submitted_qc>July 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <last_update_submitted>March 12, 2019</last_update_submitted>
  <last_update_submitted_qc>March 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chonnam National University Hospital</investigator_affiliation>
    <investigator_full_name>Jeong-il Choi</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Dexmedetomidine</keyword>
  <keyword>Sedation</keyword>
  <keyword>Paradoxical excitement response</keyword>
  <keyword>Alcohol drinkers</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcohol Drinking</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>Undecided</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/NCT02197403
org study id: an00543
nct id: NCT02197403
lead sponsor: 
has dmc: Yes
1. Adequate sedation with classical sedative agents, propofol

        2. Sedation with propofol may induce paradoxical excitement response in heavy alcohol
           drinkers

        3. Dexmedetomidine, α2 receptor agonist, may provide adequate sedation in heavy alcohol
           drinkers
1. Adequate sedation during surgery provide anxiolysis and comfort to patient. Insufficient
           sedation can't provide comfort to patient during surgery, otherwise excessive sedation
           can cause variable complications like respiratory depression or delayed awakening.

        2. Dexmedetomidine is a centrally acting α2 receptor agonist that is increasingly being
           used as a sedative for MAC and intensive care with mechanical ventilated patients
           because of its analgesic properties, "cooperative sedation," and lack of respiratory
           depression.

        3. Because of the different site of action between dexmedetomidine and propofol, we assumed
           that paradoxical excitement responses which appeared in heavy alcohol drinkers in
           midazolam or propofol-induced sedation might be less observed in dexmedetomidine-induced
           sedation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Paradoxical excitement response
time frame: Every 5 minutes up to 120minutes after drug infusion
description: Paradoxical excitement responses (verbal/movement) 0, none : no excitement response
mild : increased talkativeness, irrational talking / brief spontaneous movement with position remaining
moderate : restlessness, loss of cooperation, spontaneous movements requiring repositioning with no need of restraint
severe : agitation and spontaneous movements with a need to restrain the patient
measure: OAA/S
time frame: Every 5minutes up to 120minutes after drug infusion
description: Observer''s Assessment of Alertness/Sedation Scale (OAA/S)
:Does not respond to mild prodding or shaking
:Responds only after mild prodding or shaking
:Responds only after name is spoken loudly and/or repeatedly
:Lethargic response to name spoken in normal tone
:Responds readily to name spoken in normal tone
Goal to sedation : 3
measure: Vital signs
time frame: During operation
description: Check blood pressure, heart rate, oxygen saturation, bispectral index
arm group label: alcohol drinker & dexmedetomidine
arm group type: Experimental
description: dexmedetomidine, 200mcg in 50mL of normal saline 0.75mcg/Kg bolus injection in 10 minutes 0.1~1.0mcg/Kg infusion during surgery
arm group label: alcohol drinker & propofol
arm group type: Active Comparator
description: Propofol (2% fresofol) 25~75mcg/kg/min continuous infusion
arm group label: Non-alcohol drinker & dexmedetomidine
arm group type: Active Comparator
description: dexmedetomidine, 200mcg in 50mL of normal saline 0.75mcg/Kg bolus injection in 10 minutes 0.1~1.0mcg/Kg infusion during surgery
arm group label: Non-alcohol drinker & propofol
arm group type: Active Comparator
description: Propofol (2% fresofol) 25~75mcg/kg/min continuous infusion
intervention type: Drug
intervention name: Dexmedetomidine
description: 200mcg in 50mL of normal saline 0.75mcg/Kg bolus injection in 10 minutes 0.1~1.0mcg/Kg infusion
arm group label: Non-alcohol drinker & dexmedetomidine
arm group label: alcohol drinker & dexmedetomidine
other name: Precedex
intervention type: Drug
intervention name: Propofol
description: 25~75mcg/kg/min continuous infusion
arm group label: Non-alcohol drinker & propofol
arm group label: alcohol drinker & propofol
other name: Fresofol
criteria: 
gender: All
minimum age: 19 Years
maximum age: 65 Years
healthy volunteers: No
last name: Hyunjung Lee, MD, Master
role: Principal Investigator
affiliation: Chonnam National University Hospital
last name: Jeongil Choi, MD, PhD
role: Study Director
affiliation: Chonnam National University Hospital
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: Korea, Republic of
citation: Jeong S, Lee HG, Kim WM, Jeong CW, Lee SH, Yoon MH, Choi JI. Increase of paradoxical excitement response during propofol-induced sedation in hazardous and harmful alcohol drinkers. Br J Anaesth. 2011 Dec;107(6):930-3. doi: 10.1093/bja/aer275. Epub 2011 Sep 7.
PMID: 21903640
citation: Adams R, Brown GT, Davidson M, Fisher E, Mathisen J, Thomson G, Webster NR. Efficacy of dexmedetomidine compared with midazolam for sedation in adult intensive care patients: a systematic review. Br J Anaesth. 2013 Nov;111(5):703-10. doi: 10.1093/bja/aet194. Epub 2013 Jun 7.
PMID: 23748199
citation: Jakob SM, Ruokonen E, Grounds RM, Sarapohja T, Garratt C, Pocock SJ, Bratty JR, Takala J; Dexmedetomidine for Long-Term Sedation Investigators. Dexmedetomidine vs midazolam or propofol for sedation during prolonged mechanical ventilation: two randomized controlled trials. JAMA. 2012 Mar 21;307(11):1151-60. doi: 10.1001/jama.2012.304.
PMID: 22436955
citation: Candiotti KA, Bergese SD, Bokesch PM, Feldman MA, Wisemandle W, Bekker AY; MAC Study Group. Monitored anesthesia care with dexmedetomidine: a prospective, randomized, double-blind, multicenter trial. Anesth Analg. 2010 Jan 1;110(1):47-56. doi: 10.1213/ane.0b013e3181ae0856. Epub 2009 Aug 27.
PMID: 19713256
responsible party type: Principal Investigator
investigator affiliation: Chonnam National University Hospital
investigator full name: Jeong-il Choi
investigator title: Professor
mesh term: Alcohol Drinking
mesh term: Dexmedetomidine
mesh term: Propofol
sharing ipd: Undecided