<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/NCT03014713</url>
  </required_header>
  <id_info>
    <org_study_id>Dexmedetomidine PCA</org_study_id>
    <nct_id>NCT03014713</nct_id>
  </id_info>
  <brief_title>Effect of Dexmedetomidine for Postoperative Intravenous Patient Controlled Analgesia</brief_title>
  <official_title>Effect of Dexmedetomidine Combined With Dezocine and Flubiprofen for Postoperative Intravenous Patient Controlled Analgesia After Colorectal Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Weifeng Tu</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Guangzhou General Hospital of Guangzhou Military Command</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to explore the effectiveness of dexmedetomidine as an adjunctive&#xD;
      analgesic, combined with dezocine and flubiprofen, used in intravenous Patient-Controlled&#xD;
      Analgesia (PCA) after open colorectal surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Dexmedetomidine is a selective alpha-2 adrenoceptor agonist, which has been demonstrated to&#xD;
      have anaesthetic, sedative and analgesic-sparing effects. Besides, Dexmedetomidine has been&#xD;
      reported to cause sedative effects and reduce opioid requirements in the perioperative&#xD;
      period. Many studies had been conducted to reduce the side effect of opioid analgesic. The&#xD;
      current trend of reducing opioid analgesic side effect is direct combination of other drugs&#xD;
      in PCA. The advantages of this method are convenient in clinical use and preventive for side&#xD;
      effects.&#xD;
&#xD;
      In this study, 50 patients who is undergoing elective colorectal surgery will be randomly&#xD;
      allocated into two groups (Control group and Dexmedetomidine group). Patients in both groups&#xD;
      will be given a patient-controlled analgesia (PCA) pump in post anesthetic recovery unit&#xD;
      (PACU) after surgery.&#xD;
&#xD;
      The PCA protocol of Control group is dezocine 0.6mg/kg, flubiprofen 3mg/kg, diluted into&#xD;
      120ml and administer at a background infusion of 2ml/h, and a bolus of 2ml, with a lock-out&#xD;
      of 15min. The PCA protocol of Dexmedetomidine group is dezocine 0.6mg/kg, flubiprofen 3mg/k&#xD;
      and dexmedetomidine 6μg/kg diluted into 120ml and administer at a background infusion of&#xD;
      2ml/h, and a bolus of 2ml, with a lock-out of 15min.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2016</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2017</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>Health Services Research</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Dezocine consumption by patient-controlled analgesia</measure>
    <time_frame>At 24 hours after surgery</time_frame>
    <description>The total consumption of dezocine during 24 hours after surgery are recorded.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in pain score</measure>
    <time_frame>At 0, 2, 4, 8, 24, 48 and 72 hours after surgery</time_frame>
    <description>Pain scores at rest and movement are evaluated with a numeric rating scale (NRS).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in ramsay sedation score</measure>
    <time_frame>At 0, 2, 4, 8, 24, 48 and 72 hours after surgery</time_frame>
    <description>Measure sedation level by using ramsay sedation score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The incidence rates of postoperative nausea and vomiting (PONV)</measure>
    <time_frame>At 24 hours after surgery</time_frame>
    <description>Measure whether nausea and vomiting exist and the level of severity.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Patient-Controlled Analgesia</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in this group receive intravenous Patient-Controlled Analgesia(PCA) pump after surgery.The intravenous PCA protocol is dezocine 0.01mg/kg/h,flubiprofen 0.05mg/kg/h.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dexmedetomidine Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this group receive intravenous Patient-Controlled Analgesia(PCA) pump after surgery.The intravenous PCA protocol is dezocine 0.01mg/kg/h,flubiprofen 0.05mg/kg/h,dexmedetomidine 0.1μg/kg/h.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dezocine</intervention_name>
    <description>Dezocine 0.01mg/kg/h intravenous administration during the first two days after surgery.</description>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_label>Dexmedetomidine Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Flubiprofen</intervention_name>
    <description>Flubiprofen 0.5mg/kg/h intravenous administration during the first two days after surgery.</description>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_label>Dexmedetomidine Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexmedetomidine</intervention_name>
    <description>Dexmedetomidine 0.1μg/kg/h intravenous administration during the first two days after surgery.</description>
    <arm_group_label>Dexmedetomidine Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. American Society of Anesthesiologists(ASA) Ⅰ-Ⅱ patient undergoing open colorectal&#xD;
             surgery&#xD;
&#xD;
          2. Written informed consent from the patient or the relatives of the participating&#xD;
             patient.&#xD;
&#xD;
          3. BMI:18～30kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Mental illness or cannot communicate.;&#xD;
&#xD;
          2. A second operation during the study;&#xD;
&#xD;
          3. Slow-type arrhythmias or hypotension;&#xD;
&#xD;
          4. Lung infection or sleep apnea syndrome;&#xD;
&#xD;
          5. Renal failure;&#xD;
&#xD;
          6. Alcohol or drug abuse;&#xD;
&#xD;
          7. Already taking gabapentin, pregabalin, benzodiazepin or antidepression drug;&#xD;
&#xD;
          8. Long-term use of analgesics,sedatives or non steroidal anti-inflammatory drugs&#xD;
             history;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Weifeng Tu, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Guangzhou General Hospital of Guangzhou Military Command</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Weifeng Tu, PhD</last_name>
    <phone>+8613922116606</phone>
    <email>wftuyx02@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Guangzhou General Hospital of Guangzhou Military Command</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510010</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Weifeng Tu</last_name>
      <phone>+8613922116606</phone>
      <email>wftuyx02@163.com</email>
    </contact>
    <contact_backup>
      <last_name>Chuangbo Xie</last_name>
      <phone>+8615521118558</phone>
      <email>xiechuangbo@126.com</email>
    </contact_backup>
    <investigator>
      <last_name>Weifeng Tu, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Yang Zhou, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Chuangbo Xie, Master</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Bellon M, Le Bot A, Michelet D, Hilly J, Maesani M, Brasher C, Dahmani S. Efficacy of Intraoperative Dexmedetomidine Compared with Placebo for Postoperative Pain Management: A Meta-Analysis of Published Studies. Pain Ther. 2016 Jun;5(1):63-80. doi: 10.1007/s40122-016-0045-2. Epub 2016 Feb 10.</citation>
    <PMID>26861737</PMID>
  </reference>
  <reference>
    <citation>Ge DJ, Qi B, Tang G, Li JY. Intraoperative Dexmedetomidine Promotes Postoperative Analgesia and Recovery in Patients after Abdominal Hysterectomy: a Double-Blind, Randomized Clinical Trial. Sci Rep. 2016 Feb 23;6:21514. doi: 10.1038/srep21514.</citation>
    <PMID>26903197</PMID>
  </reference>
  <reference>
    <citation>Jessen Lundorf L, Korvenius Nedergaard H, Moller AM. Perioperative dexmedetomidine for acute pain after abdominal surgery in adults. Cochrane Database Syst Rev. 2016 Feb 18;2:CD010358. doi: 10.1002/14651858.CD010358.pub2.</citation>
    <PMID>26889627</PMID>
  </reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 3, 2017</study_first_submitted>
  <study_first_submitted_qc>January 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <last_update_submitted>January 6, 2017</last_update_submitted>
  <last_update_submitted_qc>January 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Guangzhou General Hospital of Guangzhou Military Command</investigator_affiliation>
    <investigator_full_name>Weifeng Tu</investigator_full_name>
    <investigator_title>Chief Physician</investigator_title>
  </responsible_party>
  <keyword>Dexmedetomidine</keyword>
  <keyword>Dezocine</keyword>
  <keyword>Flubiprofen</keyword>
  <keyword>Analgesia</keyword>
  <keyword>Colorectal Surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Agnosia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Flurbiprofen</mesh_term>
    <mesh_term>Dexmedetomidine</mesh_term>
    <mesh_term>Dezocine</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/NCT03014713
org study id: Dexmedetomidine PCA
nct id: NCT03014713
lead sponsor: 
has dmc: No
The purpose of this study is to explore the effectiveness of dexmedetomidine as an adjunctive
      analgesic, combined with dezocine and flubiprofen, used in intravenous Patient-Controlled
      Analgesia (PCA) after open colorectal surgery.
Dexmedetomidine is a selective alpha-2 adrenoceptor agonist, which has been demonstrated to
      have anaesthetic, sedative and analgesic-sparing effects. Besides, Dexmedetomidine has been
      reported to cause sedative effects and reduce opioid requirements in the perioperative
      period. Many studies had been conducted to reduce the side effect of opioid analgesic. The
      current trend of reducing opioid analgesic side effect is direct combination of other drugs
      in PCA. The advantages of this method are convenient in clinical use and preventive for side
      effects.

      In this study, 50 patients who is undergoing elective colorectal surgery will be randomly
      allocated into two groups (Control group and Dexmedetomidine group). Patients in both groups
      will be given a patient-controlled analgesia (PCA) pump in post anesthetic recovery unit
      (PACU) after surgery.

      The PCA protocol of Control group is dezocine 0.6mg/kg, flubiprofen 3mg/kg, diluted into
      120ml and administer at a background infusion of 2ml/h, and a bolus of 2ml, with a lock-out
      of 15min. The PCA protocol of Dexmedetomidine group is dezocine 0.6mg/kg, flubiprofen 3mg/k
      and dexmedetomidine 6μg/kg diluted into 120ml and administer at a background infusion of
      2ml/h, and a bolus of 2ml, with a lock-out of 15min.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Double (Participant, Outcomes Assessor)
measure: Dezocine consumption by patient-controlled analgesia
time frame: At 24 hours after surgery
description: The total consumption of dezocine during 24 hours after surgery are recorded.
measure: Change in pain score
time frame: At 0, 2, 4, 8, 24, 48 and 72 hours after surgery
description: Pain scores at rest and movement are evaluated with a numeric rating scale (NRS).
measure: Change in ramsay sedation score
time frame: At 0, 2, 4, 8, 24, 48 and 72 hours after surgery
description: Measure sedation level by using ramsay sedation score
measure: The incidence rates of postoperative nausea and vomiting (PONV)
time frame: At 24 hours after surgery
description: Measure whether nausea and vomiting exist and the level of severity.
arm group label: Control Group
arm group type: Active Comparator
description: Patients in this group receive intravenous Patient-Controlled Analgesia(PCA) pump after surgery.The intravenous PCA protocol is dezocine 0.01mg/kg/h,flubiprofen 0.05mg/kg/h.
arm group label: Dexmedetomidine Group
arm group type: Experimental
description: Patients in this group receive intravenous Patient-Controlled Analgesia(PCA) pump after surgery.The intravenous PCA protocol is dezocine 0.01mg/kg/h,flubiprofen 0.05mg/kg/h,dexmedetomidine 0.1μg/kg/h.
intervention type: Drug
intervention name: Dezocine
description: Dezocine 0.01mg/kg/h intravenous administration during the first two days after surgery.
arm group label: Control Group
arm group label: Dexmedetomidine Group
intervention type: Drug
intervention name: Flubiprofen
description: Flubiprofen 0.5mg/kg/h intravenous administration during the first two days after surgery.
arm group label: Control Group
arm group label: Dexmedetomidine Group
intervention type: Drug
intervention name: Dexmedetomidine
description: Dexmedetomidine 0.1μg/kg/h intravenous administration during the first two days after surgery.
arm group label: Dexmedetomidine Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Weifeng Tu, PhD
role: Principal Investigator
affiliation: Guangzhou General Hospital of Guangzhou Military Command
last name: Weifeng Tu, PhD
phone: +8613922116606
email: wftuyx02@163.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
country: China
citation: Bellon M, Le Bot A, Michelet D, Hilly J, Maesani M, Brasher C, Dahmani S. Efficacy of Intraoperative Dexmedetomidine Compared with Placebo for Postoperative Pain Management: A Meta-Analysis of Published Studies. Pain Ther. 2016 Jun;5(1):63-80. doi: 10.1007/s40122-016-0045-2. Epub 2016 Feb 10.
PMID: 26861737
citation: Ge DJ, Qi B, Tang G, Li JY. Intraoperative Dexmedetomidine Promotes Postoperative Analgesia and Recovery in Patients after Abdominal Hysterectomy: a Double-Blind, Randomized Clinical Trial. Sci Rep. 2016 Feb 23;6:21514. doi: 10.1038/srep21514.
PMID: 26903197
citation: Jessen Lundorf L, Korvenius Nedergaard H, Moller AM. Perioperative dexmedetomidine for acute pain after abdominal surgery in adults. Cochrane Database Syst Rev. 2016 Feb 18;2:CD010358. doi: 10.1002/14651858.CD010358.pub2.
PMID: 26889627
responsible party type: Sponsor-Investigator
investigator affiliation: Guangzhou General Hospital of Guangzhou Military Command
investigator full name: Weifeng Tu
investigator title: Chief Physician
mesh term: Agnosia
mesh term: Flurbiprofen
mesh term: Dexmedetomidine
mesh term: Dezocine