<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/NCT01669044</url>
  </required_header>
  <id_info>
    <org_study_id>IRB[2012]260</org_study_id>
    <nct_id>NCT01669044</nct_id>
  </id_info>
  <brief_title>Comparison the Hemodynamics Effects Between Dexmedetomidine and Propofol in Major Abdominal Surgical Patients</brief_title>
  <official_title>Comparison the Hemodynamics Effects Between Dexmedetomidine and Propofol in Major Abdominal Surgical Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>First Affiliated Hospital, Sun Yat-Sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>First Affiliated Hospital, Sun Yat-Sen University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The alpha2 agonist dexmedetomidine is a new sedative agent combined with the analgesic&#xD;
      qualities and lack of respiratory depression. Patients sedated with dexmedetomidine could be&#xD;
      easily roused, these advances shows dexmedetomidine may be a effective and safe sedative&#xD;
      agent. But some studies showed some adversely effects of dexmedetomidine on haemodynamics&#xD;
      (such as bradycardia, hypotension), the investigators want to further research the effects of&#xD;
      dexmedetomidine on haemodynamics, such as Cardiac Output (CO), Systemic Venous Resistance&#xD;
      Index(SVRI), and so on. Propofol is widely used sedative agent in ICU, it also has adversely&#xD;
      effects like bradycardia and hypotension, so the investigators want to compare the effect of&#xD;
      dexmedetomidine with propofol on haemodynamics after major abdominal surgery. Expect to&#xD;
      further research the mechanism of haemodynamics of dexmedetomidine.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      When the patients can be roused, they will first receive analgesia with bolus of fentanyl&#xD;
      0.03mg, followed by a continuous infusion at a ﬁxed dose of 0.3μg/kg/h during study period.&#xD;
      Then patients will be randomly divided into two groups (Dexmedetomidine and Propofol). All of&#xD;
      them will receive hemodynamic monitoring through &quot;Vigileo&quot;(Edwards Lifesciences) and&#xD;
      cardiogram monitor. The study will continue for 6-24 hours.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>May 2012</start_date>
  <completion_date type="Anticipated">December 2012</completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Cardiac output</measure>
    <time_frame>the study will start when the patient can be roused after major abdominal surgery and will continue for 6 to 24hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Stroke Volume</measure>
    <time_frame>the study will start when the patient can be roused after major abdominal surgery and will continue for 6 to 24hours</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Systemic Venous Resistance Index</measure>
    <time_frame>the study will start when the patient can be roused after major abdominal surgery and will continue for 6 to 24hours</time_frame>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Abdominal Tumor</condition>
  <condition>Intestinal Obstruction</condition>
  <condition>Cirrhosis</condition>
  <condition>Intestinal Fistula</condition>
  <condition>Aneurism</condition>
  <arm_group>
    <arm_group_label>dexmedetomidine,hemodynamics,injection</arm_group_label>
    <description>Group 1:when the patient can be roused after major abdominal surgery ，we will inject dexmedetomidine at 1μg/kg in 10 minutes as a loading dose, followed by a continuous infusion at 0.3μg/kg/h for 6 to 24hours.then adjust the infusion dose to maintain the ramsay scale at 3-4 scores.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>propofol,hemodynamics,injection</arm_group_label>
    <description>Group 2 :when the patient can be roused after major abdominal surgery ，we will inject propofol at 0.5mg/kg as a loading dose, followed by a continuous infusion at 0.5mg/kg.h for 6 to 24hours.then adjust the infusion dose to maintain the ramsay scale at 3-4 scores</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>dexmedetomidine</intervention_name>
    <description>dexmedetomidine: IV (in the vein)at 1μg/kg in 10 minutes as a loading dose, followed by a continuous infusion at 0.3μg/kg/h.then adjust the infusion dose to maintain the ramsay scale at 3-4 scores.</description>
    <arm_group_label>dexmedetomidine,hemodynamics,injection</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>propofol</intervention_name>
    <description>propofol: IV (in the vein)at 0.5mg/kg as a loading dose, followed by a continuous infusion at 0.5mg/kg/h.then adjust the infusion dose to maintain the ramsay scale at 3-4 scores.</description>
    <arm_group_label>propofol,hemodynamics,injection</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Postoperative patients of major abdominal surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Postoperative patients of major abdominal surgery&#xD;
&#xD;
          2. Age ≧ 18&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. heart rate ≤ 50 bpm&#xD;
&#xD;
          2. allergy with dexmedetomidine or propofol&#xD;
&#xD;
          3. pregnancy&#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>minying chen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>study principal investigator</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>mingyin chen, MD</last_name>
    <phone>008613925019136</phone>
    <email>chmy1969@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>First affiliated hostipal,Sun Yat-sen University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510080</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>mingyin chen, MD</last_name>
      <phone>008613925019136</phone>
      <email>chmy1969@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>mingyin chen, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 16, 2012</study_first_submitted>
  <study_first_submitted_qc>August 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2012</study_first_posted>
  <last_update_submitted>August 20, 2012</last_update_submitted>
  <last_update_submitted_qc>August 20, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 22, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>First Affiliated Hospital, Sun Yat-Sen University</investigator_affiliation>
    <investigator_full_name>Minying Chen</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Abdominal Neoplasms</mesh_term>
    <mesh_term>Intestinal Obstruction</mesh_term>
    <mesh_term>Intestinal Fistula</mesh_term>
    <mesh_term>Aneurysm</mesh_term>
    <mesh_term>Fistula</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>
  <!-- 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/NCT01669044
org study id: IRB[2012]260
nct id: NCT01669044
lead sponsor: 
has dmc: Yes
The alpha2 agonist dexmedetomidine is a new sedative agent combined with the analgesic
      qualities and lack of respiratory depression. Patients sedated with dexmedetomidine could be
      easily roused, these advances shows dexmedetomidine may be a effective and safe sedative
      agent. But some studies showed some adversely effects of dexmedetomidine on haemodynamics
      (such as bradycardia, hypotension), the investigators want to further research the effects of
      dexmedetomidine on haemodynamics, such as Cardiac Output (CO), Systemic Venous Resistance
      Index(SVRI), and so on. Propofol is widely used sedative agent in ICU, it also has adversely
      effects like bradycardia and hypotension, so the investigators want to compare the effect of
      dexmedetomidine with propofol on haemodynamics after major abdominal surgery. Expect to
      further research the mechanism of haemodynamics of dexmedetomidine.
When the patients can be roused, they will first receive analgesia with bolus of fentanyl
      0.03mg, followed by a continuous infusion at a ﬁxed dose of 0.3μg/kg/h during study period.
      Then patients will be randomly divided into two groups (Dexmedetomidine and Propofol). All of
      them will receive hemodynamic monitoring through "Vigileo"(Edwards Lifesciences) and
      cardiogram monitor. The study will continue for 6-24 hours.
observational model: Case-Control
time perspective: Prospective
measure: Cardiac output
time frame: the study will start when the patient can be roused after major abdominal surgery and will continue for 6 to 24hours
measure: Stroke Volume
time frame: the study will start when the patient can be roused after major abdominal surgery and will continue for 6 to 24hours
measure: Systemic Venous Resistance Index
time frame: the study will start when the patient can be roused after major abdominal surgery and will continue for 6 to 24hours
arm group label: dexmedetomidine,hemodynamics,injection
description: Group 1:when the patient can be roused after major abdominal surgery ，we will inject dexmedetomidine at 1μg/kg in 10 minutes as a loading dose, followed by a continuous infusion at 0.3μg/kg/h for 6 to 24hours.then adjust the infusion dose to maintain the ramsay scale at 3-4 scores.
arm group label: propofol,hemodynamics,injection
description: Group 2 :when the patient can be roused after major abdominal surgery ，we will inject propofol at 0.5mg/kg as a loading dose, followed by a continuous infusion at 0.5mg/kg.h for 6 to 24hours.then adjust the infusion dose to maintain the ramsay scale at 3-4 scores
intervention type: Drug
intervention name: dexmedetomidine
description: dexmedetomidine: IV (in the vein)at 1μg/kg in 10 minutes as a loading dose, followed by a continuous infusion at 0.3μg/kg/h.then adjust the infusion dose to maintain the ramsay scale at 3-4 scores.
arm group label: dexmedetomidine,hemodynamics,injection
intervention type: Drug
intervention name: propofol
description: propofol: IV (in the vein)at 0.5mg/kg as a loading dose, followed by a continuous infusion at 0.5mg/kg/h.then adjust the infusion dose to maintain the ramsay scale at 3-4 scores.
arm group label: propofol,hemodynamics,injection
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: minying chen, MD
role: Principal Investigator
affiliation: study principal investigator
last name: mingyin chen, MD
phone: 008613925019136
email: chmy1969@hotmail.com
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: First Affiliated Hospital, Sun Yat-Sen University
investigator full name: Minying Chen
investigator title: MD
mesh term: Abdominal Neoplasms
mesh term: Intestinal Obstruction
mesh term: Intestinal Fistula
mesh term: Aneurysm
mesh term: Fistula
mesh term: Dexmedetomidine
mesh term: Propofol