<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/NCT02199522</url>
  </required_header>
  <id_info>
    <org_study_id>DDMZ-1</org_study_id>
    <nct_id>NCT02199522</nct_id>
  </id_info>
  <brief_title>Clinical Observation of Titration Induction and Convention Induction of Propofol</brief_title>
  <official_title>Clinical Observation of Titration Induction and Convention Induction of Propofol</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lihong Chen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sixth Affiliated Hospital, Sun Yat-sen University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      As we know propofol is popular use in the anesthesia induction with kilogram and it always&#xD;
      cause hypotension. So we compare haemodynamic changes and drug consumption between propofol&#xD;
      titrated administration and traditional administration for anesthesia induction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      GroupⅠreceived propofol 2 mg/kg intravenously by Fresenius pump at the speed of 250 mg/min,&#xD;
      GroupⅡreceived propofol intravenously by Fresenius pump at the speed of 1 mg/kg/min, and&#xD;
      observe's assessment of alertness and sedation(OAA/S) scale of the patients was titrated to&#xD;
      1, then changed to a maintenance dose&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 28, 2014</start_date>
  <completion_date type="Actual">November 30, 2014</completion_date>
  <primary_completion_date type="Actual">November 30, 2014</primary_completion_date>
  <phase>N/A</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>systolic pressure diastolic pressure mean blood pressure</measure>
    <time_frame>15minutes</time_frame>
    <description>before propofol dosage ,1 min after the propofol dosage, 3 min , 5 min&#xD;
, endotracheal intubation done immediately,1 min,3 min,5 min,7 min,9 min after endotracheal intubation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>total dosage of propofol using</measure>
    <time_frame>15 minutes</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">160</enrollment>
  <condition>Propofol Overdose of Undetermined Intent</condition>
  <arm_group>
    <arm_group_label>titration induction of propofol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>titration induction of propofol by Fresenius pump at the speed of 1 mg•kg-1•min-1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>convention induction of propofol</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>propofol 2mg•kg-1 intravenously by Fresenius pump at the speed of 250mg•min-1</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>titration induction to propofol</intervention_name>
    <description>propofol intravenously by Fresenius pump at the speed of 1 mg•kg-1•min-1, and OAA/S scale of the patients was titrated to 1</description>
    <arm_group_label>titration induction of propofol</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with American Society of Anesthesiologists(ASA)Ⅰor Ⅱ and aged 18-60 yr, who&#xD;
             were scheduled for general anesthesia.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hypertension, Severe heart,pulmonary,brain，liver and renal dysfunction; excess obesity&#xD;
             , predicted difficult intubation,hearing obstacles;. Allergic to propofol or its fat&#xD;
             emulsion;addictive to sedative and other drugs.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>san q Jin, docter</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Anesthesia ,Sixth Affiliated hospital of Sun Yat-sen University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Anesthesia ,Sixth Affiliated hospital of Sun Yat-sen University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510655</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>July 22, 2014</study_first_submitted>
  <study_first_submitted_qc>July 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 24, 2014</study_first_posted>
  <last_update_submitted>October 19, 2020</last_update_submitted>
  <last_update_submitted_qc>October 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Sixth Affiliated Hospital, Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Lihong Chen</investigator_full_name>
    <investigator_title>Department of Anesthesia ,Sixth Affiliated hospital of Sun Yat-sen University</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Drug Overdose</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT02199522
org study id: DDMZ-1
nct id: NCT02199522
lead sponsor: 
has dmc: Yes
As we know propofol is popular use in the anesthesia induction with kilogram and it always
      cause hypotension. So we compare haemodynamic changes and drug consumption between propofol
      titrated administration and traditional administration for anesthesia induction.
GroupⅠreceived propofol 2 mg/kg intravenously by Fresenius pump at the speed of 250 mg/min,
      GroupⅡreceived propofol intravenously by Fresenius pump at the speed of 1 mg/kg/min, and
      observe's assessment of alertness and sedation(OAA/S) scale of the patients was titrated to
      1, then changed to a maintenance dose
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: systolic pressure diastolic pressure mean blood pressure
time frame: 15minutes
description: before propofol dosage ,1 min after the propofol dosage, 3 min , 5 min
, endotracheal intubation done immediately,1 min,3 min,5 min,7 min,9 min after endotracheal intubation
measure: total dosage of propofol using
time frame: 15 minutes
arm group label: titration induction of propofol
arm group type: Experimental
description: titration induction of propofol by Fresenius pump at the speed of 1 mg•kg-1•min-1
arm group label: convention induction of propofol
arm group type: No Intervention
description: propofol 2mg•kg-1 intravenously by Fresenius pump at the speed of 250mg•min-1
intervention type: Procedure
intervention name: titration induction to propofol
description: propofol intravenously by Fresenius pump at the speed of 1 mg•kg-1•min-1, and OAA/S scale of the patients was titrated to 1
arm group label: titration induction of propofol
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: san q Jin, docter
role: Principal Investigator
affiliation: Department of Anesthesia ,Sixth Affiliated hospital of Sun Yat-sen University
facility: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Sixth Affiliated Hospital, Sun Yat-sen University
investigator full name: Lihong Chen
investigator title: Department of Anesthesia ,Sixth Affiliated hospital of Sun Yat-sen University
mesh term: Drug Overdose
mesh term: Propofol