<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/NCT03755609</url>
  </required_header>
  <id_info>
    <org_study_id>2018006</org_study_id>
    <nct_id>NCT03755609</nct_id>
  </id_info>
  <brief_title>Efficacy of Oxycodone-propofol Combination Compared With a Fentanyl-propofol Combination on Conscious Sedation Effect and Early Cognitive Function During Therapeutic Endoscopic Retrograde Cholangio-pancreatography</brief_title>
  <official_title>Efficacy of Oxycodone-propofol Combination Compared With a Fentanyl-propofol Combination on Conscious Sedation Effect and Early Cognitive Function During Therapeutic Endoscopic Retrograde Cholangio-pancreatography:a Prospective,Randomized, Single- Blinded Preliminary Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Changhai Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Wuhan University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Changhai Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate and compare the sedative effect and effects on early period cognitive function of&#xD;
      a fentanyl-propofol Combination (FP) regimen with a oxycodone-propofol(OP) combination during&#xD;
      the endoscopic retrograde cholangio-pancreatography (ERCP) requiring conscious sedation&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      One hundred patients undergoing ERCP were included in this study and randomly divided into&#xD;
      two groups of 50 people each. The patients in group FP were given fentanyl infusion of 1ug/kg&#xD;
      intravenously 5 minutes before the process. They were given propofol infusion: a loading does&#xD;
      of 1-2mg/kg immediately before the process then maintenance does of 1mg/kg/h. The patients in&#xD;
      group OP were administered oxycodone of 0.1 mg/kg and 1-2mg/kg loading dose of propofol&#xD;
      intravenously 5 minutes before the process. Then they were given 1mg/kg/h maintenance does of&#xD;
      propofol infusion. In order to maintenan Ramsey Sedation Scale (RSS) between 3 and 4, all&#xD;
      patients were administered 0.2~0.5 mg/kg bolus of propofol when necessary. Time of induction&#xD;
      of anesthesia, operation time, wake-up time, recovery time, occurrence of adverse&#xD;
      cardiovascular events, bucking, nausea and vomiting and respiratory depression ,total dosage&#xD;
      of used propofol were assessed.Furthermore,different time point of regional cerebral oxygen&#xD;
      saturation (rScO2) ,serum levels of irisin and cognitive function by mini-mental state&#xD;
      examination (MMSE) were rated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 1, 2018</start_date>
  <completion_date type="Anticipated">March 2019</completion_date>
  <primary_completion_date type="Anticipated">January 2019</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>anesthesia time</measure>
    <time_frame>2 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>operation time</measure>
    <time_frame>2 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>irisin</measure>
    <time_frame>2 hours</time_frame>
    <description>serum levels of irisin</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Conscious Sedation During Endoscopic Retrograde Choledochopancreatography</condition>
  <arm_group>
    <arm_group_label>patients with oxycodone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>patients with fentanyl</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxycodone</intervention_name>
    <description>0.1 mg/kg intravenously</description>
    <arm_group_label>patients with oxycodone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>fentanyl</intervention_name>
    <description>1ug/kg intravenously</description>
    <arm_group_label>patients with fentanyl</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA I-III&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  cardiovascular disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Qiu Zhao, MD, PhD</last_name>
    <phone>13971605755</phone>
    <email>zhaoqiuwhugi@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Changhai Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200433</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>bai bai, M.D</last_name>
      <phone>021-81873241</phone>
      <email>baiyu1998@hotmail.com</email>
    </contact>
    <contact_backup>
      <last_name>fang jun, M.D</last_name>
      <phone>021-81873241</phone>
      <email>XHFANGJUN@163.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 16, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>November 27, 2018</last_update_submitted>
  <last_update_submitted_qc>November 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Changhai Hospital</investigator_affiliation>
    <investigator_full_name>fangjun</investigator_full_name>
    <investigator_title>physician</investigator_title>
  </responsible_party>
  <keyword>Endoscopic Retrograde Choledochopancreatography</keyword>
  <keyword>sedation</keyword>
  <keyword>fentanyl</keyword>
  <keyword>oxycodonel</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fentanyl</mesh_term>
    <mesh_term>Oxycodone</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/NCT03755609
org study id: 2018006
nct id: NCT03755609
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
To evaluate and compare the sedative effect and effects on early period cognitive function of
      a fentanyl-propofol Combination (FP) regimen with a oxycodone-propofol(OP) combination during
      the endoscopic retrograde cholangio-pancreatography (ERCP) requiring conscious sedation
One hundred patients undergoing ERCP were included in this study and randomly divided into
      two groups of 50 people each. The patients in group FP were given fentanyl infusion of 1ug/kg
      intravenously 5 minutes before the process. They were given propofol infusion: a loading does
      of 1-2mg/kg immediately before the process then maintenance does of 1mg/kg/h. The patients in
      group OP were administered oxycodone of 0.1 mg/kg and 1-2mg/kg loading dose of propofol
      intravenously 5 minutes before the process. Then they were given 1mg/kg/h maintenance does of
      propofol infusion. In order to maintenan Ramsey Sedation Scale (RSS) between 3 and 4, all
      patients were administered 0.2~0.5 mg/kg bolus of propofol when necessary. Time of induction
      of anesthesia, operation time, wake-up time, recovery time, occurrence of adverse
      cardiovascular events, bucking, nausea and vomiting and respiratory depression ,total dosage
      of used propofol were assessed.Furthermore,different time point of regional cerebral oxygen
      saturation (rScO2) ,serum levels of irisin and cognitive function by mini-mental state
      examination (MMSE) were rated.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: anesthesia time
time frame: 2 days
measure: operation time
time frame: 2 days
measure: irisin
time frame: 2 hours
description: serum levels of irisin
arm group label: patients with oxycodone
arm group type: Active Comparator
arm group label: patients with fentanyl
arm group type: Sham Comparator
intervention type: Drug
intervention name: Oxycodone
description: 0.1 mg/kg intravenously
arm group label: patients with oxycodone
intervention type: Drug
intervention name: fentanyl
description: 1ug/kg intravenously
arm group label: patients with fentanyl
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Qiu Zhao, MD, PhD
phone: 13971605755
email: zhaoqiuwhugi@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Changhai Hospital
investigator full name: fangjun
investigator title: physician
mesh term: Fentanyl
mesh term: Oxycodone