<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/NCT03817359</url>
  </required_header>
  <id_info>
    <org_study_id>2-107-05-079</org_study_id>
    <nct_id>NCT03817359</nct_id>
  </id_info>
  <brief_title>Use of a Remifentanil-propofol Mixture in Patients Undergoing Breast Cancer Surgery</brief_title>
  <official_title>Use of a Remifentanil-propofol Mixture in Patients With Breast Cancer Undergoing Breast Cancer Surgery: a Prospective Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tri-Service General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tri-Service General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Co-administration of propofol and remifentanil is considered to be an ideal total intravenous&#xD;
      anesthesia technique, which is widely used in induction and maintenance of general&#xD;
      anesthesia. Remifentanil and propofol can be mixed in polypropylene syringes for one hour&#xD;
      with a remaining concentration of 91% in small concentrations of remifentanil. However,&#xD;
      delivery of remifentanil-propofol mixture by target-controlled infusion(TCI) for general&#xD;
      anesthesia in surgical procedure has not been described. Breast cancer surgery ( including&#xD;
      modified radical mastectomy and breast-conserving surgery) is a less time-consuming procedure&#xD;
      for patients with breast cancer with one-hour duration in our hospital. This pilot study was&#xD;
      to examine the merit of remifentanil-propofol mixture as a GA regimen for breast cancer&#xD;
      surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Previous studies has described the feasibility and safety of remifentanil-propofol mixture&#xD;
      use in sedation of pediatric patients undergoing magnetic resonance imaging or flexible&#xD;
      fiberoptic bronchoscopy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 3, 2018</start_date>
  <completion_date type="Actual">December 27, 2018</completion_date>
  <primary_completion_date type="Actual">December 27, 2018</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>
    <intervention_model_description>84 patients scheduled for breast cancer surgery were randomly allocated to receive TIVA with propofol and remifentanil separately by two TCI pump (Separate group) or with remifentanil-propofol mixture by single TCI pump (Mix group), all TCI concentration adjustments during operation were based on BIS and ANI monitor.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Frequency of TCI device adjustments</measure>
    <time_frame>during procedure</time_frame>
    <description>Total times of TCI pump adjustment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean blood pressure</measure>
    <time_frame>at 5 minute intervals perioperatively throughout the procedure in an average of 60 minutes</time_frame>
    <description>measured by non-invasive blood pressure cuff</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate</measure>
    <time_frame>at 5 minute intervals perioperatively throughout the procedure in an average of 60 minutes</time_frame>
    <description>recorded by ECG and pulse oximetry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction</measure>
    <time_frame>the 1 day after operation</time_frame>
    <description>Rating of satisfaction by questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>postoperative analgesia rescue</measure>
    <time_frame>An average of 30 minutes after arriving at PACU</time_frame>
    <description>Analgesics use during PACU stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total dose of remifentanil</measure>
    <time_frame>At the end of surgery</time_frame>
    <description>total consumption of remifentanil during procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total dose of propofol</measure>
    <time_frame>At the end of surgery</time_frame>
    <description>total consumption of propofol during procedure</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">84</enrollment>
  <condition>Anesthetics</condition>
  <condition>Remifentanil</condition>
  <condition>Propofol</condition>
  <arm_group>
    <arm_group_label>Mix infusion using single TCI pump</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>participants receive total intravenous anesthesia with remifentanil-propofol mixture by single TCI pump infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Separate infusion using two TCI pumps</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>participants receive total intravenous anesthesia with remifentanil and propofol separately by two TCI pumps infusion</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Remifentanil-propofol mixture</intervention_name>
    <description>Participants receive total intravenous anesthesia with remifentanil-propofol mixture by single TCI pump in intervention group. All TCI target concentration adjustments or extra bolus of propofol or remifentanil during operation were based on BIS and ANI monitor.</description>
    <arm_group_label>Mix infusion using single TCI pump</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA II or III&#xD;
&#xD;
          -  age more than 18 years&#xD;
&#xD;
          -  scheduled for breast cancer surgery under general anesthesia.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previously allergic to propofol or remifentanil&#xD;
&#xD;
          -  combining other surgical procedure leading to extended operative time&#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>Zhi-Fu Wu, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Anesthesiology, Tri-Service General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tri-Service General hospital</name>
      <address>
        <city>Taipei</city>
        <zip>114</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <results_reference>
    <citation>Bedocs P, Evers DL, Buckenmaier CC 3rd. Predosing Chemical Stability of Admixtures of Propofol, Ketamine, Fentanyl, and Remifentanil. Anesth Analg. 2019 Jul;129(1):e13-e15. doi: 10.1213/ANE.0000000000003772.</citation>
    <PMID>30286006</PMID>
  </results_reference>
  <results_reference>
    <citation>Berkenbosch JW, Graff GR, Stark JM, Ner Z, Tobias JD. Use of a remifentanil-propofol mixture for pediatric flexible fiberoptic bronchoscopy sedation. Paediatr Anaesth. 2004 Nov;14(11):941-6. doi: 10.1111/j.1460-9592.2004.01355.x.</citation>
    <PMID>15500495</PMID>
  </results_reference>
  <results_reference>
    <citation>Stewart JT, Warren FW, Maddox FC, Viswanathan K, Fox JL. The stability of remifentanil hydrochloride and propofol mixtures in polypropylene syringes and polyvinylchloride bags at 22 degrees-24 degrees C. Anesth Analg. 2000 Jun;90(6):1450-1. doi: 10.1097/00000539-200006000-00037.</citation>
    <PMID>10825339</PMID>
  </results_reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 19, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>January 28, 2019</last_update_submitted>
  <last_update_submitted_qc>January 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tri-Service General Hospital</investigator_affiliation>
    <investigator_full_name>Meng-Fu Lai</investigator_full_name>
    <investigator_title>Resident physician</investigator_title>
  </responsible_party>
  <keyword>propofol</keyword>
  <keyword>remifentanil</keyword>
  <keyword>total intravenous anesthesia</keyword>
  <keyword>breast surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Remifentanil</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/NCT03817359
org study id: 2-107-05-079
nct id: NCT03817359
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Co-administration of propofol and remifentanil is considered to be an ideal total intravenous
      anesthesia technique, which is widely used in induction and maintenance of general
      anesthesia. Remifentanil and propofol can be mixed in polypropylene syringes for one hour
      with a remaining concentration of 91% in small concentrations of remifentanil. However,
      delivery of remifentanil-propofol mixture by target-controlled infusion(TCI) for general
      anesthesia in surgical procedure has not been described. Breast cancer surgery ( including
      modified radical mastectomy and breast-conserving surgery) is a less time-consuming procedure
      for patients with breast cancer with one-hour duration in our hospital. This pilot study was
      to examine the merit of remifentanil-propofol mixture as a GA regimen for breast cancer
      surgery.
Previous studies has described the feasibility and safety of remifentanil-propofol mixture
      use in sedation of pediatric patients undergoing magnetic resonance imaging or flexible
      fiberoptic bronchoscopy.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 84 patients scheduled for breast cancer surgery were randomly allocated to receive TIVA with propofol and remifentanil separately by two TCI pump (Separate group) or with remifentanil-propofol mixture by single TCI pump (Mix group), all TCI concentration adjustments during operation were based on BIS and ANI monitor.
primary purpose: Treatment
masking: Single (Participant)
measure: Frequency of TCI device adjustments
time frame: during procedure
description: Total times of TCI pump adjustment
measure: Mean blood pressure
time frame: at 5 minute intervals perioperatively throughout the procedure in an average of 60 minutes
description: measured by non-invasive blood pressure cuff
measure: Heart rate
time frame: at 5 minute intervals perioperatively throughout the procedure in an average of 60 minutes
description: recorded by ECG and pulse oximetry
measure: Patient satisfaction
time frame: the 1 day after operation
description: Rating of satisfaction by questionnaire
measure: postoperative analgesia rescue
time frame: An average of 30 minutes after arriving at PACU
description: Analgesics use during PACU stay
measure: Total dose of remifentanil
time frame: At the end of surgery
description: total consumption of remifentanil during procedure
measure: Total dose of propofol
time frame: At the end of surgery
description: total consumption of propofol during procedure
arm group label: Mix infusion using single TCI pump
arm group type: Experimental
description: participants receive total intravenous anesthesia with remifentanil-propofol mixture by single TCI pump infusion
arm group label: Separate infusion using two TCI pumps
arm group type: No Intervention
description: participants receive total intravenous anesthesia with remifentanil and propofol separately by two TCI pumps infusion
intervention type: Combination Product
intervention name: Remifentanil-propofol mixture
description: Participants receive total intravenous anesthesia with remifentanil-propofol mixture by single TCI pump in intervention group. All TCI target concentration adjustments or extra bolus of propofol or remifentanil during operation were based on BIS and ANI monitor.
arm group label: Mix infusion using single TCI pump
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Zhi-Fu Wu, M.D.
role: Principal Investigator
affiliation: Department of Anesthesiology, Tri-Service General Hospital
facility: 
country: Taiwan
citation: Bedocs P, Evers DL, Buckenmaier CC 3rd. Predosing Chemical Stability of Admixtures of Propofol, Ketamine, Fentanyl, and Remifentanil. Anesth Analg. 2019 Jul;129(1):e13-e15. doi: 10.1213/ANE.0000000000003772.
PMID: 30286006
citation: Berkenbosch JW, Graff GR, Stark JM, Ner Z, Tobias JD. Use of a remifentanil-propofol mixture for pediatric flexible fiberoptic bronchoscopy sedation. Paediatr Anaesth. 2004 Nov;14(11):941-6. doi: 10.1111/j.1460-9592.2004.01355.x.
PMID: 15500495
citation: Stewart JT, Warren FW, Maddox FC, Viswanathan K, Fox JL. The stability of remifentanil hydrochloride and propofol mixtures in polypropylene syringes and polyvinylchloride bags at 22 degrees-24 degrees C. Anesth Analg. 2000 Jun;90(6):1450-1. doi: 10.1097/00000539-200006000-00037.
PMID: 10825339
responsible party type: Principal Investigator
investigator affiliation: Tri-Service General Hospital
investigator full name: Meng-Fu Lai
investigator title: Resident physician
mesh term: Breast Neoplasms
mesh term: Remifentanil
mesh term: Propofol
sharing ipd: Undecided