<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/NCT03764202</url>
  </required_header>
  <id_info>
    <org_study_id>WUWQNXM 2015-1-36</org_study_id>
    <nct_id>NCT03764202</nct_id>
  </id_info>
  <brief_title>Determination of Sufentanil in Breast Milk of Puerpera</brief_title>
  <official_title>Determination of Sufentanil in Breast Milk of Puerpera During Analgesia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fujian Medical University Union Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fujian Medical University Union Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To determination of sufentanil in human breast milk during the administration of the&#xD;
      sufentanil via the analgesic infusion pump and after the administration, to determine whether&#xD;
      the breastfeeding after clinical anesthetic or analgesic administration has an effect on the&#xD;
      infant and provide a reference for the security issues.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The concentration of sufentanil in milk was determined by LC-MS /MS method( liquid&#xD;
      chromatography mass spectrometry).The separation was carried on Agilent ZORBAX Eclipse Plus&#xD;
      C18 column(2.1×50 mm, 3.5 μm)with a mobile phase of 10 mmol ammonium formate(A)and&#xD;
      methanol(B), and the elution conditions were optimized as follows：linear gradient 0→0.30 min,&#xD;
      A:B=50:50; 0.30→0.31 min, A:B=50:50→10:90; 3.00→3.10 min, A:B=10:90→50:50; 3.1→6.5min,&#xD;
      A:B=50:50; The flowing rate was 0.2 mL•min-1, column temperature was 30 ℃, injection volume&#xD;
      was 5 μL. ESI source was applied and operated in positive ion mode. Quantitative&#xD;
      determination was performed using multiple reaction monitoring (MRM) of m/z 387.2 → m/z 238.2&#xD;
      for sufentanil, and m/z 337.2 → m/z 158.2 for fentanyl.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2015</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">October 2017</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-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>The concentration of sufentanil in human breast milk</measure>
    <time_frame>1 year</time_frame>
    <description>The concentration of sufentanil in human breast milk was detected at each fixed time point</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The volume of human breast milk</measure>
    <time_frame>1 year</time_frame>
    <description>The volume of human breast milk was detected at each fixed time point</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The dose of sufentanil in human breast milk</measure>
    <time_frame>1 year</time_frame>
    <description>The amount of sufentanil in the milk multiplied by the concentration of sufentanil and the volume of milk at each fixed time point</description>
  </primary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Cesarean Section</condition>
  <arm_group>
    <arm_group_label>CSEA，1μg/kg•d</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The puerpera received combined spinal epidural anesthesia&#xD;
The dosage of sufentanil intravenous analgesia was 1 μg/kg•d</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CSEA，1.5μg/kg•d</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The puerpera received combined spinal epidural anesthesia&#xD;
The dosage of sufentanil intravenous analgesia was 1.5 μg/kg•d</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GA，1μg/kg•d</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The puerpera received general anesthesia&#xD;
The dosage of sufentanil intravenous analgesia was 1 μg/kg•d</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GA，1.5μg/kg•d</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The puerpera received general anesthesia&#xD;
The dosage of sufentanil intravenous analgesia was 1.5 μg/kg•d</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CSEA，Epidural analgesia</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The puerpera received combined spinal epidural anesthesia&#xD;
Postoperative analgesia was performed with epidural analgesia&#xD;
Speed of epidural analgesia pump ：6ml/h（0.1% ropivacaine , 0.5μg/ml sufentanil）</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Detection of sufentanil concentration</intervention_name>
    <description>Concentration of sufentanil in human breast milk was determined by LC-MS /MS method&#xD;
The volume of human breast milk was detected at each fixed time point</description>
    <arm_group_label>CSEA，1.5μg/kg•d</arm_group_label>
    <arm_group_label>CSEA，1μg/kg•d</arm_group_label>
    <arm_group_label>CSEA，Epidural analgesia</arm_group_label>
    <arm_group_label>GA，1.5μg/kg•d</arm_group_label>
    <arm_group_label>GA，1μg/kg•d</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 20yr to 38yr&#xD;
&#xD;
          -  Height 155~170 cm&#xD;
&#xD;
          -  Weight 65~85 Kg&#xD;
&#xD;
          -  American Society of Anesthesiologists statuses I or II&#xD;
&#xD;
          -  Normal cardiac and pulmonary function&#xD;
&#xD;
          -  Undergoing elective Cesarean section&#xD;
&#xD;
          -  Willing to provide breast milk&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy induced hypertension&#xD;
&#xD;
          -  gestational diabetes&#xD;
&#xD;
          -  gestational heart disease&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>38 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zhang liangcheng, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fujian Medical University Union Hospital</affiliation>
  </overall_official>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 25, 2018</study_first_submitted>
  <study_first_submitted_qc>December 2, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>December 2, 2018</last_update_submitted>
  <last_update_submitted_qc>December 2, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sufentanil</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/NCT03764202
org study id: WUWQNXM 2015-1-36
nct id: NCT03764202
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To determination of sufentanil in human breast milk during the administration of the
      sufentanil via the analgesic infusion pump and after the administration, to determine whether
      the breastfeeding after clinical anesthetic or analgesic administration has an effect on the
      infant and provide a reference for the security issues.
The concentration of sufentanil in milk was determined by LC-MS /MS method( liquid
      chromatography mass spectrometry).The separation was carried on Agilent ZORBAX Eclipse Plus
      C18 column(2.1×50 mm, 3.5 μm)with a mobile phase of 10 mmol ammonium formate(A)and
      methanol(B), and the elution conditions were optimized as follows：linear gradient 0→0.30 min,
      A:B=50:50; 0.30→0.31 min, A:B=50:50→10:90; 3.00→3.10 min, A:B=10:90→50:50; 3.1→6.5min,
      A:B=50:50; The flowing rate was 0.2 mL•min-1, column temperature was 30 ℃, injection volume
      was 5 μL. ESI source was applied and operated in positive ion mode. Quantitative
      determination was performed using multiple reaction monitoring (MRM) of m/z 387.2 → m/z 238.2
      for sufentanil, and m/z 337.2 → m/z 158.2 for fentanyl.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: The concentration of sufentanil in human breast milk
time frame: 1 year
description: The concentration of sufentanil in human breast milk was detected at each fixed time point
measure: The volume of human breast milk
time frame: 1 year
description: The volume of human breast milk was detected at each fixed time point
measure: The dose of sufentanil in human breast milk
time frame: 1 year
description: The amount of sufentanil in the milk multiplied by the concentration of sufentanil and the volume of milk at each fixed time point
arm group label: CSEA，1μg/kg•d
arm group type: Other
description: The puerpera received combined spinal epidural anesthesia
The dosage of sufentanil intravenous analgesia was 1 μg/kg•d
arm group label: CSEA，1.5μg/kg•d
arm group type: Other
description: The puerpera received combined spinal epidural anesthesia
The dosage of sufentanil intravenous analgesia was 1.5 μg/kg•d
arm group label: GA，1μg/kg•d
arm group type: Other
description: The puerpera received general anesthesia
The dosage of sufentanil intravenous analgesia was 1 μg/kg•d
arm group label: GA，1.5μg/kg•d
arm group type: Other
description: The puerpera received general anesthesia
The dosage of sufentanil intravenous analgesia was 1.5 μg/kg•d
arm group label: CSEA，Epidural analgesia
arm group type: Other
description: The puerpera received combined spinal epidural anesthesia
Postoperative analgesia was performed with epidural analgesia
Speed of epidural analgesia pump ：6ml/h（0.1% ropivacaine , 0.5μg/ml sufentanil）
intervention type: Other
intervention name: Detection of sufentanil concentration
description: Concentration of sufentanil in human breast milk was determined by LC-MS /MS method
The volume of human breast milk was detected at each fixed time point
arm group label: CSEA，1.5μg/kg•d
arm group label: CSEA，1μg/kg•d
arm group label: CSEA，Epidural analgesia
arm group label: GA，1.5μg/kg•d
arm group label: GA，1μg/kg•d
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 38 Years
healthy volunteers: No
last name: Zhang liangcheng, M.D.
role: Principal Investigator
affiliation: Fujian Medical University Union Hospital
responsible party type: Sponsor
mesh term: Sufentanil