Determination of Sufentanil in Breast Milk of Puerpera

Overview

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.

Full Title of Study: “Determination of Sufentanil in Breast Milk of Puerpera During Analgesia”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2017

Detailed Description

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.

Interventions

  • Other: Detection of sufentanil concentration
    • 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

Arms, Groups and Cohorts

  • Other: CSEA,1μg/kg•d
    • The puerpera received combined spinal epidural anesthesia The dosage of sufentanil intravenous analgesia was 1 μg/kg•d
  • Other: CSEA,1.5μg/kg•d
    • The puerpera received combined spinal epidural anesthesia The dosage of sufentanil intravenous analgesia was 1.5 μg/kg•d
  • Other: GA,1μg/kg•d
    • The puerpera received general anesthesia The dosage of sufentanil intravenous analgesia was 1 μg/kg•d
  • Other: GA,1.5μg/kg•d
    • The puerpera received general anesthesia The dosage of sufentanil intravenous analgesia was 1.5 μg/kg•d
  • Other: CSEA,Epidural analgesia
    • 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)

Clinical Trial Outcome Measures

Primary Measures

  • The concentration of sufentanil in human breast milk
    • Time Frame: 1 year
    • The concentration of sufentanil in human breast milk was detected at each fixed time point
  • The volume of human breast milk
    • Time Frame: 1 year
    • The volume of human breast milk was detected at each fixed time point
  • The dose of sufentanil in human breast milk
    • Time Frame: 1 year
    • The amount of sufentanil in the milk multiplied by the concentration of sufentanil and the volume of milk at each fixed time point

Participating in This Clinical Trial

Inclusion Criteria

  • Aged 20yr to 38yr – Height 155~170 cm – Weight 65~85 Kg – American Society of Anesthesiologists statuses I or II – Normal cardiac and pulmonary function – Undergoing elective Cesarean section – Willing to provide breast milk Exclusion Criteria:

  • pregnancy induced hypertension – gestational diabetes – gestational heart disease

Gender Eligibility: Female

Minimum Age: 20 Years

Maximum Age: 38 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fujian Medical University Union Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Zhang liangcheng, M.D., Principal Investigator, Fujian Medical University Union Hospital

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