Determination of Sufentanil in Breast Milk of Puerpera

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Determination of Sufentanil in Breast Milk of Puerpera During Analgesia

Conditions
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Cesarean Section

Intervention / Treatment
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* Other: Detection of sufentanil concentration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 38 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: CSEA，1μg/kg•d<br>The puerpera received combined spinal epidural anesthesia The dosage of sufentanil intravenous analgesia was 1 μg/kg•d | Other: Detection of sufentanil concentration<br>* 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<br>|
| Other: CSEA，1.5μg/kg•d<br>The puerpera received combined spinal epidural anesthesia The dosage of sufentanil intravenous analgesia was 1.5 μg/kg•d | Other: Detection of sufentanil concentration<br>* 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<br>|
| Other: GA，1μg/kg•d<br>The puerpera received general anesthesia The dosage of sufentanil intravenous analgesia was 1 μg/kg•d | Other: Detection of sufentanil concentration<br>* 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<br>|
| Other: GA，1.5μg/kg•d<br>The puerpera received general anesthesia The dosage of sufentanil intravenous analgesia was 1.5 μg/kg•d | Other: Detection of sufentanil concentration<br>* 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<br>|
| Other: CSEA，Epidural analgesia<br>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） | Other: Detection of sufentanil concentration<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The concentration of sufentanil in human breast milk | The concentration of sufentanil in human breast milk was detected at each fixed time point | 1 year | 
| The volume of human breast milk | The volume of human breast milk was detected at each fixed time point | 1 year | 
| The dose of sufentanil in human breast milk | The amount of sufentanil in the milk multiplied by the concentration of sufentanil and the volume of milk at each fixed time point | 1 year |