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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
100
* 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
The concentration of sufentanil in human breast milk
The concentration of sufentanil in human breast milk was detected at each fixed time point
Time frame: 1 year
The volume of human breast milk
The volume of human breast milk was detected at each fixed time point
Time frame: 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
Time frame: 1 year
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