Cesarean Section
Conditions
Brief summary
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
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
OTHERDetection 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
Sponsors
Fujian Medical University Union Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 38 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The concentration of sufentanil in human breast milk | 1 year | The concentration of sufentanil in human breast milk was detected at each fixed time point |
| The volume of human breast milk | 1 year | The volume of human breast milk was detected at each fixed time point |
| The dose of sufentanil in human breast milk | 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 |
Outcome results
None listed