Determination of Sufentanil in Breast Milk of Puerpera
- Conditions
- Cesarean Section
- Interventions
- Other: Detection of sufentanil concentration
- Registration Number
- NCT03764202
- Lead Sponsor
- Fujian Medical University Union Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 100
- 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
- pregnancy induced hypertension
- gestational diabetes
- gestational heart disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CSEA，1.5μg/kg•d Detection of sufentanil concentration * The puerpera received combined spinal epidural anesthesia * The dosage of sufentanil intravenous analgesia was 1.5 μg/kg•d CSEA，1μg/kg•d Detection of sufentanil concentration * The puerpera received combined spinal epidural anesthesia * The dosage of sufentanil intravenous analgesia was 1 μg/kg•d GA，1.5μg/kg•d Detection of sufentanil concentration * The puerpera received general anesthesia * The dosage of sufentanil intravenous analgesia was 1.5 μg/kg•d GA，1μg/kg•d Detection of sufentanil concentration * The puerpera received general anesthesia * The dosage of sufentanil intravenous analgesia was 1 μg/kg•d CSEA，Epidural analgesia Detection of sufentanil concentration * 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）
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method