Determination of Sufentanil in Breast Milk of Puerpera During Analgesia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 主要终点
- The concentration of sufentanil in human breast milk
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •pregnancy induced hypertension
- •gestational diabetes
- •gestational heart disease
研究组 & 干预措施
CSEA，1μg/kg•d
- The puerpera received combined spinal epidural anesthesia
- The dosage of sufentanil intravenous analgesia was 1 μg/kg•d
干预措施: Detection of sufentanil concentration (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
干预措施: Detection of sufentanil concentration (Other)
GA，1μg/kg•d
- The puerpera received general anesthesia
- The dosage of sufentanil intravenous analgesia was 1 μg/kg•d
干预措施: Detection of sufentanil concentration (Other)
GA，1.5μg/kg•d
- The puerpera received general anesthesia
- The dosage of sufentanil intravenous analgesia was 1.5 μg/kg•d
干预措施: Detection of sufentanil concentration (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）
干预措施: Detection of sufentanil concentration (Other)
结局指标
主要结局
The concentration of sufentanil in human breast milk
时间窗: 1 year
The concentration of sufentanil in human breast milk was detected at each fixed time point
The volume of human breast milk
时间窗: 1 year
The volume of human breast milk was detected at each fixed time point
The dose of sufentanil in human breast milk
时间窗: 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
次要结局
未报告次要终点