Determination of Sufentanil in Breast Milk of Puerpera

Fujian Medical University (FJMU)

Status and phase: Completed; Phase 4

Conditions: Cesarean Section

Treatments: Other: Detection of sufentanil concentration

Study type: Interventional

Funder types: Other

Identifiers

NCT03764202

WUWQNXM 2015-1-36

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: Female

Ages: 20 to 38 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 5 patient groups

CSEA，1μg/kg•d

Other group

Description:

* The puerpera received combined spinal epidural anesthesia * The dosage of sufentanil intravenous analgesia was 1 μg/kg•d

Treatment:

Other: Detection of sufentanil concentration

CSEA，1.5μg/kg•d

Other group

Description:

* The puerpera received combined spinal epidural anesthesia * The dosage of sufentanil intravenous analgesia was 1.5 μg/kg•d

Treatment:

Other: Detection of sufentanil concentration

GA，1μg/kg•d

Other group

Description:

* The puerpera received general anesthesia * The dosage of sufentanil intravenous analgesia was 1 μg/kg•d

Treatment:

Other: Detection of sufentanil concentration

GA，1.5μg/kg•d

Other group

Description:

* The puerpera received general anesthesia * The dosage of sufentanil intravenous analgesia was 1.5 μg/kg•d

Treatment:

Other: Detection of sufentanil concentration

CSEA，Epidural analgesia

Other group

Description:

* 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）

Treatment:

Other: Detection of sufentanil concentration