NCT03764202

Determination of Sufentanil in Breast Milk of Puerpera

Determination of Sufentanil in Breast Milk of Puerpera During Analgesia

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Fujian Medical University Union Hospital · Academic / Other
• Sex: Female
• Age: 20 Years – 38 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cesarean Section

Interventions

Type	Name	Description
OTHER	Detection 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

Timeline

• Start date: 2015-08-01
• Primary completion: 2017-10-01
• Completion: 2017-12-01
• First posted: 2018-12-05
• Last updated: 2018-12-05