Determination of Sufentanil in Breast Milk of Puerpera

Cesarean Section Clinical Trial

Official title: Determination of Sufentanil in Breast Milk of Puerpera During Analgesia

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Cesarean Section

• NCT number: NCT03764202
• Study type: Interventional
• Source: Fujian Medical University Union Hospital
• Status: Completed
• Phase: Phase 4
• Start date: August 2015
• Completion date: December 2017