Determination of Sufentanil in Breast Milk of Puerpera

Cesarean Section Clinical Trial

Official title:

Determination of Sufentanil in Breast Milk of Puerpera During Analgesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03764202
• Other study ID #: WUWQNXM 2015-1-36
• Status: Completed
• Phase: Phase 4
• Start date: August 2015
• Est. completion date: December 2017

Study information

• Verified date: November 2018
• Source: Fujian Medical University Union Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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 information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 38 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Medical University Union Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The concentration of sufentanil in human breast milk	The concentration of sufentanil in human breast milk was detected at each fixed time point	1 year
Primary	The volume of human breast milk	The volume of human breast milk was detected at each fixed time point	1 year
Primary	The dose of sufentanil in human breast milk	The amount of sufentanil in the milk multiplied by the concentration of sufentanil and the volume of milk at each fixed time point	1 year