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Completed

NCT Number: NCT03764202

Determination of Sufentanil in Breast Milk of Puerpera

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.

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Key information

Conditions

Cesarean Section

Age range

20 year–38 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Detection of sufentanil concentration

Other
  • 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

Primary outcomes

  1. The concentration of sufentanil in human breast milk

    Time frame: 1 year

    The concentration of sufentanil in human breast milk was detected at each fixed time point

  2. The volume of human breast milk

    Time frame: 1 year

    The volume of human breast milk was detected at each fixed time point

  3. The dose of sufentanil in human breast milk

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Fujian Medical University Union Hospital

Other

Registry information

Official study title

Determination of Sufentanil in Breast Milk of Puerpera During Analgesia

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 5, 2018
Registry last updated
Dec 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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