Determination of Sufentanil in Breast Milk of Puerpera

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2017-12-31

Brief Summary

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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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Detailed Description

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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

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Cesarean Section

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Intervention Type 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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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