Determination of Sufentanil in Breast Milk of Puerpera

Determination of Sufentanil in Breast Milk of Puerpera During Analgesia

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.

Study Overview

• Status: Completed
• Conditions: Cesarean Section
• Intervention / Treatment: Other: Detection of sufentanil concentration

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: CSEA，1μg/kg•d; The puerpera received combined spinal epidural anesthesia; The dosage of sufentanil intravenous analgesia was 1 μg/kg•d	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
Other: CSEA，1.5μg/kg•d; The puerpera received combined spinal epidural anesthesia; The dosage of sufentanil intravenous analgesia was 1.5 μg/kg•d	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
Other: GA，1μg/kg•d; The puerpera received general anesthesia; The dosage of sufentanil intravenous analgesia was 1 μg/kg•d	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
Other: GA，1.5μg/kg•d; The puerpera received general anesthesia; The dosage of sufentanil intravenous analgesia was 1.5 μg/kg•d	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
Other: CSEA，Epidural analgesia; The puerpera received combined spinal epidural anesthesia; Postoperative analgesia was performed with epidural analgesia; Speed of epidural analgesia pump ：6ml/h（0.1% ropivacaine , 0.5μg/ml sufentanil）	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
The volume of human breast milk	The volume of human breast milk was detected at each fixed time point	1 year
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

Collaborators and Investigators

• Sponsor: Fujian Medical University Union Hospital
• Investigators: Principal Investigator: Zhang liangcheng, M.D., Fujian Medical University Union Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2015
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: November 25, 2018
• First Submitted That Met QC Criteria: December 2, 2018
• First Posted (Actual): December 5, 2018

Study Record Updates

• Last Update Posted (Actual): December 5, 2018
• Last Update Submitted That Met QC Criteria: December 2, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Sufentanil
• Other Study ID Numbers: WUWQNXM 2015-1-36

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No