Determination of Sufentanil in Breast Milk of Puerpera
1 other identifier
interventional
100
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Aug 2015
Typical duration for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedFirst Submitted
Initial submission to the registry
November 25, 2018
CompletedFirst Posted
Study publicly available on registry
December 5, 2018
CompletedDecember 5, 2018
November 1, 2018
2.2 years
November 25, 2018
December 2, 2018
Conditions
Outcome Measures
Primary Outcomes (3)
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
Study Arms (5)
CSEA，1μg/kg•d
OTHER* The puerpera received combined spinal epidural anesthesia * The dosage of sufentanil intravenous analgesia was 1 μg/kg•d
CSEA，1.5μg/kg•d
OTHER* The puerpera received combined spinal epidural anesthesia * The dosage of sufentanil intravenous analgesia was 1.5 μg/kg•d
GA，1μg/kg•d
OTHER* The puerpera received general anesthesia * The dosage of sufentanil intravenous analgesia was 1 μg/kg•d
GA，1.5μg/kg•d
OTHER* The puerpera received general anesthesia * The dosage of sufentanil intravenous analgesia was 1.5 μg/kg•d
CSEA，Epidural analgesia
OTHER* 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）
Interventions
* 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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- pregnancy induced hypertension
- gestational diabetes
- gestational heart disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Officials
- PRINCIPAL INVESTIGATOR
Zhang liangcheng, M.D.
Fujian Medical University Union Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 25, 2018
First Posted
December 5, 2018
Study Start
August 1, 2015
Primary Completion
October 1, 2017
Study Completion
December 1, 2017
Last Updated
December 5, 2018
Record last verified: 2018-11