Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 3:00 AM
Study NCT ID:
NCT03764202
Status:
COMPLETED
Last Update Posted:
2018-12-05
First Post:
2018-11-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Determination of Sufentanil in Breast Milk of Puerpera
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-02', 'studyFirstSubmitDate': '2018-11-25', 'studyFirstSubmitQcDate': '2018-12-02', 'lastUpdatePostDateStruct': {'date': '2018-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The concentration of sufentanil in human breast milk', 'timeFrame': '1 year', 'description': 'The concentration of sufentanil in human breast milk was detected at each fixed time point'}, {'measure': 'The volume of human breast milk', 'timeFrame': '1 year', 'description': 'The volume of human breast milk was detected at each fixed time point'}, {'measure': 'The dose of sufentanil in human breast milk', 'timeFrame': '1 year', 'description': 'The amount of sufentanil in the milk multiplied by the concentration of sufentanil and the volume of milk at each fixed time point'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cesarean Section']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '38 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 20yr to 38yr\n* Height 155\\~170 cm\n* Weight 65\\~85 Kg\n* American Society of Anesthesiologists statuses I or II\n* Normal cardiac and pulmonary function\n* Undergoing elective Cesarean section\n* Willing to provide breast milk\n\nExclusion Criteria:\n\n* pregnancy induced hypertension\n* gestational diabetes\n* gestational heart disease'}, 'identificationModule': {'nctId': 'NCT03764202', 'briefTitle': 'Determination of Sufentanil in Breast Milk of Puerpera', 'organization': {'class': 'OTHER', 'fullName': 'Fujian Medical University Union Hospital'}, 'officialTitle': 'Determination of Sufentanil in Breast Milk of Puerpera During Analgesia', 'orgStudyIdInfo': {'id': 'WUWQNXM 2015-1-36'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'CSEA，1μg/kg•d', 'description': '* The puerpera received combined spinal epidural anesthesia\n* The dosage of sufentanil intravenous analgesia was 1 μg/kg•d', 'interventionNames': ['Other: Detection of sufentanil concentration']}, {'type': 'OTHER', 'label': 'CSEA，1.5μg/kg•d', 'description': '* The puerpera received combined spinal epidural anesthesia\n* The dosage of sufentanil intravenous analgesia was 1.5 μg/kg•d', 'interventionNames': ['Other: Detection of sufentanil concentration']}, {'type': 'OTHER', 'label': 'GA，1μg/kg•d', 'description': '* The puerpera received general anesthesia\n* The dosage of sufentanil intravenous analgesia was 1 μg/kg•d', 'interventionNames': ['Other: Detection of sufentanil concentration']}, {'type': 'OTHER', 'label': 'GA，1.5μg/kg•d', 'description': '* The puerpera received general anesthesia\n* The dosage of sufentanil intravenous analgesia was 1.5 μg/kg•d', 'interventionNames': ['Other: Detection of sufentanil concentration']}, {'type': 'OTHER', 'label': 'CSEA，Epidural analgesia', 'description': '* The puerpera received combined spinal epidural anesthesia\n* Postoperative analgesia was performed with epidural analgesia\n* Speed of epidural analgesia pump ：6ml/h（0.1% ropivacaine , 0.5μg/ml sufentanil）', 'interventionNames': ['Other: Detection of sufentanil concentration']}], 'interventions': [{'name': 'Detection of sufentanil concentration', 'type': 'OTHER', 'description': '* Concentration of sufentanil in human breast milk was determined by LC-MS /MS method\n* The volume of human breast milk was detected at each fixed time point', 'armGroupLabels': ['CSEA，1.5μg/kg•d', 'CSEA，1μg/kg•d', 'CSEA，Epidural analgesia', 'GA，1.5μg/kg•d', 'GA，1μg/kg•d']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Zhang liangcheng, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fujian Medical University Union Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fujian Medical University Union Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}