Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-28 @ 11:15 PM
Study NCT ID:
NCT04253093
Status:
UNKNOWN
Last Update Posted:
2020-02-05
First Post:
2020-01-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Rocuronium Induced Neuromuscular Blockade in Late Second Trimester Pregnant and Non-pregnant Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2020-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-01-31', 'studyFirstSubmitDate': '2020-01-29', 'studyFirstSubmitQcDate': '2020-01-31', 'lastUpdatePostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'duration of rocuronium', 'timeFrame': 'time measured to 25% recovery with T1 using Train of Four watch, assessed upto 1 hour', 'description': 'time measured with TOFwatch-SX'}], 'secondaryOutcomes': [{'measure': 'onset of rocuronium', 'timeFrame': 'time measured to 0% depression of T1 using Train of Four watch, assessed upto 5 minutes', 'description': 'time measured with TOFwatch-SX'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pregnancy Related']}, 'descriptionModule': {'briefSummary': 'The present study is to compare the onset and duration of rocuronium in late second trimester women and non-pregnant women undergoing general anesthesia.', 'detailedDescription': 'Pregnancy induces physiological changes. Plasma volume, cardiac output, hepatic blood flow and protein binding are changed from the first trimester of pregnancy. These physiological changes give effect to the onset and duration of neuromuscular blocking drugs.\n\nRocuronium is a commonly used neuromuscular blocking drug categorized as FDA category B. Rocuronium is widely used for pregnant women. Previous studies have evaluated the onset and duration of rocuronium in postpartum women. Lately, the investigators have evaluated the onset and duration of rocuronium in early second trimester pregnant women and the duration was significantly longer in early second trimester women compared to non-pregnant women.\n\nSince there is little research on the onset and duration of rocuronium in the late second trimester pregnant women, the investigators planned the present research.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'case: late second trimester pregnant women undergoing general anesthesia control: non-pregnant women undergoing general anesthesia', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women undergoing general anesthesia\n\nExclusion Criteria:\n\n* liver disease\n* renal disease\n* diabetes mellitus\n* asthma\n* allergic to specific drugs\n* BMI\\>30 or \\<18'}, 'identificationModule': {'nctId': 'NCT04253093', 'briefTitle': 'Comparison of Rocuronium Induced Neuromuscular Blockade in Late Second Trimester Pregnant and Non-pregnant Women', 'organization': {'class': 'OTHER', 'fullName': 'Hallym University Kangnam Sacred Heart Hospital'}, 'officialTitle': 'Comparison of Rocuronium Induced Neuromuscular Blockade in Late Second Trimester Pregnant and Non-pregnant Women', 'orgStudyIdInfo': {'id': '2019-05-008'}}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jun In-Jung', 'role': 'CONTACT'}], 'facility': 'Kangnam sungshim hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'InJung Jun', 'role': 'CONTACT', 'email': 'christine17@hanmail.net', 'phone': '82-10-9312-0162'}], 'overallOfficials': [{'name': 'Eunmi Choi', 'role': 'STUDY_CHAIR', 'affiliation': 'professor'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hallym University Kangnam Sacred Heart Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Choi Eun MI', 'investigatorAffiliation': 'Hallym University Kangnam Sacred Heart Hospital'}}}}