Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-29 @ 2:24 AM
Study NCT ID:
NCT04688268
Status:
UNKNOWN
Last Update Posted:
2020-12-30
First Post:
2020-12-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dose for Deep Neuromuscular Blockade Deciding Factor of Neuromuscular Blocker Dose for Deep Neuromuscular Blockade
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-01-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2021-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-28', 'studyFirstSubmitDate': '2020-12-23', 'studyFirstSubmitQcDate': '2020-12-23', 'lastUpdatePostDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the highest correlation coefficient', 'timeFrame': 'preoperative 1 days to postoperative 1 days', 'description': 'the relationship of rocuronium for deep neuromuscular blockade and 8 factors (corrected body weight, ideal body weight, lean body weight, fat-free mass, body mass index, skeletal muscle mass, body fat)'}], 'secondaryOutcomes': [{'measure': 'onset time of rocuronium', 'timeFrame': 'preoperative 1 days to postoperative 1 days', 'description': 'time from injection of rocuronium 0.6 mg/kg(TBW) to TOF ratio is less than 0.05'}, {'measure': 'Time to deep neuromuscular blockade', 'timeFrame': 'preoperative 1 days to postoperative 1 days', 'description': 'time from injection of rocuronium 0.6 mg/kg(TBW) to PTC 1'}, {'measure': 'Recovery time', 'timeFrame': 'preoperative 1 days to postoperative 1 days', 'description': 'time from sugammadex injection to TOF ratio \\> 0.9'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['laparoscopic surgery', 'deep neuromuscular blockade'], 'conditions': ['Laparoscopic Surgery']}, 'referencesModule': {'references': [{'pmid': '30719949', 'type': 'BACKGROUND', 'citation': 'Choi YJ, Hee Kim Y, Bae GE, Yu JH, Yoon SZ, Kang HW, Lee KS, Kim JH, Lee YS. Relationship between the muscle relaxation effect and body muscle mass measured using bioelectrical impedance analysis: A nonrandomized controlled trial. J Int Med Res. 2019 Apr;47(4):1521-1532. doi: 10.1177/0300060518822197. Epub 2019 Feb 5.'}]}, 'descriptionModule': {'briefSummary': 'Find out the deciding factor(total body weight, corrected body weight, ideal body weight, fat-free mass, body mass index, skeletal muscle mass, body fat) of neuromuscular blocker dose for deep neuromuscular blockade.', 'detailedDescription': 'Before the surgery, total body weight, corrected body weight, ideal body weight, fat-free mass, body mass index were measured by height and weight and skeletal muscle mass and body fat were measured by Bioelectrical impedance analysis (InbodyH20N). Find the highest correlation between the 8 factors (total body weight, corrected body weight, ideal body weight, fat-free mass, body mass index, skeletal muscle mass, body fat) and the amount of rocuronium administered to deep neuromuscular blockade.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients aged 20-80 and American Society of Anesthesiology Physical Grade (ASA) I-II, who undergo laparoscopic surgery for at least 2 hours under general anesthesia.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients aged 20-80 and American Society of Anesthesiology Physical Grade (ASA) I-II, who undergo laparoscopic surgery for at least 2 hours under general anesthesia\n\nExclusion Criteria:\n\n* kidney disease (GFR\\<60)\n* allergy to study drugs\n* decline participation\n* side effect of propofol and remifentanil\n* when anesthesia does not maintain the level of alertness (BIS) below 60 even when the anesthetic dose is increased, or when hemodynamic instability such as bradycardia and hypotension appears'}, 'identificationModule': {'nctId': 'NCT04688268', 'briefTitle': 'Dose for Deep Neuromuscular Blockade Deciding Factor of Neuromuscular Blocker Dose for Deep Neuromuscular Blockade', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Bundang Hospital'}, 'officialTitle': 'Find Out the Deciding Factor of Neuromuscular Blocker Dose for Deep Neuromuscular Blockade', 'orgStudyIdInfo': {'id': 'B-2008/633-302'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'deep neuromuscular blockade', 'description': 'patients who underwent surgery with deep neuromuscular blockade', 'interventionNames': ['Drug: deep neuromuscular blockade']}], 'interventions': [{'name': 'deep neuromuscular blockade', 'type': 'DRUG', 'description': 'Train of Four=0/4, Post tetanic count 1-2', 'armGroupLabels': ['deep neuromuscular blockade']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jiwon Han, Dr', 'role': 'CONTACT', 'email': 'hanjiwon@snubh.org', 'phone': '82-10-3447-1988'}, {'name': 'Ah-young Oh, Dr', 'role': 'CONTACT', 'email': 'oay1@snubh.org', 'phone': '82-31-787-7506'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'JiWon Han', 'investigatorAffiliation': 'Seoul National University Bundang Hospital'}}}}