Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-03-13 @ 1:27 PM
Study NCT ID:
NCT04165057
Status:
UNKNOWN
Last Update Posted:
2019-11-15
First Post:
2019-11-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Optimal Muscle Tension Management During Laparoscopic Cholecystectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'Single Blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-14', 'studyFirstSubmitDate': '2019-11-03', 'studyFirstSubmitQcDate': '2019-11-14', 'lastUpdatePostDateStruct': {'date': '2019-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surgical condition', 'timeFrame': '5 minutes', 'description': 'Surgeon describe CO2 inflation condition by 4 point King Score (1-4).\n\n1. excellent\n2. good\n3. acceptable\n4. poor or unacceptable'}], 'secondaryOutcomes': [{'measure': 'Peak inspiratory pressure during surgery', 'timeFrame': '1 hour', 'description': 'Peak inspiratory pressure during surgery'}, {'measure': 'Mean blood pressure', 'timeFrame': 'Every 5 mins', 'description': 'Mean blood pressure during the CO2 inflation'}, {'measure': 'Total surgical time', 'timeFrame': '1 hour', 'description': 'Total surgical time'}, {'measure': 'Total Rocuronium doses during surgery', 'timeFrame': '1 hour', 'description': 'Total Rocuronium doses during surgery'}, {'measure': 'Pain score at Postoperative room', 'timeFrame': '1 hour', 'description': 'describe by 11 points Numeric rating scales (0-10). From 0 which means "no pain" to 10 means "worst pain"'}, {'measure': 'Heart Rate', 'timeFrame': 'every 5 mins', 'description': 'Every beat per minutes heart rate during CO2 inflation'}, {'measure': 'Respiratory complications', 'timeFrame': 'Every 5 mins', 'description': 'Record any respiratory complications including desaturations (\\<95%, more than 30 seconds, Rispiratory rate \\< 8), aspiration or airway obstruction'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Laparoscopic surgery', 'Optimal muscle tension', 'Neuromuscular monitoring', 'Neuromuscular blockade', 'Sugammadex'], 'conditions': ['Anesthesia']}, 'descriptionModule': {'briefSummary': 'Our study is intended to compare optimal muscle tension management or conventional anesthetic management in laparoscopic cholecystectomy about surgical condition during the surgery and other conditions after surgery at POR.', 'detailedDescription': 'This study is intended to recruit 70 patients undergoing laparoscopic cholecystectomy, whom will be randomized to receive optimal muscle tension management or conventional anesthetic management without optimal muscle tension management. Our primary hypothesis is that optimal muscle tension management provides improved surgical conditions and less intra-abdominal pressure required. The secondary endpoints include surgical duration, intraoperative complications, total amount of muscle relaxants, respiratory and hemodynamic changes during surgery, extubation time and any events during post-anesthetic recovery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 20\\~80 years old\n* ASA score : 1-2\n* Regular laparoscopic cholecystectomy\n\nExclusion Criteria:\n\n* Renal function impairement (eGFR \\< 60 ml/min/1.73m2) or ESRD\n* BMI \\< 18.5 kg/m2 or \\>30 kg/m2\n* History of other abdominal surgery\n* Allergy to rocuronium, cisatracurium, neostigmine or sugammadex\n* Emergent surgery\n* Convert to open cholecystectomy'}, 'identificationModule': {'nctId': 'NCT04165057', 'briefTitle': 'Efficacy and Safety of Optimal Muscle Tension Management During Laparoscopic Cholecystectomy', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital Hsin-Chu Branch'}, 'officialTitle': 'Efficacy and Safety of Optimal Muscle Tension Management During Laparoscopic Cholecystectomy - a Prospective Randomized Control Study', 'orgStudyIdInfo': {'id': '108-084-F'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group OMT', 'description': 'Optimal muscle tension management', 'interventionNames': ['Other: Optimal muscle tension management']}, {'type': 'NO_INTERVENTION', 'label': 'Group Control', 'description': 'Conventional anesthetic management'}], 'interventions': [{'name': 'Optimal muscle tension management', 'type': 'OTHER', 'description': 'including TOF monitor and reversal of neuromuscular blockade agent : sugammadex', 'armGroupLabels': ['Group OMT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '300', 'city': 'Hsinchu', 'country': 'Taiwan', 'contacts': [{'name': 'YI-PING WANG, MD', 'role': 'CONTACT', 'email': 'joesph0502@gmail.com', 'phone': '+886-3-5326151', 'phoneExt': '3900'}], 'facility': 'National Taiwan University Hospital, Hsin-Chu Branch', 'geoPoint': {'lat': 24.80361, 'lon': 120.96861}}], 'centralContacts': [{'name': 'YI-PING WANG, MD', 'role': 'CONTACT', 'email': 'joesph0502@gmail.com', 'phone': '+886-3-5326151', 'phoneExt': '3900'}], 'overallOfficials': [{'name': 'MING-HUI HUNG, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'National Taiwan University Hospital Hsinchu Branch'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital Hsin-Chu Branch', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}