Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2025-12-26 @ 3:53 AM
Study NCT ID:
NCT00226018
Status:
COMPLETED
Last Update Posted:
2008-04-17
First Post:
2005-09-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Performance of Acceleromyography With and Without Preload
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-04', 'completionDateStruct': {'date': '2006-10'}, 'lastUpdateSubmitDate': '2008-04-16', 'studyFirstSubmitDate': '2005-09-22', 'studyFirstSubmitQcDate': '2005-09-22', 'lastUpdatePostDateStruct': {'date': '2008-04-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The precision of acceleromyography with and without preload during recovery'}], 'secondaryOutcomes': [{'measure': 'Bias and limits of agreement for acceleromyography (AMG) with and without preload compared to mechanomyography (MMG) during recovery'}, {'measure': 'All the following outcomes obtained with AMG with and without preload are compared to MMG. Furthermore the responses are compared when the AMG-values are "normalized":'}, {'measure': 'Bias og limits of agreement between control TOF'}, {'measure': 'Onset time'}, {'measure': 'Time to reappearance of T1, T2, T3 and T4'}, {'measure': 'Twitch height of T1 at reappearance of T1, T2, T3 and T4'}, {'measure': 'Time to T1=25%'}, {'measure': 'Interval 25-75%'}, {'measure': 'Time to TOF-ratio = 0.9 and 1.0'}, {'measure': 'Time to final T1'}, {'measure': 'Time to final TOF ratio'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Neuromuscular Blockade']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the precision, bias and limits of agreement when monitoring the neuromuscular block with acceleromyography with and without preload and compare the method to the gold standard, mechanomyography.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I-III\n* General anesthesia \\> 1 hour\n* Surgery under supine position with possibility of monitoring the neuromuscular block in both arms (thumbs)\n* Written informed content\n\nExclusion Criteria:\n\n* Neuromuscular disorders, hepatic and renal dysfunction\n* Medication expected to interfere with the neuromuscular blocking agent\n* Allergy to any medication used during anesthesia\n* Body weight less or exceeding 20% of the ideal body weight\n* Pregnancy or breastfeeding'}, 'identificationModule': {'nctId': 'NCT00226018', 'briefTitle': 'Performance of Acceleromyography With and Without Preload', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Performance of Acceleromyography With and Without Preload During Neuromuscular Blockade', 'orgStudyIdInfo': {'id': 'AMG01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Acceleromyography with Hand Adapter on dominant arm', 'interventionNames': ['Device: Hand Adapter (Organon, Oss, the Netherlands)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Acceleromyography with Hand Adapter on non-dominant arm', 'interventionNames': ['Device: Hand Adapter (Organon, Oss, the Netherlands)']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3', 'description': 'Acceleromyography without Hand Adapter on dominant arm', 'interventionNames': ['Device: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': '4', 'description': 'Acceleromygraphy without Hand Adapter on non-dominant arm', 'interventionNames': ['Device: Placebo']}], 'interventions': [{'name': 'Hand Adapter (Organon, Oss, the Netherlands)', 'type': 'DEVICE', 'description': 'Randomization of acceleromyography with or without Hand Adapter to dominant or non-dominant arm. Contralateral neuromuscular transmission is measured with mechanomyography (The gold standard of neuromuscular monitoring)', 'armGroupLabels': ['1', '2']}, {'name': 'Placebo', 'type': 'DEVICE', 'description': 'placebo', 'armGroupLabels': ['3', '4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'state': 'Copenhagen Ø', 'country': 'Denmark', 'facility': 'Dep. of anesthesia, HOC, Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Casper C Kjaer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rigshospitalet, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}}}}