Ignite Creation Date:
2025-12-25 @ 4:35 AM
Ignite Modification Date:
2026-03-09 @ 4:49 AM
Study NCT ID:
NCT03318718
Status:
COMPLETED
Last Update Posted:
2019-02-18
First Post:
2017-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Paraspinal Muscle Relaxation in Spine Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000758', 'term': 'Anesthesia'}], 'ancestors': [{'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2018-12-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-15', 'studyFirstSubmitDate': '2017-06-29', 'studyFirstSubmitQcDate': '2017-10-19', 'lastUpdatePostDateStruct': {'date': '2019-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'assessment of NMBA blockade', 'timeFrame': 'during surgery', 'description': 'assessment of the NMBA (neuromuscular blocking agent) blockade by measurement of the amplitude of compound muscle action potential (CMAP)'}, {'measure': 'MEP', 'timeFrame': 'during surgery', 'description': 'Motor evoked potentials (MEPs) are measured in hand, foot and paraspinal musculature'}, {'measure': 'TOF', 'timeFrame': 'during surgery', 'description': 'peak-to-peak amplitude of CMAP for each of 4 muscle contractions is measured. (supramaximal stimulation of peripheral nerve results in four twitches: T1 to T4)'}], 'secondaryOutcomes': [{'measure': 'necessary administered amount of NMBA', 'timeFrame': 'during surgery', 'description': 'Difference in the necessary administered amount of NMBA to achieve full muscle relaxation for hand and foot versus paraspinal musculature'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Paraspinal Muscle Relaxation in Spine Surgery']}, 'referencesModule': {'references': [{'pmid': '33259448', 'type': 'DERIVED', 'citation': 'Betz M, Aguirre J, Schubert M, Gotschi T, Huber B, Schupbach R, Brada M, Spirig JM, Farshad M. Hand or foot train-of-four tests and surgical site muscle relaxation assessed with multiple motor evoked potentials: A prospective observational study. Eur J Anaesthesiol. 2021 Aug 1;38(8):872-879. doi: 10.1097/EJA.0000000000001398.'}]}, 'descriptionModule': {'briefSummary': 'During anesthesia, neuromuscular blocking agents (NMBA) are routinely used for relaxation of muscles necessary for the conduction of the surgical procedure. Train-of-four (TOF) test is based on supramaximal stimulation of peripheral nerve resulting in four twitches: T1 to T4. The assessment of the NMBA blockade is performed routinely by measurement of the amplitude of compound muscle action potential (CMAP) and calculation of percentage of CMAP decrement from T1 to T4.\n\nTrain-of-four monitoring is routinely performed during spine surgery by stimulation of the ulnar nerve. Furthermore motor evoked potentials (MEPs) are routinely used in intraoperative neuromonitoring to assess the whole motor pathway from the cortical level down to the distal muscle. During anesthesia MEPs are routinely evoked by transcranial electrical stimulation with single or short train stimuli. In clinical practice even though full muscle relaxation of the hand by NMBA can be observed, utilizing the TOF test, remaining muscle tonus can be observed at the paraspinal musculature during spine surgery.\n\nThe goals of this study are to determine (1) if any differences between muscle relaxation of the hand and foot (measured by TOF test and MEPs) and MEPs of the paraspinal musculature occur; (2) how much more NMBA must be administered to achieve full muscle relaxation of the paraspinal musculature in comparison to the hand or foot.', 'detailedDescription': 'Muscle relaxation during surgery will be performed using intraoperative boli intermediate duration non-depolarizing NMBA, rocuronium (0.3 mg/kg) until TOF 0 at the hand is achieved. TOF measurements will be performed at baseline 5 minutes after induction. Moreover, TOF measurements will be performed 5 minutes after each rocuronium bolus. When TOF 0 at the hand is achieved the MEPs of the paraspinal musculature will be measured. When there is remaining muscle tonus of the paraspinal musculature another bolus of rocuronium is administered until no MEPs can be measured for the paraspinal musculature.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients that will undergo spinal surgery with intraoperative neurophysiological Monitoring\n* Age: 14 - 99 years\n\nExclusion Criteria:\n\n* No intraoperative neurophysiological Monitoring\n* Age \\<14 year\n* prior neurological diseases or deficits that may affect safety of surgery/Intraoperative neuromonitoring\n* No informed consent'}, 'identificationModule': {'nctId': 'NCT03318718', 'acronym': 'TOF', 'briefTitle': 'Paraspinal Muscle Relaxation in Spine Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Balgrist University Hospital'}, 'officialTitle': 'Paraspinal Muscle Relaxation in Spine Surgery: Comparison of the Effect of Neuromuscular Blocking Agent Rocuronium Between Extremity- and Paraspinal Musculature', 'orgStudyIdInfo': {'id': 'TOF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TOF measurement', 'description': 'TOF and MEP measurement after Anesthesia with non-depolarizing NMBA Rocuronium', 'interventionNames': ['Drug: Anesthesia with non-depolarizing NMBA Rocuronium', 'Diagnostic Test: TOF measurement', 'Diagnostic Test: MEP measurement']}], 'interventions': [{'name': 'Anesthesia with non-depolarizing NMBA Rocuronium', 'type': 'DRUG', 'description': 'Non- depolarizing NMBA Rocuronium will be used until full paraspinal muscle Relaxation. Muscle relaxation during surgery will be performed using intraoperative boli intermediate duration non-depolarizing NMBA, rocuronium (0.3 mg/kg) until good surgical conditions are achieved.', 'armGroupLabels': ['TOF measurement']}, {'name': 'TOF measurement', 'type': 'DIAGNOSTIC_TEST', 'description': 'TOF (Train-of-four) measurements will be performed at baseline 5 minutes after induction after the effect of succinylcholine will have run off. Moreover, TOF measurements will be performed 5 minutes after each rocuronium bolus', 'armGroupLabels': ['TOF measurement']}, {'name': 'MEP measurement', 'type': 'DIAGNOSTIC_TEST', 'description': 'MEPs (motor evoked potentials) are routinely obtained after intubation and before surgery, then every 10min during the critical preparation and closing phases of surgery and every 5min during the correction phase. In addition MEPs will be measured after the administration of the NMBA rocuronium. Baseline values for amplitudes and latencies are obtained directly prior to the start of the correction phase of the surgery.', 'armGroupLabels': ['TOF measurement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8008', 'city': 'Zurich', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'University Hospital Balgrist', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Michael Betz, Dr.med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Balgrist University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Balgrist University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}