Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-01-03 @ 12:34 AM
Study NCT ID:
NCT04148534
Status:
COMPLETED
Last Update Posted:
2022-06-29
First Post:
2019-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Compare the Operating Condition of Two Levels of Muscle Relaxation on Facial Nerve MEP Monitoring in CPA Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009464', 'term': 'Neuroma, Acoustic'}], 'ancestors': [{'id': 'D009442', 'term': 'Neurilemmoma'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009463', 'term': 'Neuroma'}, {'id': 'D018317', 'term': 'Nerve Sheath Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D003390', 'term': 'Cranial Nerve Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D010524', 'term': 'Peripheral Nervous System Neoplasms'}, {'id': 'D000160', 'term': 'Vestibulocochlear Nerve Diseases'}, {'id': 'D012181', 'term': 'Retrocochlear Diseases'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2020-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-23', 'studyFirstSubmitDate': '2019-10-25', 'studyFirstSubmitQcDate': '2019-10-31', 'lastUpdatePostDateStruct': {'date': '2022-06-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'End to start facial nerve MEP amplitude ratio.', 'timeFrame': '6 to 8 month', 'description': 'TCMEP recording will begin (1) prior to skin incision as baseline amplitude before muscle relaxant be taken for intubation (2) at Dural closure and end \\\\start amplitude ratio will be calculated.'}], 'secondaryOutcomes': [{'measure': 'number of hypotension episodes and the use of vasopressors', 'timeFrame': '6 to 8 month', 'description': 'hemodynamic condition'}, {'measure': 'Total volume of propofol and fentanyl infused', 'timeFrame': '6 to 8 month', 'description': 'Calculate dose consumption'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cerebellopontine Angle Tumor']}, 'descriptionModule': {'briefSummary': 'compare the operating condition of two different levels of muscle relaxation on facial nerve monitoring using transcranial motor evocked potential in CPA surgery .\n\n* To Estimate End to start facial nerve MEP amplitude ratio\n* To determine the effect of neuromuscular relaxant degrees on recovery and\n* Assessment of propofol doses needed for enhancement of early recovery and ambulation.', 'detailedDescription': '40 Patients aged from 18-60 years old undergoing Cerebellopontine angle surgery. Patients will be one of two groups: Both Induction will be accomplished with fentanyl, propofol , rocronium infusion will be given randomly to one of the groups.\n\nDepth of anaesthesia, neurotransmitter monitoring and facial nerve neurophysiological monitoring will be done.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients age between \\>18 and\\<60.\n* Patients scheduled for neurosurgical CPA surgeries\n* Ability to sign the consent\n* ASA classification I, II\n\nExclusion Criteria:\n\n* ASA \\> II\n* Hemodynamically unstable\n* Disease affecting neuromuscular transmission (myasthenia gravies ...etc.)\n* GCS \\< 15.\n* Any cardiac patient (ischemic heart disease - cardiomyopathy...etc.)'}, 'identificationModule': {'nctId': 'NCT04148534', 'briefTitle': 'Compare the Operating Condition of Two Levels of Muscle Relaxation on Facial Nerve MEP Monitoring in CPA Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Intraoperative Monitoring of Facial Nerve in Patients Undergoing Cerbellopontine Angle Tumer Resection Using Partial Versus no Neuromuscular Block', 'orgStudyIdInfo': {'id': 'D-4-2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'muscle relaxant', 'description': 'patient who will receive muscle relaxant, patients will receive rocronium infusion by (5 mcg/kg/min) , maintain partial NMB TOF count 2 and targeting BIS = (40-60)', 'interventionNames': ['Drug: Rocroniom, Non Depolarizing Muscle Relaxant']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'without muscle relaxant', 'description': 'patient who will not receive muscle relaxant, will recieve normal saline targeting BIS = 40-60.', 'interventionNames': ['Drug: Rocroniom, Non Depolarizing Muscle Relaxant']}], 'interventions': [{'name': 'Rocroniom, Non Depolarizing Muscle Relaxant', 'type': 'DRUG', 'otherNames': ['Nerve stimulator for train of four assessment', 'BIS bispectral index'], 'description': 'compare the operating condition of two different levels of muscle relaxation on facial nerve monitoring using transcranial motor evocked potential in CPA surgery', 'armGroupLabels': ['muscle relaxant', 'without muscle relaxant']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Cairo university medical school', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Cairo university', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo university faculty of medicine research ethical committee'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Muhammad Magdy Gaber', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cairo University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Ass lecturer', 'investigatorFullName': 'Muhammad Magdy Gaber', 'investigatorAffiliation': 'Cairo University'}}}}