Ignite Creation Date:
2025-12-24 @ 4:56 PM
Ignite Modification Date:
2025-12-24 @ 4:56 PM
Study NCT ID:
NCT03926650
Status:
COMPLETED
Last Update Posted:
2021-04-09
First Post:
2019-04-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Correlation Between the Frontal Electromyography Parameter in Patient State Index (PSI) Monitor and Train of Four
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D061886', 'term': 'Neuromuscular Monitoring'}], 'ancestors': [{'id': 'D008991', 'term': 'Monitoring, Physiologic'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-07', 'studyFirstSubmitDate': '2019-04-18', 'studyFirstSubmitQcDate': '2019-04-22', 'lastUpdatePostDateStruct': {'date': '2021-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient State Index', 'timeFrame': '0 minutes', 'description': 'Measures anaesthetic awakeness. It can be between 0-100. The investigators will record this parameter after using the reversal drugs'}, {'measure': 'Patient State Index', 'timeFrame': '1 minutes', 'description': 'Measures anaesthetic awakeness. It can be between 0-100. The investigators will record this parameter after using the reversal drugs'}, {'measure': 'Patient State Index', 'timeFrame': '2 minutes', 'description': 'Measures anaesthetic awakeness. It can be between 0-100. The investigators will record this parameter after using the reversal drugs'}, {'measure': 'Patient State Index', 'timeFrame': '3 minutes', 'description': 'Measures anaesthetic awakeness. It can be between 0-100. The investigators will record this parameter after using the reversal drugs'}, {'measure': 'Patient State Index', 'timeFrame': '4 minutes', 'description': 'Measures anaesthetic awakeness. It can be between 0-100. The investigators will record this parameter after using the reversal drugs'}, {'measure': 'Patient State Index', 'timeFrame': '5 minutes', 'description': 'Measures anaesthetic awakeness. It can be between 0-100. The investigators will record this parameter after using the reversal drugs'}, {'measure': 'Electromyography (Frontal EMG)', 'timeFrame': '0 minutes', 'description': "Measures frontal muscles' strength.It can be between % 0 - %100. The investigators will record this parameter after using the reversal drugs"}, {'measure': 'Electromyography (Frontal EMG)', 'timeFrame': '1 minutes', 'description': "Measures frontal muscles' strength.It can be between % 0 - %100. The investigators will record this parameter after using the reversal drugs"}, {'measure': 'Electromyography (Frontal EMG)', 'timeFrame': '2 minutes', 'description': "Measures frontal muscles' strength.It can be between % 0 - %100. The investigators will record this parameter after using the reversal drugs"}, {'measure': 'Electromyography (Frontal EMG)', 'timeFrame': '3 minutes', 'description': "Measures frontal muscles' strength.It can be between % 0 - %100. The investigators will record this parameter after using the reversal drugs"}, {'measure': 'Electromyography (Frontal EMG)', 'timeFrame': '4 minutes', 'description': "Measures frontal muscles' strength.It can be between % 0 - %100. The investigators will record this parameter after using the reversal drugs"}, {'measure': 'Electromyography (Frontal EMG)', 'timeFrame': '5 minutes', 'description': "Measures frontal muscles' strength.It can be between % 0 - %100. The investigators will record this parameter after using the reversal drugs"}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Muscle Relaxation']}, 'descriptionModule': {'briefSummary': 'The Train Of Four (TOF) Monitor will be placed on ulnar nerve on right wrist of the patients who has surgery under general anaesthesia. This is for stimulation of adductor pollicis muscle. Sedline (Masimo Electromyography(EMG) and Patient State Index(PSI)) Monitor will be placed on the frontal area of head. After the induction of general anaesthesia the investigators will wait for disappearance of eyelash reflex. TOF monitor will be calibrated and muscle relaxant will be applied. After TOF is %0 and disappearance of thumb movement the patient will be intubated. After surgery the investigators will apply muscle relaxant reversal drugs. Then the investigators will record PSI and EMG parameters when TOF is %0, %25, %50,%75,%90. When TOF is %90 the investigators will extubate the patient. The investigators will record PSI and EMG parameters after 5 minutes.', 'detailedDescription': 'The study is planned prospective and observational. The study started after approval of Erzincan Binali Yıldırım University Ethics Committee and taking written approval of patients. The study includes 84 patients who has surgery continues more then 1 hour, who is between ages 18-65, who is ASA I,II and III. The patients who has allergical reactions of the drugs used, neurological or neuromuscular diseases,the patients who use drugs effecting the neuromuscular junction, pregnant patients, electrolyte disregulations, major organ failures, liver failure, kidney failure, obese and cachectic patients are excluded from the study.\n\nAll patients will be informed and signed written approval 1 day before the surgery. Patients will be taken to the operating room, venous catheter will be applied on antecubital area. 3 channel EKG , SpO2 Monitor and noninvasive blood pressure monitorisation will be applied. The patients will be taken 2-4 litres of O2 with nasal cannula .The Train Of Four (TOF) Monitor will be placed on ulnar nerve on right wrist of the patients who has surgery under general anaesthesia. This is for stimulation of adductor pollicis muscle. Sedline (Masimo Electromyography(EMG) and Patient State Index(PSI)) Monitor will be placed on the frontal area of head. After the induction of general anaesthesia the investigators will wait for disappearance of eyelash reflex. TOF monitor will be calibrated and muscle relaxant will be applied. After TOF is %0 and disappearance of thumb movement the patient will be intubated. After surgery the investigators will apply muscle relaxant reversal drugs. PSI and EMG parameters will be recorded when TOF is %0, %25, %50,%75,%90. When TOF is %90 the investigators will extubate the patient. PSI and EMG parameters will be recorded after 5 minutes. The patient will be taken to the PACU room. On 5,10,30 minutes after surgery, the investigators will record aldrete score of patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'the patients wha has surgery continues more then 1 hour', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* surgery continues more then 1 hour\n* between ages 18-65\n* ASA I,II and III patients\n\nExclusion Criteria:\n\n* The patients who has allergical reactions of the drugs used\n* neurological or neuromuscular diseases\n* the patients who use drugs effecting the neuromuscular junction\n* pregnant patients\n* electrolyte disregulations\n* major organ failures, liver failure, kidney failure\n* obese and cachectic patients'}, 'identificationModule': {'nctId': 'NCT03926650', 'briefTitle': 'The Correlation Between the Frontal Electromyography Parameter in Patient State Index (PSI) Monitor and Train of Four', 'organization': {'class': 'OTHER', 'fullName': 'Erzincan University'}, 'officialTitle': 'Correlation of Train Of Four (TOF) With Frontal EMG Parameter Measured by Patient State Index (PSI) Monitor in Extubation Phase of General Anesthesia', 'orgStudyIdInfo': {'id': 'ErzincanUnv'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Masimo Sedline Monitor Patient State Index', 'type': 'DEVICE', 'otherNames': ['Train Of Four'], 'description': 'Masimo Sedline Monitor shows frontal electromyography and patient state index, Train of four monitor shows muscle strength on adductor pollicis muscle'}]}, 'contactsLocationsModule': {'locations': [{'zip': '24000', 'city': 'Erzincan', 'state': 'Merkez', 'country': 'Turkey (Türkiye)', 'facility': 'Erzincan University', 'geoPoint': {'lat': 39.73919, 'lon': 39.49015}}], 'overallOfficials': [{'name': 'Hakan G. Taş', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mengucek Gazi Education and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erzincan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant Doctor Hakan Gökalp TAŞ', 'investigatorFullName': 'Hakan Gokalp TAS', 'investigatorAffiliation': 'Erzincan University'}}}}