Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-03-06 @ 2:53 AM
Study NCT ID:
NCT02062333
Status:
COMPLETED
Last Update Posted:
2014-11-10
First Post:
2014-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of the Drugs Used in Hypotensive Anaesthesia on Cochlea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012021', 'term': 'Reflex, Abnormal'}, {'id': 'D014012', 'term': 'Tinnitus'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006311', 'term': 'Hearing Disorders'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D012678', 'term': 'Sensation Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'C036604', 'term': 'esmolol'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-07', 'studyFirstSubmitDate': '2014-02-06', 'studyFirstSubmitQcDate': '2014-02-12', 'lastUpdatePostDateStruct': {'date': '2014-11-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'distortion product auto acoustic emission', 'timeFrame': 'postoperative 1 day', 'description': 'distortion product measurements will be performed in 1001, 1501, 2002, 3003, 4004, 6006, 7996 Hz frequencies and change from baseline in distortion product measurements at postoperative 1 day'}], 'secondaryOutcomes': [{'measure': 'stapes reflex', 'timeFrame': 'postoperative 1 day', 'description': 'stapes muscle reflex measurements will be performed by electrical impedance. data will be taken as graphics. ıf there is an amplitude on graphic the data will be assumed as stapes reflex positive.Change from Baseline in stapes muscle reflex at postoperative 1 day'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['dexmedetomidine', 'esmolol', 'stapes reflex'], 'conditions': ['Anesthesia; Adverse Effect', 'Reflex, Abnormal', 'Tinnitus, Spontaneous Oto-Acoustic Emission']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to find the Effects of Anesthetics Used in Hypotensive Anesthesia on Stapes Reflex and Distortion Product Auto Acoustic Emission.', 'detailedDescription': 'This study was aimed at evaluating the effects of dexmedetomidine and esmolol on stapes reflex and distortion product auto acoustic emission. the stapes reflex and auto acoustic emission are of considerable diagnostic significances in otolaryngology this are objective methods for the assessment of auditory function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-65 age\n* American Society of Anaesthesiologists physical status classification (ASA)1-2\n* tympanoplasty surgery\n* patients with normal stapes reflexes\n\nExclusion Criteria:\n\n* hypertension\n* drug allergy\n* cardiac problems\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT02062333', 'briefTitle': 'The Effects of the Drugs Used in Hypotensive Anaesthesia on Cochlea', 'organization': {'class': 'OTHER', 'fullName': 'TC Erciyes University'}, 'officialTitle': 'The Effects of the Drugs Used in Hypotensive Anaesthesia on Cochlea', 'orgStudyIdInfo': {'id': '2013/425'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'dexmedetomidine', 'description': '0,4-0,8 µg./kg./h dexmedetomidine', 'interventionNames': ['Drug: Dexmedetomidine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'esmolol', 'description': '100- 300 µg./kg./min esmolol', 'interventionNames': ['Drug: esmolol']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'otherNames': ['precedex'], 'description': '1 mcg/kg dexmedetomidine is applied bolus and 0.2 mcg/kg/h dexmedetomidine is applied iv infusion', 'armGroupLabels': ['dexmedetomidine']}, {'name': 'esmolol', 'type': 'DRUG', 'otherNames': ['breviblock'], 'description': '500 mcg/kg brevibloc is applied bolus and 100 mcg/kg/h iv infusion', 'armGroupLabels': ['esmolol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38039', 'city': 'Kayseri', 'country': 'Turkey (Türkiye)', 'facility': 'Kayseri Education and Research Hospital', 'geoPoint': {'lat': 38.73222, 'lon': 35.48528}}], 'overallOfficials': [{'name': 'Gunhan Gokahmetoglu, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TC Erciyes University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor', 'investigatorFullName': 'Recep Aksu', 'investigatorAffiliation': 'TC Erciyes University'}}}}