Ignite Creation Date:
2025-12-24 @ 8:01 PM
Ignite Modification Date:
2026-02-27 @ 10:06 AM
Study NCT ID:
NCT03100604
Status:
COMPLETED
Last Update Posted:
2017-04-11
First Post:
2016-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of General Anesthesia on the Middle Ear Pressure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2017-06-08', 'releaseDate': '2017-05-04'}], 'estimatedResultsFirstSubmitDate': '2017-05-04'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D004426', 'term': 'Ear Deformities, Acquired'}], 'ancestors': [{'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077335', 'term': 'Desflurane'}, {'id': 'D000077149', 'term': 'Sevoflurane'}], 'ancestors': [{'id': 'D005019', 'term': 'Ethyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-07', 'studyFirstSubmitDate': '2016-08-31', 'studyFirstSubmitQcDate': '2017-04-03', 'lastUpdatePostDateStruct': {'date': '2017-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Middle ear pressure', 'timeFrame': 'postoperative 30th minutes', 'description': 'Tympanometric measurements were performed and recorded for each ear preoperatively, at intraoperative 5th, 10th and 15th minutes and postoperative 10th and 30th minutes. Normal middle ear pressure ranges between -200 and +200 decapascals (daPa).\n\nTreatment-Related Adverse Events, Ear and labyrinth disorder Assessed by CTCAE v4.0'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['middle ear pressure', 'sevoflurane', 'desflurane'], 'conditions': ['Ear Deformities, Acquired']}, 'descriptionModule': {'briefSummary': 'The investigators aimed to examine the effect of sevoflurane and desflurane, agents used in patients who do not have any ear pathology and undergo surgery under general anesthesia, on the MEP.', 'detailedDescription': 'Studies reported that inhalation agents are more likely to have impacts on the middle ear pressure compared to intravenous anesthetic agents. Despite numerous studies comparing the effects of inhalation agents on the middle ear pressure, this is the first clinical trial in which end tidal carbon dioxide and effects of sevoflurane and desflurane, along with other anesthetic analgesic agents used, on the middle ear pressure were compared. Our purpose in this study was to investigate the effect of sevoflurane and desflurane, inhalation agents used in patients who do not have any ear pathology and undergo non-ear surgery under general anesthesia, on the middle ear pressure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* (ASA) II-III physical status\n* elective inguinal hernia\n* lower extremity surgery\n* general anesthesia\n* supine position\n\nExclusion Criteria:\n\n* nasal septum,\n* adenotonsillar hypertrophy,\n* perforated tympanic membrane,\n* middle ear pathology\n* receive medications for middle ear pressure .'}, 'identificationModule': {'nctId': 'NCT03100604', 'briefTitle': 'The Effect of General Anesthesia on the Middle Ear Pressure', 'organization': {'class': 'OTHER', 'fullName': 'Trakya University'}, 'officialTitle': 'Prospective, Single-blind Study Investigating the Effect of Sevoflurane and Desflurane, Agents Used in Patients on the MEP', 'orgStudyIdInfo': {'id': '2013/136'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'sevoflurane 2%, 1 MAC', 'description': 'Maintenance of anesthesia was provided with 2% sevoflurane in S Group, and 6-9% desflurane in D Group, with 50% air /oxygen mixture and fresh gas flow at 4 l/min in both groups.', 'interventionNames': ['Drug: Sevoflurane']}, {'type': 'EXPERIMENTAL', 'label': 'Desfluran 6-9% 1MAC', 'description': 'Maintenance of anesthesia was provided with 2% sevoflurane in S Group, and 6-9% desflurane in D Group, with 50% air /oxygen mixture and fresh gas flow at 4 l/min in both groups.', 'interventionNames': ['Drug: desflurane,']}], 'interventions': [{'name': 'desflurane,', 'type': 'DRUG', 'otherNames': ['suprane'], 'description': 'Patients were divided into two groups according to inhalation agent administered for the surgery; Sevofluran, Group S (n=25) and Desfluran, Group D (N=25).', 'armGroupLabels': ['Desfluran 6-9% 1MAC']}, {'name': 'Sevoflurane', 'type': 'DRUG', 'otherNames': ['sefoflurane'], 'description': 'For a drug, use generic name if established. Use the same name as in the associated Arm/Group Description(s).', 'armGroupLabels': ['sevoflurane 2%, 1 MAC']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Trakya University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Sevtap Hekimoglu Sahin', 'investigatorAffiliation': 'Trakya University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2017-05-04', 'type': 'RELEASE'}, {'date': '2017-06-08', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Sevtap Hekimoglu Sahin, Clinical Professor, Trakya University'}}}}