Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-02-25 @ 8:27 PM
Study NCT ID:
NCT02682134
Status:
COMPLETED
Last Update Posted:
2016-02-15
First Post:
2016-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sore Throat Prevention Following Intubation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010612', 'term': 'Pharyngitis'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'C007792', 'term': 'Fumigant 93'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-10', 'studyFirstSubmitDate': '2016-02-05', 'studyFirstSubmitQcDate': '2016-02-10', 'lastUpdatePostDateStruct': {'date': '2016-02-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-02-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison in preventing sore throat: xylocaine gel versus dexamethasone or both following intubation.', 'timeFrame': '4 months', 'description': 'Questionnaire follow up in intubated patients.'}], 'secondaryOutcomes': [{'measure': 'Sore throat SCALE', 'timeFrame': '4 months', 'description': 'Sore throat scale from None,mild,moderate till severe.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Sore Throat', 'Intubation', 'Xylocaine', 'Dexamethasone'], 'conditions': ['Sore Throat']}, 'descriptionModule': {'briefSummary': 'The aim of this interventional study is to find out the incidence of sore throat among intubated patients in Jordan university hospital and to find out which is preventive and effective method to decrease sore throat;is it xylocaine gel on endotracheal cuff as lubricant versus dexamethasone 8 mg intravenously or both.', 'detailedDescription': 'Three groups were divided into: first group received xylocaine gel as endotracheal cuff lubricant,second group received dexamethasone 8 mg intravenously and third group received both( xylocaine and dexamethasone).\n\nThe investigator compared between the three groups regarding sore throat in intubated patients and followed them up to 48 hours.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA 1-3.\n* Elective VS Emergency.\n* Cuffed endo-tracheal tubes.\n* Different types of surgery.\n\nExclusion Criteria:\n\n* Pregnant ladies.\n* ICU patients.\n* \\<15 years of age\n* Laryngeal mask airway'}, 'identificationModule': {'nctId': 'NCT02682134', 'briefTitle': 'Sore Throat Prevention Following Intubation', 'organization': {'class': 'OTHER', 'fullName': 'University of Jordan'}, 'officialTitle': 'Comparison Between Xylocaine Gel as Endotracheal Cuff Lubricant Versus Dexamethasone 8 mg Intravenously or Both for Sore Throat Prevention Following Intubation: Interventional Study', 'orgStudyIdInfo': {'id': 'AAlJabari'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Xylocaine "X"', 'description': 'Patients received xylocaine gel as lubricant on endotracheal tube', 'interventionNames': ['Drug: xylocaine']}, {'type': 'EXPERIMENTAL', 'label': 'Dexamethasone "D"', 'description': 'Patients were given dexamethasone 8 mg intravenously', 'interventionNames': ['Drug: Dexamethasone']}, {'type': 'EXPERIMENTAL', 'label': 'xylocaine and dexamethasone "XD"', 'description': 'Patients were given both xylocaine gel and dexamethasone 8 mg intravenously', 'interventionNames': ['Drug: Xylocaine and Dexamethasone']}], 'interventions': [{'name': 'xylocaine', 'type': 'DRUG', 'otherNames': ['X'], 'description': 'First group were given xylocaine', 'armGroupLabels': ['Xylocaine "X"']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'otherNames': ['D'], 'description': 'Second group were given Dexamethasone', 'armGroupLabels': ['Dexamethasone "D"']}, {'name': 'Xylocaine and Dexamethasone', 'type': 'DRUG', 'otherNames': ['XD'], 'description': 'Third group were given both Xylocaine and Dexamethasone', 'armGroupLabels': ['xylocaine and dexamethasone "XD"']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Aboud Aljabari', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Jordan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Jordan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Regional and Cardio-thoracic anesthesia doctor', 'investigatorFullName': 'Aboud Nayef AlJabari', 'investigatorAffiliation': 'University of Jordan'}}}}