Ignite Creation Date:
2025-12-24 @ 7:06 PM
Ignite Modification Date:
2025-12-31 @ 1:19 AM
Study NCT ID:
NCT02952157
Status:
UNKNOWN
Last Update Posted:
2016-11-02
First Post:
2016-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect on Postoperative Sore Throat of Lidocaine Jelly Application Over the Endotracheal Tube of Tapered-shaped Cuff
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 210}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-10-30', 'studyFirstSubmitDate': '2016-10-20', 'studyFirstSubmitQcDate': '2016-10-30', 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with sore throat', 'timeFrame': 'At 24 hr'}], 'secondaryOutcomes': [{'measure': 'Number of participants with sore throat', 'timeFrame': 'At 1, 6, and 12 hr'}, {'measure': 'Number of participants with hoarseness', 'timeFrame': 'At 1, 6, 12 and 24 hr'}, {'measure': 'Number of participants with throat numbness', 'timeFrame': 'At 1, 6, 12 and 24 hr'}, {'measure': 'Number of participants with nausea', 'timeFrame': 'At 1, 6, 12 and 24 hr'}, {'measure': 'Number of participants with vomiting', 'timeFrame': 'At 1, 6, 12 and 24 hr'}, {'measure': 'Number of participants with cough', 'timeFrame': 'At 1, 6, 12 and 24 hr'}, {'measure': 'Number of participants with dry mouth', 'timeFrame': 'At 1, 6, 12 and 24 hr'}, {'measure': 'Number of participants with additional pain medication', 'timeFrame': 'At 24 hr'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Sore Throat']}, 'descriptionModule': {'briefSummary': 'Postoperative sore throat is a complication after general anesthesia requiring endotracheal intubation. The investigators will evaluate the efficacy of lidocaine jelly application on the endotracheal tube with taper-shaped cuff regarding postoperative sore throat.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I-III\n* Patients scheduled for general anesthesia with endotracheal intubation\n* Patients scheduled for surgery which duration is expected to less than 3 hr\n\nExclusion Criteria:\n\n* Difficult airway\n* Rapid sequence induction\n* Recent sore throat\n* Recent upper respiratory infection\n* Asthma\n* Chronic obstructive pulmonary disease\n* Chronic cough\n* Pregnancy\n* Allergy to lidocaine\n* Friable teeth\n* History of head and neck surgery\n* Multiple intubation attempts\n* Regional anesthetic agents\n* Gastric tube\n* Dexamethasone'}, 'identificationModule': {'nctId': 'NCT02952157', 'briefTitle': 'Effect on Postoperative Sore Throat of Lidocaine Jelly Application Over the Endotracheal Tube of Tapered-shaped Cuff', 'organization': {'class': 'OTHER', 'fullName': 'Keimyung University Dongsan Medical Center'}, 'officialTitle': 'Effect on Postoperative Sore Throat of Lidocaine Jelly Application Over the Endotracheal Tube of Tapered-shaped Cuff', 'orgStudyIdInfo': {'id': 'LidoTaper'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Control', 'description': 'Normal saline will be applied to the endotracheal tube.', 'interventionNames': ['Drug: Normal saline application']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lidocaine', 'description': 'Lidocaine jelly will be applied to the endotracheal tube.', 'interventionNames': ['Drug: Lidocaine jelly application']}], 'interventions': [{'name': 'Lidocaine jelly application', 'type': 'DRUG', 'armGroupLabels': ['Lidocaine']}, {'name': 'Normal saline application', 'type': 'DRUG', 'armGroupLabels': ['Control']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Keimyung University Dongsan Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}