Ignite Creation Date:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2025-12-25 @ 2:39 PM
Study NCT ID:
NCT06563050
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-22
First Post:
2024-08-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison Between Different Ways for Using Lidocaine During FB
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The study subjects will not be blinded; the bronchoscopist and the assessor of outcomes will be blinded to the group allocation.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Subjects in group A underwent nebulization with 5 mL of 2% lidocaine for 15 minutes by using a jet nebulizer.\n\nIn group B will underwent 10% lidocaine spray solution will be sprayed 10 times at the oropharynx at 5 s interval.\n\nGroup C: both nebulization and spray will be performed in the same manner except the number of spray will be 2 instead 10.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-20', 'studyFirstSubmitDate': '2024-08-05', 'studyFirstSubmitQcDate': '2024-08-17', 'lastUpdatePostDateStruct': {'date': '2024-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The severity of cough using cough severity index', 'timeFrame': 'During and within 3 hours after procedure', 'description': 'Assess the severity of cough during and within 4 hours after the procedure as (0 : absent cough is better ) , ( 5 : disturbing cough is the worst )'}, {'measure': 'pain during the procedure rated by the subjects on the Faces Pain Rating Scale.', 'timeFrame': 'During and within 3 hours after procedure', 'description': 'As (0 : no pain , the best) , ( 10 : worst pain )'}, {'measure': 'time taken to cross the vocal cords.', 'timeFrame': 'at the beginning of the procedure(time zero) till seconds after crossing the vocal cords', 'description': 'the median time in seconds will be calculated during the procedure from the introduction the tip of bronchoscope from the nostril to second at which the tip of bronchoscopy cross the the vocal cords.'}, {'measure': 'changes in heart rate', 'timeFrame': 'During and within 3 hours after procedure', 'description': 'changes in the heart rate from the baseline before procedure'}, {'measure': 'Changes in oxygen saturation', 'timeFrame': 'During and within 3 hours after procedure', 'description': 'changes in the oxygen saturation from the baseline before procedure'}], 'secondaryOutcomes': [{'measure': 'cumulative dose of lidocaine administered during the procedure.', 'timeFrame': 'During the procedure', 'description': 'Less cumulative dose of lidocaine needed during the procedure is better'}, {'measure': 'adverse reactions to lidocaine', 'timeFrame': 'During and within 3 hours after procedure', 'description': 'assess for any adverse effects related to lidocaine use especially arrhythmia or other adverse effects as convulsions, involuntary movements, bronchospasm, and anaphylaxis.'}, {'measure': 'overall satisfaction with the procedure using likert scale .', 'timeFrame': 'During and within 3 hours after procedure', 'description': 'As (1 : strongly disagree , is the worst) and (5 : strongly agree , is better)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['flexible bronchoscopy'], 'conditions': ['Lidocaine Spray', 'Nebulized Lidocaine', 'Lung Diseases', 'Lung Cancer']}, 'descriptionModule': {'briefSummary': 'compare the efficacy and safety of nebulized lidocaine, oropharyngeal lidocaine spray, or their combination for better outcome of topical anesthesia in subjects undergoing diagnostic FB; severity of cough , pain during procedure , cumulative dose of anesthesia needed and its adverse reaction , overall satisfaction .', 'detailedDescription': 'Flexible bronchoscopy (FB) is a commonly performed procedure in the diagnosis and treatment of several respiratory disease. Although FB is generally a short procedure, it is uncomfortable for the patient. At least the use of topical anesthesia during FB is essential, especially when performed without sedation. Effective topical anesthesia blunts airway reflexes such as gag, cough, and laryngospasm.\n\nThe reduction in cough not only improves patient comfort but also makes the procedure easier for the operator.\n\nAmong agents used for topical anesthesia, lidocaine is the most widely used drug because of its safety and favorable pharmacokinetic profile.\n\nLidocaine is available in various formulations (gel or solution) and can be delivered to the respiratory passages by using different modes (spray, nebulization, transtracheal injection, bronchoscope instillation, and others).\n\nIn this study, will compare the efficacy and safety of nebulized lidocaine, oropharyngeal lidocaine spray, or their combination for topical anesthesia in subjects undergoing diagnostic FB, for better outcome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients above 18 years old will undergo FB are included in this study.\n\nExclusion Criteria:\n\n* known hypersensitivity to lidocaine.\n* Pregnancy.\n* hemodynamic instability.\n* failure to provide informed consent.'}, 'identificationModule': {'nctId': 'NCT06563050', 'briefTitle': 'Comparison Between Different Ways for Using Lidocaine During FB', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Comparison Between Nebulized Lidocaine, Lidocaine Spray, or Their Combination for Topical Anesthesia During Diagnostic Flexible Bronchoscopy: a Randomized Trial', 'orgStudyIdInfo': {'id': 'Lidocaine use during FB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nebulized lidocaine', 'description': 'Subjects in group A underwent nebulization with 5 mL of 2% lidocaine for 15 minutes by using a jet nebulizer.', 'interventionNames': ['Procedure: Nebulized lidocaine']}, {'type': 'EXPERIMENTAL', 'label': 'Lidocaine spray', 'description': 'In group B will underwent 10% lidocaine spray solution will be sprayed 10 times at the oropharynx at 5 s interval.', 'interventionNames': ['Procedure: Lidocaine spray']}, {'type': 'EXPERIMENTAL', 'label': 'Combination( Nebulized lidocaine and lidocaine spray)', 'description': 'Group C: both nebulization and spray will be performed in the same manner except the number of spray will be 2 instead 10.', 'interventionNames': ['Procedure: Combination of nebulized lidocaine and lidocaine spray']}], 'interventions': [{'name': 'Nebulized lidocaine', 'type': 'PROCEDURE', 'description': 'Subjects in group A underwent nebulization with 5 mL of 2% lidocaine for 15 minutes by using a jet nebulizer.', 'armGroupLabels': ['Nebulized lidocaine']}, {'name': 'Lidocaine spray', 'type': 'PROCEDURE', 'description': 'Subjects in group B will underwent 10% lidocaine spray solution will be sprayed 10 times at the oropharynx at 5 s interval.', 'armGroupLabels': ['Lidocaine spray']}, {'name': 'Combination of nebulized lidocaine and lidocaine spray', 'type': 'PROCEDURE', 'description': 'Group C: both nebulization and spray will be performed in the same manner except the number of spray will be 2 instead 10.', 'armGroupLabels': ['Combination( Nebulized lidocaine and lidocaine spray)']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Bassem Gadallah Gad-Elkariem Kalam', 'role': 'CONTACT', 'email': 'basam.16266060@med.aun.edu.eg', 'phone': '01210414954'}], 'overallOfficials': [{'name': 'Mohamed Mostafa Abdelhadi', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Professor of Chest Diseases and Tuberculosis'}, {'name': 'Montaser Gamal Ahmed', 'role': 'STUDY_DIRECTOR', 'affiliation': 'lecturer of Chest Diseases and Tuberculosis'}, {'name': 'Nermeen Mohammed Abuelkassem', 'role': 'STUDY_DIRECTOR', 'affiliation': 'lecturer of Chest Diseases and Tuberculosis'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident doctor at Chest Diseases Department', 'investigatorFullName': 'Bassem Gadallah Gad-Elkariem Kalam', 'investigatorAffiliation': 'Assiut University'}}}}