Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-02-24 @ 4:11 AM
Study NCT ID:
NCT03040193
Status:
COMPLETED
Last Update Posted:
2018-01-30
First Post:
2017-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nebulized Lignocaine for Topical Airway Anesthesia During Flexible Bronchoscopy: A Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-28', 'studyFirstSubmitDate': '2017-01-31', 'studyFirstSubmitQcDate': '2017-02-01', 'lastUpdatePostDateStruct': {'date': '2018-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Operator rated overall procedure satisfaction VAS', 'timeFrame': 'At study completion approx. 12 months'}, {'measure': 'Operator rated cough VAS', 'timeFrame': 'At study completion approx. 12 months'}], 'secondaryOutcomes': [{'measure': 'Total dose of Lignocaine administered (mg)', 'timeFrame': 'At study completion approx. 12 months'}, {'measure': 'Number of patients receiving dose >8.2mg/Kg', 'timeFrame': 'At study completion approx. 12 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lignocaine'], 'conditions': ['Bronchopulmonary Disease']}, 'descriptionModule': {'briefSummary': 'Flexible bronchoscopy is one of the most widely performed procedures for diagnosis of various bronchopulmonary diseases. Most patients tolerate the procedure well although cough is often reported as a distressing symptom. It is likely that the acceptance of bronchoscopy would be significantly improved with control of cough. Use of sedation during bronchoscopy has been reported to improve procedure tolerance. However, awake(no sedation) bronchoscopy is routinely performed at many centres including ours.\n\nTopical lignocaine is administered during bronchoscopy for local anaesthesia. There is limited literature on the efficacy of lignocaine delivered with the nebulized route during awake flexible bronchoscopy. This study would help to determine the utility of nebulized lignocaine in airway anaesthesia during flexible bronchoscopy.', 'detailedDescription': 'For all patients meeting the inclusion criteria, the demographic profile including age, sex, weight, smoking history and the type of procedures performed during bronchoscopy shall be recorded. A written informed consent will be obtained from all participants. The patients who undergo flexible bronchoscopy would be randomised in a one is to one ratio either to nebulized lignocaine (4%) or saline (placebo) nebulization group. Prior to the bronchoscopy blood pressure, pulse rate, respiratory rate and pulse oximetry saturation will be recorded at the baseline Patients in both the groups shall be prepared in a similar fashion except for the nebulized lignocaine. Patient, Operator, outcome assessor will be blinded to the allocation.\n\nDuring the procedure, 1.5ml aliquots of 1% lignocaine will be delivered through the bronchoscope using spray-as-you go technique. The patients would be monitored for any adverse effects throughout the procedure. The bronchoscopist doing the procedure will be provided 2 VAS charts to mark the severity of cough and overall procedure satisfaction.\n\nPost procedure, patients will record the pain experienced while undergoing the procedure on the faces pain rating scale.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult (Age \\> 18 years) patients undergoing diagnostic or therapeutic flexible bronchoscopy\n\nExclusion Criteria:\n\n1. Pregnancy\n2. Hypoxemia (oxygen saturation \\[by pulse oximetry\\] \\< 92% with Fio2 of ≥ 0.3\n3. Bronchoscopy done through endotracheal or tracheostomy tube\n4. Not willing to provide informed consent.\n5. Patient requiring sedation for flexible bronchoscopy\n6. Patients with known allergy to lignocaine -'}, 'identificationModule': {'nctId': 'NCT03040193', 'acronym': 'NEBULA', 'briefTitle': 'Nebulized Lignocaine for Topical Airway Anesthesia During Flexible Bronchoscopy: A Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'All India Institute of Medical Sciences'}, 'officialTitle': 'Nebulized Lignocaine for Topical Airway Anesthesia During Flexible Bronchoscopy: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Ref.No.IEC-594/05.01.2017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nebulized Lignocaine', 'description': '4% Lignocaine administered as nebulization for topical anaesthesia during bronchoscopy procedure', 'interventionNames': ['Drug: Lignocaine Nebulization']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Nebulized Saline', 'description': 'Normal Saline administered as nebulization for topical anaesthesia during bronchoscopy procedure', 'interventionNames': ['Drug: Saline Nebulization']}], 'interventions': [{'name': 'Lignocaine Nebulization', 'type': 'DRUG', 'description': '4% Lignocaine delivered via Nebulization', 'armGroupLabels': ['Nebulized Lignocaine']}, {'name': 'Saline Nebulization', 'type': 'DRUG', 'description': 'Normal Saline Delivered via Nebulization', 'armGroupLabels': ['Nebulized Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110029', 'city': 'New Delhi', 'country': 'India', 'facility': 'All India Institute of Medical Sciences', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}], 'overallOfficials': [{'name': 'Randeep Guleria, MD, DM', 'role': 'STUDY_CHAIR', 'affiliation': 'AIIMS, New Delhi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'All India Institute of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr Karan Madan MD, DM Assistant Professor', 'investigatorFullName': 'Karan Madan', 'investigatorAffiliation': 'All India Institute of Medical Sciences'}}}}