Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2025-12-26 @ 3:34 AM
Study NCT ID:
NCT00798018
Status:
COMPLETED
Last Update Posted:
2009-12-18
First Post:
2008-11-24
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Effect of Intra-cuff Lidocaine and Tetracaine on Tracheal Tube-induced Emergence Phenomena
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'D013748', 'term': 'Tetracaine'}], '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': 'D062366', 'term': 'para-Aminobenzoates'}, {'id': 'D062365', 'term': 'Aminobenzoates'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'huanghan1981@hotmail.com', 'phone': '80-028-8550-3753', 'title': 'Han Huang', 'organization': 'Department of Anesthesiology, West China Second Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Air Alone', 'description': 'Only air was injected into the cuff, as the routine practice', 'otherNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Normal Saline', 'description': 'normal saline was used to inflate the cuff', 'otherNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Lidocaine', 'description': '2% lidiocaine was used to inflate the cuff', 'otherNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Tetracaine', 'description': '1% tetracaine was used to inflate the cuff', 'otherNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Visual Analogue Scale(0-100mm) by the Subject.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Air Alone', 'description': 'Only air was injected into the cuff, as the routine practice'}, {'id': 'OG001', 'title': 'Normal Saline', 'description': 'normal saline was used to inflate the cuff'}, {'id': 'OG002', 'title': 'Lidocaine', 'description': '2% lidiocaine was used to inflate the cuff'}, {'id': 'OG003', 'title': 'Tetracaine', 'description': '1% tetracaine was used to inflate the cuff'}], 'classes': [{'title': '6h', 'categories': [{'measurements': [{'value': '51', 'spread': '37', 'groupId': 'OG000'}, {'value': '40', 'spread': '31', 'groupId': 'OG001'}, {'value': '22', 'spread': '17', 'groupId': 'OG002'}, {'value': '9', 'spread': '8', 'groupId': 'OG003'}]}]}, {'title': '12h', 'categories': [{'measurements': [{'value': '50', 'spread': '33', 'groupId': 'OG000'}, {'value': '38', 'spread': '19', 'groupId': 'OG001'}, {'value': '25', 'spread': '15', 'groupId': 'OG002'}, {'value': '13', 'spread': '7', 'groupId': 'OG003'}]}]}, {'title': '24h', 'categories': [{'measurements': [{'value': '43', 'spread': '39', 'groupId': 'OG000'}, {'value': '41', 'spread': '30', 'groupId': 'OG001'}, {'value': '20', 'spread': '18', 'groupId': 'OG002'}, {'value': '7', 'spread': '5', 'groupId': 'OG003'}]}]}, {'title': '48h', 'categories': [{'measurements': [{'value': '45', 'spread': '36', 'groupId': 'OG000'}, {'value': '43', 'spread': '25', 'groupId': 'OG001'}, {'value': '23', 'spread': '19', 'groupId': 'OG002'}, {'value': '9', 'spread': '4', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 hours, 12 hours, 24 hours, 48 hours after extubation', 'description': 'visual analogue scale (VAS) was used to evaluate the post-intubation sore throat. The VAS was a well-recongnized standard tool for rating of pain. The VAS measures exactly 100 mm. 0 means no pain and 100 means the worst pain that one can image. Patient marks a point on the line that matches the amount of pain he or she feels.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Air Alone', 'description': 'Only air was injected into the cuff, as the routine practice'}, {'id': 'FG001', 'title': 'Normal Saline', 'description': 'normal saline was used to inflate the cuff'}, {'id': 'FG002', 'title': 'Lidocaine', 'description': '2% lidiocaine was used to inflate the cuff'}, {'id': 'FG003', 'title': 'Tetracaine', 'description': '1% tetracaine was used to inflate the cuff'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '25'}, {'groupId': 'FG003', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '25'}, {'groupId': 'FG003', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study started in November 2008 and finished in February 2009, in total 100 patients were enrolled and all of them finished this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '100', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Air Alone', 'description': 'Only air was injected into the cuff, as the routine practice'}, {'id': 'BG001', 'title': 'Normal Saline', 'description': 'normal saline was used to inflate the cuff'}, {'id': 'BG002', 'title': 'Lidocaine', 'description': '2% lidiocaine was used to inflate the cuff'}, {'id': 'BG003', 'title': 'Tetracaine', 'description': '1% tetracaine was used to inflate the cuff'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '100', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39', 'spread': '8', 'groupId': 'BG000'}, {'value': '44', 'spread': '9', 'groupId': 'BG001'}, {'value': '42', 'spread': '7', 'groupId': 'BG002'}, {'value': '41', 'spread': '10', 'groupId': 'BG003'}, {'value': '42', 'spread': '9', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '100', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '100', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-12-17', 'studyFirstSubmitDate': '2008-11-24', 'resultsFirstSubmitDate': '2009-06-01', 'studyFirstSubmitQcDate': '2008-11-24', 'lastUpdatePostDateStruct': {'date': '2009-12-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-12-17', 'studyFirstPostDateStruct': {'date': '2008-11-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analogue Scale(0-100mm) by the Subject.', 'timeFrame': '6 hours, 12 hours, 24 hours, 48 hours after extubation', 'description': 'visual analogue scale (VAS) was used to evaluate the post-intubation sore throat. The VAS was a well-recongnized standard tool for rating of pain. The VAS measures exactly 100 mm. 0 means no pain and 100 means the worst pain that one can image. Patient marks a point on the line that matches the amount of pain he or she feels.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['lidocaine', 'tetracaine', 'tracheal intubation', 'pharyngitis'], 'conditions': ['Pharyngitis']}, 'referencesModule': {'references': [{'pmid': '14970135', 'type': 'BACKGROUND', 'citation': 'Estebe JP, Delahaye S, Le Corre P, Dollo G, Le Naoures A, Chevanne F, Ecoffey C. Alkalinization of intra-cuff lidocaine and use of gel lubrication protect against tracheal tube-induced emergence phenomena. Br J Anaesth. 2004 Mar;92(3):361-6. doi: 10.1093/bja/aeh078.'}]}, 'descriptionModule': {'briefSummary': 'It has been proven that tracheal tube inflated with lidocaine could decrease the post-intubation sore throat in nitrous oxide anesthesia. In the study, the investigators would like to evaluate the effect of lidocaine inflation in non-nitrous oxide anesthesia and compare the effect of tetracaine, the best mucosal local anesthetics with lidocaine.', 'detailedDescription': 'The female patients receiving gynecological surgeries were divided into air, saline and 2% lidocaine and 1% tetracaine groups of 25 each using sealed envelope technique. The cuff of the endotracheal tube was inflated by the inflation medium (with the help of intracuff pressure monitoring device) to occlude the leak around the tube by the Minimal Occlusive Volume Technique. This was done by the same anaesthesiologist in all the patients. The cuff volume and pressure were then recorded. The primary outcome of the study was to evaluate the post-intubation sore throat using the visual analogue scale 6h, 24h and 48h after extubation. The secondary outcomes were incidence of complications during emergence of anesthesia and after extubation. Intra-cuff pressure monitoring was done with a pressure monitor, which consisted of the pressure gauge, three-way stopcock whose one end was attached to the pressure monitoring line. Net volume of the inflation medium was noted. Volume of the inflation medium, intra cuff pressure, duration from intubation to extubation and volume of the inflation medium withdrawn from the cuff was noted. Incidence (Yes/No) of tube intolerance, coughing on tube, restlessness, hoarseness, sore throat, breathlessness and laryngospasm were analyzed by the anaesthesiologist who did not know which group the patient belonged to.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients of the age group 18-60 years\n* patients belonging to ASA grade I and II undergoing gynecological surgeries in supine position under general anesthesia with controlled ventilation using Poly Vinyl Chloride ETT (same type and make in all patients)\n\nExclusion Criteria:\n\n* anticipated difficult intubation\n* more than one attempt for intubation\n* need for naso gastric tube\n* episode of coughing and straining\n* history of respiratory tract infection and smoking'}, 'identificationModule': {'nctId': 'NCT00798018', 'briefTitle': 'Effect of Intra-cuff Lidocaine and Tetracaine on Tracheal Tube-induced Emergence Phenomena', 'organization': {'class': 'OTHER', 'fullName': 'Sichuan University'}, 'officialTitle': 'Effect of Intra-cuff Lidocaine and Tetracaine on Tracheal Tube-induced Emergence Phenomena', 'orgStudyIdInfo': {'id': 'ICLT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Air', 'description': 'air was used to inflate the cuff.', 'interventionNames': ['Drug: placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Normal Saline', 'description': 'Normal saline was used to inflate the cuff.', 'interventionNames': ['Drug: N.S']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'lidocaine', 'description': '2% lidocaine was used to inflate the cuff.', 'interventionNames': ['Drug: 2% lidocaine']}, {'type': 'EXPERIMENTAL', 'label': 'tetracaine', 'description': '1% tetracaine was used to inflate the cuff.', 'interventionNames': ['Drug: 1% tetracaine']}], 'interventions': [{'name': '2% lidocaine', 'type': 'DRUG', 'description': 'lidocaine: 2%, injected into the cuff to seal the space between the trachea and the tube at minimal volume', 'armGroupLabels': ['lidocaine']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Air injected into the cuff to seal the space between the trachea and the tube at minimal volume', 'armGroupLabels': ['Air']}, {'name': '1% tetracaine', 'type': 'DRUG', 'description': 'tetracaine: 1%, injected into the cuff to seal the space between the trachea and the tube at minimal volume', 'armGroupLabels': ['tetracaine']}, {'name': 'N.S', 'type': 'DRUG', 'description': '0.9% Normal saline injected into the cuff to seal the space between the trachea and the tube at minimal volume', 'armGroupLabels': ['Normal Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'Department of Anesthesiology, West China Second Hospital, Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'overallOfficials': [{'name': 'Han Huang, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Aensthesiology, West China 2nd Hospital, Sichuan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sichuan University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr.', 'oldOrganization': 'Department of Anesthesiology, West China Second Hospital'}}}}