Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:46 PM
Study NCT ID:
NCT01708967
Status:
COMPLETED
Last Update Posted:
2014-03-13
First Post:
2012-10-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Trial of New Pretreatment Method in Transnasal Endoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ktsuk@hallym.ac.kr', 'phone': '+82-33-240-5826', 'title': 'Dr. Ki Tae Suk', 'organization': 'Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Korea'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'A limitation of this study was the small number of patients; n = 93 is insufficient to conclusively generalize the efficiency of the catheter-free method.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Catheter-free Method', 'description': 'We explored success rate, side effects, and vital signs in patients with one-time spray method.\n\nIntervention: one-time spray of epinephrine (1cc) plus 4% lidocaine (4cc)\n\npretreatment method for transnasal endoscopy : one-time spray method : patients are given simethicone (5cc) and lidocaine (2%, 10cc). After that, epinephrine (1cc) and lidocaine (2%, 3cc) are injected in both nose and mouth. Lastly, buscopan Intra Muscular (IM) is injected.\n\nspray+catheter method: patients are given simethicone (10cc). Next, epinephrine and lidocaine (4%, 4cc) are injected in both nose and mouth. Following this step, benoxinate hydrochloride (5cc) is inhaled by the patients. Subsequently, the patients are catheterized for 10 minutes using the 7Fr. Nelaton catheter. Finally, buscopan IM is injected.', 'otherNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Catheter-insertion Method', 'description': 'We explored success rate, side effects, and vital signs in patients with spray+catheter method.\n\nIntervention: use both spray and catheter\n\npretreatment method for transnasal endoscopy : one-time spray method : patients are given simethicone (5cc) and lidocaine (2%, 10cc). After that, epinephrine (1cc) and lidocaine (2%, 3cc) are injected in both nose and mouth. Lastly, buscopan Intra Muscular (IM) is injected.\n\nspray+catheter method: patients are given simethicone (10cc). Next, epinephrine and lidocaine (4%, 4cc) are injected in both nose and mouth. Following this step, benoxinate hydrochloride (5cc) is inhaled by the patients. Subsequently, the patients are catheterized for 10 minutes using the 7Fr. Nelaton catheter. Finally, buscopan IM is injected.', 'otherNumAtRisk': 43, 'otherNumAffected': 0, 'seriousNumAtRisk': 43, 'seriousNumAffected': 0}], 'frequencyThreshold': '4'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Vital Signs', 'timeFrame': 'before, during, and after transnasal endoscopy', 'description': 'Blood pressure, heart rate, and O2 saturation were assessed.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Satisfaction', 'timeFrame': 'after transnasal endoscopy', 'description': 'Patients were asked to score how well they felt during endoscopy using a visual analog scale; they were also asked whether they would accept one-time spray method or spray+catheter method in the future if necessary.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'PRIMARY', 'title': 'Success Rate of Transnasal Endoscopy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Catheter-free Method', 'description': 'We explored success rate, side effects, and vital signs in patients with one-time spray method.\n\nIntervention: one-time spray of epinephrine (1cc) plus 4% lidocaine (4cc)\n\npretreatment method for transnasal endoscopy : one-time spray method : patients are given simethicone (5cc) and lidocaine (2%, 10cc). After that, epinephrine (1cc) and lidocaine (2%, 3cc) are injected in both nose and mouth. Lastly, buscopan Intra Muscular (IM) is injected.\n\nspray+catheter method: patients are given simethicone (10cc). Next, epinephrine and lidocaine (4%, 4cc) are injected in both nose and mouth. Following this step, benoxinate hydrochloride (5cc) is inhaled by the patients. Subsequently, the patients are catheterized for 10 minutes using the 7Fr. Nelaton catheter. Finally, buscopan IM is injected.'}, {'id': 'OG001', 'title': 'Catheter-insertion Method', 'description': 'We explored success rate, side effects, and vital signs in patients with spray+catheter method.\n\nIntervention: use both spray and catheter\n\npretreatment method for transnasal endoscopy : one-time spray method : patients are given simethicone (5cc) and lidocaine (2%, 10cc). After that, epinephrine (1cc) and lidocaine (2%, 3cc) are injected in both nose and mouth. Lastly, buscopan Intra Muscular (IM) is injected.\n\nspray+catheter method: patients are given simethicone (10cc). Next, epinephrine and lidocaine (4%, 4cc) are injected in both nose and mouth. Following this step, benoxinate hydrochloride (5cc) is inhaled by the patients. Subsequently, the patients are catheterized for 10 minutes using the 7Fr. Nelaton catheter. Finally, buscopan IM is injected.'}], 'classes': [{'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000', 'lowerLimit': '80', 'upperLimit': '96'}, {'value': '88', 'groupId': 'OG001', 'lowerLimit': '80', 'upperLimit': '96'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During transnasal endoscopy, up to 1 hours', 'description': 'We difine the success of transnasal endoscopy as follows: the pateint underwent transnasal endoscopy without signicant complaint nor side effects.\n\nWe difine the failure of transnasal endoscopy as follows: the patient cannot tolerate insertion of the endoscope; the patient presents side effects such as epistaxis, pain, or a decrease in O2 saturation; and the endoscope cannot pass through the nasal or oral cavity.', 'unitOfMeasure': 'percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Catheter-free Method', 'description': 'We explored success rate, side effects, and vital signs in patients with one-time spray method.\n\nIntervention: one-time spray of epinephrine (1cc) plus 4% lidocaine (4cc)\n\npretreatment method for transnasal endoscopy : one-time spray method : patients are given simethicone (5cc) and lidocaine (2%, 10cc). After that, epinephrine (1cc) and lidocaine (2%, 3cc) are injected in both nose and mouth. Lastly, buscopan Intra Muscular (IM) is injected.\n\nspray+catheter method: patients are given simethicone (10cc). Next, epinephrine and lidocaine (4%, 4cc) are injected in both nose and mouth. Following this step, benoxinate hydrochloride (5cc) is inhaled by the patients. Subsequently, the patients are catheterized for 10 minutes using the 7Fr. Nelaton catheter. Finally, buscopan IM is injected.'}, {'id': 'FG001', 'title': 'Catheter-insertion Method', 'description': 'We explored success rate, side effects, and vital signs in patients with spray+catheter method.\n\nIntervention: use both spray and catheter\n\npretreatment method for transnasal endoscopy : one-time spray method : patients are given simethicone (5cc) and lidocaine (2%, 10cc). After that, epinephrine (1cc) and lidocaine (2%, 3cc) are injected in both nose and mouth. Lastly, buscopan Intra Muscular (IM) is injected.\n\nspray+catheter method: patients are given simethicone (10cc). Next, epinephrine and lidocaine (4%, 4cc) are injected in both nose and mouth. Following this step, benoxinate hydrochloride (5cc) is inhaled by the patients. Subsequently, the patients are catheterized for 10 minutes using the 7Fr. Nelaton catheter. Finally, buscopan IM is injected.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '43'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '7'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Catheter-free Method', 'description': 'We explored success rate, side effects, and vital signs in patients with one-time spray method.\n\nIntervention: one-time spray of epinephrine (1cc) plus 4% lidocaine (4cc)'}, {'id': 'BG001', 'title': 'Catheter-insertion Method', 'description': 'We explored success rate, side effects, and vital signs in patients with spray+catheter method.\n\nIntervention: use both spray and catheter'}, {'id': 'BG002', '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'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.4', 'spread': '10.8', 'groupId': 'BG000'}, {'value': '59.7', 'spread': '12.3', 'groupId': 'BG001'}, {'value': '59.00', 'spread': '11.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Korea, Republic of', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-29', 'studyFirstSubmitDate': '2012-10-16', 'resultsFirstSubmitDate': '2013-11-09', 'studyFirstSubmitQcDate': '2012-10-16', 'lastUpdatePostDateStruct': {'date': '2014-03-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-01-29', 'studyFirstPostDateStruct': {'date': '2012-10-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-03-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Satisfaction', 'timeFrame': 'after transnasal endoscopy', 'description': 'Patients were asked to score how well they felt during endoscopy using a visual analog scale; they were also asked whether they would accept one-time spray method or spray+catheter method in the future if necessary.'}], 'primaryOutcomes': [{'measure': 'Success Rate of Transnasal Endoscopy', 'timeFrame': 'During transnasal endoscopy, up to 1 hours', 'description': 'We difine the success of transnasal endoscopy as follows: the pateint underwent transnasal endoscopy without signicant complaint nor side effects.\n\nWe difine the failure of transnasal endoscopy as follows: the patient cannot tolerate insertion of the endoscope; the patient presents side effects such as epistaxis, pain, or a decrease in O2 saturation; and the endoscope cannot pass through the nasal or oral cavity.'}], 'secondaryOutcomes': [{'measure': 'Vital Signs', 'timeFrame': 'before, during, and after transnasal endoscopy', 'description': 'Blood pressure, heart rate, and O2 saturation were assessed.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['transnasal endoscopy', 'pretreatment method'], 'conditions': ['Pretreatment Method of Transnasal Endoscopy']}, 'descriptionModule': {'briefSummary': 'This study designed for compare efficacy of following two anesthetic method for transnasal endoscopy\n\n* "Catheter-free method"\n* "Catheter-insertion method"', 'detailedDescription': '1. Check of the medical history (both method)\n\n 1. underlying systemic disease\n 2. drug allergy\n 3. anticoagulant or antiplatelet use\n2. Premedication (both method)\n\n 1. taking premedication contain dimethylpolysiloxane, pronase, sodium bicarbonate for improved endoscopic visualization\n 2. spraying naphazolin acetate into nasal cavity for decrease secretion\n3. Different anesthetic method for transnasal endoscopy\n\n 1. "Catheter-free method" : spraying epinephrine into nasal cavity\n 2. "Catheter-insertion method" : spraying both epinephrine and lidocaine into nasal cavity'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Routine check-up patients\n\nExclusion Criteria:\n\n* nasal operation, an allergy, a possibility of hemorrhage'}, 'identificationModule': {'nctId': 'NCT01708967', 'acronym': 'RTNPMTNE', 'briefTitle': 'Trial of New Pretreatment Method in Transnasal Endoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Chuncheon Sacred Heart Hospital'}, 'officialTitle': 'One-time Spray of Epinephrine (1cc) Plus 4% Lidocaine (4cc) is Sufficient Pretreatment Method for the Preparation of Transnasal Endoscopy', 'orgStudyIdInfo': {'id': 'OTSMVSSCM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Catheter-free method', 'description': 'We explored success rate, side effects, and vital signs in patients with catether-free method.\n\nIntervention: one-time spray of epinephrine (1cc) plus 4% lidocaine (4cc)', 'interventionNames': ['Procedure: pretreatment method for transnasal endoscopy']}, {'type': 'EXPERIMENTAL', 'label': 'Catheter insertion method', 'description': 'We explored success rate, side effects, and vital signs in patients with catether insertion method : use both spray and catheter', 'interventionNames': ['Procedure: pretreatment method for transnasal endoscopy']}], 'interventions': [{'name': 'pretreatment method for transnasal endoscopy', 'type': 'PROCEDURE', 'otherNames': ['Catheter-free method/Cathter insertion method'], 'description': "Catheter-free method : The patient then takes simethicone (10cc). After that, the nasal cavity is sprayed with epinephrine (1cc) and lidocaine HCL (4%, 4cc).\n\nCatheter inesertion method: After preparation steps the same as in the 'catheter-free' method, a 14 Fr. flexible catheter is coated with 2% lidocaine HCL gel and 8% lidocaine HCL spray. After that, the catheter is inserted into the patient's nasal cavity, and maintained about 1 minute for anesthesia. A 16 Fr. catheter is prepared by the same method with as the 14Fr. catheter. After the 14 Fr. cathter has been removed from the patient's nasal cavity, the 16 Fr. catheter is inserted into the patient's nasal cavity.", 'armGroupLabels': ['Catheter insertion method', 'Catheter-free method']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200-704', 'city': 'Chuncheon', 'country': 'South Korea', 'facility': 'Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital', 'geoPoint': {'lat': 37.87472, 'lon': 127.73417}}], 'overallOfficials': [{'name': 'Ki Tae Suk, M.D.,Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chuncheon Sacred Heart Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'doctor, assistant professor', 'investigatorFullName': 'Ki Tae Suk', 'investigatorAffiliation': 'Chuncheon Sacred Heart Hospital'}}}}