Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2026-02-24 @ 11:00 AM
Study NCT ID:
NCT04725695
Status:
TERMINATED
Last Update Posted:
2025-02-06
First Post:
2021-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative Viscous Lidocaine for Upper Gastrointestinal Endoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 119}}, 'statusModule': {'whyStopped': 'Lack of ressources', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-03-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-04', 'studyFirstSubmitDate': '2021-01-19', 'studyFirstSubmitQcDate': '2021-01-23', 'lastUpdatePostDateStruct': {'date': '2025-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ease of intubation', 'timeFrame': 'Immediately after the procedure', 'description': 'The endoscopist will rate the difficulty of intubating the esophagus on a numeric rating scale (NRS) from 0 (worst) to 10 (best)'}], 'secondaryOutcomes': [{'measure': 'Ease of examination', 'timeFrame': 'Immediately after the procedure', 'description': 'The endoscopist will rate the difficulty of performing the endoscopy on a numeric rating scale (NRS) from 0 (worst) to 10 (best)'}, {'measure': 'Number of intubation attempts', 'timeFrame': 'Peroperatively counted by the assisting nurse', 'description': 'Total number of intubation attempts until the esophagus is reached'}, {'measure': 'Number of gag reflexes', 'timeFrame': 'Peroperatively counted by the assisting nurse', 'description': 'Total number of gag reflexes during the examination'}, {'measure': "Patient's perception of discomfort", 'timeFrame': 'Immediately after the procedure', 'description': "The patient's self-evaluation of discomfort during the examination on a numeric rating scale (NRS) from 0 (worst) to 10 (best)"}, {'measure': "Patient's willingness to be reexamined", 'timeFrame': 'Immediately after the procedure', 'description': "The patient's willingness to have the procedure performed again in the future on a numeric rating scale (NRS) from 0 (worst) to 10 (best)"}, {'measure': 'Sedation 1', 'timeFrame': 'Peroperatively', 'description': 'Number of milligrams midazolam administered during the procedure'}, {'measure': 'Sedation 2', 'timeFrame': 'Peroperatively', 'description': 'Number of milligrams alfentanil administered during the procedure'}, {'measure': 'Perception of gag reflexes', 'timeFrame': 'Immediately after the procedure', 'description': "The endoscopist's rating of the patient's degree of gag reflexes, numeric rating scale (NRS) from 0 (worst) to 10 (best)"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anesthetics, Local', 'Esophagogastroduodenoscopy']}, 'descriptionModule': {'briefSummary': 'In this randomized placebo-controlled clinical trial, patients will be randomized to be administered viscous lidocaine or placebo preoperatively to elective upper GI endoscopy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients referred to and found fit for upper GI endoscopy in an out patient setting\n* Between 18 and 75 years old\n* Speaks and understands Danish\n\nExclusion Criteria:\n\n* Patients admitted for upper GI endoscopy in an in-patient setting\n* Patients with dementia and/or other cognitive dysfunction disorders\n* Patients primarily complaining of dysphagia\n* Patients allergic to lidocaine\n* Patients with suspected retention\n* Patients who will undergo upper GI endoscopy with nurse-assisted propofol sedation\n* Patients who will undergo upper GI endoscopy with assistance of anesthesia-personnel'}, 'identificationModule': {'nctId': 'NCT04725695', 'acronym': 'LIDOGAS', 'briefTitle': 'Preoperative Viscous Lidocaine for Upper Gastrointestinal Endoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Bispebjerg Hospital'}, 'officialTitle': 'Preoperative Viscous Lidocaine for Upper Gastrointestinal Endoscopy - a Blinded, Randomized, Placebo-controlled Clinical Trial', 'orgStudyIdInfo': {'id': '2020-005177-27'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Viscous lidocaine', 'description': 'Oral viscous lidocaine 20 mg/ml, 10 ml', 'interventionNames': ['Drug: Viscous Lidocaine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Oral viscous solution without active drug, 10 ml', 'interventionNames': ['Drug: Viscous Lidocaine']}], 'interventions': [{'name': 'Viscous Lidocaine', 'type': 'DRUG', 'description': 'The patients will be randomized to either viscous lidocaine or placebo', 'armGroupLabels': ['Placebo', 'Viscous lidocaine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2400', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Department of Endoscopy, Digestive Disease Center, Bispebjerg Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Erling Oma, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Digestive Disease Center, Bispebjerg Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'After publication for 10 years', 'ipdSharing': 'YES', 'accessCriteria': 'On demand'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bispebjerg Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Erling Oma', 'investigatorAffiliation': 'Bispebjerg Hospital'}}}}