Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2025-12-28 @ 8:22 PM
Study NCT ID:
NCT06185933
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-04-17
First Post:
2023-12-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lidocaine Spray vs Viscous Lidocaine Solution Plus Lidocaine Spray in Patients Undergoing Non-Sedated EGD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D017060', 'term': 'Patient Satisfaction'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, '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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-02-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-16', 'studyFirstSubmitDate': '2023-12-15', 'studyFirstSubmitQcDate': '2023-12-15', 'lastUpdatePostDateStruct': {'date': '2024-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'procedural pain, measured using the visual analog scale (VAS).', 'timeFrame': '30 minute after finished precedure', 'description': 'The procedural pain was evaluated using a visual analog scale (VAS, 0-10) with 0 being none and 10 being the most painfull'}], 'secondaryOutcomes': [{'measure': 'patient tolerance', 'timeFrame': 'immediately after finished precedure', 'description': '1 = exceptional; 2 = well; 3 = fair; 4 = poor answer by endoscopist'}, {'measure': 'endoscopist satisfaction', 'timeFrame': 'immediately after finished precedure', 'description': '1 = very satisfied; 2 = satisfied; 3 = neutral; and 4 = dissatisfied'}, {'measure': 'patient satisfaction', 'timeFrame': '30 minute after finished precedure', 'description': '1 = very satisfied; 2 = satisfied; 3 = neutral; and 4 = dissatisfied'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['lidocaine spray', 'lidocaine solution', 'non-sedating EGD'], 'conditions': ['Pain', 'Satisfaction, Patient']}, 'descriptionModule': {'briefSummary': 'This study aimed to compare the efficacy of lidocaine spray (S) alone versus lidocaine spray combined with lidocaine viscous solution (S+V) in facilitating pharyngeal observation during Non-sedating upper gastrointestinal endoscopy (UGE).', 'detailedDescription': 'A randomized controlled trial was conducted between July and October 2023 at Sawanpracharak hospital, Thailand. Of 250 patients undergoing UGE, 125 were randomly assigned to group S (lidocaine spray alone) and 125 to group S+V (lidocaine spray plus lidocaine viscous solution). The total dose of lidocaine did not exceed 5 mg/kg in both groups'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for upper gastrointestinal endoscopy:\n* Patients who are robust, without chronic illnesses, or with controlled chronic conditions that do not adversely affect the function of any organ (American Society of Anesthesiologists (ASA) physical status classification I-II).\n\nExclusion Criteria:\n\n* Has a history of receiving painkillers or sleeping pills within 24 hours before the endoscopy.\n* Has a history of post-endoscopy nausea and vomiting.\n* Patients who have undergone upper gastrointestinal endoscopy previously.\n* Has chronic conditions such as epilepsy, vertigo, or mental health disorders.\n* Has a history of allergy to anesthesia used in the study.\n* Pregnant or currently breastfeeding.\n* Refuses to participate in the study.'}, 'identificationModule': {'nctId': 'NCT06185933', 'briefTitle': 'Lidocaine Spray vs Viscous Lidocaine Solution Plus Lidocaine Spray in Patients Undergoing Non-Sedated EGD', 'organization': {'class': 'OTHER', 'fullName': 'Sawanpracharak hospital'}, 'officialTitle': 'Lidocaine Spray vs Viscous Lidocaine Solution Plus Lidocaine Spray in Patients Undergoing Non-Sedated Esophagogastroduodenoscopy: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'NF01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'lidocaine spray alone', 'description': 'patient in this arm will receive lidocaine spray five puffs of 10 % lidocaine spray (Xylocaine 10 % Spray, Astra Zeneca) (1 puff = 10 mg of lidocaine) 5 minutes before the start of the procedure', 'interventionNames': ['Drug: Lidocaine Spray']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'receive lidocaine spray + lidocaine viscous solution', 'description': 'patient in this arm will receive lidocaine spray + lidocaine viscous solution five puffs of 10 % lidocaine spray (Xylocaine 10 % Spray, Astra Zeneca) (1 puff = 10 mg of lidocaine) Plus 5 mL of 2 % viscous lidocaine solution (20 mg/mL) (Xylocaine 2 %, Astra Zeneca, London, UK)', 'interventionNames': ['Drug: Lidocaine Viscous+Lidocane spray']}], 'interventions': [{'name': 'Lidocaine Spray', 'type': 'DRUG', 'otherNames': ['liocaine spray'], 'description': 'Pharyngeal anesthesia using a topical lidocaine spray was administered in the preprocedure room, in the absence of the endoscopist or the research assistant. 5 minute before the UGE without any sedation', 'armGroupLabels': ['lidocaine spray alone']}, {'name': 'Lidocaine Viscous+Lidocane spray', 'type': 'DRUG', 'otherNames': ['Lidocaine Viscous', 'Lidocane spray'], 'description': 'Pharyngeal anesthesia using topical viscous lidocaine solution + lidocaine spray were administered in the preprocedure room, in the absence of the endoscopist or the research assistant. 5 minute before the UGE without any sedation', 'armGroupLabels': ['receive lidocaine spray + lidocaine viscous solution']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60000', 'city': 'Nakhon Sawan', 'state': 'Nakhonsawan', 'country': 'Thailand', 'facility': 'Sawanpracharak hospital', 'geoPoint': {'lat': 15.70472, 'lon': 100.13717}}], 'overallOfficials': [{'name': 'Natee Faknak', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Saawanpracharak hospital Thailand'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sawanpracharak hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical doctor at Department of medicine Sawanpracharak hospital', 'investigatorFullName': 'Natee Faknak', 'investigatorAffiliation': 'Sawanpracharak hospital'}}}}