Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 11:24 PM
Study NCT ID:
NCT01838993
Status:
UNKNOWN
Last Update Posted:
2013-04-24
First Post:
2013-04-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Inhalation of Lidocaine Before Intubation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'lastUpdateSubmitDate': '2013-04-23', 'studyFirstSubmitDate': '2013-04-21', 'studyFirstSubmitQcDate': '2013-04-23', 'lastUpdatePostDateStruct': {'date': '2013-04-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood pressure', 'timeFrame': '3 min', 'description': 'Non invasive blood pressure every min for 3 min'}], 'secondaryOutcomes': [{'measure': 'Post operative sore throat', 'timeFrame': '3 days', 'description': 'Questionnaire for Post operative sore throat'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['anesthetics,', 'local,', 'lidocaine;', 'nebulizers and vaporizers;', 'complications,', 'intubation,', 'intratracheal.'], 'conditions': ['Sore Throat']}, 'descriptionModule': {'briefSummary': 'We investigate the potential benefits of ultrasound-driven lidocaine inhalation immediately before induction.', 'detailedDescription': "Sudden increases in blood pressure and heart rate after tracheal intubation and post-operative sore throat are two common undesirable side effects of general anesthesia and might lead to patients' morbidity or dissatisfaction. We investigated the possibility to attenuate both side effects with one single method, i.e. ultrasound-driven lidocaine inhalation immediately before induction."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) physical status I or II. Patients scheduled for elective surgery under general anesthesia with orotracheal intubation\n\nExclusion Criteria:\n\n* patient's refusal to join, major surgery or expected operation duration longer than 3 hours, patients with a anticipated difficult airway, requiring a nasogastric tube in peri-operative stage, having recent upper respiratory tract infection (within 1 week) or pre-existing sore throat."}, 'identificationModule': {'nctId': 'NCT01838993', 'briefTitle': 'Inhalation of Lidocaine Before Intubation', 'organization': {'class': 'OTHER', 'fullName': 'New Taipei City Hospital'}, 'officialTitle': 'The Effect of Ultrasonic Nebulizer Delivered Lidocaine on Circulatory Responses During Tracheal Intubation and Postoperative Sore Throat', 'orgStudyIdInfo': {'id': 'CS 2013011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lidocaine', 'description': 'Inhalation of lidocaine before intubation', 'interventionNames': ['Drug: Lidocaine inhalation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Normal saline inhalation before intubation', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Lidocaine inhalation', 'type': 'DRUG', 'description': 'Lidocaine inhalation before intubation', 'armGroupLabels': ['Lidocaine']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'New Taipei City', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Lin Chi-Hsuan, MD', 'role': 'CONTACT', 'email': 'ad2354@ntpc.gov.tw'}], 'facility': 'New Taipei City Hospital', 'geoPoint': {'lat': 25.06199, 'lon': 121.45703}}], 'centralContacts': [{'name': 'Chen Yen Po, MD', 'role': 'CONTACT', 'email': 'drbrianchan@yahoo.com.tw'}], 'overallOfficials': [{'name': 'Chen Yen Po, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New Taipei City Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'New Taipei City Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physician', 'investigatorFullName': 'Chen Yen-Po', 'investigatorAffiliation': 'New Taipei City Hospital'}}}}