Ignite Creation Date:
2025-12-25 @ 3:43 AM
Ignite Modification Date:
2025-12-26 @ 2:29 AM
Study NCT ID:
NCT05850702
Status:
UNKNOWN
Last Update Posted:
2023-05-09
First Post:
2023-04-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Attenuation of the Hemodynamic Response to Double-lumen Endotracheal Intubation With Nebulized Lidocaine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], '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': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 92}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-06-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-06', 'studyFirstSubmitDate': '2023-04-24', 'studyFirstSubmitQcDate': '2023-05-06', 'lastUpdatePostDateStruct': {'date': '2023-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mean arterial pressure after intubation', 'timeFrame': 'Immediately after intubation'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Double-lumen Endotracheal Intubation'], 'conditions': ['Lung Neoplasms']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to test the effect of nebulized lidocaine on the hemodynamic response in the participant undergoing double-lumen endotracheal intubation.\n\nThe main question it aims to answer is to evaluate the changes in mean arterial pressure after intubation.\n\nParticipants will inhale 5ml of 2% lidocaine by nebulization15min before intubation.\n\nResearchers will compare saline group to see if saline effects'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. aged 18-65 years, American Society of Anesthesiologists class I-II\n2. participants undergoing double-lumen endotracheal intubation under general anesthesia\n3. signed informed consent and volunteered to participate in the experiment\n\nExclusion Criteria:\n\n1. Poor control of hypertension\n2. preoperative arrhythmia\n3. severe coronary artery or heart valve disease\n4. sequelae of cerebrovascular accident\n5. severe lung, liver, kidney and immune system diseases\n6. Suspected difficult airway\n7. confirmed or suspected allergy to this trial drug\n8. As judged by the investigator to be ineligible for the study, such as communication impairment (language or intelligence)'}, 'identificationModule': {'nctId': 'NCT05850702', 'briefTitle': 'Attenuation of the Hemodynamic Response to Double-lumen Endotracheal Intubation With Nebulized Lidocaine', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': 'Attenuation of the Hemodynamic Response to Double-lumen Endotracheal Intubation With Nebulized Lidocaine: a Randomized, Double-blind, Controlled Trial', 'orgStudyIdInfo': {'id': 'IIT-2022-0250'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'lidocaine', 'description': 'Intervention group', 'interventionNames': ['Drug: Lidocaine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'saline', 'description': 'control group', 'interventionNames': ['Drug: Saline']}], 'interventions': [{'name': 'Lidocaine', 'type': 'DRUG', 'description': 'inhale 5ml of 2% lidocaine by nebulization', 'armGroupLabels': ['lidocaine']}, {'name': 'Saline', 'type': 'DRUG', 'description': 'inhale 5ml of saline by nebulization', 'armGroupLabels': ['saline']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Hao Zhu', 'role': 'CONTACT', 'email': 'zhuhaossmu@163.com', 'phone': '008602168383702'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RenJi Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'attending physician', 'investigatorFullName': 'zhuhao', 'investigatorAffiliation': 'RenJi Hospital'}}}}