Ignite Creation Date:
2025-12-25 @ 1:04 AM
Ignite Modification Date:
2026-02-23 @ 11:35 AM
Study NCT ID:
NCT03395093
Status:
UNKNOWN
Last Update Posted:
2018-01-10
First Post:
2017-12-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BIS of Sedation Depth During Flexible Bronchoscopy.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008171', 'term': 'Lung Diseases'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D008874', 'term': 'Midazolam'}, {'id': 'D015742', 'term': 'Propofol'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-07-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-01-08', 'studyFirstSubmitDate': '2017-12-25', 'studyFirstSubmitQcDate': '2018-01-08', 'lastUpdatePostDateStruct': {'date': '2018-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'perioperative changes of blood pressure', 'timeFrame': 'every 5 minutes from the operation beginning to end', 'description': 'For each patient,bispectral index monitoring after anesthesia. Bp will be measured.'}], 'secondaryOutcomes': [{'measure': 'perioperative time', 'timeFrame': 'from the operation beginning to end', 'description': 'For each patient, record the time bronchoscopy in and out'}, {'measure': 'Adverse events', 'timeFrame': 'in the process of the operation', 'description': 'For each patient, Adverse events (overall intraoperative cough,bleeding,low oxygen solution) will be record in the operation'}, {'measure': 'Patient satisfaction rate', 'timeFrame': 'One day after the operation', 'description': 'One day after the patient do the bronchoscopy, ask him/her about the satisfaction to the operation'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bronchoscopy', 'conscious sedation', 'fentanyl', 'Bispectral Index'], 'conditions': ['Pulmonary Disease']}, 'referencesModule': {'references': [{'pmid': '19443532', 'type': 'RESULT', 'citation': 'Clark G, Licker M, Younossian AB, Soccal PM, Frey JG, Rochat T, Diaper J, Bridevaux PO, Tschopp JM. Titrated sedation with propofol or midazolam for flexible bronchoscopy: a randomised trial. Eur Respir J. 2009 Dec;34(6):1277-83. doi: 10.1183/09031936.00142108. Epub 2009 May 14.'}, {'pmid': '22045879', 'type': 'RESULT', 'citation': 'Wahidi MM, Jain P, Jantz M, Lee P, Mackensen GB, Barbour SY, Lamb C, Silvestri GA. American College of Chest Physicians consensus statement on the use of topical anesthesia, analgesia, and sedation during flexible bronchoscopy in adult patients. Chest. 2011 Nov;140(5):1342-1350. doi: 10.1378/chest.10-3361.'}], 'seeAlsoLinks': [{'url': 'https://www.ncbi.nlm.nih.gov/pubmed/19443532', 'label': 'Titrated sedation with propofol or midazolam for flexible bronchoscopy: a randomised trial.'}, {'url': 'https://www.ncbi.nlm.nih.gov/pubmed/?term=American+College+of+Chest+Physicians++Consensus+Statement+on+the+Use+of+Topical++Anesthesia%2C+Analgesia%2C+and+Sedation+During+Flexible+Bronchoscopy+in+Adult+Patients', 'label': 'American College of Chest Physicians consensus statement on the use of topical anesthesia, analgesia, and sedation during flexible bronchoscopy in adult patients.'}]}, 'descriptionModule': {'briefSummary': 'Fentanyl is analgesia medication. There has not pain nerve in the lung. Flexible bronchoscopy(FB) is used in the respiratory medicine. So people will not feel pain in the process of FB. The purpose of the study is to know if Fentanyl is useful in the conscious sedation of FB.', 'detailedDescription': 'Fentanyl is opioid receptor agonists. It is a fast-acting, short duration and potent analgesics.\n\nFlexible bronchoscopy (FB) is mostly used in the diagnosis and therapy in the respiratory disease. As we know, there has not pain nerve in the lung. People will not feel pain when they are in FB.\n\nIf fentanyl will be effective in FB? Our study will observe the effect of conscious sedation in FB with fentanyl or without fentanyl.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nCough reflex is good agree to do bronchoscopy agree to take part in the study no the contraindication of bronchoscopy\n\nExclusion Criteria:\n\nForced expiratory volume in one second\\<1 L severe hemoptysis severe heart, liver,kidney failure psychiatric and nervous disorders allergic to the anesthetic ( fentanyl, midazolam, or propofol)'}, 'identificationModule': {'nctId': 'NCT03395093', 'acronym': 'BIS', 'briefTitle': 'BIS of Sedation Depth During Flexible Bronchoscopy.', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing First Hospital, Nanjing Medical University'}, 'officialTitle': 'Bispectral Index Monitoring of Sedation Depth During Flexible Bronchoscopy: With or Without Fentanyl .', 'orgStudyIdInfo': {'id': 'YL20160713-021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FB with fentanyl', 'description': 'In the Bispectral Index monitoring,our study will use midazolam, propofol and fentanyl in the conscious sedation of FB', 'interventionNames': ['Drug: Fentanyl', 'Drug: Midazolam', 'Drug: Propofol', 'Device: Bispectral Index monitoring']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'FB without fentanyl', 'description': 'In the Bispectral Index monitoring, our study will use midazolam, propofol in the conscious sedation of FB', 'interventionNames': ['Drug: Midazolam', 'Drug: Propofol', 'Device: Bispectral Index monitoring']}], 'interventions': [{'name': 'Fentanyl', 'type': 'DRUG', 'otherNames': ['fentanest', 'fantail', 'sublimaze'], 'description': 'Five minutes before the patients is done the flexible bronchoscopy, fentanyl will be intravenous injected.', 'armGroupLabels': ['FB with fentanyl']}, {'name': 'Midazolam', 'type': 'DRUG', 'otherNames': ['Ro-21-3981'], 'description': 'Five minutes before the patients is done the flexible bronchoscopy, midazolam will be intravenous injected.', 'armGroupLabels': ['FB with fentanyl', 'FB without fentanyl']}, {'name': 'Propofol', 'type': 'DRUG', 'otherNames': ['diprivan', 'disoprofol'], 'description': 'Propofol will be intravenous injected as soon as the flexible bronchoscopy begins.', 'armGroupLabels': ['FB with fentanyl', 'FB without fentanyl']}, {'name': 'Bispectral Index monitoring', 'type': 'DEVICE', 'description': 'Bispectral Index monitoring will be used in the process of the flexible bronchoscopy.', 'armGroupLabels': ['FB with fentanyl', 'FB without fentanyl']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'wei gu, master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital with Nanjing Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing First Hospital, Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}