Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-26 @ 4:02 AM
Study NCT ID:
NCT02157818
Status:
COMPLETED
Last Update Posted:
2017-05-19
First Post:
2014-06-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Comparison of Sedative Drugs for Conscious Sedation During Ultrasound Guided Transbronchial Needle Aspiration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2021-09-14', 'releaseDate': '2021-08-18'}, {'resetDate': '2021-10-13', 'releaseDate': '2021-09-16'}], 'estimatedResultsFirstSubmitDate': '2021-08-18'}}, 'interventionBrowseModule': {'meshes': [{'id': 'D008874', 'term': 'Midazolam'}, {'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-17', 'studyFirstSubmitDate': '2014-06-01', 'studyFirstSubmitQcDate': '2014-06-04', 'lastUpdatePostDateStruct': {'date': '2017-05-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-06-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of Desaturation events', 'timeFrame': 'Patient followed for the entire duration of EBUS-TBNA and until discharge of bronchoscopy room, an expected average of 2 hours', 'description': 'The number of desaturation (SpO2 \\<90% for more than 5 seconds) events'}], 'secondaryOutcomes': [{'measure': 'RSS score', 'timeFrame': 'Patient followed for the entire duration of EBUS-TBNA and until discharge of bronchoscopy room, an expected average of 2 hours', 'description': 'RSS score: at the beginning of the procedure, minimum RSS score, every 5 minute'}, {'measure': 'Total dose of intratracheal lidocaine instillation', 'timeFrame': 'Patient followed for the entire duration of EBUS-TBNA and until discharge of bronchoscopy room, an expected average of 2 hours', 'description': 'Cumulative dose of lidocaine administered at bronchus by the endoscopist for local anesthesia by topical instillation.\n\nTopical lidocaine instillation is performed in both the two arms for procedure as routine bronchoscopy.'}, {'measure': 'Endoscopist satisfaction', 'timeFrame': 'Patient followed for the entire duration of EBUS-TBNA and until discharge of bronchoscopy room', 'description': 'Endoscopist global satisfaction score based on a VAS score'}, {'measure': 'Patient satisfaction', 'timeFrame': 'Patient followed for the entire duration of EBUS-TBNA and until discharge of bronchoscopy room, an expected average of 2 hours', 'description': 'Global patient satisfaction associated with the procedure. Score based on a VAS score measured before the patients leave the bronchoscopy room.'}, {'measure': 'Use of rescue midazolam', 'timeFrame': 'Patient followed for the entire duration of EBUS-TBNA and until discharge of bronchoscopy room, an expected average of 2 hours', 'description': 'Use of rescue midazolam, total dose'}, {'measure': 'Duration of desaturation (sec)', 'timeFrame': 'Patient followed for the entire duration of EBUS-TBNA, an expected average of 2 hours'}, {'measure': 'Hemodynamic adverse event', 'timeFrame': 'Patient followed for the entire duration of EBUS-TBNA and until discharge of bronchoscopy room, an expected average of 2 hours', 'description': 'Hypotension ( \\< mean BP 60 mmHg) Bradycardia ( \\< 50 bpm)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Endobronchial Ultrasound Guided Transbronchial Needle Aspiration']}, 'referencesModule': {'references': [{'pmid': '33122573', 'type': 'DERIVED', 'citation': 'Kim J, Choi SM, Park YS, Lee CH, Lee SM, Yoo CG, Kim YW, Lee J. Dexmedetomidine versus midazolam for sedation during endobronchial ultrasound-guided transbronchial needle aspiration: A randomised controlled trial. Eur J Anaesthesiol. 2021 May 1;38(5):534-540. doi: 10.1097/EJA.0000000000001370.'}]}, 'descriptionModule': {'briefSummary': '1. Appropriate sedation is needed for medical diagnosis, treatment, and the safety for patients. In non-surgical approaches, benzodiazepines are broadly used for ideal sedated status for patients.\n\n * However, especially in bronchoscope procedure, continuous monitoring of oxygen saturation is needed to prevent hypoxia due to respiratory distress induced by benzodiazepine.\n * A alpha-2 agonist, dexmedetomidine, which has similar sedative effect, but has less adverse effect of respiratory distress compared to previous agents, was introduced.\n2. It is necessary to compare the efficacy and safety of dexmedetomidine with that of midazolam in ultrasound guided transbronchial needle aspiration (EBUS-TBNA).\n\n * Double blind randomized trial\n * Primary outcome: The number and duration of desaturation, volume of sedative, any use of rescue midazolam, and Ramsay Sedation Scale (RSS) score (for efficacy), and hypertension, tachycardia, any need for mandible support or manual ventilation, and any need for intubation (for safety).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who visit Seoul National University Hospital between 2014.04 - 2015.04\n* Patients who undergo EBUS-TBNA during the period\n* Aged between 18-75\n* Patients who meet the criteria of American Society of Anesthesiologists (ASA) physical status classification I-III\n\nExclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) physical status classification \\>3\n* Have glomerular filtration rate (GFR) less than 15ml/min 1.73m2 or undergoing hemodialysis\n* End stage liver disease.\n* Impaired ventricular functions (EF \\<30%)\n* Patients with baseline oxygen desaturation (resting SpO2 \\<90%)\n* Asthma or chronic obstructive pulmonary disease or a forced expiratory volume in 1 s (FEV1)of \\< 1.0 liter\n* Bradycardia \\[baseline heart rate (HR)\\< 60 beats/min\\]\n* Hypotension \\[baseline systolic arterial pressure (SAP) \\< 100 mm Hg\\]\n* Pregnant state\n* Those intolerant or with an allergy to the study drug\n* those unable or who refused to give informed consent'}, 'identificationModule': {'nctId': 'NCT02157818', 'briefTitle': 'A Comparison of Sedative Drugs for Conscious Sedation During Ultrasound Guided Transbronchial Needle Aspiration', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'A Comparison of Dexmedetomidine Versus Midazolam for Conscious Sedation During Endobronchial Ultrasound Guided Transbronchial Needle Aspiration (EBUS-TBNA)', 'orgStudyIdInfo': {'id': 'dex512'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'midazolam', 'description': 'midazolam IV bolus 0.05ml/kg bolus in 1minute. rescue drug(Midazolam) 1 mg, IV boluses for double blinding setting, we use saline, 0.4 mcg/kg IV bolus in 10 minutes and 0.5 mcg/kg/h, as placebo.', 'interventionNames': ['Drug: midazolam']}, {'type': 'EXPERIMENTAL', 'label': 'Dexmedetomidine', 'description': 'Dexmedetomidine 0.4 mcg/kg IV bolus in 10 minutes. Dexmedetomidine 0.25-0.75 mcg/kg/h for RSS 3-5. Midazolam 1mg bolus IV pro re nata (PRN).\n\nfor double blinding setting, IV bolus 0.05ml/kg bolus in 1minute.', 'interventionNames': ['Drug: Dexmedetomidine']}], 'interventions': [{'name': 'midazolam', 'type': 'DRUG', 'armGroupLabels': ['midazolam']}, {'name': 'Dexmedetomidine', 'type': 'DRUG', 'armGroupLabels': ['Dexmedetomidine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-799', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jinwoo Lee', 'investigatorAffiliation': 'Seoul National University Hospital'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2021-08-18', 'type': 'RELEASE'}, {'date': '2021-09-14', 'type': 'RESET'}, {'date': '2021-09-16', 'type': 'RELEASE'}, {'date': '2021-10-13', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Jinwoo Lee, Professor, Seoul National University Hospital'}}}}