Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2026-01-02 @ 4:01 PM
Study NCT ID:
NCT02148432
Status:
COMPLETED
Last Update Posted:
2017-01-25
First Post:
2014-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Establishment of Ideal IV Sedative Regimen for Successful Fiberoptic Bronchoscopy in Assessing the Site, Severity of Sleep Apnea Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}], 'ancestors': [{'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-04-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-23', 'studyFirstSubmitDate': '2014-05-22', 'studyFirstSubmitQcDate': '2014-05-27', 'lastUpdatePostDateStruct': {'date': '2017-01-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Desaturation rate', 'timeFrame': 'Baseline from 5 min after remifentanil TCI start, 10 min after dexmedetomidine loading start, every 5 min until surgeon can do endoscopy successfully, to immediately after endoscopy', 'description': 'SpO2 \\< 90% (checked by pulse oximetry)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['sleep apnea syndrome, fiberoptic bronchoscopy, IV sedation'], 'conditions': ['Sleep Apnea Syndrome']}, 'descriptionModule': {'briefSummary': 'Venous thromboembolism(VTE) is the third most common cardiovascular complication among hospitalized patients, and can even cause death. VTE often occurs in intensive care patients and there had been many efforts to prevent such complication. The American College of Chest Physicians (ACCP) had published evidence-based clinical practice guideline for VTE prophylaxis.\n\nThis study focuses on how VTE prophylaxis is being performed in both medical and surgical ICUs in a single University hospital, and sees the differences in such prophylactic patterns.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 20-60 years old patients with ASA class I-II\n2. Scheduled for drug induced sleep endoscope after diagnosed with sleep apnea syndrome\n\nExclusion Criteria:\n\n1. Patients having hearing difficulties, taking any CNS related medication, history of any adverse drug reaction, Glasgow coma scale \\< 15\n2. Patients with severe cardiopulmonary dysfunction\n3. Patients refusal'}, 'identificationModule': {'nctId': 'NCT02148432', 'briefTitle': 'Establishment of Ideal IV Sedative Regimen for Successful Fiberoptic Bronchoscopy in Assessing the Site, Severity of Sleep Apnea Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'orgStudyIdInfo': {'id': '4-2014-0232'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'dexmedetomidine 0.5 mcg/kg/hr', 'interventionNames': ['Drug: dexmedetomidine infusion rate, 0.5 mcg/kg/hr']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'dexmedetomidine 1.0 mcg/kg/hr', 'interventionNames': ['Drug: dexmedetomidine infusion rate, 1.0 mcg/kg/hr']}], 'interventions': [{'name': 'dexmedetomidine infusion rate, 0.5 mcg/kg/hr', 'type': 'DRUG', 'description': 'continuous infusion of dexmedetomidine at rate of 0.5 mcg/kg/hr', 'armGroupLabels': ['dexmedetomidine 0.5 mcg/kg/hr']}, {'name': 'dexmedetomidine infusion rate, 1.0 mcg/kg/hr', 'type': 'DRUG', 'description': 'continuous infusion of dexmedetomidine at rate of 1.0 mcg/kg/hr', 'armGroupLabels': ['dexmedetomidine 1.0 mcg/kg/hr']}]}, 'contactsLocationsModule': {'locations': [{'zip': '120-752', 'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}