Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2025-12-26 @ 1:33 AM
Study NCT ID:
NCT03406533
Status:
TERMINATED
Last Update Posted:
2019-06-12
First Post:
2017-12-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sedation Strategies for Diagnostic Bronchoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008874', 'term': 'Midazolam'}, {'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D000077208', 'term': 'Remifentanil'}, {'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D015742', 'term': 'Propofol'}], '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'}, {'id': 'D011422', 'term': 'Propionates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'whyStopped': 'The sample size should be re-calculated based on the first 28 cases.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2018-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-10', 'studyFirstSubmitDate': '2017-12-13', 'studyFirstSubmitQcDate': '2018-01-15', 'lastUpdatePostDateStruct': {'date': '2019-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cough score', 'timeFrame': 'From the completion of local anesthesia with lidocaine to the completion of bronchoscopy procedure, assessed up to 2 hours', 'description': 'Cough score across the procedure will be classified into 4 degree (1-4) as follows. 1 = none, 2 = one gag or cough only, 3 = \\>1 gag or cough, but acceptable conditions, 4 = unacceptable conditions'}], 'secondaryOutcomes': [{'measure': 'Body movement', 'timeFrame': 'From the completion of local anesthesia with lidocaine to the completion of bronchoscopy procedure, assessed up to 2 hours', 'description': 'The numbers of the times of any body movement across the procedure'}, {'measure': 'Satisfaction score of the patients and bronchoscopists', 'timeFrame': 'Across the procedure, assessed up to 2 hours', 'description': 'Satisfaction score of the patients and bronchoscopists regarding to the sedation quality measured by a 0-100 visual analogue scale (VAS). 100 refers to the highest satisfaction degree while 0 refers to the worst satisfaction degree.'}, {'measure': 'Amount of the rescue use of propofol', 'timeFrame': 'After sedation induction, assessed up to 2 hours', 'description': 'The total amount of propofol used as a rescue therapy when the sedation is not deep enough as assessed by the anesthesiologists.'}, {'measure': 'Recovery time', 'timeFrame': 'After termination of the sedation medication, assessed up to 2 hours', 'description': 'Duration of the recovery from sedation'}, {'measure': 'Prevalence of the side effects of respiratory and circulatory system', 'timeFrame': 'Across the sedation duration, assessed up to 2 hours', 'description': 'The number of the side effects in respiratory and circulatory system during the procedure, including hypertension, hypotension, tackycardia, bradycardia, hypoxia and larynx spasm.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bronchoscopy', 'Sedation']}, 'descriptionModule': {'briefSummary': 'Diagnostic bronchoscopy is an invasive procedure performed to diagnose respiratory diseases. But pain has been complained by most of the patients receiving such procedures. Sedation or anesthesia was required by both of the patients and bronchoscopists. Unfortunately, no consensus has been made upon the sedation strategies. Multiple sedation approaches have been applied, such as midazolam and fentanyl, remifentanil and propofol, dexmedetomidine and propofol. The present study was designed to compare these protocols in sedation for diagnostic bronchoscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Scheduled for flexible diagnostic bronchoscopy\n* Adult patients aged 18 to 65 years\n* American Society of Anesthesiologists (ASA) Physical Status Classification I-II\n* BMI 18.5-25kg/m2\n* Subjects provide informed consent\n\nExclusion Criteria:\n\n* Severe airway obstruction\n* Coagulation disorder\n* Repeat bronchoscopy (more than 3 times)\n* Severe liver and renal dysfunction\n* Cardiovascular and cerebrovascular diseases\n* Pregnancy\n* Chronic opioid user\n* Drug abusers or addicts'}, 'identificationModule': {'nctId': 'NCT03406533', 'briefTitle': 'Sedation Strategies for Diagnostic Bronchoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Changhai Hospital'}, 'officialTitle': 'The Effect and Safety of Different Sedation Strategies for Diagnostic Bronchoscopy', 'orgStudyIdInfo': {'id': 'SED-DFB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group F', 'description': 'Sedated with midazolam and fentanyl', 'interventionNames': ['Drug: Midazolam', 'Drug: Fentanyl']}, {'type': 'EXPERIMENTAL', 'label': 'Group DR', 'description': 'Sedated with midazolam, dexmedetomidine and remifentanil', 'interventionNames': ['Drug: Midazolam', 'Drug: Dexmedetomidine', 'Drug: Remifentanil']}, {'type': 'EXPERIMENTAL', 'label': 'Group DF', 'description': 'Sedated with midazolam, dexmedetomidine and fentanyl', 'interventionNames': ['Drug: Midazolam', 'Drug: Dexmedetomidine', 'Drug: Fentanyl']}, {'type': 'EXPERIMENTAL', 'label': 'Group PR', 'description': 'Sedated with midazolam, propofol and remifentanil', 'interventionNames': ['Drug: Midazolam', 'Drug: Remifentanil', 'Drug: Propofol']}], 'interventions': [{'name': 'Midazolam', 'type': 'DRUG', 'description': 'Midazolam is used as a common medication for sedation in all groups.', 'armGroupLabels': ['Group DF', 'Group DR', 'Group F', 'Group PR']}, {'name': 'Dexmedetomidine', 'type': 'DRUG', 'description': 'Dexmedetomidine is used for sedation in bronchoscopy with less impact on respiration.', 'armGroupLabels': ['Group DF', 'Group DR']}, {'name': 'Remifentanil', 'type': 'DRUG', 'description': 'Remifentanil is used for analgesia to prevent bronchoscopy induced cough.', 'armGroupLabels': ['Group DR', 'Group PR']}, {'name': 'Fentanyl', 'type': 'DRUG', 'description': 'Fentanyl is another opioid drug used for analgesia to prevent bronchoscopy induced cough.', 'armGroupLabels': ['Group DF', 'Group F']}, {'name': 'Propofol', 'type': 'DRUG', 'description': 'Propofol is used for sedation with high efficacy but more side effect on respiration than dexmedetomidine.', 'armGroupLabels': ['Group PR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200433', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Faculty of Anesthesiology, Changhai Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changhai Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, {'name': 'Ruijin Hospital', 'class': 'OTHER'}, {'name': 'Shanghai Pulmonary Hospital, Shanghai, China', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Jia-feng Wang', 'investigatorAffiliation': 'Changhai Hospital'}}}}