Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
50 participants
INTERVENTIONAL
2010-06-30
2012-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
midazolam load fentanyl load midazolam demand fentanyl demand benadryl demand
Midazolam load
2 mg bolus prior to bronchoscopy
Fentanyl load
50 µg bolus prior to bronchoscopy
Midazolam demand
0.5 mg demand bolus at discretion of pulmonologist
Fentanyl demand
12.5 µg demand bolus at discretion of pulmonologist
Benadryl demand
25 mg bolus after 6th and 13th demand midazolam/fentanyl bolus
dexmedetomidine and ketamine
dexmedetomidine load ketamine load dexmedetomidine maintenance ketamine maintenance midazolam demand fentanyl demand benadryl demand
Dexmedetomidine load
Dexmedetomidine 1 µg/kg prior to bronchoscopy
Ketamine load
Ketamine 30 mg bolus prior to bronchoscopy
Dexmedetomidine maintenance
0.5 µg/kg/hour for the duration of bronchoscopy (58.5 minutes average)
Ketamine maintenance
8 µg/kg/min for the duration of bronchoscopy (58.5 minutes average)
Midazolam demand
0.5 mg demand bolus at discretion of pulmonologist
Fentanyl demand
12.5 µg demand bolus at discretion of pulmonologist
Benadryl demand
25 mg bolus after 6th and 13th demand midazolam/fentanyl bolus
Interventions
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Dexmedetomidine load
Dexmedetomidine 1 µg/kg prior to bronchoscopy
Ketamine load
Ketamine 30 mg bolus prior to bronchoscopy
Midazolam load
2 mg bolus prior to bronchoscopy
Fentanyl load
50 µg bolus prior to bronchoscopy
Dexmedetomidine maintenance
0.5 µg/kg/hour for the duration of bronchoscopy (58.5 minutes average)
Ketamine maintenance
8 µg/kg/min for the duration of bronchoscopy (58.5 minutes average)
Midazolam demand
0.5 mg demand bolus at discretion of pulmonologist
Fentanyl demand
12.5 µg demand bolus at discretion of pulmonologist
Benadryl demand
25 mg bolus after 6th and 13th demand midazolam/fentanyl bolus
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Requiring more than 2 LPM supplemental oxygen to maintain SaO2 \> 90%
* History of allergy to study medications
* Pregnancy
* A history of psychosis
* Any condition deemed likely by the pulmonologist or anesthesiologist to pose a significant risk due to elevation of blood pressure, including cerebral/aortic aneurysm, and or ischemic cardiovascular disease
* Bradydysrhythmia deemed significant by the anesthesiologist or pulmonologist
* A diagnosis of significant renal or hepatic impairment
18 Years
90 Years
ALL
No
Sponsors
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Hospira, now a wholly owned subsidiary of Pfizer
INDUSTRY
University of Pennsylvania
OTHER
Responsible Party
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Principal Investigators
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Jeff E Mandel, MD MS
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
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University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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References
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Yarmus LB, Akulian JA, Gilbert C, Mathai SC, Sathiyamoorthy S, Sahetya S, Harris K, Gillespie C, Haas A, Feller-Kopman D, Sterman D, Lee HJ. Comparison of moderate versus deep sedation for endobronchial ultrasound transbronchial needle aspiration. Ann Am Thorac Soc. 2013 Apr;10(2):121-6. doi: 10.1513/AnnalsATS.201209-074OC.
Other Identifiers
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810981
Identifier Type: -
Identifier Source: org_study_id
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