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| Name | Class |
|---|---|
| Hospira, now a wholly owned subsidiary of Pfizer | INDUSTRY |
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This protocol hopes to determine whether the use of dexmedetomidine-ketamine can reduce the use of standard of care fentanyl-midazolam sedation during bronchoscopy. This may result in less respiratory depression while providing better compliance with the procedure.
All patients enrolled in the study will be undergoing bronchoscopy, which is typically performed with sedation. All procedural sedation carries some risk. Several features of the study may lower the risk of sedation relative to that of conventional sedation. An anesthesiologist will be present throughout the procedure. Continuous monitoring of respiration with RIP will be employed. Administration of sedation will be via a volumetric syringe pump. Benefits specific to dexmedetomidine-ketamine include the lack of respiratory depression and greater hemodynamic stability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | midazolam load fentanyl load midazolam demand fentanyl demand benadryl demand |
|
| dexmedetomidine and ketamine | Active Comparator | dexmedetomidine load ketamine load dexmedetomidine maintenance ketamine maintenance midazolam demand fentanyl demand benadryl demand |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine load | Drug | Dexmedetomidine 1 µg/kg prior to bronchoscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Decreased Minute Ventilation | An initial baseline minute ventilation estimate was obtained via calibrated respiratory impedance plethysmography bands. Subsequent minute ventilation was normalized to this value. Values exceeding 100% were excluded from analysis, as these typically reflected a period of hyperpnea subsequent to relief of airway obstruction by chin lift or jaw thrust. | During the bronchoscopy procedure only, 58.5 minutes average |
| Total Fentanyl | Total fentanyl dose delivered during the procedure | During the bronchoscopy procedure only, 58.5 minutes average |
| Total Midazolam | Total midazolam delivered during procedure | Duration of procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Desaturation (Cumulative) | Cumulative time below saturation of 90% - the total number of seconds that the pulse oximeter reported a saturation below 90% | During the bronchoscopy procedure only, 58.5 minutes average |
| Desaturation (Longest) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeff E Mandel, MD MS | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23607840 | Result | 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. |
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Patients were recruited from the practices of the pulmonologist sub investigators by the principal investigator
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo |
placebo + Standard of Care of midazolam and fentanyl: Control Saline 50 ml Midazolam 2 mg + Fentanyl 50 µg Saline 20 ml Midazolam 1 |
| FG001 | Dexmedetomidine and Ketamine |
dexmedetomidine and ketamine Study Medication: Experimental Dexmedetomidine 200 µg in 50 ml Ketamine 30 mg Ketamine 200 mg in 20 ml M |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo + Standard of Care of midazolam and fentanyl |
| BG001 | Dexmedetomidine and Ketamine | dexmedetomidine and ketamine + Standard of Care of midazolam and fentanyl |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Decreased Minute Ventilation | An initial baseline minute ventilation estimate was obtained via calibrated respiratory impedance plethysmography bands. Subsequent minute ventilation was normalized to this value. Values exceeding 100% were excluded from analysis, as these typically reflected a period of hyperpnea subsequent to relief of airway obstruction by chin lift or jaw thrust. | Posted | Median | Inter-Quartile Range | percentage of baseline | During the bronchoscopy procedure only, 58.5 minutes average |
|
The AE data was collected over a 2 year period from the enrollment date for each participant .
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo + Standard of Care (midazolam and fentanyl) | 0 |
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The presence of an anesthesiologist may have affected the aggressiveness of the pulmonologists in administering sedation.
Alterations in the study drug were not permitted; an open label study might find larger differences in respiratory measures
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeff E Mandel MD MS | Department of Anesthesiology & Critical Care | 2156150553 | mandelj@uphs.upenn.edu |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D007649 | Ketamine |
| D008874 | Midazolam |
| D005283 | Fentanyl |
| D004155 | Diphenhydramine |
| D004319 | Doxylamine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Ketamine load | Drug | Ketamine 30 mg bolus prior to bronchoscopy |
|
|
| Midazolam load | Drug | 2 mg bolus prior to bronchoscopy |
|
|
| Fentanyl load | Drug | 50 µg bolus prior to bronchoscopy |
|
|
| Dexmedetomidine maintenance | Drug | 0.5 µg/kg/hour for the duration of bronchoscopy (58.5 minutes average) |
|
|
| Ketamine maintenance | Drug | 8 µg/kg/min for the duration of bronchoscopy (58.5 minutes average) |
|
|
| Midazolam demand | Drug | 0.5 mg demand bolus at discretion of pulmonologist |
|
|
| Fentanyl demand | Drug | 12.5 µg demand bolus at discretion of pulmonologist |
|
|
| Benadryl demand | Drug | 25 mg bolus after 6th and 13th demand midazolam/fentanyl bolus |
|
|
Longest time below saturation of 90% (the number of seconds elapsed between the start of a period in which the pulse oximeter saturation fell below 90% and the return above 90%)
| During the bronchoscopy procedure only, 58.5 minutes average |
| Conversion to General Anesthesia | Patients in which the procedure could not be completed without conversion to general anesthesia | During the bronchoscopy procedure only, 58.5 minutes average |
| Patient Satisfaction | Satisfaction rated by 10 point Likert scale (0 = Totally dissatisfied, 10 = Totally satisfied) | After the bronchoscopy procedure only |
| Endoscopist Satisfaction | Satisfaction rated by 10 point Likert scale (0 = Totally dissatisfied, 10 = Totally satisfied) | After the bronchoscopy procedure only |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Primary | Total Fentanyl | Total fentanyl dose delivered during the procedure | Posted | Median | Inter-Quartile Range | µg | During the bronchoscopy procedure only, 58.5 minutes average |
|
|
|
|
| Primary | Total Midazolam | Total midazolam delivered during procedure | Posted | Median | Inter-Quartile Range | mg | Duration of procedure |
|
|
|
|
| Secondary | Desaturation (Cumulative) | Cumulative time below saturation of 90% - the total number of seconds that the pulse oximeter reported a saturation below 90% | Posted | Median | Inter-Quartile Range | seconds | During the bronchoscopy procedure only, 58.5 minutes average |
|
|
|
| Secondary | Desaturation (Longest) | Longest time below saturation of 90% (the number of seconds elapsed between the start of a period in which the pulse oximeter saturation fell below 90% and the return above 90%) | Posted | Median | Inter-Quartile Range | seconds | During the bronchoscopy procedure only, 58.5 minutes average |
|
|
|
| Secondary | Conversion to General Anesthesia | Patients in which the procedure could not be completed without conversion to general anesthesia | Posted | Count of Participants | Participants | During the bronchoscopy procedure only, 58.5 minutes average |
|
|
|
| Secondary | Patient Satisfaction | Satisfaction rated by 10 point Likert scale (0 = Totally dissatisfied, 10 = Totally satisfied) | Posted | Median | Inter-Quartile Range | score on a scale | After the bronchoscopy procedure only |
|
|
|
| Secondary | Endoscopist Satisfaction | Satisfaction rated by 10 point Likert scale (0 = Totally dissatisfied, 10 = Totally satisfied) | Posted | Median | Inter-Quartile Range | score on a scale | After the bronchoscopy procedure only |
|
|
|
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Dexmedetomidine and Ketamine | dexmedetomidine and ketamine + Standard of Care (midazolam + fentanyl) | 0 | 25 | 0 | 25 | 0 | 25 |
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| D003510 |
| Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010880 | Piperidines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D011725 | Pyridines |