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This is a randomized clinical trial of deep procedural sedation with propofol with and without supplemental alfentanil. Patients will be assessed for total and fractionated serum catecholamines before and after the procedure in addition to usual procedural sedation outcomes parameters to assess the adrenergic effect of propofol sedation without supplemental opioid.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propofol | Active Comparator | propofol only for deep procedural sedation |
|
| Propofol/alfentanil | Active Comparator | Propofol with alfentanil for deep procedural sedation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| propofol | Drug | 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Serum Catecholamines | change in serum catecholamine levels, values indicate a decrease over the procedure. These patients underwent fracture reduction procedures which are typically associated with an increase in catecholamines. | one minute prior to the start of the procedure and immediately at the end of sedation procedure (median time of procedure 12 minutes range 6-26 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory Depression | categorized as a change in end tidal CO2 from baseline >10mmhg, a loss of end tidal CO2 waveform for more than 6 seconds, or an oxygen saturation less than 93%. | From one minute prior to the start of the sedation procedure until the patient has returned to baseline mental status |
| Patient Reported Pain and Recall of the Painful Procedure for Which They Were Sedated Measure by Patient Query After They Had Regained Their Baseline Level of Consciousness After the Procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James R. Miner, MD | Hennepin Faculty Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hennepin County Medical Center | Minneapolis | Minnesota | 55415 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23701339 | Result | Miner JR, Moore JC, Plummer D, Gray RO, Patel S, Ho JD. Randomized clinical trial of the effect of supplemental opioids in procedural sedation with propofol on serum catecholamines. Acad Emerg Med. 2013 Apr;20(4):330-7. doi: 10.1111/acem.12110. |
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34 patients were elligible, 14 underwent sedation emergently before the patient could be approached for study enrollment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Propofol | propofol only for deep procedural sedation propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation |
| FG001 | Propofol/Alfentanil | Propofol with alfentanil for deep procedural sedation propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation alfentanil: alfentanil 10 ug/kg immediately prior to propofol dose |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Propofol | propofol only for deep procedural sedation propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation |
| BG001 | Propofol/Alfentanil | Propofol with alfentanil for deep procedural sedation propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation alfentanil: alfentanil 10 ug/kg immediately prior to propofol dose |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Change in Serum Catecholamines | change in serum catecholamine levels, values indicate a decrease over the procedure. These patients underwent fracture reduction procedures which are typically associated with an increase in catecholamines. | Median | Inter-Quartile Range | mcg/ml | one minute prior to the start of the procedure and immediately at the end of sedation procedure (median time of procedure 12 minutes range 6-26 minutes |
|
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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 | Propofol | propofol only for deep procedural sedation propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| apnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | patient inadvertently given 5 times the study dose of alfentanil, developed apnea that resovled with bag valve mask ventilation over 2 minutes, resolved completely after 2 minutes without subsequent difficulty |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James Miner | Minneapolis Medical Reseach Foundation | 6128738791 | miner015@umn.edu |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| D015760 | Alfentanil |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| alfentanil | Drug | alfentanil 10 ug/kg immediately prior to propofol dose |
|
Pain and recall were measured seperately by direct patient query. The patient was asked if they experienced any pain during the procedure. The patient was then asked if they could recall any part of the fracture reduction. Patients who had either pain with the procedure of recall of the procedure were counted as having pain or recall with the procedure. |
| single time point measured after sedation procedure completed |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Secondary | Respiratory Depression | categorized as a change in end tidal CO2 from baseline >10mmhg, a loss of end tidal CO2 waveform for more than 6 seconds, or an oxygen saturation less than 93%. | Number | participants | From one minute prior to the start of the sedation procedure until the patient has returned to baseline mental status |
|
|
|
| Secondary | Patient Reported Pain and Recall of the Painful Procedure for Which They Were Sedated Measure by Patient Query After They Had Regained Their Baseline Level of Consciousness After the Procedure | Pain and recall were measured seperately by direct patient query. The patient was asked if they experienced any pain during the procedure. The patient was then asked if they could recall any part of the fracture reduction. Patients who had either pain with the procedure of recall of the procedure were counted as having pain or recall with the procedure. | Number | participants | single time point measured after sedation procedure completed |
|
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| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Propofol/Alfentanil | Propofol with alfentanil for deep procedural sedation propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation alfentanil: alfentanil 10 ug/kg immediately prior to propofol dose | 0 | 10 | 1 | 10 |
|
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D005283 | Fentanyl |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |