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This study is a clinical trial of moderate sedation with propofol versus moderate sedation with ketamine for procedural sedation in the Emergency Department.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propofol | Active Comparator | propofol 1 milligram per kilogram intravenous bolus followed by 0.5 millligrams per kilogram as needed for mooderate procedural sedation |
|
| Ketamine | Active Comparator | ketamine 1 milligram per kilogram followed by 0.5 millgram per kilogram as needed for moderate procedural sedation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| propofol | Drug | propofol 1 millgram per kilogram intravenous bolus followed by 0.5 milligrams per kilogram as needed for moderate procedural sedation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory Depression (Sub-clinical and Clinical Signs) | binary measure based on the occurrence of an oxygen saturation less than 93 at any time, a change in baseline end tidal co2 >10 or an absence on capnographic waveform | From one minute prior to start of the procedure until the patient has returned to baseline mental status after the conclusion of the sedation procedure up to 60 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Return of Baseline Mental Status | time in seconds from the first dose of medication until the patient has regained baseline mental status | from start of procedure until the return of baseline mental status up to 120 minutes |
| Patient Reported Pain or Recall of the Procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James R Miner, MD | Hennepin Healthcare Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hennepin County Medical Center | Minneapolis | Minnesota | 55415 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20624140 | Result | Miner JR, Gray RO, Bahr J, Patel R, McGill JW. Randomized clinical trial of propofol versus ketamine for procedural sedation in the emergency department. Acad Emerg Med. 2010 Jun;17(6):604-11. doi: 10.1111/j.1553-2712.2010.00776.x. |
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97 enrolled subjects underwent procedural sedation
100 patients recruited in the Emergency Department
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| ID | Title | Description |
|---|---|---|
| FG000 | Propofol | propofol 1 milligram per kilogram at the start of the procedure followed by 0.5 milligrams per kilogram every 3 minutes as needed for moderate procedural sedation |
| FG001 | Ketamine | ketamine 1 milligram per kilogram intravenous bolus to start procedure followed by 0.5 mg/kg every three minutes as needed for moderate procedural sedation |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Propofol | propofol 1 milligram per kilogram at the start of the procedure followed by 0.5 milligrams per kilogram every 3 minutes as needed for moderate procedural sedation |
| BG001 | Ketamine |
| 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 | Respiratory Depression (Sub-clinical and Clinical Signs) | binary measure based on the occurrence of an oxygen saturation less than 93 at any time, a change in baseline end tidal co2 >10 or an absence on capnographic waveform | 50 subjects were randomized to each group, 50 subjects in the propofol arm completed the study, 47 in the ketamine arm | Posted | Number | 95% Confidence Interval | percentage of participants | From one minute prior to start of the procedure until the patient has returned to baseline mental status after the conclusion of the sedation procedure up to 60 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 1 milligram per kilogram at the start of the procedure followed by 0.5 milligrams per kilogram every 3 minutes as needed for moderate procedural sedation |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James Miner | MinneapolisMRF | 612-873-3000 | miner015@umn.edu |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Ketamine | Drug | ketamine milligram per kilogram followed by 0.5 milligrams per kilogram as need for moderate procedural sedation |
|
patient completed question after return to baseline mental status "did you feel pain during the procedure" and "do you remember any part of the procedure" answered by circling yes or no on a question sheet, positive if yes to either question |
| single measurement immediately after patient returns to baseline mental status after sedation procedure |
| Depth of Sedation | Observes assesment of alertness scale, 1-5 ordinal scale measuring level of awareness, one represents awake, 5 general anesthesia/unresponsive to pain | single measurement during sedation procedure |
ketamine 1 milligram per kilogram intravenous bolus to start procedure followed by 0.5 mg/kg every three minutes as needed for moderate procedural sedation
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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percentage of participants with respiratory depression
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| Secondary | Time to Return of Baseline Mental Status | time in seconds from the first dose of medication until the patient has regained baseline mental status | 50 patients were randomized to the propofol group and 50 to ketamine, 50 underwent the procedure in the propofol group and 47 in the ketamine group | Posted | Median | 95% Confidence Interval | minutes | from start of procedure until the return of baseline mental status up to 120 minutes |
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| Secondary | Patient Reported Pain or Recall of the Procedure | patient completed question after return to baseline mental status "did you feel pain during the procedure" and "do you remember any part of the procedure" answered by circling yes or no on a question sheet, positive if yes to either question | 100 patients were randomized, 50 to each group, 50 underwent the procedure in the propofol group and 47 in the ketamine group | Posted | Number | 95% Confidence Interval | percentage of participants | single measurement immediately after patient returns to baseline mental status after sedation procedure |
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|
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| Secondary | Depth of Sedation | Observes assesment of alertness scale, 1-5 ordinal scale measuring level of awareness, one represents awake, 5 general anesthesia/unresponsive to pain | 100 patients were randomized, 50 to the propofol group, 50 of whom underwent sedation, and 50 in the ketamine group, 47 of whom underwent sedation | Posted | Median | Full Range | score on a scale | single measurement during sedation procedure |
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| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | Ketamine | ketamine 1 milligram per kilogram intravenous bolus to start procedure followed by 0.5 mg/kg every three minutes as needed for moderate procedural sedation | 0 | 47 | 0 | 47 |
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |