Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a clinical trial of propofol and alfentanil as agents for moderated procedural sedation in patients undergoing sedation in the emergency department (ED).
This was initially going to be a trial of propofol vs alfentanil vs nitrous oxide, but our use of nitrous oxide was discontinued before the trial began and the trial was conducted with only two arms
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propofol | Active Comparator | Propofol 1m g/kg IV followed by 0.5 mg/kg IV prn sedation |
|
| Alfentanil | Active Comparator | Sedation using alfentanil 10 ug/kg followed by 5 ug/kg prn sedation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propofol | Drug | Propofol 1 mg/kg IV followed by 0.5 mg/kg prn sedation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Sub-clinical Respiratory Depression and Clinical Events Associated With Respiratory Depression During the Sedation Procedure | From one minute prior to start of procedure until the patient has returned to baseline mental status after the conclusion of the sedation procedure (~3-60 minutes depending on procedure duration) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Return of Baseline Mental Status From Start of Procedure in Minutes | Single time point after completion of sedation procedure, measured from start of procedure until the patient returns to baseline mental status up to 24 hours | |
| Depth of Sedation Measured Using the OAAS Scale |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Propofol | Propofol 1m g/kg IV followed by 0.5 mg/kg IV prn sedation Propofol: Propofol 1 mg/kg IV followed by 0.5 mg/kg prn sedation |
| FG001 | Alfentanil | Sedation using alfentanil 10 ug/kg followed by 5 ug/kg prn sedation Alfentanil: Alfentanil 10 ug/kg IV followed by 5 ug/kg prn sedation |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Propofol | Propofol 1m g/kg IV followed by 0.5 mg/kg IV prn sedation Propofol: Propofol 1 mg/kg IV followed by 0.5 mg/kg prn sedation |
| BG001 | Alfentanil | Sedation using alfentanil 10 ug/kg followed by 5 ug/kg prn sedation Alfentanil: Alfentanil 10 ug/kg IV followed by 5 ug/kg prn sedation |
| 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 | Number of Participants With Sub-clinical Respiratory Depression and Clinical Events Associated With Respiratory Depression During the Sedation Procedure | Posted | Number | participants | From one minute prior to start of procedure until the patient has returned to baseline mental status after the conclusion of the sedation procedure (~3-60 minutes depending on procedure duration) |
|
From 1 minute prior to the procedure until the patient returned to baseline mental status
Not provided
Not provided
| 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 1m g/kg IV followed by 0.5 mg/kg IV prn sedation Propofol: Propofol 1 mg/kg IV followed by 0.5 mg/kg prn sedation |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| any airway or respiratory adverse event | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | interventions during the procedure associated with respiratory depression, or change in ventilation including an oxygen sat <93% or apnea >6 seconds |
our capability of administering nitrous oxide was diminished as the trial was started, and the trial was conducted using on the propofol and alfentanil arms.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James Miner | MinneapolisMRF | 6128732493 | miner015@umn.edu |
Not provided
| ID | Term |
|---|---|
| D015742 | Propofol |
| D015760 | Alfentanil |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Alfentanil |
| Drug |
Alfentanil 10 ug/kg IV followed by 5 ug/kg prn sedation |
|
Observers Assesment of Alertness Scale, 5 responds normally to voice, 4 lethargic response to voice, 3 responds only to loud voice or light touch, 2 responds only to mild prodding or shaking, 1 responds only to painful stimuli, 0 no response to painful stimuli
| Single measurement during sedation procedure |
| Patient Reported Pain | Single measurement immediately after patient returns to baseline mental status after sedation procedure |
| Patient Reported Recall of the Procedure | Single measurement immediately after patient returns to baseline mental status after sedation procedure |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Gender | Count of Participants | Participants |
|
|
|
| Secondary | Time to Return of Baseline Mental Status From Start of Procedure in Minutes | Posted | Median | Inter-Quartile Range | minutes | Single time point after completion of sedation procedure, measured from start of procedure until the patient returns to baseline mental status up to 24 hours |
|
|
|
| Secondary | Depth of Sedation Measured Using the OAAS Scale | Observers Assesment of Alertness Scale, 5 responds normally to voice, 4 lethargic response to voice, 3 responds only to loud voice or light touch, 2 responds only to mild prodding or shaking, 1 responds only to painful stimuli, 0 no response to painful stimuli | Posted | Median | Inter-Quartile Range | units on a scale | Single measurement during sedation procedure |
|
|
|
| Secondary | Patient Reported Pain | Posted | Number | participants | Single measurement immediately after patient returns to baseline mental status after sedation procedure |
|
|
|
| Secondary | Patient Reported Recall of the Procedure | Posted | Number | participants | Single measurement immediately after patient returns to baseline mental status after sedation procedure |
|
|
|
|
| 0 |
| 56 |
| 25 |
| 56 |
| EG001 | Alfentanil | Sedation using alfentanil 10 ug/kg followed by 5 ug/kg prn sedation Alfentanil: Alfentanil 10 ug/kg IV followed by 5 ug/kg prn sedation | 0 | 52 | 29 | 52 |
|
Not provided
Not provided
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D005283 | Fentanyl |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |