A Phase 4 interventional study of Propofol and Alfentanil in Sedation, sponsored by Hennepin Healthcare Research Institute. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-01-27.
Sponsored by Hennepin Healthcare Research Institute · Phase 4, Interventional, and Treatment
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
Hennepin Healthcare Research Institute is the lead sponsor of 69 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Propofol 1m g/kg IV followed by 0.5 mg/kg IV prn sedation
Drug: Propofol
Sedation using alfentanil 10 ug/kg followed by 5 ug/kg prn sedation
Drug: Alfentanil
Propofol 1 mg/kg IV followed by 0.5 mg/kg prn sedation
Alfentanil 10 ug/kg IV followed by 5 ug/kg prn sedation
Number of Participants With Sub-clinical Respiratory Depression and Clinical Events Associated With Respiratory Depression During the Sedation Procedure
Time frame: 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)
Time to Return of Baseline Mental Status From Start of Procedure in Minutes
Time frame: 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
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
Time frame: Single measurement during sedation procedure
Patient Reported Pain
Time frame: Single measurement immediately after patient returns to baseline mental status after sedation procedure
Patient Reported Recall of the Procedure
Time frame: Single measurement immediately after patient returns to baseline mental status after sedation procedure
| Milestone | Propofol | Alfentanil |
|---|---|---|
| Started | 63 | 63 |
| Completed | 56 | 52 |
| Not completed | 7 | 11 |
| Withdrew: Physician decision | 7 | 11 |
| participants | Propofol | Alfentanil |
|---|---|---|
| Number of Participants With Sub-clinical Respiratory Depression and Clinical Events Associated With Respiratory Depression During the Sedation Procedure | 11 | 12 |
| minutes | Propofol | Alfentanil |
|---|---|---|
| Time to Return of Baseline Mental Status From Start of Procedure in Minutes | 13 (9 to 17) | 13 (10 to 17) |
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
| units on a scale | Propofol | Alfentanil |
|---|---|---|
| Depth of Sedation Measured Using the OAAS Scale | 2 (1 to 3) | 3 (2 to 4) |
| participants | Propofol | Alfentanil |
|---|---|---|
| Patient Reported Pain | 7 | 25 |
| participants | Propofol | Alfentanil |
|---|---|---|
| Patient Reported Recall of the Procedure | 13 | 39 |
Collected over From 1 minute prior to the procedure until the patient returned to baseline mental status. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Propofol | — | 0/56 (0%) | 25/56 (44.6%) |
| Alfentanil | — | 0/52 (0%) | 29/52 (55.8%) |
| Event | Propofol | Alfentanil |
|---|---|---|
| any airway or respiratory adverse eventRespiratory, thoracic and mediastinal disorders | 25/56 | 29/52 |
| Age, Continuous(years) | Propofol | Alfentanil | Total |
|---|---|---|---|
| Median | 36 (18 to 64) | 32 (18 to 82) | 34 (18 to 82) |
| Gender(Participants) | Propofol | Alfentanil | Total |
|---|---|---|---|
| Female | 31 | 23 | 54 |
| Male | 25 | 29 | 54 |
This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hennepin Healthcare Research Institute