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 2014-09-25.
Sponsored by Hennepin Healthcare Research Institute · Phase 4, Interventional, and Treatment
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.
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 only for deep procedural sedation
Drug: propofol
Propofol with alfentanil for deep procedural sedation
Drug: propofol · Drug: alfentanil
1 mg/kg IV followed by 0.5 mg/kg iv prn sedation
alfentanil 10 ug/kg immediately prior to propofol dose
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.
Time frame: 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
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%.
Time frame: 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
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.
Time frame: single time point measured after sedation procedure completed
34 patients were elligible, 14 underwent sedation emergently before the patient could be approached for study enrollment.
| Milestone | Propofol | Propofol/Alfentanil |
|---|---|---|
| Started | 10 | 10 |
| Completed | 10 | 10 |
| Not completed | 0 | 0 |
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.
| mcg/ml | Propofol | Propofol/Alfentanil |
|---|---|---|
| Change in Serum Catecholamines | 87 (1 to 353) | 106 (21 to 295) |
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%.
| participants | Propofol | Propofol/Alfentanil |
|---|---|---|
| Respiratory Depression | 4 | 5 |
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.
| participants | Propofol | Propofol/Alfentanil |
|---|---|---|
| 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 | 2 | 5 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Propofol | — | 0/10 (0%) | 0/10 (0%) |
| Propofol/Alfentanil | — | 0/10 (0%) | 1/10 (10%) |
| Event | Propofol | Propofol/Alfentanil |
|---|---|---|
| apneaRespiratory, thoracic and mediastinal disorders | 0/10 | 1/10 |
| Age, Continuous(years) | Propofol | Propofol/Alfentanil | Total |
|---|---|---|---|
| Median | 34 (18 to 60) | 36 (20 to 58) | 35 (18 to 60) |
| Age, Categorical(Participants) | Propofol | Propofol/Alfentanil | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 10 | 10 | 20 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Propofol | Propofol/Alfentanil | Total |
|---|---|---|---|
| Female | 4 | 6 | 10 |
| Male | 6 | 4 | 10 |
| Region of Enrollment(participants) | Propofol | Propofol/Alfentanil | Total |
|---|---|---|---|
| United States | 10 | 10 | 20 |
This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.
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Hennepin Healthcare Research Institute