Sedation
Conditions
Keywords
propofol, alfentanil, procedural sedation, stress biomarkers, Deep procedural sedation in the ED
Brief summary
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.
Interventions
DRUGpropofol
1 mg/kg IV followed by 0.5 mg/kg iv prn sedation
DRUGalfentanil
alfentanil 10 ug/kg immediately prior to propofol dose
Sponsors
Hennepin Healthcare Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients who will require deep procedural sedation with propofol in the ED
Exclusion criteria
* age \<18 * intoxication * unable to provide informed consent * allergy to propofol or alfentanil * pregnant * ASA physical status score \> 2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Serum 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory Depression | From one minute prior to the start of the sedation procedure until the patient has returned to baseline mental status | 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%. |
| 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 | single time point measured after sedation procedure completed | 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. |
Countries
United States
Participant flow
Recruitment details
34 patients were elligible, 14 underwent sedation emergently before the patient could be approached for study enrollment.
Participants by arm
| Arm | Count |
|---|---|
| Propofol propofol only for deep procedural sedation
propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation | 10 |
| 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 | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Propofol | Propofol/Alfentanil | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 10 Participants | 20 Participants |
| Age, Continuous | 34 years | 36 years | 35 years |
| Region of Enrollment United States | 10 participants | 10 participants | 20 participants |
| Sex: Female, Male Female | 4 Participants | 6 Participants | 10 Participants |
| Sex: Female, Male Male | 6 Participants | 4 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 1 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
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.
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Propofol | Change in Serum Catecholamines | 87 mcg/ml |
| Propofol/Alfentanil | Change in Serum Catecholamines | 106 mcg/ml |
Comparison: Comparison of the change in serum catecholamines from one minute before the procedure to one minute after. In order to detect a 20% difference in mean catecholamine values between groups, assuming a 30% standard deviation, with an alpha of 0.05 and a beta of 0.2 (80% power), power analysis indicated that 10 patients per group were required.p-value: 0.94Wilcoxon (Mann-Whitney)
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.
Time frame: single time point measured after sedation procedure completed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Propofol | 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 participants |
| 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 | 5 participants |
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%.
Time frame: From one minute prior to the start of the sedation procedure until the patient has returned to baseline mental status
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Propofol | Respiratory Depression | 4 participants |
| Propofol/Alfentanil | Respiratory Depression | 5 participants |