Sedation
Conditions
Keywords
propofol, alfentanil, nitrous oxide, moderate procedural sedation, Moderate Procedural Sedation in the Emergency Department
Brief summary
This is a clinical trial of propofol and alfentanil as agents for moderated procedural sedation in patients undergoing sedation in the emergency department (ED).
Detailed description
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
Interventions
DRUGPropofol
Propofol 1 mg/kg IV followed by 0.5 mg/kg prn sedation
DRUGAlfentanil
Alfentanil 10 ug/kg IV followed by 5 ug/kg prn sedation
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
* Adults undergoing moderate procedural sedation in the Emergency Department
Exclusion criteria
* Age \<18 years * Pregnancy * Intoxication * Cannot give informed consent * Allergy to any of the three study medications * ASA physical status score \> 2 * Patients who require deep procedural sedation
Design outcomes
Primary
| Measure | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Single measurement during sedation procedure | 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 |
| 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 | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 56 |
| 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 | 52 |
| Total | 108 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 7 | 11 |
Baseline characteristics
| Characteristic | Propofol | Alfentanil | Total |
|---|---|---|---|
| Age, Continuous | 36 years | 32 years | 34 years |
| Gender Female | 31 Participants | 23 Participants | 54 Participants |
| Gender Male | 25 Participants | 29 Participants | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 25 / 56 | 29 / 52 |
| serious Total, serious adverse events | 0 / 56 | 0 / 52 |
Outcome results
Primary
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)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Propofol | Number of Participants With Sub-clinical Respiratory Depression and Clinical Events Associated With Respiratory Depression During the Sedation Procedure | 11 participants |
| Alfentanil | Number of Participants With Sub-clinical Respiratory Depression and Clinical Events Associated With Respiratory Depression During the Sedation Procedure | 12 participants |
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
Time frame: Single measurement during sedation procedure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Propofol | Depth of Sedation Measured Using the OAAS Scale | 2 units on a scale |
| Alfentanil | Depth of Sedation Measured Using the OAAS Scale | 3 units on a scale |
Secondary
Patient Reported Pain
Time frame: Single measurement immediately after patient returns to baseline mental status after sedation procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Propofol | Patient Reported Pain | 7 participants |
| Alfentanil | Patient Reported Pain | 25 participants |
Secondary
Patient Reported Recall of the Procedure
Time frame: Single measurement immediately after patient returns to baseline mental status after sedation procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Propofol | Patient Reported Recall of the Procedure | 13 participants |
| Alfentanil | Patient Reported Recall of the Procedure | 39 participants |
p-value: 0.657Chi-squared
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Propofol | Time to Return of Baseline Mental Status From Start of Procedure in Minutes | 13 minutes |
| Alfentanil | Time to Return of Baseline Mental Status From Start of Procedure in Minutes | 13 minutes |