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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
126
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
Hennepin County Medical Center
Minneapolis, Minnesota, United States
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
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