Propofol Versus Alfentanil Versus Nitrous Oxide for Moderate Procedural Sedation in the Emergency Department
Overview
- Phase
- Phase 4
- Intervention
- Propofol
- Conditions
- Sedation
- Sponsor
- Hennepin Healthcare Research Institute
- Enrollment
- 126
- Locations
- 1
- Primary Endpoint
- Number of Participants With Sub-clinical Respiratory Depression and Clinical Events Associated With Respiratory Depression During the Sedation Procedure
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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
Investigators
Eligibility Criteria
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
Arms & Interventions
Propofol
Propofol 1m g/kg IV followed by 0.5 mg/kg IV prn sedation
Intervention: Propofol
Alfentanil
Sedation using alfentanil 10 ug/kg followed by 5 ug/kg prn sedation
Intervention: Alfentanil
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- Depth of Sedation Measured Using the OAAS Scale(Single measurement during sedation procedure)
- 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)
- 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)