Propofol Versus Alfentanil Versus Nitrous Oxide for Moderate Procedural Sedation

Study Overview
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Brief Summary
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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
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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

Official Title
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Propofol Versus Alfentanil Versus Nitrous Oxide for Moderate Procedural Sedation in the Emergency Department

Conditions
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Sedation

Intervention / Treatment
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* Drug: Propofol
* Drug: Alfentanil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Propofol<br>Propofol 1m g/kg IV followed by 0.5 mg/kg IV prn sedation | Drug: Propofol<br>* Propofol 1 mg/kg IV followed by 0.5 mg/kg prn sedation<br>|
| Active Comparator: Alfentanil<br>Sedation using alfentanil 10 ug/kg followed by 5 ug/kg prn sedation | Drug: Alfentanil<br>* Alfentanil 10 ug/kg IV followed by 5 ug/kg prn sedation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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propofol, alfentanil, nitrous oxide, moderate procedural sedation, Moderate Procedural Sedation in the Emergency Department